Solymbic
1 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

ANNEX I 

 

SUMMARY OF PRODUCT CHARACTERISTICS 

 

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This medicinal product is subject to additional monitoring. This will allow quick identification of 

new safety information. Healthcare professionals are asked to report any suspected adverse reactions. 

See section 4.8 for how to report adverse reactions. 

 

 

1.  NAME OF THE MEDICINAL PRODUCT  

 

SOLYMBIC 20 mg solution for injection in pre-filled syringe. 

SOLYMBIC 40 mg solution for injection in pre-filled syringe. 

SOLYMBIC 40 mg solution for injection in pre-filled pen. 

 

 

2.  QUALITATIVE AND QUANTITATIVE COMPOSITION  

 

SOLYMBIC 20 mg solution for injection in pre-filled syringe 

Each single dose pre-filled syringe contains 20 mg of adalimumab in 0.4 mL (50 mg/mL) solution.  

 

SOLYMBIC 40 mg solution for injection in pre-filled syringe 

Each single dose pre-filled syringe contains 40 mg of adalimumab in 0.8 mL (50 mg/mL) solution.  

 

SOLYMBIC 40 mg solution for injection in pre-filled pen 

Each single dose pre-filled pen contains 40 mg of adalimumab in 0.8 mL (50 mg/mL) solution. 

 

Adalimumab is a recombinant human monoclonal antibody expressed in Chinese Hamster Ovary cells.  

 

For the full list of excipients, see section 6.1.  

 

 

3.  PHARMACEUTICAL FORM  

 

SOLYMBIC 20 mg solution for injection in pre-filled syringe 

SOLYMBIC 40 mg solution for injection in pre-filled syringe 

Solution for injection. 

 

SOLYMBIC 40 mg solution for injection in pre-filled pen (SureClick) 

Solution for injection. 

 

Clear and colourless to slightly yellow solution. 

 

 

4.  CLINICAL PARTICULARS  

 

4.1  Therapeutic indications  

 

Rheumatoid arthritis  

 

SOLYMBIC in combination with methotrexate, is indicated for:  

• the treatment of moderate to severe, active rheumatoid arthritis in adult patients when the 
response to disease-modifying anti-rheumatic drugs including methotrexate has been 

inadequate.  

• the treatment of severe, active and progressive rheumatoid arthritis in adults not previously 
treated with methotrexate.  

 

SOLYMBIC can be given as monotherapy in case of intolerance to methotrexate or when continued 

treatment with methotrexate is inappropriate.  

 

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SOLYMBIC reduces the rate of progression of joint damage as measured by x-ray and improves 

physical function, when given in combination with methotrexate.  

 

Juvenile idiopathic arthritis  

 

Enthesitis-related arthritis 

 

SOLYMBIC is indicated for the treatment of active enthesitis-related arthritis in patients, 6 years of 

age and older, who have had an inadequate response to, or who are intolerant of, conventional therapy 

(see section 5.1). 

 

Axial spondyloarthritis  

 

Ankylosing spondylitis (AS)  

 

SOLYMBIC is indicated for the treatment of adults with severe active ankylosing spondylitis who 

have had an inadequate response to conventional therapy.  

 

Axial spondyloarthritis without radiographic evidence of AS  

 

SOLYMBIC is indicated for the treatment of adults with severe axial spondyloarthritis without 

radiographic evidence of AS but with objective signs of inflammation by elevated CRP and/or MRI, 

who have had an inadequate response to, or are intolerant to non-steroidal anti-inflammatory drugs. 

 

Psoriatic arthritis  

 

SOLYMBIC is indicated for the treatment of active and progressive psoriatic arthritis in adults when 

the response to previous disease-modifying anti-rheumatic drug therapy has been inadequate. 

SOLYMBIC reduces the rate of progression of peripheral joint damage as measured by x-ray in 

patients with polyarticular symmetrical subtypes of the disease (see section 5.1) and improves physical 

function.  

 

Psoriasis  

 

SOLYMBIC is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult 

patients who are candidates for systemic therapy.  

 

Paediatric plaque psoriasis  

 

SOLYMBIC is indicated for the treatment of severe chronic plaque psoriasis in children and 

adolescents from 4 years of age who have had an inadequate response to or are inappropriate 

candidates for topical therapy and phototherapies. 

 

Hidradenitis suppurativa (HS) 

 

SOLYMBIC is indicated for the treatment of active moderate to severe hidradenitis suppurativa (acne 

inversa) in adult patients with an inadequate response to conventional systemic HS therapy. 

 

Crohn’s disease  

 

SOLYMBIC is indicated for treatment of moderately to severely active Crohn’s disease, in adult 

patients who have not responded despite a full and adequate course of therapy with a corticosteroid 

and/or an immunosuppressant; or who are intolerant to or have medical contraindications for such 

therapies. 

 

Paediatric Crohn's disease  

 

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SOLYMBIC is indicated for the treatment of moderately to severely active Crohn's disease in 

paediatric patients (from 6 years of age) who have had an inadequate response to conventional therapy 

including primary nutrition therapy, a corticosteroid, and an immunomodulator, or who are intolerant 

to or have contraindications for such therapies.  

 

Ulcerative colitis  

 

SOLYMBIC is indicated for treatment of moderately to severely active ulcerative colitis in adult 

patients who have had an inadequate response to conventional therapy including corticosteroids and 6-

mercaptopurine (6-MP) or azathioprine (AZA), or who are intolerant to or have medical 

contraindications for such therapies. 

 

Uveitis 

 

SOLYMBIC is indicated for the treatment of non-infectious intermediate, posterior and panuveitis in 

adult patients who have had an inadequate response to corticosteroids, in patients in need of 

corticosteroid-sparing, or in whom corticosteroid treatment is inappropriate. 

 

4.2  Posology and method of administration  

 

SOLYMBIC treatment should be initiated and supervised by specialist physicians experienced in the 

diagnosis and treatment of conditions for which SOLYMBIC is indicated. Ophthalmologists are 

advised to consult with an appropriate specialist before initiation of treatment with SOLYMBIC (see 

section 4.4). Patients treated with SOLYMBIC should be given the special alert card.  

 

After proper training in injection technique, patients may self-inject with SOLYMBIC if their 

physician determines that it is appropriate and with medical follow-up as necessary.  

 

During treatment with SOLYMBIC, other concomitant therapies (e.g. corticosteroids and/or 

immunomodulatory agents) should be optimised. 

 

Posology 

 

Rheumatoid arthritis  

 

The recommended dose of SOLYMBIC for adult patients with rheumatoid arthritis is 40 mg 

adalimumab administered every other week as a single dose via subcutaneous injection. Methotrexate 

should be continued during treatment with SOLYMBIC.  

 

Glucocorticoids, salicylates, non-steroidal anti-inflammatory drugs, or analgesics can be continued 

during treatment with SOLYMBIC. Regarding combination with disease-modifying anti-rheumatic 

drugs other than methotrexate see sections 4.4 and 5.1. 

 

In monotherapy, some patients who experience a decrease in their response may benefit from an 

increase in dose intensity to 40 mg adalimumab every week. 

 

Available adalimumab data suggest that the clinical response is usually achieved within 12 weeks of 

treatment. Continued therapy should be reconsidered in a patient not responding within this time 

period. 

 

Dose interruption  

 

There may be a need for dose interruption, for instance before surgery or if a serious infection occurs.  

 

Re-introduction of SOLYMBIC after discontinuation for 70 days or longer should result in the same 

magnitudes of clinical response and similar safety profile as before dose interruption. 

 

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Ankylosing spondylitis, axial spondyloarthritis without radiographic evidence of AS and psoriatic 

arthritis  

 

The recommended dose of SOLYMBIC for patients with ankylosing spondylitis, axial 

spondyloarthritis without radiographic evidence of AS and for patients with psoriatic arthritis is 40 mg 

adalimumab administered every other week as a single dose via subcutaneous injection. 

 

For all of the above indications, available data suggest that the clinical response is usually achieved 

within 12 weeks of treatment. Continued therapy should be carefully reconsidered in a patient not 

responding within this time period.  

 

Psoriasis  

 

The recommended dose of SOLYMBIC for adult patients is an initial dose of 80 mg administered 

subcutaneously, followed by 40 mg subcutaneously given every other week starting one week after the 

initial dose. 

 

Continued therapy beyond 16 weeks should be carefully reconsidered in a patient not responding 

within this time period.  

 

Beyond 16 weeks, patients with inadequate response may benefit from an increase in dosing frequency 

to 40 mg every week. The benefits and risks of continued weekly therapy should be carefully 

reconsidered in a patient with an inadequate response after the increase in dosing frequency (see 

section 5.1). If adequate response is achieved with an increased dosing frequency, the dose may 

subsequently be reduced to 40 mg every other week. 

 

Hidradenitis suppurativa 

 

The recommended SOLYMBIC dose regimen for adult patients with hidradenitis suppurativa (HS) is 

160 mg initially at day 1 (given as four 40 mg injections in one day or as two 40 mg injections per day 

for two consecutive days), followed by 80 mg two weeks later at day 15 (given as two 40 mg 

injections in one day). Two weeks later (day 29) continue with a dose of 40 mg every week. 

Antibiotics may be continued during treatment with SOLYMBIC if necessary. It is recommended that 

the patient should use a topical antiseptic wash on their HS lesions on a daily basis during treatment 

with SOLYMBIC. 

 

Continued therapy beyond 12 weeks should be carefully reconsidered in a patient with no 

improvement within this time period.  

 

Should treatment be interrupted, SOLYMBIC 40 mg every week may be re-introduced (see 

section 5.1).  

 

The benefit and risk of continued long-term treatment should be periodically evaluated (see 

section 5.1). 

 

Crohn’s disease  

 

The recommended SOLYMBIC induction dose regimen for adult patients with moderately to severely 

active Crohn’s disease is 80 mg at week 0 followed by 40 mg at week 2. In case there is a need for a 

more rapid response to therapy, the regimen 160 mg at week 0 (dose can be administered as four 

injections in one day or as two injections per day for two consecutive days), 80 mg at week 2, can be 

used with the awareness that the risk for adverse events is higher during induction.  

 

After induction treatment, the recommended dose is 40 mg every other week via subcutaneous 

injection. Alternatively, if a patient has stopped SOLYMBIC and signs and symptoms of disease 

recur, SOLYMBIC may be re-administered. There is little experience from re-administration after 

more than 8 weeks since the previous dose. 

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During maintenance treatment, corticosteroids may be tapered in accordance with clinical practice 

guidelines.  

 

Some patients who experience decrease in their response may benefit from an increase in dosing 

frequency to 40 mg SOLYMBIC every week.  

 

Some patients who have not responded by week 4 may benefit from continued maintenance therapy 

through week 12. Continued therapy should be carefully reconsidered in a patient not responding 

within this time period.  

 

Ulcerative colitis  

 

The recommended SOLYMBIC induction dose regimen for adult patients with moderate to severe 

ulcerative colitis is 160 mg at week 0 (dose can be administered as four injections in one day or as two 

injections per day for two consecutive days) and 80 mg at week 2. After induction treatment, the 

recommended dose is 40 mg every other week via subcutaneous injection. 

 

During maintenance treatment, corticosteroids may be tapered in accordance with clinical practice 

guidelines.  

 

Some patients who experience decrease in their response may benefit from an increase in dosing 

frequency to 40 mg SOLYMBIC every week.  

 

Clinical response is usually achieved within 2-8 weeks of treatment. SOLYMBIC therapy should not 

be continued in patients failing to respond within this time period. 

 

Uveitis 

 

The recommended dose of SOLYMBIC for adult patients with uveitis is an initial dose of 80 mg, 

followed by 40 mg given every other week starting one week after the initial dose. There is limited 

experience in the initiation of treatment with adalimumab alone. Treatment with SOLYMBIC can be 

initiated in combination with corticosteroids and/or with other non-biologic immunomodulatory 

agents. Concomitant corticosteroids may be tapered in accordance with clinical practice starting two 

weeks after initiating treatment with SOLYMBIC. 

 

It is recommended that the benefit and risk of continued long-term treatment should be evaluated on a 

yearly basis (see section 5.1). 

 

Elderly patients  

 

No dose adjustment is required.  

 

Impaired renal and/or hepatic function  

 

Adalimumab has not been studied in these patient populations. No dose recommendations can be 

made. 

 

Paediatric population  

 

SOLYMBIC is only available as 20 mg and 40 mg pre-filled syringe and 40 mg pre-filled pen. It is not 

possible to administer SOLYMBIC to paediatric patients that require less than a full 20 mg or 40 mg 

dose. If an alternate dose is required, other adalimumab products offering such an option should be 

used. 

 

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Enthesitis-related arthritis 

 

The recommended dose of SOLYMBIC for patients with enthesitis-related arthritis 6 years of age and 

older is 24 mg/m² body surface area up to a maximum single dose of 40 mg adalimumab administered 

every other week via subcutaneous injection. The volume for injection is selected based on the 

patients' height and weight (table 1).  

 

Adalimumab has not been studied in patients with enthesitis-related arthritis aged less than 6 years. 

 

Table 1. SOLYMBIC dose in milligrams (mg) by height and weight of patients for 

enthesitis-related arthritis 

 

Height 

(cm) 

Total body weight (kg) 

10 15 20 25 30 35 40 45 50 55 60 65 70 

80 - - - -          

90 - - - 20 20 20        

100 - - - 20 20 20 - -      

110 - - 20 20 20 - - - - - -   

120 - 20 20 20 - - - - - - - - - 

130  20 20 - - - - - - - - - - 

140  20 20 - - - - - - - - - 40* 

150   - - - - - - - - - 40* 40* 

160   - - - - - - - 40* 40* 40* 40* 

170    - - - - - 40* 40* 40* 40* 40* 

180     - - - 40* 40* 40* 40* 40* 40* 

* Maximum single dose is 40 mg (0.8 mL) 
-  Not applicable, SOLYMBIC is only available as 20 mg and 40 mg pre-filled syringe and 40 mg pre-filled 

pen 

 

Paediatric plaque psoriasis  

 

The recommended SOLYMBIC dose is 0.8 mg per kg body weight (up to a maximum of 40 mg per 

dose) administered subcutaneously weekly for the first two doses and every other week thereafter. 

Continued therapy beyond 16 weeks should be carefully considered in a patient not responding within 

this time period. 

 

If retreatment with SOLYMBIC is indicated, the above guidance on dose and treatment duration 

should be followed.  

 

The safety of adalimumab in paediatric patients with plaque psoriasis has been assessed for a mean of 

13 months.  

 

Patients above 4 years of age but with a weight less than 23 kg or between 29 and 46 kg are not 

possible to dose with this product. There is no relevant use of adalimumab in children aged less than 4 

years in this indication.  

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The administered dose is selected based on the patients' weight (table 2). 

 

Table 2 SOLYMBIC dose in milligrams (mg) by weight for patients with paediatric psoriasis 

 

Body weight (kg) Paediatric psoriasis dose 

13–16 - 

17–22 - 

23–28 20 mg 

29–34 - 

35–40 - 

41–46 - 

47+ 40 mg 
-  Not applicable, SOLYMBIC is only available as 20 mg and 40 mg pre-filled syringe and 40 mg pre-filled 

pen. 

 

Paediatric Crohn's disease  

 

Paediatric Crohn's disease patients < 40 kg: 

 

The recommended SOLYMBIC induction dose regimen for paediatric subjects with severe Crohn's 

disease is 40 mg at week 0 followed by 20 mg at week 2. In case there is a need for a more rapid 

response to therapy, the regimen 80 mg at week 0 (dose can be administered as two injections in one 

day), 40 mg at week 2 can be used, with the awareness that the risk for adverse events may be higher 

with use of the higher induction dose.  

 

After induction treatment, the recommended dose is 20 mg every other week via subcutaneous 

injection. Some subjects who experience insufficient response may benefit from an increase in dosing 

frequency to 20 mg SOLYMBIC every week.  

 

Paediatric Crohn's disease patients ≥ 40 kg:  

 

The recommended SOLYMBIC induction dose regimen for paediatric subjects with severe Crohn's 

disease is 80 mg at week 0 followed by 40 mg at week 2. In case there is a need for a more rapid 

response to therapy, the regimen 160 mg at week 0 (dose can be administered as four injections in one 

day or as two injections per day for two consecutive days), 80 mg at week 2 can be used, with the 

awareness that the risk for adverse events may be higher with use of the higher induction dose.  

 

After induction treatment, the recommended dose is 40 mg every other week via subcutaneous 

injection. Some subjects who experience insufficient response may benefit from an increase in dosing 

frequency to 40 mg SOLYMBIC every week.  

 

Continued therapy should be carefully considered in a subject not responding by week 12.  

 

There is no relevant use of adalimumab in children aged less than 6 years in this indication.  

 

Paediatric hidradenitis suppurativa 

 

The safety and efficacy of adalimumab in children aged 12-17 years have not yet been established for 

hidradenitis suppurativa. No data are available. There is no relevant use of adalimumab in children 

aged below 12 years in this indication. 

 

Paediatric ulcerative colitis 

 

The safety and efficacy of adalimumab in children aged 4-17 years have not yet been established. No 

data are available. There is no relevant use of adalimumab in children aged < 4 years in this indication.  

 

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Psoriatic arthritis and axial spondyloarthritis including ankylosing spondylitis  

 

There is no relevant use of adalimumab in the paediatric population in the indications, ankylosing 

spondylitis and psoriatic arthritis. 

 

Paediatric uveitis 

 

The safety and efficacy of adalimumab in children aged 2-17 years have not yet been established. No 

data are available. 

 

Method of administration  

 

SOLYMBIC is administered by subcutaneous injection. Full instructions for use are provided in the 

package leaflet. 

 

A 40 mg pen, and a 20 mg and 40 mg pre-filled syringes are available for patients to administer a full 

20 mg or 40 mg dose. 

 

4.3  Contraindications  

 

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.  

 

Active tuberculosis or other severe infections such as sepsis, and opportunistic infections (see 

section 4.4).  

 

Moderate to severe heart failure (NYHA class III/IV) (see section 4.4).  

 

4.4  Special warnings and precautions for use  

 

In order to improve traceability of biological medicinal products, the trade name and the batch number 

of the administered product should be clearly recorded.  

 

Infections  

 

Patients taking TNF-antagonists are more susceptible to serious infections. Impaired lung function 

may increase the risk for developing infections. Patients must therefore be monitored closely for 

infections, including tuberculosis, before, during and after treatment with SOLYMBIC. Because the 

elimination of adalimumab may take up to four months, monitoring should be continued throughout 

this period.  

 

Treatment with SOLYMBIC should not be initiated in patients with active infections including 

chronic or localised infections until infections are controlled. In patients who have been exposed to 

tuberculosis and patients who have travelled in areas of high risk of tuberculosis or endemic mycoses, 

such as histoplasmosis, coccidioidomycosis, or blastomycosis, the risk and benefits of treatment with 

SOLYMBIC should be considered prior to initiating therapy (see Other opportunistic infections).  

 

Patients who develop a new infection while undergoing treatment with SOLYMBIC, should be 

monitored closely and undergo a complete diagnostic evaluation. Administration of SOLYMBIC 

should be discontinued if a patient develops a new serious infection or sepsis, and appropriate 

antimicrobial or antifungal therapy should be initiated until the infection is controlled. Physicians 

should exercise caution when considering the use of SOLYMBIC in patients with a history of 

recurring infection or with underlying conditions which may predispose patients to infections, 

including the use of concomitant immunosuppressive medications.  

 

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Serious infections 

 

Serious infections, including sepsis, due to bacterial, mycobacterial, invasive fungal, parasitic, viral, or 

other opportunistic infections such as listeriosis, legionellosis and pneumocystis have been reported in 

patients receiving adalimumab.  

 

Other serious infections seen in clinical trials include pneumonia, pyelonephritis, septic arthritis and 

septicaemia. Hospitalisation or fatal outcomes associated with infections have been reported.  

 

Tuberculosis 

 

Tuberculosis, including reactivation and new onset of tuberculosis, has been reported in patients 

receiving adalimumab. Reports included cases of pulmonary and extra-pulmonary (i.e. disseminated) 

tuberculosis. 

 

Before initiation of therapy with SOLYMBIC, all patients must be evaluated for both active or 

inactive (“latent”) tuberculosis infection. This evaluation should include a detailed medical assessment 

of patient history of tuberculosis or possible previous exposure to people with active tuberculosis and 

previous and/or current immunosuppressive therapy. Appropriate screening tests (i.e. tuberculin skin 

test and chest x-ray) should be performed in all patients (local recommendations may apply). It is 

recommended that the conduct and results of these tests are recorded in the patient alert card. 

Prescribers are reminded of the risk of false negative tuberculin skin test results, especially in patients 

who are severely ill or immunocompromised.  

 

If active tuberculosis is diagnosed, SOLYMBIC therapy must not be initiated (see section 4.3). 

 

In all situations described below, the benefit/risk balance of therapy should be very carefully 

considered. 

 

If latent tuberculosis is suspected, a physician with expertise in the treatment of tuberculosis should be 

consulted. 

 

If latent tuberculosis is diagnosed, appropriate treatment must be started with anti-tuberculosis 

prophylaxis treatment before the initiation of SOLYMBIC, and in accordance with local 

recommendations. 

 

Use of anti-tuberculosis prophylaxis treatment should also be considered before the initiation of 

SOLYMBIC in patients with several or significant risk factors for tuberculosis despite a negative test 

for tuberculosis and in patients with a past history of latent or active tuberculosis in whom an adequate 

course of treatment cannot be confirmed. 

 

Despite prophylactic treatment for tuberculosis, cases of reactivated tuberculosis have occurred in 

patients treated with adalimumab. Some patients who have been successfully treated for active 

tuberculosis have redeveloped tuberculosis while being treated with adalimumab.  

 

Patients should be instructed to seek medical advice if signs/symptoms suggestive of a tuberculosis 

infection (e.g. persistent cough, wasting/weight loss, low grade fever, listlessness) occur during or 

after therapy with SOLYMBIC.  

 

Other opportunistic infections 

 

Opportunistic infections, including invasive fungal infections have been observed in patients receiving 

adalimumab. These infections have not consistently been recognised in patients taking TNF-

antagonists and this has resulted in delays in appropriate treatment, sometimes resulting in fatal 

outcomes.  

 

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For patients who develop the signs and symptoms such as fever, malaise, weight loss, sweats, cough, 

dyspnoea, and/or pulmonary infiltrates or other serious systemic illness with or without concomitant 

shock an invasive fungal infection should be suspected and administration of SOLYMBIC should be 

promptly discontinued. Diagnosis and administration of empiric antifungal therapy in these patients 

should be made in consultation with a physician with expertise in the care of patients with invasive 

fungal infections.  

 

Hepatitis B reactivation  

 

Reactivation of hepatitis B has occurred in patients receiving a TNF-antagonist including adalimumab, 

who are chronic carriers of this virus (i.e. surface antigen positive). Some cases have had a fatal 

outcome. Patients should be tested for HBV infection before initiating treatment with SOLYMBIC. 

For patients who test positive for hepatitis B infection, consultation with a physician with expertise in 

the treatment of hepatitis B is recommended.  

 

Carriers of HBV who require treatment with SOLYMBIC should be closely monitored for signs and 

symptoms of active HBV infection throughout therapy and for several months following termination 

of therapy. Adequate data from treating patients who are carriers of HBV with anti-viral therapy in 

conjunction with TNF-antagonist therapy to prevent HBV reactivation are not available. In patients 

who develop HBV reactivation, SOLYMBIC should be stopped and effective anti-viral therapy with 

appropriate supportive treatment should be initiated.  

 

Neurological events  

 

TNF-antagonists including adalimumab have been associated in rare instances with new onset or 

exacerbation of clinical symptoms and/or radiographic evidence of central nervous system 

demyelinating disease including multiple sclerosis and optic neuritis, and peripheral demyelinating 

disease, including Guillain-Barré syndrome. Prescribers should exercise caution in considering the use 

of SOLYMBIC in patients with pre-existing or recent-onset central or peripheral nervous system 

demyelinating disorders; discontinuation of SOLYMBIC should be considered if any of these 

disorders develop. There is a known association between intermediate uveitis and central 

demyelinating disorders. Neurologic evaluation should be performed in patients with non-infectious 

intermediate uveitis prior to the initiation of SOLYMBIC therapy and regularly during treatment to 

assess for pre-existing or developing central demyelinating disorders. 

 

Allergic reactions  

 

Serious allergic reactions associated with adalimumab were rare during clinical trials. Non-serious 

allergic reactions associated with adalimumab were uncommon during clinical trials. Reports of 

serious allergic reactions including anaphylaxis have been received following adalimumab 

administration. If an anaphylactic reaction or other serious allergic reaction occurs, administration of 

SOLYMBIC should be discontinued immediately and appropriate therapy initiated.  

 

Dry natural rubber 

 

The needle cover of the pre-filled syringe or pen is made from dry natural rubber (a derivative of 

latex), which may cause allergic reactions. 

 

Immunosuppression  

 

In a study of 64 patients with rheumatoid arthritis that were treated with adalimumab, there was no 

evidence of depression of delayed-type hypersensitivity, depression of immunoglobulin levels, or 

change in enumeration of effector T-, B-, NK-cells, monocyte/macrophages, and neutrophils.  

 

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Malignancies and lymphoproliferative disorders  

 

In the controlled portions of adalimumab clinical trials of TNF-antagonists, more cases of 

malignancies including lymphoma have been observed among patients receiving a TNF-antagonist 

compared with control patients. However, the occurrence was rare. In the post-marketing setting, cases 

of leukaemia have been reported in patients treated with a TNF-antagonist. There is an increased 

background risk for lymphoma and leukaemia in rheumatoid arthritis patients with long-standing 

highly active, inflammatory disease, which complicates the risk estimation. With the current 

knowledge, a possible risk for the development of lymphomas, leukaemia, and other malignancies in 

patients treated with a TNF-antagonist cannot be excluded.  

 

Malignancies, some fatal, have been reported among children, adolescents and young adults (up to 

22 years of age) treated with TNF-antagonists (initiation of therapy ≤ 18 years of age), including 

adalimumab in the post-marketing setting. Approximately half the cases were lymphomas. The other 

cases represented a variety of different malignancies and included rare malignancies usually associated 

with immunosuppression. A risk for the development of malignancies in children and adolescents 

treated with TNF-antagonists cannot be excluded.  

 

Rare post-marketing cases of hepatosplenic T-cell lymphoma have been identified in patients treated 

with adalimumab. This rare type of T-cell lymphoma has a very aggressive disease course and is 

usually fatal. Some of these hepatosplenic T-cell lymphomas with adalimumab have occurred in 

young adult patients on concomitant treatment with azathioprine or 6-mercaptopurine used for 

inflammatory bowel disease. The potential risk with the combination of azathioprine or 

6-mercaptopurine and SOLYMBIC should be carefully considered. A risk for the development of 

hepatosplenic T-cell lymphoma in patients treated with SOLYMBIC cannot be excluded (see 

section 4.8).  

 

No studies have been conducted that include patients with a history of malignancy or in whom 

treatment with adalimumab is continued following development of malignancy. Thus additional 

caution should be exercised in considering SOLYMBIC treatment of these patients (see section 4.8).  

 

All patients, and in particular patients with a medical history of extensive immunosuppressant therapy 

or psoriasis patients with a history of PUVA treatment should be examined for the presence of non-

melanoma skin cancer prior to and during treatment with SOLYMBIC. Melanoma and Merkel cell 

carcinoma have also been reported in patients treated with TNF-antagonists including adalimumab 

(see section 4.8).  

 

In an exploratory clinical trial evaluating the use of another TNF-antagonist, infliximab, in patients 

with moderate to severe chronic obstructive pulmonary disease (COPD), more malignancies, mostly in 

the lung or head and neck, were reported in infliximab-treated patients compared with control patients. 

All patients had a history of heavy smoking. Therefore, caution should be exercised when using any 

TNF-antagonist in COPD patients, as well as in patients with increased risk for malignancy due to 

heavy smoking.  

 

With current data it is not known if adalimumab treatment influences the risk for developing dysplasia 

or colon cancer. All patients with ulcerative colitis who are at increased risk for dysplasia or colon 

carcinoma (for example, patients with long-standing ulcerative colitis or primary sclerosing 

cholangitis), or who had a prior history of dysplasia or colon carcinoma should be screened for 

dysplasia at regular intervals before therapy and throughout their disease course. This evaluation 

should include colonoscopy and biopsies per local recommendations.  

 

Haematologic reactions  

 

Rare reports of pancytopenia including aplastic anaemia have been reported with TNF-antagonists. 

Adverse events of the haematologic system, including medically significant cytopenia (e.g. 

thrombocytopenia, leucopenia) have been reported with adalimumab. All patients should be advised to 

seek immediate medical attention if they develop signs and symptoms suggestive of blood dyscrasias 

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(e.g. persistent fever, bruising, bleeding, pallor) while on SOLYMBIC. Discontinuation of 

SOLYMBIC therapy should be considered in patients with confirmed significant haematologic 

abnormalities.  

 

Vaccinations  

 

Similar antibody responses to the standard 23-valent pneumococcal vaccine and the influenza trivalent 

virus vaccination were observed in a study in 226 adult subjects with rheumatoid arthritis who were 

treated with adalimumab or placebo. No data are available on the secondary transmission of infection 

by live vaccines in patients receiving adalimumab.  

 

It is recommended that paediatric patients, if possible, be brought up to date with all immunisations in 

agreement with current immunisation guidelines prior to initiating SOLYMBIC therapy.  

 

Patients on SOLYMBIC may receive concurrent vaccinations, except for live vaccines. 

Administration of live vaccines to infants exposed to SOLYMBIC in utero is not recommended for 

5 months following the mother’s last SOLYMBIC injection during pregnancy. 

 

Congestive heart failure  

 

In a clinical trial with another TNF-antagonist worsening congestive heart failure and increased 

mortality due to congestive heart failure have been observed. Cases of worsening congestive heart 

failure have also been reported in patients receiving adalimumab. SOLYMBIC should be used with 

caution in patients with mild heart failure (NYHA class I/II). SOLYMBIC is contraindicated in 

moderate to severe heart failure (see section 4.3). Treatment with SOLYMBIC must be discontinued 

in patients who develop new or worsening symptoms of congestive heart failure.  

 

Autoimmune processes  

 

Treatment with SOLYMBIC may result in the formation of autoimmune antibodies. The impact of 

long-term treatment with SOLYMBIC on the development of autoimmune diseases is unknown. If a 

patient develops symptoms suggestive of a lupus-like syndrome following treatment with SOLYMBIC 

and is positive for antibodies against double-stranded DNA, further treatment with SOLYMBIC 

should not be given (see section 4.8).  

 

Concurrent administration of biologic DMARDS or TNF-antagonists  

 

Serious infections were seen in clinical studies with concurrent use of anakinra and another TNF-

antagonist, etanercept, with no added clinical benefit compared to etanercept alone. Because of the 

nature of the adverse events seen with the combination of etanercept and anakinra therapy, similar 

toxicities may also result from the combination of anakinra and other TNF-antagonists. Therefore, the 

combination of SOLYMBIC and anakinra is not recommended (see section 4.5).  

 

Concomitant administration of SOLYMBIC with other biologic DMARDS (e.g. anakinra and 

abatacept) or other TNF-antagonists is not recommended based upon the possible increased risk for 

infections, including serious infections and other potential pharmacological interactions (see section 

4.5). 

 

Surgery  

 

There is limited safety experience of surgical procedures in patients treated with adalimumab. The 

long half-life of adalimumab should be taken into consideration if a surgical procedure is planned. A 

patient who requires surgery while on SOLYMBIC should be closely monitored for infections, and 

appropriate actions should be taken. There is limited safety experience in patients undergoing 

arthroplasty while receiving adalimumab. 

 

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Small bowel obstruction  

 

Failure to respond to treatment for Crohn’s disease may indicate the presence of fixed fibrotic stricture 

that may require surgical treatment. Available data suggest that adalimumab does not worsen or cause 

strictures. 

 

Elderly patients  

 

The frequency of serious infections among adalimumab-treated subjects over 65 years of age (3.7%) 

was higher than for those under 65 years of age (1.5%). Some of those had a fatal outcome. Particular 

attention regarding the risk for infection should be paid when treating the elderly.  

 

Paediatric population  

 

See Vaccinations above. 

 

4.5  Interaction with other medicinal products and other forms of interaction  

 

Adalimumab has been studied in rheumatoid arthritis, polyarticular juvenile idiopathic arthritis and 

psoriatic arthritis patients taking adalimumab as monotherapy and those taking concomitant 

methotrexate. Antibody formation was lower when adalimumab was given together with methotrexate 

in comparison with use as monotherapy. Administration of adalimumab without methotrexate resulted 

in increased formation of antibodies, increased clearance and reduced efficacy of adalimumab (see 

section 5.1).  

 

The combination of SOLYMBIC and anakinra is not recommended (see section 4.4 “Concurrent 

administration of biologic DMARDS or TNF-antagonists”).  

 

The combination of SOLYMBIC and abatacept is not recommended (see section 4.4 “Concurrent 

administration of biologic DMARDS or TNF-antagonists”).  

 

4.6  Fertility, pregnancy and lactation  

 

Women of child bearing potential/Contraception in males and females 

 

Women of childbearing potential are strongly recommended to use adequate contraception to prevent 

pregnancy and continue its use for at least five months after the last SOLYMBIC treatment. 

 

Pregnancy  

 

For adalimumab, limited clinical data on exposed pregnancies are available.  

 

In a developmental toxicity study conducted in monkeys, there was no indication of maternal toxicity, 

embryotoxicity or teratogenicity. Preclinical data on postnatal toxicity of adalimumab are not available 

(see section 5.3).  

 

Due to its inhibition of TNFα, adalimumab administered during pregnancy could affect normal 

immune responses in the newborn. Administration of SOLYMBIC is not recommended during 

pregnancy. 

 

Adalimumab may cross the placenta into the serum of infants born to women treated with adalimumab 

during pregnancy. Consequently, these infants may be at increased risk for infection. Administration 

of live vaccines to infants exposed to adalimumab in utero is not recommended for 5 months following 

the mother’s last adalimumab injection during pregnancy.  

 

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Breast-feeding  

 

It is not known whether adalimumab is excreted in human milk or absorbed systemically after 

ingestion.  

 

However, because human immunoglobulins are excreted in milk, women must not breast-feed for at 

least five months after the last SOLYMBIC treatment.  

 

Fertility  

 

Preclinical data on fertility effects of adalimumab are not available.  

 

4.7  Effects on ability to drive and use machines  

 

SOLYMBIC may have a minor influence on the ability to drive and use machines. Vertigo and visual 

impairment may occur following administration of SOLYMBIC (see section 4.8).  

 

4.8  Undesirable effects  

 

Summary of the safety profile  

 

Adalimumab was studied in 9,506 patients in pivotal controlled and open-label trials for up to 

60 months or more. These trials included rheumatoid arthritis patients with short term and long-

standing disease, juvenile idiopathic arthritis (polyarticular juvenile idiopathic arthritis and enthesitis-

related arthritis) as well as axial spondyloarthritis (ankylosing spondylitis and axial spondyloarthritis 

without radiographic evidence of AS), psoriatic arthritis, Crohn’s disease, ulcerative colitis, psoriasis, 

hidradenitis suppurativa and uveitis patients. The pivotal controlled studies involved 6,089 patients 

receiving adalimumab and 3,801 patients receiving placebo or active comparator during the controlled 

period.  

 

The proportion of patients who discontinued treatment due to adverse events during the double-blind, 

controlled portion of pivotal studies was 5.9% for patients taking adalimumab and 5.4% for control 

treated patients.  

 

The most commonly reported adverse reactions are infections (such as nasopharyngitis, upper 

respiratory tract infection and sinusitis), injection site reactions (erythema, itching, haemorrhage, pain 

or swelling), headache and musculoskeletal pain. 

 

Serious adverse reactions have been reported for adalimumab. TNF-antagonists, such as SOLYMBIC 

affect the immune system and their use may affect the body’s defence against infection and cancer.  

 

Fatal and life-threatening infections (including sepsis, opportunistic infections and TB), HBV 

reactivation and various malignancies (including leukaemia, lymphoma and HSTCL) have also been 

reported with use of adalimumab.  

 

Serious haematological, neurological and autoimmune reactions have also been reported. These 

include rare reports of pancytopenia, aplastic anaemia, central and peripheral demyelinating events 

and reports of lupus, lupus-related conditions and Stevens-Johnson syndrome.  

 

Paediatric population  

 

Undesirable effects in paediatric patients  

 

In general, the adverse events in paediatric patients were similar in frequency and type to those seen in 

adult patients.  

 

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Tabulated list of adverse reactions  

 

The following list of adverse reactions is based on experience from clinical trials and on post-

marketing experience and are displayed by system organ class and frequency in table 3 below: very 

common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to 

< 1/1,000); and not known (cannot be estimated from the available data). Within each frequency 

grouping, undesirable effects are presented in order of decreasing seriousness. The highest frequency 

seen among the various indications has been included. An asterisk (*) appears in the SOC column if 

further information is found elsewhere in sections 4.3, 4.4 and 4.8. 

 

Table 3 Undesirable effects 

 

System Organ Class  Frequency  Adverse Reaction  

Infections and 

infestations*  

Very common  Respiratory tract infections (including lower and upper 

respiratory tract infection, pneumonia, sinusitis, pharyngitis, 

nasopharyngitis and pneumonia herpes viral) 

Common Systemic infections (including sepsis, candidiasis and 

influenza),  

Intestinal infections (including gastroenteritis viral),  

Skin and soft tissue infections (including paronychia, 

cellulitis, impetigo, necrotising fasciitis and herpes zoster),  

Ear infections,  

Oral infections (including herpes simplex, oral herpes and 

tooth infections),  

Reproductive tract infections (including vulvovaginal 

mycotic infection),  

Urinary tract infections (including pyelonephritis),  

Fungal infections,  

Joint infection 

Uncommon Neurological infections (including viral meningitis),  

Opportunistic infections and tuberculosis (including 

coccidioidomycosis, histoplasmosis and mycobacterium 

avium complex infection),  

Bacterial infections,  

Eye infections,  

Diverticulitis1) 

Neoplasms benign, 

malignant and 

unspecified (including 

cysts and polyps)*  

Common  Skin cancer excluding melanoma (including basal cell 

carcinoma and squamous cell carcinoma),  

Benign neoplasm 

Uncommon Lymphoma**,  

Solid organ neoplasm (including breast cancer, lung 

neoplasm and thyroid neoplasm),  

Melanoma** 

Rare Leukaemia1) 

Not known Hepatosplenic T-cell lymphoma1), 

Merkel cell carcinoma (neuroendocrine carcinoma of the 

skin)1) 

Blood and the 

lymphatic system 

disorders* 

 

Very common  

 

Leucopaenia (including neutropaenia and agranulocytosis),  

Anaemia  

Common  

 

Leucocytosis,  

Thrombocytopaenia  

Uncommon  Idiopathic thrombocytopaenic purpura  

Rare  Pancytopaenia  

Immune system 

disorders*  

 

Common  

 

Hypersensitivity,  

Allergies (including seasonal allergy)  

Uncommon  

 

Sarcoidosis1),  

Vasculitis  

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System Organ Class  Frequency  Adverse Reaction  

Rare  Anaphylaxis1)  

Metabolism and 

nutrition disorders  

 

Very common  Lipids increased  

Common  

 

Hypokalaemia,  

Uric acid increased,  

Blood sodium abnormal,  

Hypocalcaemia,  

Hyperglycaemia,  

Hypophosphataemia,  

Dehydration  

Psychiatric disorders  

 

Common  

 

Mood alterations (including depression),  

Anxiety,  

Insomnia  

Nervous system 

disorders*  

 

Very common  Headache  

Common  

 

Paraesthesias (including hypoaesthesia),  

Migraine,  

Nerve root compression 

Uncommon  

 

Cerebrovascular accident1),  

Tremor,  

Neuropathy  

Rare  

 

Multiple sclerosis,  

Demyelinating disorders (e.g. optic neuritis, Guillain-Barré 

syndrome)1)  

Eye disorders  

 

Common  

 

Visual impairment,  

Conjunctivitis,  

Blepharitis,  

Eye swelling  

Uncommon  Diplopia  

Ear and labyrinth 

disorders 

Common Vertigo 

Uncommon Deafness,  

Tinnitus 

Cardiac disorders* Common Tachycardia 

Uncommon Myocardial infarction1),  

Arrhythmia,  

Congestive heart failure 

Rare Cardiac arrest 

Vascular disorders Common Hypertension,  

Flushing,  

Haematoma 

Uncommon Aortic aneurysm,  

Vascular arterial occlusion,  

Thrombophlebitis 

Respiratory, thoracic 

and mediastinal 

disorders* 

Common Asthma,  

Dyspnoea,  

Cough 

Uncommon Pulmonary embolism1),  

Interstitial lung disease,  

Chronic obstructive pulmonary disease,  

Pneumonitis,  

Pleural effusion1)  

Rare Pulmonary fibrosis1)  

Gastrointestinal 

disorders  

Very common  Abdominal pain,  

Nausea and vomiting  

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System Organ Class  Frequency  Adverse Reaction  

Common  GI haemorrhage,  

Dyspepsia,  

Gastroesophageal reflux disease,  

Sicca syndrome  

Uncommon  Pancreatitis,  

Dysphagia,  

Face oedema  

Rare  Intestinal perforation1)  

Hepato-biliary 

disorders*  

Very common  Elevated liver enzymes  

Uncommon  Cholecystitis and cholelithiasis,  

Hepatic steatosis,  

Bilirubin increased  

Rare  Hepatitis,  

Reactivation of hepatitis B1),  

Autoimmune hepatitis1)  

Not known  Liver failure1)  

Skin and subcutaneous 

tissue disorders  

Very common  Rash (including exfoliative rash)  

Common  Worsening or new onset of psoriasis (including palmoplantar 

pustular psoriasis)1),  

Urticaria,  

Bruising (including purpura),  

Dermatitis (including eczema),  

Onychoclasis,  

Hyperhidrosis,  

Alopecia1),  

Pruritus 

Uncommon  Night sweats,  

Scar  

Rare  Erythema multiforme1),  

Stevens-Johnson syndrome1),  

Angioedema1),  

Cutaneous vasculitis1)  

Not known  Worsening of symptoms of dermatomyositis1)  

Musculoskeletal and 

connective tissue 

disorders  

Very common  Musculoskeletal pain  

Common  Muscle spasms (including blood creatine phosphokinase 

increased)  

Uncommon  Rhabdomyolysis,  

Systemic lupus erythematosus  

Rare  Lupus-like syndrome1)  

Renal and urinary 

disorders  

Common  Renal impairment,  

Haematuria  

Uncommon  Nocturia  

Reproductive system 

and breast disorders  

Uncommon  Erectile dysfunction  

General disorders and 

administration site 

conditions*  

Very common  Injection site reaction (including injection site erythema)  

Common  Chest pain,  

Oedema,  

Pyrexia1)  

Uncommon  Inflammation  

Investigations*  Common  Coagulation and bleeding disorders (including activated 

partial thromboplastin time prolonged),  

Autoantibody test positive (including double stranded DNA 

antibody),  

Blood lactate dehydrogenase increased 

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System Organ Class  Frequency  Adverse Reaction  

Injury, poisoning and 

procedural 

complications  

Common  

 

Impaired healing  

 

* further information is found elsewhere in sections 4.3, 4.4 and 4.8  

** including open-label extension studies  
1) including spontaneous reporting data 

 

Hidradenitis suppurativa 

 

The safety profile for patients with HS treated with adalimumab weekly was consistent with the 

known safety profile of adalimumab. 

 

Uveitis 

 

The safety profile for patients with uveitis treated with adalimumab every other week was consistent 

with the known safety profile of adalimumab. 

 

Description of selected adverse reactions  

 

Injection site reactions  

 

In the pivotal controlled trials in adults and children, 12.9% of patients treated with adalimumab 

developed injection site reactions (erythema and/or itching, haemorrhage, pain or swelling), compared 

to 7.2% of patients receiving placebo or active control. Injection site reactions generally did not 

necessitate discontinuation of the medicinal product. 

 

Infections  

 

In the pivotal controlled trials in adults and children, the rate of infection was 1.51 per patient year in 

the adalimumab-treated patients and 1.46 per patient year in the placebo and active control-treated 

patients. The infections consisted primarily of nasopharyngitis, upper respiratory tract infection, and 

sinusitis. Most patients continued on adalimumab after the infection resolved.  

 

The incidence of serious infections was 0.04 per patient year in adalimumab-treated patients and 0.03 

per patient year in placebo and active control-treated patients.  

 

In controlled and open-label adult and paediatric studies with adalimumab, serious infections 

(including fatal infections, which occurred rarely) have been reported, which include reports of 

tuberculosis (including miliary and extra-pulmonary locations) and invasive opportunistic infections 

(e.g. disseminated or extrapulmonary histoplasmosis, blastomycosis, coccidioidomycosis, 

pneumocystis, candidiasis, aspergillosis and listeriosis). Most of the cases of tuberculosis occurred 

within the first eight months after initiation of therapy and may reflect recrudescence of latent disease.  

 

Malignancies and lymphoproliferative disorders  

 

No malignancies were observed in 249 paediatric patients with an exposure of 655.6 patient-years 

during adalimumab trials in patients with juvenile idiopathic arthritis (polyarticular juvenile idiopathic 

arthritis and enthesitis-related arthritis). In addition, no malignancies were observed in 192 paediatric 

patients with an exposure of 498.1 patient-years during an adalimumab trial in paediatric patients with 

Crohn’s disease. No malignancies were observed in 77 paediatric patients with an exposure of 80.0 

patient-years during an adalimumab trial in paediatric patients with chronic plaque psoriasis. 

 

During the controlled portions of pivotal adalimumab trials in adults of at least 12 weeks in duration in 

patients with moderately to severely active rheumatoid arthritis, ankylosing spondylitis, axial 

spondyloarthritis without radiographic evidence of AS, psoriatic arthritis, psoriasis, hidradenitis 

suppurativa, Crohn’s disease, ulcerative colitis and uveitis, malignancies, other than lymphoma and 

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non-melanoma skin cancer, were observed at a rate (95% confidence interval) of 6.8 (4.4, 10.5) per 

1,000 patient-years among 5,291 adalimumab-treated patients versus a rate of 6.3 (3.4, 11.8) per 1,000 

patient-years among 3,444 control patients (median duration of treatment was 4.0 months for 

adalimumab and 3.8 months for control-treated patients). The rate (95% confidence interval) of non-

melanoma skin cancers was 8.8 (6.0, 13.0) per 1,000 patient-years among adalimumab-treated patients 

and 3.2 (1.3, 7.6) per 1,000 patient-years among control patients. Of these skin cancers, squamous cell 

carcinomas occurred at rates (95% confidence interval) of 2.7 (1.4, 5.4) per 1,000 patient-years among 

adalimumab-treated patients and 0.6 (0.1, 4.5) per 1,000 patient-years among control patients. The rate 

(95% confidence interval) of lymphomas was 0.7 (0.2, 2.7) per 1,000 patient-years among 

adalimumab-treated patients and 0.6 (0.1, 4.5) per 1,000 patient-years among control patients.  

 

When combining controlled portions of these trials and ongoing and completed open-label extension 

studies of adalimumab, with a median duration of approximately 3.3 years including 6,427 patients 

and over 26,439 patient-years of therapy, the observed rate of malignancies, other than lymphoma and 

non-melanoma skin cancers is approximately 8.5 per 1,000 patient-years. The observed rate of non-

melanoma skin cancers is approximately 9.6 per 1,000 patient-years, and the observed rate of 

lymphomas is approximately 1.3 per 1,000 patient-years.  

 

In post-marketing experience from January 2003 to December 2010, predominantly in patients with 

rheumatoid arthritis, the reported rate of malignancies is approximately 2.7 per 1,000 patient treatment 

years. The reported rates for non-melanoma skin cancers and lymphomas are approximately 0.2 and 

0.3 per 1,000 patient treatment years, respectively (see section 4.4). 

 

Rare post-marketing cases of hepatosplenic T-cell lymphoma have been reported in patients treated 

with adalimumab (see section 4.4).  

 

Autoantibodies  

 

Patients had serum samples tested for autoantibodies at multiple time points in rheumatoid arthritis 

studies I−V. In these trials, 11.9% of patients treated with adalimumab and 8.1% of placebo and active 

control-treated patients that had negative baseline anti-nuclear antibody titres reported positive titres at 

week 24. Two patients out of 3,441 treated with adalimumab in all rheumatoid arthritis and psoriatic 

arthritis studies developed clinical signs suggestive of new onset lupus-like syndrome. The patients 

improved following discontinuation of therapy. No patients developed lupus nephritis or central 

nervous system symptoms. 

 

Hepato-biliary events  

 

In controlled phase 3 trials of adalimumab in patients with rheumatoid arthritis and psoriatic arthritis 

with a control period duration ranging from 4 to 104 weeks, ALT elevations ≥ 3 x ULN occurred in 

3.7% of adalimumab-treated patients and 1.6% of control-treated patients.  

 

In controlled phase 3 trials of adalimumab in patients with polyarticular juvenile idiopathic arthritis 

who were 4 to 17 years and enthesitis-related arthritis who were 6 to 17 years, ALT elevations 

≥ 3 x ULN occurred in 6.1% of adalimumab-treated patients and 1.3% of control-treated patients. 

Most ALT elevations occurred with concomitant methotrexate use. No ALT elevations ≥ 3 x ULN 

occurred in the Phase 3 trial of adalimumab in patients with polyarticular juvenile idiopathic arthritis 

who were 2 to < 4 years.  

 

In controlled phase 3 trials of adalimumab in patients with Crohn’s disease and ulcerative colitis with 

a control period ranging from 4 to 52 weeks. ALT elevations ≥ 3 x ULN occurred in 0.9% of 

adalimumab-treated patients and 0.9% of controlled-treated patients.  

 

In the phase 3 trial of adalimumab in patients with paediatric Crohn’s disease which evaluated efficacy 

and safety of two body weight adjusted maintenance dose regimens following body weight adjusted 

induction therapy up to 52 weeks of treatment, ALT elevations ≥ 3 x ULN occurred in 2.6% (5/192) of 

patients of whom 4 were receiving concomitant immunosuppressants at baseline.  

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In controlled phase 3 trials of adalimumab in patients with plaque psoriasis with a control period 

duration ranging from 12 to 24 weeks, ALT elevations ≥ 3 x ULN occurred in 1.8% of adalimumab-

treated patients and 1.8% of control-treated patients.  

 

No ALT elevations ≥ 3 X ULN occurred in the phase 3 trial of adalimumab in paediatric patients with 

plaque psoriasis. 

 

In controlled trials of adalimumab (initial doses of 160 mg at week 0 and 80 mg at week 2, followed 

by 40 mg every week starting at week 4), in patients with hidradenitis suppurativa with a control 

period duration ranging from 12 to 16 weeks, ALT elevations ≥ 3 x ULN occurred in 0.3% of 

adalimumab-treated patients and 0.6% of control-treated patients. 

 

In controlled trials of adalimumab (initial doses of 80 mg at week 0 followed by 40 mg every other 

week starting at week 1) in patients with uveitis up to 80 weeks with a median exposure of 166.5 days 

and 105.0 days in adalimumab-treated and control-treated patients, respectively, ALT elevations 

≥ 3 x ULN occurred in 2.4% of adalimumab-treated patients and 2.4% of control-treated patients. 

 

Across all indications in clinical trials patients with raised ALT were asymptomatic and in most cases 

elevations were transient and resolved on continued treatment. However, there have also been post-

marketing reports of liver failure as well as less severe liver disorders that may precede liver failure, 

such as hepatitis including autoimmune hepatitis in patients receiving adalimumab.  

 

Concurrent treatment with azathioprine/6-mercaptopurine  

 

In adult Crohn’s disease studies, higher incidences of malignant and serious infection-related adverse 

events were seen with the combination of adalimumab and azathioprine/6-mercaptopurine compared 

with adalimumab alone.  

 

Reporting of suspected adverse reactions  

 

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It 

allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare 

professionals are asked to report any suspected adverse reactions via the national reporting system 

listed in Appendix V. 

 

4.9  Overdose  

 

No dose-limiting toxicity was observed during clinical trials. The highest dose level evaluated has 

been multiple intravenous doses of 10 mg/kg, which is approximately 15 times the recommended 

dose.  

 

5.  PHARMACOLOGICAL PROPERTIES  

 

5.1  Pharmacodynamic properties  

 

Pharmacotherapeutic group: Immunosuppressants, Tumour Necrosis Factor alpha (TNFα) inhibitors. 

ATC code: L04AB04  

 

SOLYMBIC is a biosimilar medicinal product. Detailed information is available on the website of the 

European Medicines Agency http://www.ema.europa.eu. 

 

Mechanism of action  

 

Adalimumab binds specifically to TNF and neutralises the biological function of TNF by blocking its 

interaction with the p55 and p75 cell surface TNF receptors.  

 

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22 

Adalimumab also modulates biological responses that are induced or regulated by TNF, including 

changes in the levels of adhesion molecules responsible for leucocyte migration (ELAM-1, VCAM-1, 

and ICAM-1 with an IC50 of 0.1-0.2 nM).  

 

Pharmacodynamic effects  

 

After treatment with adalimumab, a rapid decrease in levels of acute phase reactants of inflammation 

(C-reactive protein (CRP) and erythrocyte sedimentation rate (ESR)) and serum cytokines (IL-6) was 

observed, compared to baseline in patients with rheumatoid arthritis. Serum levels of matrix 

metalloproteinases (MMP-1 and MMP-3) that produce tissue remodelling responsible for cartilage 

destruction were also decreased after adalimumab administration. Patients treated with adalimumab 

usually experienced improvement in haematological signs of chronic inflammation.  

 

A rapid decrease in CRP levels was also observed in patients with polyarticular juvenile idiopathic 

arthritis, Crohn's disease, ulcerative colitis and hidradenitis suppurativa after treatment with 

adalimumab. In patients with Crohn’s disease, a reduction of the number of cells expressing 

inflammatory markers in the colon including a significant reduction of expression of TNFα was seen. 

Endoscopic studies in intestinal mucosa have shown evidence of mucosal healing in adalimumab-

treated patients.  

 

Clinical efficacy and safety  

 

Rheumatoid arthritis  

 

Adalimumab was evaluated in over 3,000 patients in all rheumatoid arthritis clinical trials. The 

efficacy and safety of adalimumab were assessed in five randomised, double-blind and well-controlled 

studies. Some patients were treated for up to 120 months duration.  

 

RA study I evaluated 271 patients with moderately to severely active rheumatoid arthritis who were 

≥ 18 years old, had failed therapy with at least one disease-modifying, anti-rheumatic drug and had 

insufficient efficacy with methotrexate at doses of 12.5 to 25 mg (10 mg if methotrexate-intolerant) 

every week and whose methotrexate dose remained constant at 10 to 25 mg every week. Doses of 20, 

40 or 80 mg of adalimumab or placebo were given every other week for 24 weeks. 

 

RA study II evaluated 544 patients with moderately to severely active rheumatoid arthritis who were 

≥ 18 years old and had failed therapy with at least one disease-modifying, anti-rheumatic drugs. Doses 

of 20 or 40 mg of adalimumab were given by subcutaneous injection every other week with placebo 

on alternative weeks or every week for 26 weeks; placebo was given every week for the same 

duration. No other disease-modifying anti-rheumatic drugs were allowed.  

 

RA study III evaluated 619 patients with moderately to severely active rheumatoid arthritis who were 

≥ 18 years old, and who had an ineffective response to methotrexate at doses of 12.5 to 25 mg or have 

been intolerant to 10 mg of methotrexate every week. There were three groups in this study. The first 

received placebo injections every week for 52 weeks. The second received 20 mg of adalimumab 

every week for 52 weeks. The third group received 40 mg of adalimumab every other week with 

placebo injections on alternate weeks. Upon completion of the first 52 weeks, 457 patients enrolled in 

an open-label extension phase in which 40 mg of adalimumab/MTX was administered every other 

week up to 10 years. 

 

RA study IV primarily assessed safety in 636 patients with moderately to severely active rheumatoid 

arthritis who were ≥ 18 years old. Patients were permitted to be either disease-modifying, anti-

rheumatic drug-naïve or to remain on their pre-existing rheumatologic therapy provided that therapy 

was stable for a minimum of 28 days. These therapies include methotrexate, leflunomide, 

hydroxychloroquine, sulfasalazine and/or gold salts. Patients were randomised to 40 mg of 

adalimumab or placebo every other week for 24 weeks.  

 

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RA study V evaluated 799 methotrexate-naïve, adult patients with moderate to severely active early 

rheumatoid arthritis (mean disease duration less than 9 months). This study evaluated the efficacy of 

adalimumab 40 mg every other week/methotrexate combination therapy, adalimumab 40 mg every 

other week monotherapy and methotrexate monotherapy in reducing the signs and symptoms and rate 

of progression of joint damage in rheumatoid arthritis for 104 weeks. Upon completion of the first 104 

weeks, 497 patients enrolled in an open-label extension phase in which 40 mg of adalimumab was 

administered every other week up to 10 years. 

 

The primary end point in RA studies I, II and III and the secondary endpoint in RA study IV was the 

percent of patients who achieved an ACR 20 response at week 24 or 26. The primary endpoint in RA 

study V was the percent of patients who achieved an ACR 50 response at week 52. RA studies III and 

V had an additional primary endpoint at 52 weeks of retardation of disease progression (as detected by 

x-ray results). RA study III also had a primary endpoint of changes in quality of life. 

 

ACR response 

 

The percent of adalimumab-treated patients achieving ACR 20, 50 and 70 responses was consistent 

across RA studies I, II and III. The results for the 40 mg every other week dose are summarised in 

table 4. 

 

Table 4 ACR responses in placebo-controlled trials (percent of patients) 

 

Response  

  

RA study Ia** RA study IIa** RA study IIIa** 
Placebo/ 

MTXc 

n = 60 

Adalimumabb

/ MTXc 

n = 63 

Placebo 

n = 110 
Adalimumabb 

n = 113 

Placebo/ 

MTXc 

n = 200 

Adalimumabb

/ MTXc 

n = 207 

ACR 20  

6 months 13.3% 65.1% 19.1% 46.0% 29.5% 63.3% 

12 months NA NA NA NA 24.0% 58.9% 

ACR 50  

6 months 6.7% 52.4% 8.2% 22.1% 9.5% 39.1% 

12 months NA NA NA NA 9.5% 41.5% 

ACR 70  

6 months 3.3% 23.8% 1.8% 12.4% 2.5% 20.8% 

12 months NA NA NA NA 4.5% 23.2% 
a RA study I at 24 weeks, RA study II at 26 weeks, and RA study III at 24 and 52 weeks  
b 40 mg adalimumab administered every other week  
c MTX = methotrexate  

** p < 0.01, adalimumab versus placebo  

 

In RA studies I-IV, all individual components of the ACR response criteria (number of tender and 

swollen joints, physician and patient assessment of disease activity and pain, disability index (HAQ) 

scores and CRP (mg/dL) values) improved at 24 or 26 weeks compared to placebo. In RA study III, 

these improvements were maintained throughout 52 weeks.  

 

In the open-label extension for RA study III, most patients who were ACR responders maintained 

response when followed for up to 10 years. Of 207 patients who were randomised to adalimumab 

40 mg every other week, 114 patients continued on adalimumab 40 mg every other week for 5 years. 

Among those, 86 patients (75.4%) had ACR 20 responses; 72 patients (63.2%) had ACR 50 responses; 

and 41 patients (36%) had ACR 70 responses. Of 207 patients, 81 patients continued on adalimumab 

40 mg every other week for 10 years. Among those, 64 patients (79.0%) had ACR 20 responses; 56 

patients (69.1%) had ACR 50 responses; and 43 patients (53.1%) had ACR 70 responses. 

 

In RA study IV, the ACR 20 response of patients treated with adalimumab plus standard of care was 

statistically significantly better than patients treated with placebo plus standard of care (p < 0.001).  

 

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In RA studies I-IV, adalimumab-treated patients achieved statistically significant ACR 20 and 50 

responses compared to placebo as early as one to two weeks after initiation of treatment.  

 

In RA study V with early rheumatoid arthritis patients who were methotrexate naïve, combination 

therapy with adalimumab and methotrexate led to faster and significantly greater ACR responses than 

methotrexate monotherapy and adalimumab monotherapy at week 52 and responses were sustained at 

week 104 (see table 5). 

 

Table 5 ACR responses in RA study V (percent of patients) 

 

Response  MTX 

n = 257 

Adalimumab

n = 274 

Adalimumab 

/MTX 

n = 268 

p-valuea p-valueb p-valuec 

ACR 20  

Week 52 62.6% 54.4% 72.8% 0.013 < 0.001 0.043 

Week 104 56.0% 49.3% 69.4% 0.002 < 0.001 0.140 

ACR 50  

Week 52 45.9% 41.2% 61.6% < 0.001 < 0.001 0.317 

Week 104 42.8% 36.9% 59.0% < 0.001 < 0.001 0.162 

ACR 70  

Week 52 27.2% 25.9% 45.5% < 0.001 < 0.001 0.656 

Week 104 28.4% 28.1% 46.6% < 0.001 < 0.001 0.864 
a p-value is from the pairwise comparison of methotrexate monotherapy and adalimumab/methotrexate 

combination therapy using the Mann-Whitney U test  
b p-value is from the pairwise comparison of adalimumab monotherapy and adalimumab/methotrexate 

combination therapy using the Mann-Whitney U test  
c p-value is from the pairwise comparison of adalimumab monotherapy and methotrexate monotherapy using 

the Mann-Whitney U test  

 

In the open-label extension for RA study V, ACR response rates were maintained when followed for 

up to 10 years. Of 542 patients who were randomised to adalimumab 40 mg every other week, 170 

patients continued on adalimumab 40 mg every other week for 10 years. Among those, 154 patients 

(90.6%) had ACR 20 responses; 127 patients (74.7%) had ACR 50 responses; and 102 patients 

(60.0%) had ACR 70 responses. 

 

At week 52, 42.9% of patients who received adalimumab/methotrexate combination therapy achieved 

clinical remission (DAS28 < 2.6) compared to 20.6% of patients receiving methotrexate monotherapy 

and 23.4% of patients receiving adalimumab monotherapy. Adalimumab/methotrexate combination 

therapy was clinically and statistically superior to methotrexate (p < 0.001) and adalimumab 

monotherapy (p < 0.001) in achieving a low disease state in patients with recently diagnosed moderate 

to severe rheumatoid arthritis. The response for the two monotherapy arms was similar (p = 0.447).  

 

Radiographic response  

 

In RA study III, where adalimumab-treated patients had a mean duration of rheumatoid arthritis of 

approximately 11 years, structural joint damage was assessed radiographically and expressed as 

change in modified Total Sharp Score (TSS) and its components, the erosion score and joint space 

narrowing score. Adalimumab/methotrexate patients demonstrated significantly less radiographic 

progression than patients receiving methotrexate alone at 6 and 12 months (see table 6).  

 

In the open-label extension of RA study III, the reduction in rate of progression of structural damage is 

maintained for 8 and 10 years in a subset of patients. At 8 years, 81 of 207 patients originally treated 

with 40 mg adalimumab every other week were evaluated radiographically. Among those, 48 patients 

showed no progression of structural damage defined by a change from baseline in the mTSS of 0.5 or 

less. At 10 years, 79 of 207 patients originally treated with 40 mg adalimumab every other week were 

evaluated radiographically. Among those, 40 patients showed no progression of structural damage 

defined by a change from baseline in the mTSS of 0.5 or less. 

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Table 6 Radiographic mean changes over 12 months in RA study III 

 

 Placebo/ 

MTXa 

Adalimumab 

/MTX 

40 mg every other 

week 

Placebo/MTX- 

adalimumab /MTX 

(95% confidence 

intervalb) 

p-value 

Total Sharp Score 2.7 0.1 2.6 (1.4, 3.8) < 0.001c 

Erosion score 1.6 0.0 1.6 (0.9, 2.2) < 0.001 

JSNd score 1.0 0.1 0.9 (0.3, 1.4) 0.002 
a methotrexate  
b 95% confidence intervals for the differences in change scores between methotrexate and adalimumab  
c Based on rank analysis  
d Joint Space Narrowing 

 

In RA study V, structural joint damage was assessed radiographically and expressed as change in 

modified Total Sharp Score (see table 7).  

 

Table 7 Radiographic mean changes at week 52 in RA study V 

 

 MTX 

n = 257 

(95% 

confidence 

interval) 

Adalimumab 

n = 274 

(95% 

confidence 

interval) 

Adalimumab 

/MTX 

n = 268 

(95% 

confidence 

interval) 

p-valuea p-valueb p-valuec 

Total sharp 

score 

5.7 (4.2-7.3) 3.0 (1.7-4.3) 1.3 (0.5-2.1) < 0.001 0.0020 < 0.001 

Erosion 

score 

3.7 (2.7-4.7) 1.7 (1.0-2.4) 0.8 (0.4-1.2) < 0.001 0.0082 < 0.001 

JSN score 2.0 (1.2-2.8) 1.3 (0.5-2.1) 0.5 (0-1.0) < 0.001 0.0037 0.151 
a p-value is from the pairwise comparison of methotrexate monotherapy and adalimumab/methotrexate 

combination therapy using the Mann-Whitney U test  
b p-value is from the pairwise comparison of adalimumab monotherapy and adalimumab/methotrexate 

combination therapy using the Mann-Whitney U test  
c p-value is from the pairwise comparison of adalimumab monotherapy and methotrexate monotherapy using 

the Mann-Whitney U test  
 

Following 52 weeks and 104 weeks of treatment, the percentage of patients without progression 

(change from baseline in modified Total Sharp Score ≤ 0.5) was significantly higher with 

adalimumab/methotrexate combination therapy (63.8% and 61.2% respectively) compared to 

methotrexate monotherapy (37.4% and 33.5% respectively, p < 0.001) and adalimumab monotherapy 

(50.7%, p < 0.002 and 44.5%, p < 0.001 respectively). 

 

In the open-label extension of RA study V, the mean change from baseline at year 10 in the modified 

Total Sharp Score was 10.8, 9.2 and 3.9 in patients originally randomised to methotrexate 

monotherapy, adalimumab monotherapy and adalimumab/methotrexate combination therapy, 

respectively. The corresponding proportions of patients with no radiographic progression were 31.3%, 

23.7% and 36.7% respectively. 

 

Quality of life and physical function  

 

Health-related quality of life and physical function were assessed using the disability index of the 

Health Assessment Questionnaire (HAQ) in the four original adequate and well-controlled trials, 

which was a pre-specified primary endpoint at week 52 in RA study III. All doses/schedules of 

adalimumab in all four studies showed statistically significantly greater improvement in the disability 

index of the HAQ from baseline to month 6 compared to placebo and in RA study III the same was 

seen at week 52. Results from the Short Form Health Survey (SF 36) for all doses/schedules of 

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adalimumab in all four studies support these findings, with statistically significant physical component 

summary (PCS) scores, as well as statistically significant pain and vitality domain scores for the 

40 mg every other week dose. A statistically significant decrease in fatigue as measured by functional 

assessment of chronic illness therapy (FACIT) scores was seen in all three studies in which it was 

assessed (RA studies I, III, IV).  

 

In RA study III, most subjects who achieved improvement in physical function and continued 

treatment maintained improvement through week 520 (120 months) of open-label treatment. 

Improvement in quality of life was measured up to week 156 (36 months) and improvement was 

maintained through that time. 

 

In RA study V, the improvement in the HAQ disability index and the physical component of the SF 36 

showed greater improvement (p < 0.001) for adalimumab/methotrexate combination therapy versus 

methotrexate monotherapy and adalimumab monotherapy at week 52, which was maintained through 

week 104. Among the 250 subjects who completed the open-label extension study, improvements in 

physical function were maintained through 10 years of treatment. 

 

Enthesitis-related arthritis 

 

The safety and efficacy of adalimumab were assessed in a multicentre, randomised, double-blind study 

in 46 paediatric patients (6 to 17 years old) with moderate enthesitis-related arthritis. Patients were 

randomised to receive either 24 mg/m2 body surface area (BSA) of adalimumab up to a maximum of 

40 mg, or placebo every other week for 12 weeks. The double-blind period is followed by an open-

label (OL) period during which patients received 24 mg/m2 BSA of adalimumab up to a maximum of 

40 mg every other week subcutaneously for up to an additional 192 weeks. The primary endpoint was 

the percent change from baseline to week 12 in the number of active joints with arthritis (swelling not 

due to deformity or joints with loss of motion plus pain and/or tenderness), which was achieved with 

mean percent decrease of -62.6% (median percent change -88.9%) in patients in the adalimumab 

group compared to -11.6% (median percent change -50.0%) in patients in the placebo group. 

Improvement in number of active joints with arthritis was maintained during the OL period through 

week 156 for the 26 of 31 (84%) patients in the adalimumab group who remained in the study. 

Although not statistically significant, the majority of patients demonstrated clinical improvement in 

secondary endpoints such as number of sites of enthesitis, tender joint count (TJC), swollen joint count 

(SJC), paediatric ACR 50 response, and paediatric ACR 70 response. 

 

Axial spondyloarthritis 

 

Ankylosing spondylitis (AS) 

 

Adalimumab 40 mg every other week was assessed in 393 patients in two randomised, 24 week 

double-blind, placebo-controlled studies in patients with active ankylosing spondylitis (mean baseline 

score of disease activity [Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)] was 6.3 in 

all groups) who have had an inadequate response to conventional therapy. Seventy-nine (20.1%) 

patients were treated concomitantly with disease-modifying anti-rheumatic drugs, and 37 (9.4%) 

patients with glucocorticoids. The blinded period was followed by an open-label period during which 

patients received adalimumab 40 mg every other week subcutaneously for up to an additional 28 

weeks. Subjects (n = 215, 54.7%) who failed to achieve ASAS 20 at weeks 12, or 16 or 20 received 

early escape open-label adalimumab 40 mg every other week subcutaneously and were subsequently 

treated as non-responders in the double-blind statistical analyses. 

 

In the larger AS study I with 315 patients, results showed statistically significant improvement of the 

signs and symptoms of ankylosing spondylitis in patients treated with adalimumab compared to 

placebo. Significant response was first observed at week 2 and maintained through 24 weeks (table 8). 

 

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Table 8 Efficacy responses in placebo-controlled AS study – study I reduction of signs and 

symptoms 

 

Response  Placebo 

N = 107 

Adalimumab 
N = 208 

ASASa 20   

Week 2 16% 42%*** 

Week 12 21% 58%*** 

Week 24 19% 51%*** 

ASAS 50   

Week 2 3% 16%*** 

Week 12 10% 38%*** 

Week 24 11% 35%*** 

ASAS 70   

Week 2 0% 7%** 

Week 12 5% 23%*** 

Week 24 8% 24%*** 

BASDAIb 50    

Week 2 4% 20%*** 

Week 12 16% 45%*** 

Week 24 15% 42%*** 
***, ** Statistically significant at p < 0.001, < 0.01 for all comparisons between adalimumab and placebo at 

weeks 2, 12 and 24  
a Assessments in Ankylosing Spondylitis  
b Bath Ankylosing Spondylitis Disease Activity Index 

 

Adalimumab-treated patients had significantly greater improvement at week 12 which was maintained 

through week 24 in both the SF36 and Ankylosing Spondylitis Quality of Life Questionnaire 

(ASQoL).  

 

Similar trends (not all statistically significant) were seen in the smaller randomised, double-blind, 

placebo controlled AS study II of 82 adult patients with active ankylosing spondylitis. 

 

Axial spondyloarthritis without radiographic evidence of AS  

 

Adalimumab 40 mg every other week was assessed in 185 patients in one randomised, 12 week 

double-blind, placebo-controlled study in patients with active non-radiographic axial spondyloarthritis 

(mean baseline score of disease activity [Bath Ankylosing Spondylitis Disease Activity Index 

(BASDAI)] was 6.4 for patients treated with adalimumab and 6.5 for those on placebo) who have had 

an inadequate response to or intolerance to ≥ 1 NSAIDs, or a contraindication for NSAIDs.  

 

Thirty-three (18%) of patients were treated concomitantly with disease-modifying anti-rheumatic 

drugs, and 146 (79%) patients with NSAIDs at baseline. The double-blind period was followed by an 

open-label period during which patients receive adalimumab 40 mg every other week subcutaneously 

for up to an additional 144 weeks. Week 12 results showed statistically significant improvement of the 

signs and symptoms of active non-radiographic axial spondyloarthritis in patients treated with 

adalimumab compared to placebo (table 9). 

 

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Table 9 Efficacy response in placebo-controlled axial SpA study  

 

Double-Blind Response at week 

12  

Placebo 

N = 94 

Adalimumab  

N = 91 

ASASa 40  15% 36%*** 

ASAS 20  31% 52%** 

ASAS 5/6  6% 31%*** 

ASAS partial remission  5% 16%* 

BASDAIb 50  15% 35%** 

ASDASc,d,e -0.3  -1.0***  

ASDAS Inactive Disease  4%  24%***  

hs-CRPd,f,g -0.3  -4.7***  

SPARCCh MRI Sacroiliac Jointsd,i -0.6  -3.2**  

SPARCC MRI Spined,j -0.2 -1.8** 
a Assessment of Spondyloarthritis International Society  
b Bath Ankylosing Spondylitis Disease Activity Index  
c Ankylosing Spondylitis Disease Activity Score  
d mean change from baseline  
e n = 91 placebo and n = 87 adalimumab  
f high sensitivity C-Reactive Protein (mg/L)  
g n = 73 placebo and n = 70 adalimumab  
h Spondyloarthritis Research Consortium of Canada  
i n = 84 placebo and adalimumab  
j n = 82 placebo and n = 85 adalimumab  

***, **, * Statistically significant at p < 0.001, < 0.01, and < 0.05, respectively, for all comparisons between 

adalimumab and placebo 

 

In the open-label extension, improvement in the signs and symptoms was maintained with 

adalimumab therapy through week 156. 

 

Inhibition of inflammation 

 

Significant improvement of signs of inflammation as measured by hs-CRP and MRI of both Sacroiliac 

Joints and the Spine was maintained in adalimumab-treated patients through week 156 and week 104, 

respectively. 

 

Quality of life and physical function 

 

Health-related quality of life and physical function were assessed using the HAQ-S and the SF-36 

questionnaires. Adalimumab showed statistically significantly greater improvement in the HAQ-S 

total score and the SF-36 Physical Component Score (PCS) from baseline to week 12 compared to 

placebo. Improvement in health-related quality of life and physical function was maintained during the 

open-label extension through week 156. 

 

Psoriatic arthritis  

 

Adalimumab, 40 mg every other week, was studied in patients with moderately to severely active 

psoriatic arthritis in two placebo-controlled studies, PsA studies I and II. PsA study I with 24 week 

duration, treated 313 adult patients who had an inadequate response to non-steroidal anti-inflammatory 

drug therapy and of these, approximately 50% were taking methotrexate. PsA study II with 12-week 

duration, treated 100 patients who had an inadequate response to DMARD therapy. Upon completion 

of both studies, 383 patients enrolled in an open-label extension study, in which 40 mg adalimumab 

was administered every other week (eow).  

 

There is insufficient evidence of the efficacy of adalimumab in patients with ankylosing spondylitis-

like psoriatic arthropathy due to the small number of patients studied. 

 

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Table 10 ACR response in placebo-controlled psoriatic arthritis studies (percent of patients) 

 

                PsA study I PsA Study II 
 

PsA study II 

Response  Placebo 

N = 162 

Adalimumab 

N = 151 

Placebo 

N = 49 

Adalimumab 

N = 51 

ACR 20      

Week 12  14% 58%*** 16% 39%* 

Week 24  15% 57%*** N/A N/A 

ACR 50      

Week 12  4% 36%*** 2% 25%*** 

Week 24  6% 39%*** N/A N/A 

ACR 70      

Week 12  1% 20%*** 0% 14%* 

Week 24  1% 23%*** N/A N/A 
*** p < 0.001 for all comparisons between adalimumab and placebo  

* p < 0.05 for all comparisons between adalimumab and placebo  

N/A not applicable  

 

ACR responses in PsA study I were similar with and without concomitant methotrexate therapy. ACR 

responses were maintained in the open-label extension study for up to 136 weeks.  

 

Radiographic changes were assessed in the psoriatic arthritis studies. Radiographs of hands, wrists, 

and feet were obtained at baseline and week 24 during the double-blind period when patients were on 

adalimumab or placebo and at week 48 when all patients were on open-label adalimumab. A modified 

Total Sharp Score (mTSS), which included distal interphalangeal joints (i.e. not identical to the TSS 

used for rheumatoid arthritis), was used.  

 

Adalimumab treatment reduced the rate of progression of peripheral joint damage compared with 

placebo treatment as measured by change from baseline in mTSS (mean ± SD) 0.8 ± 2.5 in the placebo 

group (at week 24) compared with 0.0 ± 1.9; (p < 0.001) in the adalimumab group (at week 48). 

 

In subjects treated with adalimumab with no radiographic progression from baseline to week 48 

(n = 102), 84% continued to show no radiographic progression through 144 weeks of treatment. 

Adalimumab-treated patients demonstrated statistically significant improvement in physical function 

as assessed by HAQ and Short Form Health Survey (SF 36) compared to placebo at week 24. 

Improved physical function continued during the open-label extension up to week 136. 

 

Psoriasis  

 

The safety and efficacy of adalimumab were studied in adult patients with chronic plaque psoriasis 

(≥ 10% BSA involvement and Psoriasis Area and Severity Index (PASI) ≥ 12 or ≥ 10) who were 

candidates for systemic therapy or phototherapy in randomised, double-blind studies. 73% of patients 

enrolled in psoriasis studies I and II had received prior systemic therapy or phototherapy. The safety 

and efficacy of adalimumab were also studied in adult patients with moderate to severe chronic plaque 

psoriasis with concomitant hand and/or foot psoriasis who were candidates for systemic therapy in a 

randomised double-blind study (psoriasis study III). 

 

Psoriasis study I (REVEAL) evaluated 1,212 patients within three treatment periods. In period A, 

patients received placebo or adalimumab at an initial dose of 80 mg followed by 40 mg every other 

week starting one week after the initial dose. After 16 weeks of therapy, patients who achieved at least 

a PASI 75 response (PASI score improvement of at least 75% relative to baseline), entered period B 

and received open-label 40 mg adalimumab every other week. Patients who maintained ≥ PASI 75 

response at week 33 and were originally randomised to active therapy in period A, were re-randomised 

in period C to receive 40 mg adalimumab every other week or placebo for an additional 19 weeks. 

Across all treatment groups, the mean baseline PASI score was 18.9 and the baseline Physician’s 

Global Assessment (PGA) score ranged from “moderate” (53% of subjects included) to “severe” 

(41%) to “very severe” (6%). 

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Psoriasis study II (CHAMPION) compared the efficacy and safety of adalimumab versus methotrexate 

and placebo in 271 patients. Patients received placebo, an initial dose of MTX 7.5 mg and thereafter 

dose increases up to week 12, with a maximum dose of 25 mg or an initial dose of 80 mg adalimumab 

followed by 40 mg every other week (starting one week after the initial dose) for 16 weeks. There are 

no data available comparing adalimumab and MTX beyond 16 weeks of therapy. Patients receiving 

MTX who achieved a ≥ PASI 50 response at week 8 and/or 12 did not receive further dose increases. 

Across all treatment groups, the mean baseline PASI score was 19.7 and the baseline PGA score 

ranged from “mild” (< 1%) to “moderate” (48%) to “severe” (46%) to “very severe” (6%). 

 

Patients participating in all phase 2 and phase 3 psoriasis studies were eligible to enrol into an open-

label extension trial, where adalimumab was given for at least an additional 108 weeks.  

 

In psoriasis studies I and II, a primary endpoint was the proportion of patients who achieved a PASI 

75 response from baseline at week 16 (see tables 11 and 12). 

 

Table 11 Ps study I (REVEAL) - efficacy results at 16 weeks 

 

  Placebo 

N = 398 

n (%) 

Adalimumab 40 mg eow 

N = 814 

n (%) 

≥ PASI 75a  26 (6.5) 578 (70.9)b 

PASI 100  3 (0.8) 163 (20.0)b 

PGA: Clear/minimal  17 (4.3) 506 (62.2)b 
a Percent of patients achieving PASI75 response was calculated as centre-adjusted rate  
b p < 0.001, adalimumab versus placebo  

 

Table 12 Ps study II (CHAMPION) efficacy results at 16 weeks 

 

  Placebo 

N = 53 

n (%) 

MTX 

N = 110 

n (%) 

Adalimumab 40 mg eow 

N = 108 

n (%) 

≥ PASI 75  10 (18.9) 39 (35.5) 86 (79.6) a, b 

PASI 100  1 (1.9) 8 (7.3) 18 (16.7) c, d 

PGA: Clear/minimal  6 (11.3) 33 (30.0) 79 (73.1) a, b 
a p < 0.001 adalimumab versus placebo  
b p < 0.001 adalimumab versus methotrexate  
c p < 0.01 adalimumab versus placebo  
d p < 0.05 adalimumab versus methotrexate  

 

In psoriasis study I, 28% of patients who were PASI 75 responders and were re-randomised to placebo 

at week 33 compared to 5% continuing on adalimumab, p < 0.001, experienced “loss of adequate 

response” (PASI score after week 33 and on or before week 52 that resulted in a < PASI 50 response 

relative to baseline with a minimum of a 6-point increase in PASI score relative to week 33). Of the 

patients who lost adequate response after re-randomisation to placebo who then enrolled into the open-

label extension trial, 38% (25/66) and 55% (36/66) regained PASI 75 response after 12 and 24 weeks 

of retreatment, respectively. 

 

A total of 233 PASI 75 responders at week 16 and week 33 received continuous adalimumab therapy 

for 52 weeks in psoriasis study I, and continued adalimumab in the open-label extension trial. PASI 75 

and PGA of clear or minimal response rates in these patients were 74.7% and 59.0%, respectively, 

after an additional 108 weeks of open-label therapy (total of 160 weeks). In an analysis in which all 

patients who dropped out of the study for adverse events or lack of efficacy, or who dose-escalated, 

were considered non-responders, PASI 75 and PGA of clear or minimal response rates in these 

patients were 69.6% and 55.7%, respectively, after an additional 108 weeks of open-label therapy 

(total of 160 weeks).  

 

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A total of 347 stable responders participated in a withdrawal and retreatment evaluation in an open-

label extension study. During the withdrawal period, symptoms of psoriasis returned over time with a 

median time to relapse (decline to PGA “moderate” or worse) of approximately 5 months. None of 

these patients experienced rebound during the withdrawal period. A total of 76.5% (218/285) of 

patients who entered the retreatment period had a response of PGA “clear” or “minimal” after 16 

weeks of retreatment, irrespective of whether they relapsed during withdrawal (69.1%[123/178] and 

88.8% [95/107] for patients who relapsed and who did not relapse during the withdrawal period, 

respectively). A similar safety profile was observed during retreatment as before withdrawal.  

 

Significant improvements at week 16 from baseline compared to placebo (studies I and II) and MTX 

(study II) were demonstrated in the DLQI (Dermatology Life Quality Index). In study I, improvements 

in the physical and mental component summary scores of the SF-36 were also significant compared to 

placebo. 

 

In an open-label extension study, for patients who dose escalated from 40 mg every other week to 

40 mg weekly due to a PASI response below 50%, 26.4% (92/349) and 37.8% (132/349) of patients 

achieved PASI 75 response at week 12 and 24, respectively. 

 

Psoriasis study III (REACH) compared the efficacy and safety of adalimumab versus placebo in 72 

patients with moderate to severe chronic plaque psoriasis and hand and/or foot psoriasis. Patients 

received an initial dose of 80 mg adalimumab followed by 40 mg every other week (starting one week 

after the initial dose) or placebo for 16 weeks. At week 16, a statistically significantly greater 

proportion of patients who received adalimumab achieved PGA of 'clear' or 'almost clear' for the hands 

and/or feet compared to patients who received placebo (30.6% versus 4.3%, respectively [P = 0.014]). 

 

Psoriasis study IV compared efficacy and safety of adalimumab versus placebo in 217 adult patients 

with moderate to severe nail psoriasis. Patients received an initial dose of 80 mg adalimumab followed 

by 40 mg every other week (starting one week after the initial dose) or placebo for 26 weeks followed 

by open-label adalimumab treatment for an additional 26 weeks. Nail psoriasis assessments included 

the Modified Nail Psoriasis Severity Index (mNAPSI), the Physician’s Global Assessment of 

Fingernail Psoriasis (PGA-F) and the Nail Psoriasis Severity Index (NAPSI) (see table 13). 

Adalimumab demonstrated a treatment benefit in nail psoriasis patients with different extents of skin 

involvement (BSA ≥ 10% (60% of patients) and BSA < 10% and ≥ 5% (40% of patients)). 
 

Table 13 Ps study IV efficacy results at 16, 26 and 52 weeks 

 

Endpoint Week 16 

Placebo-controlled 

Week 26 

Placebo-controlled 

Week 52 

Open-label 

Placebo 

N = 108 

Adalimumab

40 mg eow  

N = 109 

Placebo 

N = 108 

Adalimumab 

40 mg eow  

N = 109 

Adalimumab 

40 mg eow  

N = 80 

≥ mNAPSI 75 (%) 2.9 26.0a 3.4 46.6a 65.0 

PGA-F clear/minimal and 

≥ 2-grade improvement 

(%) 

2.9 29.7a 6.9 48.9a 61.3 

Percent change in total 

fingernail NAPSI (%) 

-7.8 -44.2 a -11.5 -56.2a -72.2 

a p < 0.001, Adalimumab versus placebo  

 

Adalimumab treated patients showed statistically significant improvements at week 26 compared with 

placebo in the DLQI.  

 

 

Paediatric plaque psoriasis  

 

The efficacy of adalimumab was assessed in a randomised, double-blind, controlled study of 

114 paediatric patients from 4 years of age with severe chronic plaque psoriasis (as defined by a PGA 

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≥ 4 or > 20% BSA involvement or > 10% BSA involvement with very thick lesions or PASI ≥ 20 or 

≥ 10 with clinically relevant facial, genital, or hand/foot involvement) who were inadequately 

controlled with topical therapy and heliotherapy or phototherapy. 

 

Patients received adalimumab 0.8 mg/kg every other week (up to 40 mg), 0.4 mg/kg every other week 

(up to 20 mg), or methotrexate 0.1–0.4 mg/kg weekly (up to 25 mg). At week 16, more patients 

randomised to adalimumab 0.8 mg/kg had positive efficacy responses (e.g. PASI 75) than those 

randomised to 0.4 mg/kg every other week or MTX. 

 

Table 14 Paediatric plaque psoriasis efficacy results at 16 weeks  

 

  MTXa 

N = 37 

Adalimumab 0.8 mg/kg eow 

N = 38 

PASI 75b  12 (32.4%)  22 (57.9%)  

PGA: Clear/minimalc 15 (40.5%)  23 (60.5%)  
a MTX = methotrexate  
b P = 0.027, adalimumab 0.8 mg/kg versus MTX  
c P = 0.083, adalimumab 0.8 mg/kg versus MTX  

 

Patients who achieved PASI 75 and PGA clear or minimal were withdrawn from treatment for up to 

36 weeks and monitored for loss of disease control (i.e. a worsening of PGA by at least 2 grades). 

Patients were then retreated with adalimumab 0.8 mg/kg every other week for an additional 16 weeks 

and response rates observed during retreatment were similar to the previous double-blind period: PASI 

75 response of 78.9% (15 of 19 subjects) and PGA clear or minimal of 52.6% (10 of 19 subjects).  

 

In the open-label period of the study, PASI 75 and PGA clear or minimal responses were maintained 

for up to an additional 52 weeks with no new safety findings. 

 

Hidradenitis suppurativa 

 

The safety and efficacy of adalimumab were assessed in randomised, double-blind, placebo-controlled 

studies and an open-label extension study in adult patients with moderate to severe hidradenitis 

suppurativa (HS) who were intolerant, had a contraindication or an inadequate response to at least a 3-

month trial of systemic antibiotic therapy. The patients in HS-I and HS-II had Hurley Stage II or III 

disease with at least 3 abscesses or inflammatory nodules. 

 

Study HS-I (PIONEER I) evaluated 307 patients with 2 treatment periods. In Period A, patients 

received placebo or adalimumab at an initial dose of 160 mg at week 0, 80 mg at week 2, and 40 mg 

every week starting at week 4 to week 11. Concomitant antibiotic use was not allowed during the 

study. After 12 weeks of therapy, patients who had received adalimumab in Period A were re-

randomised in Period B to 1 of 3 treatment groups (adalimumab 40 mg every week, adalimumab 

40 mg every other week, or placebo from week 12 to week 35). Patients who had been randomised to 

placebo in Period A were assigned to receive adalimumab 40 mg every week in Period B. 

 

Study HS-II (PIONEER II) evaluated 326 patients with 2 treatment periods. In Period A, patients 

received placebo or adalimumab at an initial dose of 160 mg at week 0 and 80 mg at week 2 and 

40 mg every week starting at week 4 to week 11. 19.3% of patients had continued baseline oral 

antibiotic therapy during the study. After 12 weeks of therapy, patients who had received adalimumab 

in Period A were re-randomised in Period B to 1 of 3 treatment groups (adalimumab 40 mg every 

week, adalimumab 40 mg every other week, or placebo from week 12 to week 35). Patients who had 

been randomised to placebo in Period A were assigned to receive placebo in Period B. 

 

Patients participating in Studies HS-I and HS-II were eligible to enrol into an open-label extension 

study in which adalimumab 40 mg was administered every week. Mean exposure in all adalimumab 

population was 762 days. Throughout all 3 studies patients used topical antiseptic wash daily. 

 

Clinical response 

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Reduction of inflammatory lesions and prevention of worsening of abscesses and draining fistulas was 

assessed using Hidradenitis Suppurativa clinical response (HiSCR; at least a 50% reduction in total 

abscess and inflammatory nodule count with no increase in abscess count and no increase in draining 

fistula count relative to Baseline). Reduction in HS-related skin pain was assessed using a Numeric 

Rating Scale in patients who entered the study with an initial baseline score of 3 or greater on a 11 

point scale.  

 

At week 12, a significantly higher proportion of patients treated with adalimumab versus placebo 

achieved HiSCR. At week 12, a significantly higher proportion of patients in study HS-II experienced 

a clinically relevant decrease in HS-related skin pain (see table 15). Patients treated with adalimumab 

had significantly reduced risk of disease flare during the initial 12 weeks of treatment.  

 

Table 15 Efficacy results at 12 weeks, HS studies I and II  

  
HS study I HS study II 

Placebo Adalimumab 40 mg 

weekly 

Placebo  Adalimumab 40 mg 

weekly 

Hidradenitis 

Suppurativa Clinical 

Response (HiSCR)a 

N = 154 

40 (26.0%)  

N = 153 

64 (41.8%) * 

N = 163  

45 (27.6%)  

N = 163  

96 (58.9%)*** 

≥30% Reduction in 

Skin Painb 

N = 109 

27 (24.8%)  

N = 122 

34 (27.9%)  

N = 111  

23 (20.7%)  

N = 105  

48 (45.7%)*** 

*P < 0.05, ***P < 0.001, adalimumab versus placebo  
a Among all randomised patients  
b Among patients with baseline HS-related skin pain assessment ≥ 3, based on Numeric Rating Scale 0 – 10; 0 = 

no skin pain, 10 = skin pain as bad as you can imagine  

 

Treatment with adalimumab 40 mg every week significantly reduced the risk of worsening of 

abscesses and draining fistulas. Approximately twice the proportion of patients in the placebo group in 

the first 12 weeks of Studies HS-I and HS-II, compared with those in the adalimumab group 

experienced worsening of abscesses (23.0% versus 11.4%, respectively) and draining fistulas (30.0% 

versus 13.9%, respectively). 

 

Greater improvements at week 12 from baseline compared to placebo were demonstrated in skin-

specific health-related quality of life, as measured by the Dermatology Life Quality Index (DLQI; 

Studies HS-I and HS-II), patient global satisfaction with medication treatment as measured by the 

Treatment Satisfaction Questionnaire-medication (TSQM; Studies HS-I and HS-II), and physical 

health as measured by the physical component summary score of the SF-36 (study HS-I). 

 

In patients with at least a partial response to adalimumab 40 mg weekly at week 12, the HiSCR rate at 

week 36 was higher in patients who continued weekly adalimumab than in patients in whom dosing 

frequency was reduced to every other week, or in whom treatment was withdrawn (see table 16).  

 

Table 16 Proportion of patientsa achieving HiSCRb at weeks 24 and 36 after treatment 

reassignment from weekly adalimumab at week 12 

  
Placebo (treatment 

withdrawal) 

N = 73 

Adalimumab 40 mg 

every other week 

N = 70 

Adalimumab 40 mg 

weekly 

N = 70 

Week 24  24 (32.9%)  36 (51.4%)  40 (57.1%)  

Week 36  22 (30.1%)  28 (40.0%)  39 (55.7%)  

a Patients with at least a partial response to adalimumab 40 mg weekly after 12 weeks of treatment  
b Patients meeting protocol-specified criteria for loss of response or no improvement were required to 

discontinue from the studies and were counted as non-responders  

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34 

 

Among patients who were at least partial responders at week 12, and who received continuous weekly 

adalimumab therapy, the HiSCR rate at week 48 was 68.3% and at week 96 was 65.1%. Longer term 

treatment with adalimumab 40 mg weekly for 96 weeks identified no new safety findings. 

 

Among patients whose adalimumab treatment was withdrawn at week 12 in Studies HS-I and HS-II, 

the HiSCR rate 12 weeks after re-introduction of adalimumab 40 mg weekly returned to levels similar 

to that observed before withdrawal (56.0%). 

 

Crohn’s disease  

 

The safety and efficacy of adalimumab were assessed in over 1,500 patients with moderately to 

severely active Crohn’s disease (Crohn’s Disease Activity Index (CDAI) ≥ 220 and ≤ 450) in 

randomised, double-blind, placebo-controlled studies. Concomitant stable doses of aminosalicylates, 

corticosteroids, and/or immunomodulatory agents were permitted and 80% of patients continued to 

receive at least one of these medications.  

 

Induction of clinical remission (defined as CDAI < 150) was evaluated in two studies, CD study I 

(CLASSIC I) and CD study II (GAIN). In CD study I, 299 TNF-antagonist naïve patients were 

randomised to one of four treatment groups; placebo at weeks 0 and 2, 160 mg adalimumab at week 0 

and 80 mg at week 2, 80 mg at week 0 and 40 mg at week 2, and 40 mg at week 0 and 20 mg at week 

2. In CD study II, 325 patients who had lost response or were intolerant to infliximab were randomised 

to receive either 160 mg adalimumab at week 0 and 80 mg at week 2 or placebo at weeks 0 and 2. The 

primary non-responders were excluded from the studies and therefore these patients were not further 

evaluated. 

 

Maintenance of clinical remission was evaluated in CD study III (CHARM). In CD study III, 854 

patients received open-label 80 mg at week 0 and 40 mg at week 2. At week 4 patients were 

randomised to 40 mg every other week, 40 mg every week, or placebo with a total study duration of 

56 weeks. Patients in clinical response (decrease in CDAI ≥ 70) at week 4 were stratified and analysed 

separately from those not in clinical response at week 4. Corticosteroid taper was permitted after week 

8.  

 

CD study I and CD study II induction of remission and response rates are presented in table 17 

 

Table 17 Induction of clinical remission and response (percent of patients) 

 

 CD study I: infliximab naïve patients CD study II: infliximab 

experienced patients  

 Placebo 

N = 74 

Adalimumab 

80/40 mg 

N = 75 

Adalimumab 

160/80 mg 

N = 76 

Placebo 

N = 166 

Adalimumab 

160/80 mg 

N = 159 

Week 4  

Clinical remission  12% 24% 36%* 7% 21%* 

Clinical response 

(CR-100)  

24% 37% 49%** 25% 38%** 

All p-values are pairwise comparisons of proportions for adalimumab versus placebo  

* p < 0.001  

** p < 0.01  

 

Similar remission rates were observed for the 160/80 mg and 80/40 mg induction regimens by week 8 

and adverse events were more frequently noted in the 160/80 mg group.  

 

In CD study III, at week 4, 58% (499/854) of patients were in clinical response and were assessed in 

the primary analysis. Of those in clinical response at week 4, 48% had been previously exposed to 

other TNF-antagonists. Maintenance of remission and response rates are presented in table 18. Clinical 

remission results remained relatively constant irrespective of previous TNF-antagonist exposure.  

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35 

 

Disease-related hospitalisations and surgeries were statistically significantly reduced with adalimumab 

compared with placebo at week 56. 

 

Table 18 Maintenance of clinical remission and response (percent of patients) 

 

 Placebo 40 mg adalimumab 

every other week 

40 mg 

adalimumab every 

week 

Week 26 N = 170 N = 172 N = 157 

Clinical remission  17% 40%* 47%* 

Clinical response (CR-100)  27% 52%* 52%* 

Patients in steroid-free 

remission for > = 90 

daysa 

3% (2/66) 19% (11/58)** 15% (11/74)** 

Week 56  N = 170 N = 172 N = 157 

Clinical remission  12% 36%* 41%* 

Clinical response (CR-100)  17% 41%* 48%* 

Patients in steroid-free 

remission for > = 90 

daysa  

5% (3/66) 29% (17/58)* 20% (15/74)** 

* p < 0.001 for adalimumab versus placebo pairwise comparisons of proportions  

** p < 0.02 for adalimumab versus placebo pairwise comparisons of proportions  
a Of those receiving corticosteroids at baseline  

 

Among patients who were not in response at week 4, 43% of adalimumab maintenance patients 

responded by week 12 compared to 30% of placebo maintenance patients. These results suggest that 

some patients who have not responded by week 4 benefit from continued maintenance therapy through 

week 12. Therapy continued beyond 12 weeks did not result in significantly more responses (see 

section 4.2).  

 

117/276 patients from CD study I and 272/777 patients from CD studies II and III were followed 

through at least 3 years of open-label adalimumab therapy. 88 and 189 patients, respectively, 

continued to be in clinical remission. Clinical response (CR-100) was maintained in 102 and 

233 patients, respectively. 

 

Quality of life  

 

In CD study I and CD study II, statistically significant improvement in the disease-specific 

inflammatory bowel disease questionnaire (IBDQ) total score was achieved at week 4 in patients 

randomised to adalimumab 80/40 mg and 160/80 mg compared to placebo and was seen at weeks 26 

and 56 in CD study III as well among the adalimumab treatment groups compared to the placebo 

group. 

 

Paediatric Crohn’s disease  

 

Adalimumab was assessed in a multicentre, randomised, double-blind clinical trial designed to 

evaluate the efficacy and safety of induction and maintenance treatment with doses dependent on body 

weight (< 40 kg or ≥ 40 kg) in 192 paediatric subjects between the ages of 6 and 17 (inclusive) years, 

with moderate to severe Crohn´s disease (CD) defined as Paediatric Crohn's Disease Activity Index 

(PCDAI) score > 30. Subjects had to have failed conventional therapy (including a corticosteroid 

and/or an immunomodulator) for CD. Subjects may also have previously lost response or been 

intolerant to infliximab.  

 

All subjects received open-label induction therapy at a dose based on their baseline body weight: 

160 mg at week 0 and 80 mg at week 2 for subjects ≥ 40 kg, and 80 mg and 40 mg, respectively, for 

subjects < 40 kg.  

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At week 4, subjects were randomised 1:1 based on their body weight at the time to either the low dose 

or standard dose maintenance regimens as shown in table 19. 

 

Table 19 Maintenance regimen 

 

Patient weight  Low dose  Standard dose  

< 40 kg  10 mg eow  20 mg eow  

≥ 40 kg  20 mg eow  40 mg eow 

 

Efficacy results  

 

The primary endpoint of the study was clinical remission at week 26, defined as PCDAI score ≤ 10.  

 

Clinical remission and clinical response (defined as reduction in PCDAI score of at least 15 points 

from baseline) rates are presented in table 20. Rates of discontinuation of corticosteroids or 

immunomodulators are presented in table 21. 

 

Table 20 Paediatric CD study PCDAI clinical remission and response 

 

 Standard dose 

40/20 mg eow N = 93 

Low dose 

20/10 mg eow 

N = 95 

P value* 

Week 26 

Clinical remission 38.7% 28.4% 0.075 

Clinical response 59.1% 48.4% 0.073 

Week 52 

Clinical remission 33.3% 23.2% 0.100 

Clinical response 41.9% 28.4% 0.038 

* p value for standard dose versus low dose comparison 

 

Table 21 Paediatric CD study discontinuation of corticosteroids or immunomodulators and 

fistula remission  

 

 Standard dose 

40/20 mg eow 

Low dose 

20/10 mg eow 

P value1 

Discontinued corticosteroids  N = 33 N = 38  

Week 26  84.8% 65.8% 0.066 

Week 52  69.7% 60.5% 0.420 

Discontinuation of 

Immunomodulators2  

N = 60 N = 57  

Week 52  30.0% 29.8% 0.983 

Fistula remission3  N = 15 N = 21  

Week 26  46.7% 38.1% 0.608 

Week 52 40.0% 23.8% 0.303 
1 p value for standard dose versus low dose comparison  
2 Immunosuppressant therapy could only be discontinued at or after week 26 at the investigator's discretion if the 

subject met the clinical response criterion  
3 defined as a closure of all fistulas that were draining at baseline for at least 2 consecutive post-baseline visits  

 

Statistically significant increases (improvement) from baseline to week 26 and 52 in body mass index 

and height velocity were observed for both treatment groups.  

 

Statistically and clinically significant improvements from baseline were also observed in both 

treatment groups for quality of life parameters (including IMPACT III). 

 

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One hundred patients (n = 100) from the Paediatric CD Study continued in an open-label long-term 

extension study. After 5 years of adalimumab therapy, 74.0% (37/50) of the 50 patients remaining in 

the study continued to be in clinical remission, and 92.0% (46/50) of patients continued to be in 

clinical response per PCDAI. 

 

Ulcerative colitis  

 

The safety and efficacy of multiple doses of adalimumab were assessed in adult patients with 

moderately to severely active ulcerative colitis (Mayo score 6 to 12 with endoscopy subscore of 2 to 3) 

in randomised, double-blind, placebo-controlled studies.  

 

In study UC-I, 390 TNF-antagonist naïve patients were randomised to receive either placebo at weeks 

0 and 2, 160 mg adalimumab at week 0 followed by 80 mg at week 2, or 80 mg adalimumab at week 0 

followed by 40 mg at week 2. After week 2, patients in both adalimumab arms received 40 mg every 

other week. Clinical remission (defined as Mayo score ≤ 2 with no subscore > 1) was assessed at week 

8.  

 

In study UC-II, 248 patients received 160 mg of adalimumab at week 0, 80 mg at week 2 and 40 mg 

every other week thereafter, and 246 patients received placebo. Clinical results were assessed for 

induction of remission at week 8 and for maintenance of remission at week 52.  

 

Patients induced with 160/80 mg adalimumab achieved clinical remission versus placebo at week 8 in 

statistically significantly greater percentages in study UC-I (18% versus 9% respectively, p = 0.031) 

and study UC-II (17% versus 9% respectively, p = 0.019). In study UC-II, among those treated with 

adalimumab who were in remission at week 8, 21/41 (51%) were in remission at week 52.  

 

Results from the overall UC-II study population are shown in table 22. 

 

Table 22 Response, remission and mucosal healing in study UC-II (percent of patients) 

 

 Placebo Adalimumab 40 mg 

eow 
 

Week 52   
 

N = 246 N=248 
 

N = 248 

Clinical response  18% 30%* 

Clinical remission  9% 17%* 

Mucosal healing  15% 25%* 

Steroid-free remission for ≥ 90 daysa  6% 

(N = 140) 

13%* 

(N = 150) 

Week 8 and 52    

Sustained response  12% 24%** 

Sustained remission  4% 8%* 

Sustained mucosal healing  11% 19%* 

Clinical remission is Mayo score ≤ 2 with no subscore > 1;  

Clinical response is decrease from baseline in Mayo score ≥ 3 points and ≥ 30% plus a decrease in the rectal 

bleeding subscore [RBS] ≥ 1 or an absolute RBS of 0 or 1;  

* p < 0.05 for adalimumab versus placebo pairwise comparison of proportions  

** p < 0.001 for adalimumab versus placebo pairwise comparison of proportions  
a Of those receiving corticosteroids at baseline  

 

Of those patients who had a response at week 8, 47% were in response, 29% were in remission, 41% 

had mucosal healing, and 20% were in steroid-free remission for ≥ 90 days at week 52.  

 

Approximately 40% of patients in study UC-II had failed prior anti-TNF treatment with infliximab. 

The efficacy of adalimumab in those patients was reduced compared to that in anti-TNF naïve 

patients. Among patients who had failed prior anti-TNF treatment, week 52 remission was achieved by 

3% on placebo and 10% on adalimumab.  

 

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Patients from studies UC-I and UC-II had the option to roll over into an open-label long-term 

extension study (UC III). Following 3 years of adalimumab therapy, 75% (301/402) continued to be in 

clinical remission per partial Mayo score. 

 

Hospitalisation rates  

 

During 52 weeks of studies UC-I and UC-II, lower rates of all-cause hospitalisations and UC-related 

hospitalisations were observed for the adalimumab-treated arm compared to the placebo arm. The 

number of all cause hospitalisations in the adalimumab treatment group was 0.18 per patient year 

versus 0.26 per patient year in the placebo group and the corresponding figures for UC-related 

hospitalisations were 0.12 per patient year versus 0.22 per patient year. 

 

Quality of life  

 

In study UC-II, treatment with adalimumab resulted in improvements in the Inflammatory Bowel 

Disease Questionnaire (IBDQ) score. 

 

Uveitis 

 

The safety and efficacy of adalimumab were assessed in adult patients with non-infectious 

intermediate, posterior, and panuveitis, excluding patients with isolated anterior uveitis, in two 

randomised, doublemasked, placebo-controlled studies (UV I and II). Patients received placebo or 

adalimumab at an initial dose of 80 mg followed by 40 mg every other week starting one week after 

the initial dose. Concomitant stable doses of one non-biologic immunosuppressant were permitted. 

 

Study UV I evaluated 217 patients with active uveitis despite treatment with corticosteroids (oral 

prednisone at a dose of 10 to 60 mg/day). All patients received a 2 week standardised dose of 

prednisone 60 mg/day at study entry followed by a mandatory taper schedule, with complete 

corticosteroid discontinuation by week 15. 

 

Study UV II evaluated 226 patients with inactive uveitis requiring chronic corticosteroid treatment 

(oral prednisone 10 to 35 mg/day) at baseline to control their disease. Patients subsequently underwent 

a mandatory taper schedule, with complete corticosteroid discontinuation by week 19. 

 

The primary efficacy endpoint in both studies was ‘time to treatment failure’. Treatment failure was 

defined by a multi-component outcome based on inflammatory chorioretinal and/or inflammatory 

retinal vascular lesions, anterior chamber (AC) cell grade, vitreous haze (VH) grade and best corrected 

visual acuity (BCVA). 

 

Clinical response 

 

Results from both studies demonstrated statistically significant reduction of the risk of treatment 

failure in patients treated with adalimumab versus patients receiving placebo (See table 23). Both 

studies demonstrated an early and sustained effect of adalimumab on the treatment failure rate versus 

placebo (see figure 1). 

 

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Table 23 Time to treatment failure in studies UV I and UV II 

 

Analysis 

          Treatment 

 

N Failure 

N (%) 

 

Median 

time to 

failure 

(months) 

 

HRa CI 95% 

for HRa 

 

P Value 
b

 

 

Time to treatment failure at or after week 6 in study UV I 

Primary analysis (ITT) 

 

          Placebo 107 84 (78.5) 3.0 -- -- -- 

          Adalimumab 110 60 (54.5) 5.6 0.50 0.36, 

0.70 

< 0.001 

Time to treatment failure at or after week 2 in study UV II 

Primary analysis (ITT) 

 

          Placebo 111 61 (55.0) 8.3 -- -- -- 

          Adalimumab 115 45 (39.1) NEc 0.57 0.39, 

0.84 

0.004 

 
Note: Treatment failure at or after week 6 (study UV I), or at or after week 2 (study UV II), was counted as 

event. Drop outs due to reasons other than treatment failure were censored at the time of dropping out. 
a HR of adalimumab versus placebo from proportional hazards regression with treatment as factor. 
b 2-sided P value from log rank test. 
c NE = not estimable. Fewer than half of at-risk subjects had an event. 

 

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Figure 1: Kaplan-Meier curves summarising time to treatment failure on or after week 6 (study 

UV I) or week 2 (study UV II) 

 

Note: P# = Placebo (number of events/number at risk); A# = Adalimumab (number of events/number at risk). 

 

In study UV I statistically significant differences in favour of adalimumab versus placebo were 

observed for each component of treatment failure. In study UV II, statistically significant differences 

were observed for visual acuity only, but the other components were numerically in favour of 

adalimumab. 

 

Of the 417 subjects included in the uncontrolled long-term extension of Studies UV I and UV II, 46 

subjects were regarded ineligible (e.g. developed complications secondary to diabetic retinopathy, due 

to cataract surgery or vitrectomy) and were excluded from the primary analysis of efficacy. Of the 371 

remaining patients, 276 evaluable patients reached 78 weeks of open-label adalimumab treatment. 

Based on the observed data approach, 222 (80.4%) were in quiescence (no active inflammatory 

lesions, AC cell grade  ≤ 0.5+, VH grade ≤ 0.5+) with a concomitant steroid dose ≤ 7.5 mg per day, 

and 184 (66.7%) were in steroid-free quiescence. BCVA was either improved or maintained (< 5 

letters deterioration) in 88.4% of the eyes at week 78. Among the patients who discontinued the study 

prior to week 78, 11% discontinued due to adverse events, and 5% due to insufficient response to 

adalimumab treatment. 

 

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Quality of life 

 

Patient reported outcomes regarding vision-related functioning were measured in both clinical studies, 

using the NEI VFQ-25. Adalimumab was numerically favoured for the majority of subscores with 

statistically significant mean differences for general vision, ocular pain, near vision, mental health, and 

total score in study UV I, and for general vision and mental health in study UV II. vision related 

effects were not numerically in favour of adalimumab for colour vision in study UVI and for colour 

vision, peripheral vision and near vision in study UV II. 

 

Immunogenicity  

 

Anti-adalimumab antibodies may develop during adalimumab treatment. Formation of anti-

adalimumab antibodies is associated with increased clearance and reduced efficacy of adalimumab. 

There is no apparent correlation between the presence of anti-adalimumab antibodies and the 

occurrence of adverse events.  

 

Paediatric population  

 

The European Medicines Agency has deferred the obligation to submit the results of the studies with 

adalimumab in one or more subsets of the paediatric population in ulcerative colitis and non-infectious 

uveitis, see section 4.2 for information on paediatric use. 

 

5.2  Pharmacokinetic properties  

 

Absorption and distribution  

 

After subcutaneous administration of a single 40 mg dose, absorption and distribution of adalimumab 

was slow, with peak serum concentrations being reached about 5 days after administration. The 

average absolute bioavailability of adalimumab estimated from three studies following a single 40 mg 

subcutaneous dose was 64%. After single intravenous doses ranging from 0.25 to 10 mg/kg, 

concentrations were dose proportional. After doses of 0.5 mg/kg (~40 mg), clearances ranged from 

11 to 15 mL/hour, the distribution volume (Vss) ranged from 5 to 6 litres and the mean terminal phase 

half-life was approximately two weeks. Adalimumab concentrations in the synovial fluid from several 

rheumatoid arthritis patients ranged from 31-96% of those in serum.  

 

Following subcutaneous administration of 40 mg of adalimumab every other week in adult rheumatoid 

arthritis (RA) patients the mean steady-state trough concentrations were approximately 5 μg/mL 

(without concomitant methotrexate) and 8 to 9 μg/mL (with concomitant methotrexate), respectively. 

The serum adalimumab trough levels at steady-state increased roughly proportionally with dose 

following 20, 40 and 80 mg subcutaneous dosing every other week and every week.  

 

Following the administration of 24 mg/m2 (up to a maximum of 40 mg) subcutaneously every other 

week to patients with enthesitis-related arthritis who were 6 to 17 years, the mean trough steady-state 

(values measured at week 24) serum adalimumab concentrations were 8.8 ± 6.6 µg/mL for 

adalimumab without concomitant methotrexate and 11.8 ± 4.3 µg/mL with concomitant methotrexate. 

 

In adult patients with psoriasis, the mean steady-state trough concentration was 5 μg/mL during 

adalimumab 40 mg every other week monotherapy treatment.  

 

Following the administration of 0.8 mg/kg (up to a maximum of 40 mg) subcutaneously every other 

week to paediatric patients with chronic plaque psoriasis, the mean ± SD steady-state adalimumab 

trough concentration was approximately 7.4 ± 5.8 μg/mL (79% CV). 

 

In patients with hidradenitis suppurativa, a dose of 160 mg adalimumab on week 0 followed by 80 mg 

on week 2 achieved serum adalimumab trough concentrations of approximately 7 to 8 μg/mL at week 

2 and week 4. The mean steady-state trough concentration at week 12 through week 36 were 

approximately 8 to 10 μg/mL during adalimumab 40 mg every week treatment.  

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In patients with Crohn’s disease, the loading dose of 80 mg adalimumab on week 0 followed by 40 mg 

adalimumab on week 2 achieves serum adalimumab trough concentrations of approximately 

5.5 μg/mL during the induction period. A loading dose of 160 mg adalimumab on week 0 followed by 

80 mg adalimumab on week 2 achieves serum adalimumab trough concentrations of approximately 

12 μg/mL during the induction period. Mean steady-state trough levels of approximately 7 μg/mL 

were observed in Crohn’s disease patients who received a maintenance dose of 40 mg adalimumab 

every other week. 

 

In paediatric patients with moderate to severe CD, the open-label adalimumab induction dose was 

160/80 mg or 80/40 mg at weeks 0 and 2, respectively, dependent on a body weight cut-off of 40 kg. 

At week 4, patients were randomised 1:1 to either the Standard Dose (40/20 mg eow) or Low Dose 

(20/10 mg eow) maintenance treatment groups based on their body weight. The mean (±SD) serum 

adalimumab trough concentrations achieved at week 4 were 15.7 ± 6.6 μg/mL for patients ≥ 40 kg 

(160/80 mg) and 10.6 ± 6.1 μg/mL for patients < 40 kg (80/40 mg).  

 

For patients who stayed on their randomised therapy, the mean (±SD) adalimumab trough 

concentrations at week 52 were 9.5 ± 5.6 μg/mL for the standard dose group and 3.5 ± 2.2 μg/mL for 

the low dose group. The mean trough concentrations were maintained in patients who continued to 

receive adalimumab treatment every other week for 52 weeks. For patients who dose escalated from 

every other week to weekly regimen, the mean (±SD) serum concentrations of adalimumab at week 52 

were 15.3 ± 11.4 μg/mL (40/20 mg, weekly) and 6.7 ± 3.5 μg/mL (20/10 mg, weekly).  

 

In patients with ulcerative colitis, a loading dose of 160 mg adalimumab on week 0 followed by 80 mg 

adalimumab on week 2 achieves serum adalimumab trough concentrations of approximately 12 μg/mL 

during the induction period. Mean steady-state trough levels of approximately 8 μg/mL were observed 

in ulcerative colitis patients who received a maintenance dose of 40 mg adalimumab every other week. 

 

In patients with uveitis, a loading dose of 80 mg adalimumab on week 0 followed by 40 mg 

adalimumab every other week starting at week 1, resulted in mean steady-state concentrations of 

approximately 8 to 10 μg/mL. 

 

Elimination  

 

Population pharmacokinetic analyses with data from over 1,300 RA patients revealed a trend toward 

higher apparent clearance of adalimumab with increasing body weight. After adjustment for weight 

differences, gender and age appeared to have a minimal effect on adalimumab clearance. The serum 

levels of free adalimumab (not bound to anti-adalimumab antibodies, AAA) were observed to be 

lower in patients with measurable AAA.  

 

Hepatic or renal impairment  

 

Adalimumab has not been studied in patients with hepatic or renal impairment.  

 

5.3  Preclinical safety data  

 

Non-clinical data reveal no special hazard for humans based on studies of single dose toxicity, 

repeated dose toxicity, and genotoxicity.  

 

An embryo-foetal developmental toxicity/perinatal developmental study has been performed in 

Cynomolgus monkeys at 0, 30 and 100 mg/kg (9-17 monkeys/group) and has revealed no evidence of 

harm to the foetuses due to adalimumab. Neither carcinogenicity studies, nor a standard assessment of 

fertility and postnatal toxicity, were performed with adalimumab due to the lack of appropriate models 

for an antibody with limited cross-reactivity to rodent TNF and to the development of neutralising 

antibodies in rodents.  

 

 

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6.  PHARMACEUTICAL PARTICULARS  

 

6.1  List of excipients  

 

Glacial acetic acid  

Sucrose  

Polysorbate 80 

Sodium hydroxide (for pH adjustment) 

Water for injections 

 

6.2  Incompatibilities  

 

In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal 

products.  

 

6.3  Shelf life  

 

2 years  

 

6.4  Special precautions for storage  

 

Store in a refrigerator (2°C – 8°C).  

Do not freeze.  

Keep SOLYMBIC in the outer carton in order to protect from light. 

 

The pre-filled syringe or pre-filled pen may be stored at temperatures up to a maximum of 25°C for a 

period of up to 14 days. The pre-filled syringe or pre-filled pen must be protected from light, and 

discarded if not used within the 14-day period. 

 

6.5  Nature and contents of container  

 

SOLYMBIC 20 mg solution for injection in pre-filled syringe 

0.4 mL solution in pre-filled syringe (type I glass) with a plunger stopper (bromobutyl rubber) and a 

stainless steel needle with a needle shield (thermoplastic elastomer). The needle cover of the pre-filled 

syringe is made from dry natural rubber (a derivative of latex) (see section 4.4). 

 

Packs size of one pre-filled syringe. 

 

SOLYMBIC 40 mg solution for injection in pre-filled syringe 

0.8 mL solution in pre-filled syringe (type I glass) with a plunger stopper (bromobutyl rubber) and a 

stainless steel needle with a needle shield (thermoplastic elastomer). The needle cover of the pre-filled 

syringe is made from dry natural rubber (a derivative of latex) (see section 4.4). 
 

Packs sizes of one, two, four and six pre-filled syringes. 

Not all pack sizes may be marketed. 

 

SOLYMBIC 40 mg solution for injection in pre-filled pen 

0.8 mL solution for injection in pre-filled pen for patient use containing a pre-filled syringe (type I 

glass). The pen is a single use, disposable, handheld, mechanical injection device. The needle cover of 

the pre-filled pen is made from dry natural rubber (a derivative of latex) (see section 4.4). 

 

Packs sizes of one, two, four and six pre-filled pens. 

Not all pack sizes may be marketed. 

 

6.6  Special precautions for disposal and other handling 

 

Detailed instructions for use are provided in the package leaflet.  

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44 

 

Any unused medicinal product or waste material should be disposed of in accordance with local 

requirements.  

 

 

7.  MARKETING AUTHORISATION HOLDER  

 

Amgen Europe B.V. 

Minervum 7061 

NL-4817 ZK Breda 

The Netherlands 

 

 

8.  MARKETING AUTHORISATION NUMBER(S) 

 

SOLYMBIC 20 mg solution for injection in pre-filled syringe 

EU/1/16/1163/001 – 1 pack 

SOLYMBIC 40 mg solution for injection in pre-filled syringe 

EU/1/16/1163/002 – 1 pack 

EU/1/16/1163/003 – 2 pack 

EU/1/16/1163/004 – 4 pack  

EU/1/16/1163/005 – 6 pack  

SOLYMBIC 40 mg solution for injection in pre-filled pen  

EU/1/16/1163/006 – 1 pack 

EU/1/16/1163/007 – 2 pack 

EU/1/16/1163/008 – 4 pack  

EU/1/16/1163/009 – 6 pack 

 

 

9.  DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION  

 

Date of first authorisation: 22 March 2017 

 

 

10.  DATE OF REVISION OF THE TEXT  

 

 

 

Detailed information on this medicinal product is available on the website of the European Medicines 

Agency http://www.ema.europa.eu 

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45 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

ANNEX II 

 

A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND 

MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE  

 

B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE 

 

C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING 

AUTHORISATION 

 

D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND 

EFFECTIVE USE OF THE MEDICINAL PRODUCT 

 

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A.  MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND 

MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE 

 

Name and address of the manufacturer of the biological active substance  

Amgen Inc 

One Amgen Center Drive 

Thousand Oaks, California 

91320  

United States 

 

Name and address of the manufacturers responsible for batch release 

Amgen Europe B.V. 

Minervum 7061 

4817 ZK Breda 

The Netherlands 

 

Amgen Technology Ireland UC 

Pottery Road 

Dun Laoghaire, Co Dublin 

Ireland 

 

Amgen NV 

Telecomlaan 5-7 

1831 Diegem 

Belgium 

 

The printed package leaflet of the medicinal product must state the name and address of the 

manufacturer responsible for the release of the concerned batch. 

 

 

B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE 

 

Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product 

Characteristics, section 4.2). 

 

 

C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING 

AUTHORISATION  

 

• Periodic safety update reports  
 

The requirements for submission of periodic safety update reports for this medicinal product are set 

out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 

2001/83/EC and any subsequent updates published on the European medicines web-portal. 

 

 

D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND 

EFFECTIVE USE OF THE MEDICINAL PRODUCT 

 

• Risk Management Plan (RMP) 
 

The MAH shall perform the required pharmacovigilance activities and interventions detailed in the 

agreed RMP presented in Module 1.8.2 of the marketing authorisation and any agreed subsequent 

updates of the RMP. 

 

An updated RMP should be submitted: 

• At the request of the European Medicines Agency; 

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47 

• Whenever the risk management system is modified, especially as the result of new information 
being received that may lead to a significant change to the benefit/risk profile or as the result of 

an important (pharmacovigilance or risk minimisation) milestone being reached.  

 

• Additional risk minimisation measures  
 

Prior to launch of Solymbic in each Member State the Marketing Authorisation Holder (MAH) must 

agree about the content and format of the educational programme, including communication media, 

distribution modalities, and any other aspects of the programme, with the National Competent 

Authority.  

 

The MAH shall ensure that in each Member State where Solymbic is marketed, all healthcare 

professionals who are expected to prescribe Solymbic have are provided with the following 

educational package: 

• Physician educational material 

• Patient information pack 
 

The physician educational material should contain: 

• The Summary of Product Characteristics 

• Guide for healthcare professionals 

• Patient alert card 
 

The Guide for healthcare professionals shall contain the following key elements: 

• Relevant information on the safety concerns of serious infections, sepsis, tuberculosis and 
opportunistic infections; congestive heart failure; demyelinating disorders; malignancies to be 

addressed by the additional risk minimisation measures (e.g. seriousness, severity, frequency, 

time to onset, reversibility of the AE as applicable). 

 

The patient alert card shall contain the following key messages:  

• A warning message for HCPs treating the patient at any time, including in conditions of 
emergency, that the patient is using Solymbic. 

• That Solymbic treatment may increase the potential risks of serious infections, sepsis, 
tuberculosis and opportunistic infections; congestive heart failure; demyelinating disorders; 

malignancies. 

• Signs or symptoms of the safety concern and when to seek attention from a HCP 

• Contact details of the prescriber  
 

The patient information pack should contain: 

• Patient information leaflet 
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48 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

ANNEX III 

 

LABELLING AND PACKAGE LEAFLET 

 

  

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49 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

A. LABELLING 

  

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PARTICULARS TO APPEAR ON THE OUTER PACKAGING  

 

CARTON PRE-FILLED SYRINGE 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

SOLYMBIC 20 mg solution for injection in pre-filled syringe 

adalimumab 

 

 

2. STATEMENT OF ACTIVE SUBSTANCE(S) 

 

Each pre-filled syringe contains 20 mg of adalimumab in 0.4 mL of solution. 

 

 

3. LIST OF EXCIPIENTS 

 

Glacial acetic acid, sucrose, polysorbate 80, sodium hydroxide and water for injection.  

 

 

4. PHARMACEUTICAL FORM AND CONTENTS 

 

Solution for injection. 

1 pre-filled syringe. 

 

 

5. METHOD AND ROUTE(S) OF ADMINISTRATION 

 

For subcutaneous use. 

Read the package leaflet before use. 

Single use only. 

 

 

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 

 

Keep out of the sight and reach of children. 

 

 

7. OTHER SPECIAL WARNING(S), IF NECESSARY 

 

Contains latex, read the package leaflet before use. 

 

 

8. EXPIRY DATE 

 

EXP  

 

 

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9. SPECIAL STORAGE CONDITIONS 

 

Store in a refrigerator. 

Do not freeze. 

Do not shake. 

Store in the original carton in order to protect from light. 

 

 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 

APPROPRIATE 

 

 

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 

 

Amgen Europe B.V. 

Minervum 7061, 

NL-4817 ZK Breda, 

The Netherlands  

 

 

12. MARKETING AUTHORISATION NUMBER(S)  

 

EU/1/16/1163/001 

 

 

13. BATCH NUMBER 

 

Lot 

 

 

14. GENERAL CLASSIFICATION FOR SUPPLY 

 

 

15. INSTRUCTIONS ON USE 

 

 

16. INFORMATION IN BRAILLE 

 

SOLYMBIC 20 mg syringe 

 

 

17. UNIQUE IDENTIFIER – 2D BARCODE 

 

2D barcode carrying the unique identifier included. 

 

 

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 

 

PC 

SN 

NN 

  

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MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 

 

LABEL PRE-FILLED SYRINGE 

 

 

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 

 

SOLYMBIC 20 mg injection 

adalimumab 

SC 

 

 

2. METHOD OF ADMINISTRATION 

 

 

3. EXPIRY DATE 

 

EXP  

 

 

4. BATCH NUMBER  

 

Lot 

 

 

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 

 

0.4 mL 

 

 

6. OTHER 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING  

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CARTON PRE-FILLED SYRINGE 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

SOLYMBIC 40 mg solution for injection in pre-filled syringe 

adalimumab 

 

 

2. STATEMENT OF ACTIVE SUBSTANCE(S) 

 

Each pre-filled syringe contains 40 mg of adalimumab in 0.8 mL of solution. 

 

 

3. LIST OF EXCIPIENTS 

 

Glacial acetic acid, sucrose, polysorbate 80, sodium hydroxide and water for injection.  

 

 

4. PHARMACEUTICAL FORM AND CONTENTS 

 

Solution for injection. 

1 pre-filled syringe. 

2 pre-filled syringes. 

4 pre-filled syringes. 

6 pre-filled syringes. 

 

 

5. METHOD AND ROUTE(S) OF ADMINISTRATION 

 

For subcutaneous use. 

Read the package leaflet before use. 

Single use only. 

 

 

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 

 

Keep out of the sight and reach of children. 

 

 

7. OTHER SPECIAL WARNING(S), IF NECESSARY 

 

Contains latex, read the package leaflet before use. 

 

 

8. EXPIRY DATE 

 

EXP  

 

 

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9. SPECIAL STORAGE CONDITIONS 

 

Store in a refrigerator. 

Do not freeze. 

Do not shake. 

Store in the original carton in order to protect from light. 

 

 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 

APPROPRIATE 

 

 

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 

 

Amgen Europe B.V. 

Minervum 7061, 

NL-4817 ZK Breda, 

The Netherlands  

 

 

12. MARKETING AUTHORISATION NUMBER(S)  

 

EU/1/16/1163/002 1 pack 

EU/1/16/1163/003 2 pack 

EU/1/16/1163/004 4 pack 

EU/1/16/1163/005 6 pack 

 
 

13. BATCH NUMBER  

 

Lot 

 

 

14. GENERAL CLASSIFICATION FOR SUPPLY 

 

 

15. INSTRUCTIONS ON USE 

 

 

16. INFORMATION IN BRAILLE 

 

SOLYMBIC 40 mg syringe 

 

 

17. UNIQUE IDENTIFIER – 2D BARCODE 

 

2D barcode carrying the unique identifier included. 

 

 

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18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 

 

PC 

SN 

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MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 

 

LABEL PRE-FILLED SYRINGE 

 

 

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 

 

SOLYMBIC 40 mg injection 

adalimumab 

SC 

 

 

2. METHOD OF ADMINISTRATION 

 

 

3. EXPIRY DATE 

 

EXP  

 

 

4. BATCH NUMBER  

 

Lot 

 

 

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 

 

0.8 mL 

 

 

6. OTHER 

 

 

 

  

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PARTICULARS TO APPEAR ON THE OUTER PACKAGING  

 

CARTON PRE-FILLED PEN 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

SOLYMBIC 40 mg solution for injection in pre-filled pen 

adalimumab 

 

 

2. STATEMENT OF ACTIVE SUBSTANCE(S) 

 

Each pre-filled pen contains 40 mg of adalimumab in 0.8 mL of solution. 

 

 

3. LIST OF EXCIPIENTS 

 

Glacial acetic acid, sucrose, polysorbate 80, sodium hydroxide and water for injection. 

 

 

4. PHARMACEUTICAL FORM AND CONTENTS 

 

Solution for injection. 

1 SureClick pre-filled pen. 

2 SureClick pre-filled pens. 

4 SureClick pre-filled pens. 

6 SureClick pre-filled pens. 

 

 

5. METHOD AND ROUTE(S) OF ADMINISTRATION 

 

For subcutaneous use. 

Read the package leaflet before use. 

Single use only. 

 

 

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 

 

Keep out of the sight and reach of children. 

 

 

7. OTHER SPECIAL WARNING(S), IF NECESSARY 

 

Contains latex, read the package leaflet before use. 

 

 

8. EXPIRY DATE 

 

EXP  

 

 

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9. SPECIAL STORAGE CONDITIONS 

 

Store in a refrigerator. 

Do not freeze. 

Do not shake. 

Store in the original carton in order to protect from light. 

 

 

 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 

APPROPRIATE 

 

 

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 

 

Amgen Europe B.V. 

Minervum 7061, 

NL-4817 ZK Breda, 

The Netherlands  

 

 

12. MARKETING AUTHORISATION NUMBER(S)  

 

EU/1/16/1163/006 1 pack 

EU/1/16/1163/007 2 pack 

EU/1/16/1163/008 4 pack 

EU/1/16/1163/009 6 pack 

 

 

13. BATCH NUMBER  

 

Lot 

 

 

14. GENERAL CLASSIFICATION FOR SUPPLY 

 

 

15. INSTRUCTIONS ON USE 

 

 

16. INFORMATION IN BRAILLE 

 

SOLYMBIC 40 mg pen 

 

 

17. UNIQUE IDENTIFIER – 2D BARCODE 

 

2D barcode carrying the unique identifier included. 

 

 

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18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 

 

PC 

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MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 

 

LABEL PRE-FILLED PEN 

 

 

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 

 

SOLYMBIC 40 mg injection 

adalimumab 

SC 

 

 

2. METHOD OF ADMINISTRATION 

 

 

3. EXPIRY DATE 

 

EXP  

 

 

4. BATCH NUMBER  

 

Lot 

 

 

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 

 

0.8 mL 

 

 

6. OTHER 

 

 

  

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B. PACKAGE LEAFLET 

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Package leaflet: Information for the user 

 

SOLYMBIC 20 mg solution for injection in pre-filled syringe 

SOLYMBIC 40 mg solution for injection in pre-filled syringe 

adalimumab 

 

This medicine is subject to additional monitoring. This will allow quick identification of new 

safety information. You can help by reporting any side effects you may get. See the end of section 4 

for how to report side effects. 

 

Read all of this leaflet carefully before you start using this medicine because it contains 

important information for you. 

- Keep this leaflet. You may need to read it again.  
- Your doctor will also give you a Patient Alert Card, which contains important safety 

information that you need to be aware of before you are given SOLYMBIC and during 

treatment with SOLYMBIC. Keep this Patient Alert Card with you.  

- If you have any further questions, ask your doctor or pharmacist. 
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, 

even if their signs of illness are the same as yours.  

- If you get any side effects, talk to your doctor or pharmacist. This includes any possible side 

effects not listed in this leaflet (see section 4). 

 

What is in this leaflet 

 

1. What SOLYMBIC is and what it is used for  

2. What you need to know before you use SOLYMBIC  

3. How to use SOLYMBIC 

4. Possible side effects  

5. How to store SOLYMBIC  

6. Contents of the pack and other information 

 

 

1. What SOLYMBIC is and what it is used for 

 

SOLYMBIC contains the active substance adalimumab, a selective immuno suppressive agent.  

 

SOLYMBIC is intended for treatment of rheumatoid arthritis, enthesitis-related arthritis in children 6 

to 17 years, ankylosing spondylitis, axial spondyloarthritis without radiographic evidence of 

ankylosing spondylitis, psoriatic arthritis, psoriasis, hidradenitis suppurativa, paediatric psoriasis 

(patients weighing either 23 to 28 kg or 47 kg and greater), Crohn’s disease in adults and children, 

ulcerative colitis and non-infectious uveitis affecting the back of the eye. It is a medicine that 

decreases the inflammation process of these diseases. The active ingredient, adalimumab, is a human 

monoclonal antibody produced by cultured cells. Monoclonal antibodies are proteins that recognise 

and bind to other unique proteins.  

 

Adalimumab binds to a specific protein (tumour necrosis factor or TNFα), which is present at 

increased levels in inflammatory diseases such as rheumatoid arthritis, enthesitis-related arthritis, 

ankylosing spondylitis, axial spondyloarthritis without radiographic evidence of ankylosing 

spondylitis, psoriatic arthritis, psoriasis, hidradenitis suppurativa, Crohn’s disease, ulcerative colitis 

and non-infectious uveitis affecting the back of the eye.  

 

Rheumatoid arthritis  

 

Rheumatoid arthritis is an inflammatory disease of the joints.  

 

SOLYMBIC is used to treat rheumatoid arthritis in adults. If you have moderate to severe active 

rheumatoid arthritis, you may first be given other disease-modifying medicines, such as methotrexate. 

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If you do not respond well enough to these medicines, you will be given SOLYMBIC to treat your 

rheumatoid arthritis.  

 

SOLYMBIC can also be used to treat severe, active and progressive rheumatoid arthritis without 

previous methotrexate treatment. 

 

SOLYMBIC slows down the damage to the cartilage and bone of the joints caused by the disease and 

to improve physical function.  

 

Usually, SOLYMBIC is used with methotrexate. If your doctor determines that methotrexate is 

inappropriate, SOLYMBIC can be given alone. 

 

Enthesitis-related arthritis  

 

Enthesitis-related arthritis is an inflammatory disease of the joints. 

 

SOLYMBIC is used to treat enthesitis-related arthritis in children and adolescents aged 6 to 17 years. 

You may first be given other disease-modifying medicines, such as methotrexate. If you do not 

respond well enough to these medicines, you will be given SOLYMBIC to treat your enthesitis-related 

arthritis.  

 

Ankylosing spondylitis and axial spondyloarthritis without radiographic evidence of ankylosing 

spondylitis  

 

Ankylosing spondylitis and axial spondyloarthritis without radiographic evidence of ankylosing 

spondylitis, are inflammatory diseases of the spine.  

 

SOLYMBIC is used to treat ankylosing spondylitis and axial spondyloarthritis without radiographic 

evidence of ankylosing spondylitis in adults. If you have ankylosing spondylitis or axial 

spondyloarthritis without radiographic evidence of ankylosing spondylitis, you will first be given other 

medicines. If you do not respond well enough to these medicines, you will be given SOLYMBIC to 

reduce the signs and symptoms of your disease.  

 

Psoriatic arthritis  

 

Psoriatic arthritis is an inflammation of the joints associated with psoriasis.  

 

SOLYMBIC is used to treat psoriatic arthritis in adults. SOLYMBIC slows down the damage to the 

cartilage and bone of the joints caused by the disease and to improve physical function.  

 

Plaque psoriasis in adults and children 

 

Plaque psoriasis is a skin condition that causes red, flaky, crusty patches of skin covered with silvery 

scales. Plaque psoriasis can also affect the nails, causing them to crumble, become thickened and lift 

away from the nail bed which can be painful. Psoriasis is believed to be caused by a problem with the 

body’s immune system that leads to an increased production of skin cells. 

 

SOLYMBIC is used to treat moderate to severe plaque psoriasis in adults. SOLYMBIC is also used to 

treat severe plaque psoriasis in children and adolescents weighing either 23 to 28 kg or 47 kg or 

greater for whom topical therapy and phototherapies have either not worked very well or are not 

suitable. 

 

Hidradenitis suppurativa 

 

Hidradenitis suppurativa (sometimes called acne inversa) is a chronic and often painful inflammatory 

skin disease. Symptoms may include tender nodules (lumps) and abscesses (boils) that may leak pus. 

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It most commonly affects specific areas of the skin, such as under the breasts, the armpits, inner 

thighs, groin and buttocks. Scarring may also occur in affected areas. 

 

SOLYMBIC is used to treat hidradenitis suppurativa in adults. SOLYMBIC can reduce the number of 

nodules and abscesses you have, and the pain that is often associated with the disease. 

 

Crohn’s disease in adults and children  

 

Crohn’s disease is an inflammatory disease of the digestive tract. 

 
SOLYMBIC is used to treat Crohn’s disease in adults and children aged 6 to 17 years. If you have 

Crohn’s disease you will first be given other medicines. If you do not respond well enough to these 

medicines, you will be given SOLYMBIC to reduce the signs and symptoms of your Crohn’s disease.  

 

Ulcerative colitis  

 

Ulcerative colitis is an inflammatory disease of the bowel. 

 

SOLYMBIC is used to treat ulcerative colitis in adults. If you have ulcerative colitis you will first be 

given other medicines. If you do not respond well enough to these medicines, you will be given 

SOLYMBIC to reduce the signs and symptoms of your disease. 

 

Non-infectious uveitis affecting the back of the eye 

 

Non-infectious uveitis is an inflammatory disease affecting certain parts of the eye. SOLYMBIC is 

used to treat adults with non-infectious uveitis with inflammation affecting the back of the eye. This 

inflammation leads to a decrease of vision and/or the presence of floaters in the eye (black dots or 

wispy lines that move across the field of vision). SOLYMBIC works by reducing this inflammation. 

 

 

2. What you need to know before you use SOLYMBIC 

 

Do not use SOLYMBIC: 

 

- if you are allergic to adalimumab or any of the other ingredients of this medicine (listed in 

section 6). 

- if you have a severe infection, including active tuberculosis (see “Warnings and precautions”). 

It is important that you tell your doctor if you have symptoms of infections, e.g. fever, wounds, 

feeling tired, dental problems.  

- if you have moderate or severe heart failure. It is important to tell your doctor if you have had or 

have a serious heart condition (see “Warnings and precautions”).  

 

Warnings and precautions  

 

Talk to your doctor or pharmacist before using SOLYMBIC: 

 

- If you experience allergic reactions with symptoms such as chest tightness, wheezing, dizziness, 

swelling or rash do not inject more SOLYMBIC and contact your doctor immediately  since, in 

rare cases, these reactions can be life threatening.  
 

- If you have an infection, including long-term or localised infection (for example, leg ulcer) 

consult your doctor before starting SOLYMBIC. If you are unsure, please contact your doctor.  

 

- You might get infections more easily while you are receiving SOLYMBIC treatment. This risk 

may increase if your lung function is impaired. These infections may be serious and include 

tuberculosis, infections caused by viruses, fungi, parasites or bacteria, or other opportunistic 

infections and sepsis that may, in rare cases, be life-threatening. It is important to tell your 

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doctor if you get symptoms such as fever, wounds, feeling tired or dental problems. Your doctor 

may recommend temporary discontinuation of SOLYMBIC.  

 

- As cases of tuberculosis have been reported in patients treated with adalimumab, your doctor 

will check you for signs and symptoms of tuberculosis before starting SOLYMBIC. This will 

include a thorough medical evaluation including your medical history and appropriate screening 

tests (for example chest x-ray and a tuberculin test). The conduct and results of these tests 

should be recorded on your Patient Alert Card. It is very important that you tell your doctor if 

you have ever had tuberculosis, or if you have been in close contact with someone who has had 

tuberculosis. Tuberculosis can develop during therapy even if you have received preventative 

treatment for tuberculosis. If symptoms of tuberculosis (persistent cough, weight loss, 

listlessness, mild fever), or any other infection appear during or after therapy, tell your doctor 

immediately.  

 

- Advise your doctor if you reside or travel in regions where fungal infections such as 

histoplasmosis coccidioidomycosis or blastomycosis are endemic.  

 

- Advise your doctor if you have a history of recurrent infections or other conditions that increase 

the risk of infections.  

 

- Advise your doctor if you are a carrier of the hepatitis B virus (HBV), if you have active HBV 

or if you think you might be at risk of contracting HBV. Your doctor should test you for HBV. 

SOLYMBIC can cause reactivation of HBV in people who carry this virus. In some rare cases, 

especially if you are taking other medicines that suppress the immune system, reactivation of 

HBV can be life-threatening.  

 
- If you are over 65 years you may be more susceptible to infections while taking SOLYMBIC. 

You and your doctor should pay special attention to signs of infection while you are being 

treated with SOLYMBIC. It is important to tell your doctor if you get symptoms of infections, 

such as fever, wounds, feeling tired or dental problems. 

 

- If you are about to undergo surgery or dental procedures please inform your doctor that you are 

taking SOLYMBIC. Your doctor may recommend temporary discontinuation of SOLYMBIC. 

 

- If you have or develop demyelinating disease such as multiple sclerosis, your doctor will decide 

if you should receive or continue to receive SOLYMBIC. Tell your doctor immediately if you 

experience symptoms like changes in your vision, weakness in your arms or legs or numbness 

or tingling in any part of your body. 

 

- Certain vaccines may cause infections and should not be given while receiving SOLYMBIC. 

Please check with your doctor before you receive any vaccines. It is recommended that children, 

if possible, be brought up to date with all immunisations in agreement with current 

immunisation guidelines prior to initiating SOLYMBIC therapy. If you received SOLYMBIC 

while you were pregnant, your baby may be at higher risk for getting such an infection for up to 

approximately five months after the last dose you received during pregnancy. It is important that 

you tell your baby's doctors and other health care professionals about your SOLYMBIC use 

during your pregnancy so they can decide when your baby should receive any vaccine. 

 

- If you have mild heart failure and you are being treated with SOLYMBIC, your heart failure 

status must be closely monitored by your doctor. It is important to tell your doctor if you have 

had or have a serious heart condition. If you develop new or worsening symptoms of heart 

failure (e.g. shortness of breath, or swelling of your feet), you must contact your doctor 

immediately.  

 

- In some patients the body may fail to produce enough of the blood cells that help your body 

fight infections or help you to stop bleeding. If you develop a fever that does not go away, 

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bruise or bleed very easily or look very pale, call your doctor right away. Your doctor may 

decide to stop treatment. 

 

- There have been very rare cases of certain kinds of cancer in children and adult patients taking 

adalimumab or other TNF blockers. People with more serious rheumatoid arthritis that have had 

the disease for a long time may have a higher than average risk of getting lymphoma (a type of 

cancer that affects the lymph system), and leukaemia (a type of cancer that affects the blood and 

bone marrow). If you take SOLYMBIC the risk of getting lymphoma, leukaemia, or other 

cancers may increase. On rare occasions, a specific and severe type of lymphoma has been 

observed in some patients taking adalimumab. Some of those patients were also treated with 

azathioprine or 6-mercaptopurine. Tell your doctor if you are taking azathioprine or 

6-mercaptopurine with SOLYMBIC. In addition, cases of non-melanoma skin cancer have been 

observed in patients taking adalimumab. If new skin lesions appear during or after therapy or if 

existing lesions change appearance, tell your doctor. 

 

- There have been cases of cancers other than lymphoma in patients with a specific type of lung 

disease called Chronic Obstructive Pulmonary Disease (COPD) treated with another TNF 

blocker. If you have COPD, or are a heavy smoker, you should discuss with your doctor 

whether treatment with a TNF blocker is appropriate for you.  

 

The needle cover of the pre-filled syringe is made from dry natural rubber (a derivative of latex), 

which may cause allergic reactions. 

 

In order to improve the traceability of this medicine, your doctor or pharmacist should record the 

tradename and the lot number of the product you have been given in your patient file. You may also 

wish to make a note of these details in case you are asked for this information in the future. 

 

Children and adolescents 

 
- Vaccinations: if possible children should be up to date with all vaccinations before using 

SOLYMBIC. 

- Do not use the 20 mg or 40 mg pre-filled syringe if doses other than 20 mg or 40 mg are 

recommended. 

 

Other medicines and SOLYMBIC  

 

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other 

medicines. 

 

SOLYMBIC can be taken together with methotrexate or certain disease-modifying anti-rheumatic 

agents (sulfasalazine, hydroxychloroquine, leflunomide and injectable gold preparations), steroids or 

pain medications including non-steroidal anti-inflammatory drugs (NSAIDs).  

 

You should not take SOLYMBIC with medicines containing the active substance, anakinra or 

abatacept. If you have questions, please ask your doctor. 

 

Pregnancy and breast-feeding 

 

The effects of SOLYMBIC in pregnant women are not known and so the use of SOLYMBIC in 

pregnant women is not recommended. You are advised to avoid becoming pregnant and must use 

adequate contraception while using SOLYMBIC and for at least 5 months after the last SOLYMBIC 

treatment. If you become pregnant, you should consult your doctor.  

 

It is not known whether SOLYMBIC passes into breast milk.  

 

If you are a breast-feeding mother, you should stop breast-feeding during SOLYMBIC treatment and 

for at least 5 months after the last SOLYMBIC treatment. If you received SOLYMBIC during your 

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pregnancy, your baby may have a higher risk for getting an infection. It is important that you tell your 

baby’s doctors and other health care professionals about your SOLYMBIC use during your pregnancy 

before the baby receives any vaccine (for more information see section on vaccination). 

 

If you think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for 

advice before taking this medicine.  

 

Driving and using machines 

 

SOLYMBIC may have a minor influence on your ability to drive, cycle or use machines. Room 

spinning sensation and vision disturbances may occur after taking SOLYMBIC. 

 

SOLYMBIC contains sodium 

 

This medicine contains less than 1 mmol of sodium (23 mg) per 0.8 mL dose, i.e. essentially ‘sodium-

free’. 

 

 

3. How to use SOLYMBIC 

 

Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor 

or pharmacist if you are not sure. 

 

Adults with rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis or axial spondyloarthritis 

without radiographic evidence of ankylosing spondylitis  

 

SOLYMBIC is injected under the skin (subcutaneous use). The usual dose for adults with rheumatoid 

arthritis, ankylosing spondylitis, axial spondyloarthritis without radiographic evidence of ankylosing 
spondylitis, and for patients with psoriatic arthritis is 40 mg given every other week as a single dose.  

 

In rheumatoid arthritis, methotrexate is continued while using SOLYMBIC. If your doctor determines 

that methotrexate is inappropriate, SOLYMBIC can be given alone.  

 

If you have rheumatoid arthritis and you do not receive methotrexate with your SOLYMBIC therapy, 

your doctor may decide to give 40 mg every week. 

 

Children with enthesitis-related arthritis 

 

The recommended dose of SOLYMBIC for patients with enthesitis-related arthritis, aged 6 to 17 years 

depends on the height and weight of the child. Your child’s doctor will tell you the correct dose to use. 

 

Adults with psoriasis  

 

The usual dose for adults with psoriasis is an initial dose of 80 mg, followed by 40 mg given every 

other week starting one week after the initial dose. You should continue to inject SOLYMBIC for as 

long as your doctor has told you. Depending on your response, your doctor may increase the dose 

frequency to 40 mg every week. 

 

Children or adolescents with plaque psoriasis  

 

The recommended dose of SOLYMBIC for patients aged 4 to 17 years with plaque psoriasis depends 

on the weight of your child. SOLYMBIC should only be used in patients weighing either 23 to 28 kg 

or 47 kg and greater. Your child’s doctor will tell you the correct dose to use. 

 

Adults with hidradenitis suppurativa 

 

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The usual dose regimen for hidradenitis suppurativa is an initial dose of 160 mg (as four 40 mg 

injections in one day or two 40 mg injections per day for two consecutive days), followed by an 80 mg 

dose (as two 40 mg injections on the same day) two weeks later. After two further weeks, continue 

with a dose of 40 mg every week. It is recommended that you use an antiseptic wash daily on the 

affected areas. 

 

Adults with Crohn’s disease  

 

The usual dose regimen for Crohn’s disease is 80 mg initially followed by 40 mg every other week 

two weeks later. If a faster response is required, your doctor may prescribe an initial dose of 160 mg 

(as four 40 mg injections in one day or two 40 mg injections per day for two consecutive days), 

followed by 80 mg two weeks later, and thereafter as 40 mg every other week. Depending on your 

response, your doctor may increase the dose frequency to 40 mg every week.  

 

Children or adolescents with Crohn's disease  

 

Children or adolescents weighing less than 40 kg:  

 

The usual dose regimen is 40 mg initially followed by 20 mg two weeks later. If a faster response is 

required, your doctor may prescribe an initial dose of 80 mg (as two 40 mg injections in 1 day) 

followed by 40 mg two weeks later.  

 

Thereafter, the usual dose is 20 mg every other week. Depending on your response, your doctor may 

increase the dose frequency to 20 mg every week.  

 

Children or adolescents weighing 40 kg or more:  

 

The usual dose regimen is 80 mg initially followed by 40 mg two weeks later. If a faster response is 

required, your doctor may prescribe an initial dose of 160 mg (as four 40 mg injections in 1 day or as 

two 40 mg injections per day for 2 consecutive days) followed by 80 mg two weeks later. 

 

Thereafter, the usual dose is 40 mg every other week. Depending on your response, your doctor may 

increase the dose frequency to 40 mg every week.  

 

Adults with ulcerative colitis  

 

The usual SOLYMBIC dose for adults with ulcerative colitis is 160 mg initially (dose can be 

administered as four 40 mg injections in one day or as two 40 mg injections per day for two 

consecutive days) followed by 80 mg two weeks later, then 40 mg every other week. Depending on 

your response, your doctor may increase the dose to 40 mg every week. 

 

Adults with non-infectious uveitis 

 

The usual dose for adults with non-infectious uveitis is an initial dose of 80 mg, followed by 40 mg 

given every other week starting one week after the initial dose. You should continue to inject 

SOLYMBIC for as long as your doctor has told you. 

 

In non-infectious uveitis, corticosteroids or other medicines that influence the immune system may be 

continued while using SOLYMBIC. SOLYMBIC can also be given alone. 
 

Method and route of administration  

 

SOLYMBIC is administered by injection under the skin (subcutaneous injection).  

 

If you use more SOLYMBIC than you should 

 

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If you accidentally inject SOLYMBIC more frequently than told to by your doctor or pharmacist, you 

should call your doctor or pharmacist and tell him/her that you have taken more. Always take the outer 

carton of this medicine with you, even if it is empty. 

 

If you forget to use SOLYMBIC 

 

If you forget to give yourself an injection, you should inject it as soon as you remember. Then take 

your next dose as you would have on your originally scheduled day, had you not forgotten a dose. 

 

If you stop using SOLYMBIC 

 

The decision to stop using SOLYMBIC should be discussed with your doctor. Your symptoms may 

return upon discontinuation. 

 

If you have any further questions on the use of this medicine, ask your doctor or pharmacist. 

 

 

4. Possible side effects 

 

Like all medicines, this medicine can cause side effects, although not everybody gets them. Most side 

effects are mild to moderate. However, some may be serious and require treatment. Side effects may 

occur at least up to 4 months after the last SOLYMBIC injection.  

 

Tell your doctor immediately if you notice any of the following:  

• severe rash, hives or other signs of allergic reaction;  

• swollen face, hands, feet;  

• trouble breathing, swallowing;  

• shortness of breath with exertion or upon lying down or swelling of the feet. 
 

Tell your doctor as soon as possible if you notice any of the following:  

• signs of infection such as fever, feeling sick, wounds, dental problems, burning on urination;  

• feeling weak or tired;  

• coughing;  

• tingling;  

• numbness;  

• double vision;  

• arm or leg weakness;  

• a bump or open sore that doesn't heal; 

• signs and symptoms suggestive of blood disorders such as persistent fever, bruising, bleeding, 

paleness. 

 

The symptoms described above can be signs of the below listed side effects, which have been 

observed with adalimumab:  

 

Very common side effects (may affect more than 1 in 10 people):  

• injection site reactions (including pain, swelling, redness or itching);  

• respiratory tract infections (including cold, runny nose, sinus infection, pneumonia);  

• headache;  

• abdominal pain;  

• nausea and vomiting; 

• rash;  

• musculoskeletal pain.  
 

Common side effects (may affect up to 1 in 10 people):  

• serious infections (including blood poisoning and influenza);  

• skin infections (including cellulitis and shingles);  

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• ear infections;  

• oral infections (including tooth infections and cold sores);  

• reproductive tract infections;  

• urinary tract infection;  

• fungal infections;  

• joint infections;  

• benign tumours;  

• skin cancer;  

• allergic reactions (including seasonal allergy);  

• dehydration;  

• mood swings (including depression);  

• anxiety;  

• difficulty sleeping;  

• sensation disorders such as tingling, prickling or numbness;  

• migraine;  

• nerve root compression (including low back pain and leg pain);  

• vision disturbances;  

• eye inflammation;  

• inflammation of the eye lid and eye swelling;  

• vertigo;  

• sensation of heart beating rapidly;  

• high blood pressure;  

• flushing;  

• haematoma;  

• cough;  

• asthma;  

• shortness of breath;  

• gastrointestinal bleeding;  

• dyspepsia (indigestion, bloating, heart burn);  

• acid reflux disease;  

• sicca syndrome (including dry eyes and dry mouth);  

• itching;  

• itchy rash;  

• bruising;  

• inflammation of the skin (such as eczema);  

• breaking of finger nails and toe nails;  

• increased sweating;  

• hair loss;  

• new onset or worsening of psoriasis;  

• muscle spasms;  

• blood in urine;  

• kidney problems;  

• chest pain;  

• oedema;  

• fever;  

• reduction in blood platelets which increases risk of bleeding or bruising; 

• impaired healing.  

 

Uncommon side effects (may affect up to 1 in 100 people):  

• opportunistic infections (which include tuberculosis and other infections that occur when 

resistance to disease is lowered);  

• neurological infections (including viral meningitis);  

• eye infections;  

• bacterial infections;  

• diverticulitis (inflammation and infection of the large intestine);  

• cancer;  

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• cancer that affects the lymph system;  

• melanoma;  

• immune disorders that could affect the lungs, skin and lymph nodes (most commonly presenting 

as sarcoidosis);  

• vasculitis (inflammation of blood vessels); 

• tremor;  

• neuropathy;  

• stroke;  

• double vision;  

• hearing loss, buzzing;  

• sensation of heart beating irregularly such as skipped beats;  

• heart problems that can cause shortness of breath or ankle swelling;  

• heart attack;  

• a sac in the wall of a major artery, inflammation and clot of a vein, blockage of a blood vessel;  

• lung diseases causing shortness of breath (including inflammation);  

• pulmonary embolism (blockage in an artery of the lung);  

• pleural effusion (abnormal collection of fluid in the pleural space);  

• inflammation of the pancreas which causes severe pain in the abdomen and back;  

• difficulty in swallowing;  

• facial oedema;  

• gallbladder inflammation, gallbladder stones;  

• fatty liver;  

• night sweats;  

• scar;  

• abnormal muscle breakdown;  

• systemic lupus erythematosus (including inflammation of skin, heart, lung, joints and other 

organ systems);  

• sleep interruptions;  

• impotence;  

• inflammations.  
 

Rare side effects (may affect up to 1 in 1,000 people):  

• leukaemia (cancer affecting the blood and bone marrow);  

• severe allergic reaction with shock;  

• multiple sclerosis;  

• nerve disorders (such as eye nerve inflammation and Guillain-Barré syndrome that may cause 

muscle weakness, abnormal sensations, tingling in the arms and upper body);  

• heart stops pumping;  

• pulmonary fibrosis (scarring of the lung);  

• intestinal perforation; 

• hepatitis;  
• reactivation of hepatitis B;  

• autoimmune hepatitis (inflammation of the liver caused by the body's own immune system); 

• cutaneous vasculitis (inflammation of blood vessels in the skin);  

• Stevens-Johnson syndrome (early symptoms include malaise, fever, headache and rash);  

• facial oedema associated with allergic reactions;  

• erythema multiforme (inflammatory skin rash);  

• lupus-like syndrome.  
 

Not known (frequency cannot be estimated from available data):  

• hepatosplenic T-cell lymphoma (a rare blood cancer that is often fatal);  

• Merkel cell carcinoma (a type of skin cancer);  

• liver failure;  

• worsening of a condition called dermatomyositis (seen as a skin rash accompanying muscle 

weakness).  

 

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Some side effects observed with adalimumab may not have symptoms and may only be discovered 

through blood tests. These include:  

 

Very common side effects (may affect more than 1 in 10 people):  

• low blood measurements for white blood cells;  

• low blood measurements for red blood cells;  

• increased lipids in the blood;  

• elevated liver enzymes.  
 

Common side effects (may affect up to 1 in 10 people):  

• high blood measurements for white blood cells;  

• low blood measurements for platelets;  

• increased uric acid in the blood;  

• abnormal blood measurements for sodium;  

• low blood measurements for calcium;  

• low blood measurements for phosphate;  

• high blood sugar;  

• high blood measurements for lactate dehydrogenase;  

• autoantibodies present in the blood.  
 

Rare side effects (may affect up to 1 in 1,000 people):  

• low blood measurements for white blood cells, red blood cells and platelet count.  
 

Not known (frequency cannot be estimated from available data):  

• liver failure.  

 
Reporting of side effects 

 

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects 

not listed in this leaflet. You can also report side effects directly via the national reporting system 

listed in Appendix V. By reporting side effects you can help provide more information on the safety of 

this medicine. 

 

 

5. How to store SOLYMBIC 

 

Keep this medicine out of the sight and reach of children. 

 

Do not use this medicine after the expiry date which is stated on the label and carton after EXP. The 

expiry date refers to the last day of that month. 

 

Store in a refrigerator (2C – 8C). Do not freeze.  

 

Store in the original carton in order to protect from light.  

 

A single SOLYMBIC pre-filled syringe may be stored at temperatures up to a maximum of 25°C for a 

period of up to 14 days. The pre-filled syringe must be protected from light, and discarded if not used 

within the 14-day period. 

 

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to 

throw away medicines you no longer use. These measures will help protect the environment.  

 

 

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73 

6. Contents of the pack and other information 

 

What SOLYMBIC contains  

- The active substance is adalimumab. Each pre-filled syringe contains 20 mg of adalimumab in 
0.4 mL of solution or 40 mg of adalimumab in 0.8 mL of solution. 

- The other ingredients are glacial acetic acid, sucrose, polysorbate 80, sodium hydroxide and 
water for injection. 

 

What SOLYMBIC looks like and contents of the pack 

 

SOLYMBIC is a clear and colourless to slightly yellow solution. 

 

Each pack contains 1 single-use 20 mg pre-filled syringe (with yellow plunger rod).  

Each pack contains 1, 2, 4 or 6 single-use 40 mg pre-filled syringes (with blue plunger rod). 

 

Marketing Authorisation Holder and Manufacturer 

Amgen Europe B.V.  

Minervum 7061  

NL-4817 ZK Breda  

The Netherlands 

 

Marketing Authorisation Holder 

Amgen Europe B.V.  

Minervum 7061  

NL-4817 ZK Breda  

The Netherlands 

 

Manufacturer 

Amgen Technology Ireland UC  

Pottery Road 

Dun Laoghaire 

Co Dublin 

Ireland 

 

Manufacturer 

Amgen NV 

Telecomlaan 5-7 

1831 Diegem 

Belgium  

 

For any information about this medicine, please contact the local representative of the Marketing 

Authorisation Holder: 

 

België/Belgique/Belgien 

s.a. Amgen n.v. 

Tel/Tél: +32 (0)2 7752711 

 

Lietuva 

Amgen Switzerland AG Vilniaus filialas 

Tel: +370 5 219 7474 

 

България 

Амджен България ЕООД 

Тел.: +359 (0)2 424 7440 

 

Luxembourg/Luxemburg 

s.a. Amgen  

Belgique/Belgien 

Tel/Tél: +32 (0)2 7752711 

 

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74 

Česká republika 

Amgen s.r.o. 

Tel: +420 221 773 500 

 

Magyarország 

Amgen Kft. 

Tel.: +36 1 35 44 700 

 

Danmark 

Amgen, filial af Amgen AB, Sverige 

Tlf: +45 39617500 

 

Malta 

Amgen B.V. 

The Netherlands 

Tel: +31 (0)76 5732500 

 

Deutschland 

AMGEN GmbH 

Tel.: +49 89 1490960 

 

Nederland 

Amgen B.V. 

Tel: +31 (0)76 5732500 

 

Eesti 

Amgen Switzerland AG Vilniaus filialas 

Tel: +372 586 09553 

 

Norge 

Amgen AB 

Tel: +47 23308000 

 

Ελλάδα 

Amgen Ελλάς Φαρμακευτικά Ε.Π.Ε.  

Τηλ.: +30 210 3447000 

 

Österreich 

Amgen GmbH  

Tel: +43 (0)1 50 217 

 

España 

Amgen S.A. 

Tel: +34 93 600 18 60  
 

Polska 

Amgen Biotechnologia Sp. z o.o. 

Tel.: +48 22 581 3000 

 

France 

Amgen S.A.S. 

Tél: +33 (0)9 69 363 363 

 

Portugal 

Amgen Biofarmacêutica, Lda. 

Tel: +351 21 4220550 

 

Hrvatska 

Amgen d.o.o. 

Tel: +385 (0)1 562 57 20 

 

România 

Amgen România SRL 

Tel: +4021 527 3000 

 

Ireland 

Amgen Limited 

United Kingdom 

Tel: +44 (0)1223 420305 
 

Slovenija 

AMGEN zdravila d.o.o. 

Tel: +386 (0)1 585 1767 

 

Ísland 

Vistor hf. 

Sími: +354 535 7000 

 

Slovenská republika 

Amgen Slovakia s.r.o. 

Tel: +421 2 321 114 49 

 

 

Italia 

Amgen S.r.l. 

Tel: +39 02 6241121 

 

Suomi/Finland 

Amgen AB, sivuliike Suomessa/Amgen AB, filial 

i Finland 

Puh/Tel: +358 (0)9 54900500 

 

Kύπρος 

C.A. Papaellinas Ltd 

Τηλ.: +357 22741 741 

 

Sverige 

Amgen AB  

Tel: +46 (0)8 6951100 

 

Latvija 

Amgen Switzerland AG Rīgas filiāle 

Tel: +371 257 25888 

 

United Kingdom 

Amgen Limited 

Tel: +44 (0)1223 420305 

 

 

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This leaflet was last revised in 

 

Other sources of information 

 

Detailed information on this medicine is available on the European Medicines Agency web site: 

http://www.ema.europa.eu. 

 

--------------------------------------------------------------------------------------------------------------------------- 

 

Instructions for use: 

SOLYMBIC single use pre-filled syringe 

For subcutaneous use 

 

Guide to parts 

 

Before use After use 

Plunger rod 

Finger flange  

Label and 

expiration date 

Syringe barrel  

Medicine 

Needle  

cap on 
 

 

 

Used plunger rod 

Finger flange 

Label and 

expiration date 

Used syringe barrel 

Used needle 

Needle cap off 
 

Important: Needle is inside 

 

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76 

Important 

Before you use a SOLYMBIC pre-filled syringe, read this important information: 

 

Using your SOLYMBIC pre-filled syringe 

● It is important that you do not try to give the injection unless you or your caregiver has 

received training. 

● Do not use a SOLYMBIC pre-filled syringe if it has been dropped on a hard surface. Part of 

the SOLYMBIC pre-filled syringe may be broken even if you cannot see the break. Use a new 

SOLYMBIC pre-filled syringe. 

● The needle cover of the SOLYMBIC pre-filled syringe is made from dry natural rubber, which 

contains latex. Tell your healthcare provider if you are allergic to latex. 

 

Step 1: Prepare 
 

A. Remove the number of SOLYMBIC pre-filled syringes you need from the package. 

 

Grab the syringe 

barrel to remove 

the syringe from 

the tray. 

  

 

 

Place your finger or thumb on 

edge of tray to secure it while 

you remove the syringe. 

Grab Here 

Put the original package with any unused syringes back in the refrigerator. 

 

For safety reasons: 

● Do not grasp the plunger rod. 

● Do not grasp the needle cap. 

● Do not remove the needle cap until you are ready to inject. 

● Do not remove the finger flange. This is part of the syringe. 

For a more comfortable injection, leave the syringe at room temperature for 15 to 30 minutes before 

injecting. 

● Do not put the syringe back in the refrigerator once it has reached room temperature. 

● Do not try to warm the syringe by using a heat source such as hot water or microwave. 

● Do not leave the syringe in direct sunlight. 

● Do not shake the syringe. 

Important: Always hold the pre-filled syringe by the syringe barrel. 

 

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77 

B. Inspect the SOLYMBIC pre-filled syringe. 

 Syringe barrel 

Label expiration 

date Plunger rod 

 
Needle cap on Medicine Finger flange 

 

Always hold the syringe by the syringe barrel. 

 

Make sure the medicine in the syringe is clear and colourless to slightly yellow. 

● Do not use the syringe if: 

 - The medicine is cloudy or discoloured or contains flakes, or particles. 
- Any part appears cracked or broken. 
- The needle cap is missing or not securely attached. 
- The expiration date printed on the label has passed. 

In all cases, use a new syringe. 

 

C. Gather all materials needed for your injection(s). 

Wash your hands thoroughly with soap and water.  

On a clean, well-lit work surface, place a new, pre-filled syringe. 

 

You will also need these additional items, as they are not included in the carton: 

● Alcohol wipes 

● Cotton ball or gauze pad 

● Plaster 

● Sharps disposal container 

 

  
 

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78 

D. Prepare and clean your injection site(s). 

 
Belly 

 

Thigh 

 

You can use: 

● Your thigh 

● Belly, except for a 2 inch (5 centimetres) area around your belly button 

 

Clean your injection site with an alcohol wipe. Let your skin dry. 

● Do not touch this area again before injecting. 

● If you want to use the same injection site, make sure it is not the same spot on the injection 

site you used for a previous injection. 

 - Do not inject into areas where the skin is tender, bruised, red, or hard. Avoid injecting 
into areas with scars or stretch marks. 

● If you have psoriasis, you should avoid injecting directly into raised, thick, red, or scaly skin 

patch or lesion. 

 

Step 2: Get ready 
 

E. Pull the needle cap straight out and away from your body when you are ready to inject. 

 

It is normal to see a drop of liquid at the end of the needle. 

● Do not twist or bend the needle cap. 

● Do not put the needle cap back onto the syringe. 

● Do not remove the needle cap from the syringe until you are ready to inject. 

Important: Throw the needle cap into the sharps disposal container provided. 

 

 

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79 

F. Pinch your injection site to create a firm surface. 

 

Pinch the skin firmly between your thumb and fingers, creating an area about 2 inch (5 centimetres) 

wide. 

Important: Keep the skin pinched while injecting. 

 

Step 3: Inject 
 

G. Hold the pinch. With the needle cap off, insert the syringe into your skin at 45 to 90 degrees. 

 

Do not place your finger on the plunger rod while inserting the needle. 

 

H. Using slow and constant pressure, push the plunger rod all the way down until it stops moving. 

 

 

I. When done, release your thumb, and gently lift the syringe off of your skin. 

 

 

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Step 4: Finish 
 

J. Discard the used syringe and the needle cap. 

 

● Do not reuse the used syringe. 

● Do not use any medicine that is left in the used syringe. 

● Put the used SOLYMBIC syringe in a sharps disposal container immediately after use. Do not 

throw away (dispose of) the syringe in your household waste. 

● Talk with your doctor or pharmacist about proper disposal. There may be local guidelines for 

disposal. 

● Do not recycle the syringe or sharps disposal container or throw them into the household 

waste. 

Important: Always keep the sharps disposal container out of the sight and reach of children. 

 

K. Examine the injection site. 

If there is blood, press a cotton ball or gauze pad on your injection site. Do not rub the injection site. 

Apply a plaster if needed. 

 

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Package leaflet: Information for the user 

 

SOLYMBIC 40 mg solution for injection in a pre-filled pen 

adalimumab 

 

This medicine is subject to additional monitoring. This will allow quick identification of new safety 

information. You can help by reporting any side effects you may get. See the end of section 4 for how 

to report side effects. 

 

Read all of this leaflet carefully before you start using this medicine because it contains 

important information for you. 

- Keep this leaflet. You may need to read it again.  
- Your doctor will also give you a Patient Alert Card, which contains important safety 

information that you need to be aware of before you are given SOLYMBIC and during 

treatment with SOLYMBIC. Keep this Patient Alert Card with you.  

- If you have any further questions, ask your doctor or pharmacist. 
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, 

even if their signs of illness are the same as yours.  

- If you get any side effects, talk to your doctor or pharmacist. This includes any possible side 

effects not listed in this leaflet (see section 4). 

 

What is in this leaflet 

 

1. What SOLYMBIC is and what it is used for  

2. What you need to know before you use SOLYMBIC  

3. How to use SOLYMBIC 

4. Possible side effects  

5. How to store SOLYMBIC  

6. Contents of the pack and other information 

 

 

1. What SOLYMBIC is and what it is used for 

 

SOLYMBIC contains the active substance adalimumab, a selective immuno suppressive agent.  

 

SOLYMBIC is intended for treatment of rheumatoid arthritis, enthesitis-related arthritis in children 6 

to 17 years, ankylosing spondylitis, axial spondyloarthritis without radiographic evidence of 

ankylosing spondylitis, psoriatic arthritis, psoriasis, hidradenitis suppurativa, paediatric psoriasis 

(patients weighing either 23 to 28 kg or 47 kg and greater), Crohn’s disease in adults and children, 

ulcerative colitis and non-infectious uveitis affecting the back of the eye. It is a medicine that 

decreases the inflammation process of these diseases. The active ingredient, adalimumab, is a human 

monoclonal antibody produced by cultured cells. Monoclonal antibodies are proteins that recognise 

and bind to other unique proteins.  

 

Adalimumab binds to a specific protein (tumour necrosis factor or TNFα), which is present at 

increased levels in inflammatory diseases such as rheumatoid arthritis, enthesitis-related arthritis, 

ankylosing spondylitis, axial spondyloarthritis without radiographic evidence of ankylosing 

spondylitis, psoriatic arthritis, psoriasis, hidradenitis suppurativa, Crohn’s disease, ulcerative colitis 

and non-infectious uveitis affecting the back of the eye.  

 

Rheumatoid arthritis  

 

Rheumatoid arthritis is an inflammatory disease of the joints.  

 

SOLYMBIC is used to treat rheumatoid arthritis in adults. If you have moderate to severe active 

rheumatoid arthritis, you may first be given other disease-modifying medicines, such as methotrexate. 

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82 

If you do not respond well enough to these medicines, you will be given SOLYMBIC to treat your 

rheumatoid arthritis.  

 

SOLYMBIC can also be used to treat severe, active and progressive rheumatoid arthritis without 

previous methotrexate treatment. 

 

SOLYMBIC slows down the damage to the cartilage and bone of the joints caused by the disease and 

to improve physical function.  

 

Usually, SOLYMBIC is used with methotrexate. If your doctor determines that methotrexate is 

inappropriate, SOLYMBIC can be given alone. 

 

Enthesitis-related arthritis  

 

Enthesitis-related arthritis is an inflammatory disease of the joints. 

 

SOLYMBIC is used to treat enthesitis-related arthritis in children and adolescents aged 6 to 17 years. 

You may first be given other disease-modifying medicines, such as methotrexate. If you do not 

respond well enough to these medicines, you will be given SOLYMBIC to treat your enthesitis-related 

arthritis.  

 

Ankylosing spondylitis and axial spondyloarthritis without radiographic evidence of ankylosing 

spondylitis  

 

Ankylosing spondylitis and axial spondyloarthritis without radiographic evidence of ankylosing 

spondylitis, are inflammatory diseases of the spine.  

 

SOLYMBIC is used to treat ankylosing spondylitis and axial spondyloarthritis without radiographic 

evidence of ankylosing spondylitis in adults. If you have ankylosing spondylitis or axial 

spondyloarthritis without radiographic evidence of ankylosing spondylitis, you will first be given other 

medicines. If you do not respond well enough to these medicines, you will be given SOLYMBIC to 

reduce the signs and symptoms of your disease.  

 

Psoriatic arthritis  

 

Psoriatic arthritis is an inflammation of the joints associated with psoriasis.  

 

SOLYMBIC is used to treat psoriatic arthritis in adults. SOLYMBIC slows down the damage to the 

cartilage and bone of the joints caused by the disease and to improve physical function.  

 

Plaque psoriasis in adults and children 

 

Plaque psoriasis is a skin condition that causes red, flaky, crusty patches of skin covered with silvery 

scales. Plaque psoriasis can also affect the nails, causing them to crumble, become thickened and lift 

away from the nail bed which can be painful. Psoriasis is believed to be caused by a problem with the 

body’s immune system that leads to an increased production of skin cells. 

 

SOLYMBIC is used to treat moderate to severe plaque psoriasis in adults. SOLYMBIC is also used to 

treat severe plaque psoriasis in children and adolescents weighing either 23 to 28 kg or 47 kg or 

greater for whom topical therapy and phototherapies have either not worked very well or are not 

suitable. 

 

Hidradenitis suppurativa 

 

Hidradenitis suppurativa (sometimes called acne inversa) is a chronic and often painful inflammatory 

skin disease. Symptoms may include tender nodules (lumps) and abscesses (boils) that may leak pus. 

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It most commonly affects specific areas of the skin, such as under the breasts, the armpits, inner 

thighs, groin and buttocks. Scarring may also occur in affected areas. 

 

SOLYMBIC is used to treat hidradenitis suppurativa in adults. SOLYMBIC can reduce the number of 

nodules and abscesses you have, and the pain that is often associated with the disease. 

 

Crohn’s disease in adults and children  

 

Crohn’s disease is an inflammatory disease of the digestive tract. 

 
SOLYMBIC is used to treat Crohn’s disease in adults and children aged 6 to 17 years. If you have 

Crohn’s disease you will first be given other medicines. If you do not respond well enough to these 

medicines, you will be given SOLYMBIC to reduce the signs and symptoms of your Crohn’s disease.  

 

Ulcerative colitis  

 

Ulcerative colitis is an inflammatory disease of the bowel. 

 

SOLYMBIC is used to treat ulcerative colitis in adults. If you have ulcerative colitis you will first be 

given other medicines. If you do not respond well enough to these medicines, you will be given 

SOLYMBIC to reduce the signs and symptoms of your disease. 

 

Non-infectious uveitis affecting the back of the eye 

 

Non-infectious uveitis is an inflammatory disease affecting certain parts of the eye. SOLYMBIC is 

used to treat adults with non-infectious uveitis with inflammation affecting the back of the eye. This 

inflammation leads to a decrease of vision and/or the presence of floaters in the eye (black dots or 

wispy lines that move across the field of vision). SOLYMBIC works by reducing this inflammation. 

 

 

2. What you need to know before you use SOLYMBIC 

 

Do not use SOLYMBIC: 

 

- if you are allergic to adalimumab or any of the other ingredients of this medicine (listed in 

section 6). 

- if you have a severe infection, including active tuberculosis (see “Warnings and precautions”). 

It is important that you tell your doctor if you have symptoms of infections, e.g. fever, wounds, 

feeling tired, dental problems.  

- if you have moderate or severe heart failure. It is important to tell your doctor if you have had or 

have a serious heart condition (see “Warnings and precautions”).  

 

Warnings and precautions  

 

Talk to your doctor or pharmacist before using SOLYMBIC: 

 

- If you experience allergic reactions with symptoms such as chest tightness, wheezing, dizziness, 

swelling or rash do not inject more SOLYMBIC and contact your doctor immediately since, in 

rare cases, these reactions can be life threatening.  
 

- If you have an infection, including long-term or localised infection (for example, leg ulcer) 

consult your doctor before starting SOLYMBIC. If you are unsure, please contact your doctor.  

 

- You might get infections more easily while you are receiving SOLYMBIC treatment. This risk 

may increase if your lung function is impaired. These infections may be serious and include 

tuberculosis, infections caused by viruses, fungi, parasites or bacteria, or other opportunistic 

infections and sepsis that may, in rare cases, be life-threatening. It is important to tell your 

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84 

doctor if you get symptoms such as fever, wounds, feeling tired or dental problems. Your doctor 

may recommend temporary discontinuation of SOLYMBIC.  

 

- As cases of tuberculosis have been reported in patients treated with adalimumab, your doctor 

will check you for signs and symptoms of tuberculosis before starting SOLYMBIC. This will 

include a thorough medical evaluation including your medical history and appropriate screening 

tests (for example chest x-ray and a tuberculin test). The conduct and results of these tests 

should be recorded on your Patient Alert Card. It is very important that you tell your doctor if 

you have ever had tuberculosis, or if you have been in close contact with someone who has had 

tuberculosis. Tuberculosis can develop during therapy even if you have received preventative 

treatment for tuberculosis. If symptoms of tuberculosis (persistent cough, weight loss, 

listlessness, mild fever), or any other infection appear during or after therapy, tell your doctor 

immediately.  

 

- Advise your doctor if you reside or travel in regions where fungal infections such as 

histoplasmosis coccidioidomycosis or blastomycosis are endemic.  

 

- Advise your doctor if you have a history of recurrent infections or other conditions that increase 

the risk of infections.  

 

- Advise your doctor if you are a carrier of the hepatitis B virus (HBV), if you have active HBV 

or if you think you might be at risk of contracting HBV. Your doctor should test you for HBV. 

SOLYMBIC can cause reactivation of HBV in people who carry this virus. In some rare cases, 

especially if you are taking other medicines that suppress the immune system, reactivation of 

HBV can be life-threatening.  

 
- If you are over 65 years you may be more susceptible to infections while taking SOLYMBIC. 

You and your doctor should pay special attention to signs of infection while you are being 

treated with SOLYMBIC. It is important to tell your doctor if you get symptoms of infections, 

such as fever, wounds, feeling tired or dental problems. 

 

- If you are about to undergo surgery or dental procedures please inform your doctor that you are 

taking SOLYMBIC. Your doctor may recommend temporary discontinuation of SOLYMBIC. 

 

- If you have or develop demyelinating disease such as multiple sclerosis, your doctor will decide 

if you should receive or continue to receive SOLYMBIC. Tell your doctor immediately if you 

experience symptoms like changes in your vision, weakness in your arms or legs or numbness 

or tingling in any part of your body. 

 

- Certain vaccines may cause infections and should not be given while receiving SOLYMBIC. 

Please check with your doctor before you receive any vaccines. It is recommended that children, 

if possible, be brought up to date with all immunisations in agreement with current 

immunisation guidelines prior to initiating SOLYMBIC therapy. If you received SOLYMBIC 

while you were pregnant, your baby may be at higher risk for getting such an infection for up to 

approximately five months after the last dose you received during pregnancy. It is important that 

you tell your baby's doctors and other health care professionals about your SOLYMBIC use 

during your pregnancy so they can decide when your baby should receive any vaccine. 

 

- If you have mild heart failure and you are being treated with SOLYMBIC, your heart failure 

status must be closely monitored by your doctor. It is important to tell your doctor if you have 

had or have a serious heart condition. If you develop new or worsening symptoms of heart 

failure (e.g. shortness of breath, or swelling of your feet), you must contact your doctor 

immediately. 

 

- In some patients the body may fail to produce enough of the blood cells that help your body 

fight infections or help you to stop bleeding. If you develop a fever that does not go away, 

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85 

bruise or bleed very easily or look very pale, call your doctor right away. Your doctor may 

decide to stop treatment. 

 

- There have been very rare cases of certain kinds of cancer in children and adult patients taking 

adalimumab or other TNF blockers. People with more serious rheumatoid arthritis that have had 

the disease for a long time may have a higher than average risk of getting lymphoma (a type of 

cancer that affects the lymph system), and leukaemia (a type of cancer that affects the blood and 

bone marrow). If you take SOLYMBIC the risk of getting lymphoma, leukaemia, or other 

cancers may increase. On rare occasions, a specific and severe type of lymphoma has been 

observed in some patients taking adalimumab. Some of those patients were also treated with 

azathioprine or 6-mercaptopurine. Tell your doctor if you are taking azathioprine or 6-

mercaptopurine with SOLYMBIC. In addition, cases of non-melanoma skin cancer have been 

observed in patients taking adalimumab. If new skin lesions appear during or after therapy or if 

existing lesions change appearance, tell your doctor. 

 

- There have been cases of cancers other than lymphoma in patients with a specific type of lung 

disease called Chronic Obstructive Pulmonary Disease (COPD) treated with another TNF 

blocker. If you have COPD, or are a heavy smoker, you should discuss with your doctor 

whether treatment with a TNF blocker is appropriate for you.  

 

The needle cover of the pre-filled pen is made from dry natural rubber (a derivative of latex), which 

may cause allergic reactions. 

 

In order to improve the traceability of this medicine, your doctor or pharmacist should record the 

tradename and the lot number of the product you have been given in your patient file. You may also 

wish to make a note of these details in case you are asked for this information in the future. 

 

Children and adolescents 

 
- Vaccinations: if possible children should be up to date with all vaccinations before using 

SOLYMBIC. 

 

- Do not use the 40 mg pre-filled pen if doses other than 40 mg are recommended. 

 

Other medicines and SOLYMBIC  

 

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other 

medicines. 

 

SOLYMBIC can be taken together with methotrexate or certain disease-modifying anti-rheumatic 

agents (sulfasalazine, hydroxychloroquine, leflunomide and injectable gold preparations), steroids or 

pain medications including non-steroidal anti-inflammatory drugs (NSAIDs).  

 

You should not take SOLYMBIC with medicines containing the active substance, anakinra or 

abatacept. If you have questions, please ask your doctor. 

 

Pregnancy and breast-feeding 

 

The effects of SOLYMBIC in pregnant women are not known and so the use of SOLYMBIC in 

pregnant women is not recommended. You are advised to avoid becoming pregnant and must use 

adequate contraception while using SOLYMBIC and for at least 5 months after the last SOLYMBIC 

treatment. If you become pregnant, you should consult your doctor.  

 

It is not known whether SOLYMBIC passes into breast milk.  

 

If you are a breast-feeding mother, you should stop breast-feeding during SOLYMBIC treatment and 

for at least 5 months after the last SOLYMBIC treatment. If you received SOLYMBIC during your 

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pregnancy, your baby may have a higher risk for getting an infection. It is important that you tell your 

baby’s doctors and other health care professionals about your SOLYMBIC use during your pregnancy 

before the baby receives any vaccine (for more information see section on vaccination). 

 

If you think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for 

advice before taking this medicine.  

 

Driving and using machines 

 

SOLYMBIC may have a minor influence on your ability to drive, cycle or use machines. Room 

spinning sensation and vision disturbances may occur after taking SOLYMBIC. 

 

SOLYMBIC contains sodium 

 

This medicine contains less than 1 mmol of sodium (23 mg) per 0.8 mL dose, i.e. essentially ‘sodium-

free’. 

 

 

3. How to use SOLYMBIC 

 

Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor 

or pharmacist if you are not sure. 

 

Adults with rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis or axial spondyloarthritis 

without radiographic evidence of ankylosing spondylitis  

 

SOLYMBIC is injected under the skin (subcutaneous use). The usual dose for adults with rheumatoid 

arthritis, ankylosing spondylitis, axial spondyloarthritis without radiographic evidence of ankylosing 
spondylitis, and for patients with psoriatic arthritis is 40 mg given every other week as a single dose.  

 

In rheumatoid arthritis, methotrexate is continued while using SOLYMBIC. If your doctor determines 

that methotrexate is inappropriate, SOLYMBIC can be given alone.  

 

If you have rheumatoid arthritis and you do not receive methotrexate with your SOLYMBIC therapy, 

your doctor may decide to give 40 mg every week. 

 

Children with enthesitis-related arthritis 

 

The recommended dose of SOLYMBIC for patients with enthesitis-related arthritis, aged 6 to 17 years 

depends on the height and weight of the child. Your child’s doctor will tell you the correct dose to use. 

 

Adults with psoriasis  

 

The usual dose for adults with psoriasis is an initial dose of 80 mg, followed by 40 mg given every 

other week starting one week after the initial dose. You should continue to inject SOLYMBIC for as 

long as your doctor has told you. Depending on your response, your doctor may increase the dose 

frequency to 40 mg every week.  

 

Children or adolescents with plaque psoriasis  

 

The recommended dose of SOLYMBIC for patients aged 4 to 17 years with plaque psoriasis depends 

on the weight of your child. SOLYMBIC should only be used in patients weighing either 23 to 28 kg 

or 47 kg and greater. Your child’s doctor will tell you the correct dose to use. 

 

Adults with hidradenitis suppurativa 

 

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The usual dose regimen for hidradenitis suppurativa is an initial dose of 160 mg (as four 40 mg 

injections in one day or two 40 mg injections per day for two consecutive days), followed by an 80 mg 

dose (as two 40 mg injections on the same day) two weeks later. After two further weeks, continue 

with a dose of 40 mg every week. It is recommended that you use an antiseptic wash daily on the 

affected areas. 

 

Adults with Crohn’s disease  

 

The usual dose regimen for Crohn’s disease is 80 mg initially followed by 40 mg every other week 

two weeks later. If a faster response is required, your doctor may prescribe an initial dose of 160 mg 

(as four 40 mg injections in one day or two 40 mg injections per day for two consecutive days), 

followed by 80 mg two weeks later, and thereafter as 40 mg every other week. Depending on your 

response, your doctor may increase the dose frequency to 40 mg every week.  

 

Children or adolescents with Crohn's disease  

 

Children or adolescents weighing less than 40 kg:  

 

The usual dose regimen is 40 mg initially followed by 20 mg two weeks later. If a faster response is 

required, your doctor may prescribe an initial dose of 80 mg (as two 40 mg injections in 1 day) 

followed by 40 mg two weeks later.  

 

Thereafter, the usual dose is 20 mg every other week. Depending on your response, your doctor may 

increase the dose frequency to 20 mg every week. 

 

Do not use the 40 mg pre-filled pen for the 20 mg dose in children or adolescent weighing less than 

40 kg with Crohn’s disease. The 20 mg solution for injection in pre-filled syringe can be used for the 

20 mg dose. 

 

Children or adolescents weighing 40 kg or more:  

 

The usual dose regimen is 80 mg initially followed by 40 mg two weeks later. If a faster response is 

required, your doctor may prescribe an initial dose of 160 mg (as four 40 mg injections in 1 day or as 

two 40 mg injections per day for 2 consecutive days) followed by 80 mg two weeks later. 

 

Thereafter, the usual dose is 40 mg every other week. Depending on your response, your doctor may 

increase the dose frequency to 40 mg every week.  

 

Adults with ulcerative colitis  

 

The usual SOLYMBIC dose for adults with ulcerative colitis is 160 mg initially (dose can be 

administered as four 40 mg injections in one day or as two 40 mg injections per day for two 

consecutive days) followed by 80 mg two weeks later, then 40 mg every other week. Depending on 

your response, your doctor may increase the dose to 40 mg every week. 

 

Adults with non-infectious uveitis 

 

The usual dose for adults with non-infectious uveitis is an initial dose of 80 mg, followed by 40 mg 

given every other week starting one week after the initial dose. You should continue to inject 

SOLYMBIC for as long as your doctor has told you. 

 

In non-infectious uveitis, corticosteroids or other medicines that influence the immune system may be 

continued while using SOLYMBIC. SOLYMBIC can also be given alone. 
 

Method and route of administration  

 

SOLYMBIC is administered by injection under the skin (subcutaneous injection).  

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88 

 

If you use more SOLYMBIC than you should 

 

If you accidentally inject SOLYMBIC more frequently than told to by your doctor or pharmacist, you 

should call your doctor or pharmacist and tell him/her that you have taken more. Always take the outer 

carton of this medicine with you, even if it is empty. 

 

If you forget to use SOLYMBIC 

 

If you forget to give yourself an injection, you should inject it as soon as you remember. Then take 

your next dose as you would have on your originally scheduled day, had you not forgotten a dose. 

 

If you stop using SOLYMBIC 

 

The decision to stop using SOLYMBIC should be discussed with your doctor. Your symptoms may 

return upon discontinuation. 

 

If you have any further questions on the use of this medicine, ask your doctor or pharmacist. 

 

 

4. Possible side effects 

 

Like all medicines, this medicine can cause side effects, although not everybody gets them. Most side 

effects are mild to moderate. However, some may be serious and require treatment. Side effects may 

occur at least up to 4 months after the last SOLYMBIC injection.  

 

Tell your doctor immediately if you notice any of the following:  

• severe rash, hives or other signs of allergic reaction;  

• swollen face, hands, feet;  

• trouble breathing, swallowing;  

• shortness of breath with exertion or upon lying down or swelling of the feet. 
 

Tell your doctor as soon as possible if you notice any of the following:  

• signs of infection such as fever, feeling sick, wounds, dental problems, burning on urination;  

• feeling weak or tired;  

• coughing;  

• tingling;  

• numbness;  

• double vision;  

• arm or leg weakness;  

• a bump or open sore that doesn't heal; 

• signs and symptoms suggestive of blood disorders such as persistent fever, bruising, bleeding, 

paleness. 

 

The symptoms described above can be signs of the below listed side effects, which have been 

observed with adalimumab:  

 

Very common side effects (may affect more than 1 in 10 people):  

• injection site reactions (including pain, swelling, redness or itching);  

• respiratory tract infections (including cold, runny nose, sinus infection, pneumonia);  

• headache;  

• abdominal pain;  

• nausea and vomiting; 

• rash;  

• musculoskeletal pain.  
 

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89 

Common side effects (may affect up to 1 in 10 people):  

• serious infections (including blood poisoning and influenza);  

• skin infections (including cellulitis and shingles);  

• ear infections;  

• oral infections (including tooth infections and cold sores);  

• reproductive tract infections;  

• urinary tract infection;  

• fungal infections;  

• joint infections;  

• benign tumours;  

• skin cancer;  

• allergic reactions (including seasonal allergy);  

• dehydration;  

• mood swings (including depression);  

• anxiety;  

• difficulty sleeping;  

• sensation disorders such as tingling, prickling or numbness;  

• migraine;  

• nerve root compression (including low back pain and leg pain);  

• vision disturbances;  

• eye inflammation;  

• inflammation of the eye lid and eye swelling;  

• vertigo;  

• sensation of heart beating rapidly;  

• high blood pressure;  

• flushing;  

• haematoma;  

• cough;  

• asthma;  

• shortness of breath;  

• gastrointestinal bleeding;  

• dyspepsia (indigestion, bloating, heart burn);  

• acid reflux disease;  

• sicca syndrome (including dry eyes and dry mouth);  

• itching;  

• itchy rash;  

• bruising;  

• inflammation of the skin (such as eczema);  

• breaking of finger nails and toe nails;  

• increased sweating;  

• hair loss;  

• new onset or worsening of psoriasis;  

• muscle spasms;  

• blood in urine;  

• kidney problems;  

• chest pain;  

• oedema;  

• fever;  

• reduction in blood platelets which increases risk of bleeding or bruising; 

• impaired healing.  

 

Uncommon side effects (may affect up to 1 in 100 people):  

• opportunistic infections (which include tuberculosis and other infections that occur when 

resistance to disease is lowered);  

• neurological infections (including viral meningitis);  

• eye infections;  

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90 

• bacterial infections;  

• diverticulitis (inflammation and infection of the large intestine);  

• cancer;  

• cancer that affects the lymph system;  

• melanoma;  

• immune disorders that could affect the lungs, skin and lymph nodes (most commonly presenting 

as sarcoidosis);  

• vasculitis (inflammation of blood vessels); 

• tremor;  

• neuropathy;  

• stroke;  

• double vision;  

• hearing loss, buzzing;  

• sensation of heart beating irregularly such as skipped beats;  

• heart problems that can cause shortness of breath or ankle swelling;  

• heart attack;  

• a sac in the wall of a major artery, inflammation and clot of a vein, blockage of a blood vessel;  

• lung diseases causing shortness of breath (including inflammation);  

• pulmonary embolism (blockage in an artery of the lung);  

• pleural effusion (abnormal collection of fluid in the pleural space);  

• inflammation of the pancreas which causes severe pain in the abdomen and back;  

• difficulty in swallowing;  

• facial oedema;  

• gallbladder inflammation, gallbladder stones;  

• fatty liver;  

• night sweats;  

• scar;  

• abnormal muscle breakdown;  

• systemic lupus erythematosus (including inflammation of skin, heart, lung, joints and other 

organ systems);  

• sleep interruptions;  

• impotence;  

• inflammations.  
 

Rare side effects (may affect up to 1 in 1,000 people):  

• leukaemia (cancer affecting the blood and bone marrow);  

• severe allergic reaction with shock;  

• multiple sclerosis;  

• nerve disorders (such as eye nerve inflammation and Guillain-Barré syndrome that may cause 

muscle weakness, abnormal sensations, tingling in the arms and upper body);  

• heart stops pumping;  

• pulmonary fibrosis (scarring of the lung);  

• intestinal perforation; 

• hepatitis;  
• reactivation of hepatitis B;  

• autoimmune hepatitis (inflammation of the liver caused by the body's own immune system); 

• cutaneous vasculitis (inflammation of blood vessels in the skin);  

• Stevens-Johnson syndrome (early symptoms include malaise, fever, headache and rash);  

• facial oedema associated with allergic reactions;  

• erythema multiforme (inflammatory skin rash);  

• lupus-like syndrome.  
 

Not known (frequency cannot be estimated from available data):  

• hepatosplenic T-cell lymphoma (a rare blood cancer that is often fatal);  

• Merkel cell carcinoma (a type of skin cancer);  

• liver failure;  

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91 

• worsening of a condition called dermatomyositis (seen as a skin rash accompanying muscle 

weakness).  

 

Some side effects observed with adalimumab may not have symptoms and may only be discovered 

through blood tests. These include:  

 

Very common side effects (may affect more than 1 in 10 people):  

• low blood measurements for white blood cells;  

• low blood measurements for red blood cells;  

• increased lipids in the blood;  

• elevated liver enzymes.  
 

Common side effects (may affect up to 1 in 10 people):  

• high blood measurements for white blood cells;  

• low blood measurements for platelets;  

• increased uric acid in the blood;  

• abnormal blood measurements for sodium;  

• low blood measurements for calcium;  

• low blood measurements for phosphate;  

• high blood sugar;  

• high blood measurements for lactate dehydrogenase;  

• autoantibodies present in the blood.  
 

Rare side effects (may affect up to 1 in 1,000 people):  

• low blood measurements for white blood cells, red blood cells and platelet count.  
 

Not known (frequency cannot be estimated from available data):  

• liver failure.  

 
Reporting of side effects 

 

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects 

not listed in this leaflet. You can also report side effects directly via the national reporting system 
listed in Appendix V. By reporting side effects you can help provide more information on the safety of 

this medicine. 

 

 

5. How to store SOLYMBIC 

 

Keep this medicine out of the sight and reach of children. 

 

Do not use this medicine after the expiry date which is stated on the label and carton after EXP. The 

expiry date refers to the last day of that month. 

 

Store in a refrigerator (2C – 8C). Do not freeze.  

 

Store in the original carton in order to protect from light.  

 

A single SOLYMBIC pre-filled pen may be stored at temperatures up to a maximum of 25°C for a 

period of up to 14 days. The pre-filled pen must be protected from light, and discarded if not used 

within the 14-day period. 

 

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to 

throw away medicines you no longer use. These measures will help protect the environment.  

 

 

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http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


 

92 

6. Contents of the pack and other information 

 

What SOLYMBIC contains  

- The active substance is adalimumab. Each pre-filled pen contains 40 mg of adalimumab in 
0.8 mL of solution. 

- The other ingredients are glacial acetic acid, sucrose, polysorbate 80, sodium hydroxide and 
water for injection. 

 

What SOLYMBIC looks like and contents of the pack 

 

SOLYMBIC is a clear and colourless to slightly yellow solution. 

 

Each pack contains 1, 2, 4, or 6 single use SureClick pre-filled pens.  

 

Marketing Authorisation Holder and Manufacturer 

Amgen Europe B.V.  

Minervum 7061  

NL-4817 ZK Breda  

The Netherlands 

 

Marketing Authorisation Holder 

Amgen Europe B.V.  

Minervum 7061  

NL-4817 ZK Breda  

The Netherlands 

 

Manufacturer 

Amgen Technology Ireland UC  

Pottery Road 

Dun Laoghaire 

Co Dublin 

Ireland 

 

Manufacturer 

Amgen NV 

Telecomlaan 5-7 

1831 Diegem 

Belgium  

For any information about this medicine, please contact the local representative of the Marketing 

Authorisation Holder: 

 

België/Belgique/Belgien 

s.a. Amgen n.v. 

Tel/Tél: +32 (0)2 7752711 

 

Lietuva 

Amgen Switzerland AG Vilniaus filialas 

Tel: +370 5 219 7474 

 

България 

Амджен България ЕООД 

Тел.: +359 (0)2 424 7440 

 

Luxembourg/Luxemburg 

s.a. Amgen  

Belgique/Belgien 

Tel/Tél: +32 (0)2 7752711 

 

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93 

Česká republika 

Amgen s.r.o. 

Tel: +420 221 773 500 

 

Magyarország 

Amgen Kft. 

Tel.: +36 1 35 44 700 

 

Danmark 

Amgen, filial af Amgen AB, Sverige 

Tlf: +45 39617500 

 

Malta 

Amgen B.V. 

The Netherlands 

Tel: +31 (0)76 5732500 

 

Deutschland 

AMGEN GmbH 

Tel.: +49 89 1490960 

 

Nederland 

Amgen B.V. 

Tel: +31 (0)76 5732500 

 

Eesti 

Amgen Switzerland AG Vilniaus filialas 

Tel: +372 586 09553 

 

Norge 

Amgen AB 

Tel: +47 23308000 

 

Ελλάδα 

Amgen Ελλάς Φαρμακευτικά Ε.Π.Ε.  

Τηλ.: +30 210 3447000 

 

Österreich 

Amgen GmbH  

Tel: +43 (0)1 50 217 

 

España 

Amgen S.A. 

Tel: +34 93 600 18 60  
 

Polska 

Amgen Biotechnologia Sp. z o.o. 

Tel.: +48 22 581 3000 

 

France 

Amgen S.A.S. 

Tél: +33 (0)9 69 363 363 

 

Portugal 

Amgen Biofarmacêutica, Lda. 

Tel: +351 21 4220550 

 

Hrvatska 

Amgen d.o.o. 

Tel: +385 (0)1 562 57 20 

 

România 

Amgen România SRL 

Tel: +4021 527 3000 

 

Ireland 

Amgen Limited 

United Kingdom 

Tel: +44 (0)1223 420305 
 

Slovenija 

AMGEN zdravila d.o.o. 

Tel: +386 (0)1 585 1767 

 

Ísland 

Vistor hf. 

Sími: +354 535 7000 

 

Slovenská republika 

Amgen Slovakia s.r.o. 

Tel: +421 2 321 114 49 

 

Italia 

Amgen S.r.l. 

Tel: +39 02 6241121 

 

Suomi/Finland 

Amgen AB, sivuliike Suomessa/Amgen AB, filial 

i Finland 

Puh/Tel: +358 (0)9 54900500 

 

Kύπρος 

C.A. Papaellinas Ltd 

Τηλ.: +357 22741 741 

 

Sverige 

Amgen AB  

Tel: +46 (0)8 6951100 

 

Latvija 

Amgen Switzerland AG Rīgas filiāle 

Tel: +371 257 25888 

 

United Kingdom 

Amgen Limited 

Tel: +44 (0)1223 420305 

 

 

This leaflet was last revised in 

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94 

 

Other sources of information 

 

Detailed information on this medicine is available on the European Medicines Agency web site: 

http://www.ema.europa.eu. 

 

--------------------------------------------------------------------------------------------------------------------------- 
 

Instructions for use: 

SOLYMBIC single use SureClick pre-filled pen 

For subcutaneous use 

 

Guide to parts 

 

Before use After use 

Blue start button  

Expiration date 

Window 

Medicine 

Yellow cap on 
  

 

Expiration date 

Yellow window 

(injection complete) 

Yellow safety guard  

Yellow cap off 
 

Important: Needle is inside 

 

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http://www.ema.europa.eu/


 

95 

Important 

Before you use a SOLYMBIC pre-filled pen, read this important information: 

 

Using your SOLYMBIC pre-filled pen 

● It is important that you do not try to give the injection unless you or your caregiver has 

received training. 

● Do not use a SOLYMBIC pre-filled pen if it has been dropped on a hard surface. Part of the 

SOLYMBIC pre-filled pen may be broken even if you cannot see the break. Use a new 

SOLYMBIC pre-filled pen. 

● The needle cover of the SOLYMBIC pre-filled pen is made from dry natural rubber, which 

contains latex. Tell your healthcare provider if you are allergic to latex. 

 

Step 1: Prepare 
 

A. Remove one SOLYMBIC pre-filled pen from the package. 

Carefully lift the pre-filled pen straight up out of the box. 

 

Put the original package with any unused pre-filled pens back in the refrigerator. 

 

For a more comfortable injection, leave the pre-filled pen at room temperature for 15 to 30 minutes 

before injecting. 

 

● Do not put the pre-filled pen back in the refrigerator once it has reached room temperature. 

● Do not try to warm the pre-filled pen by using a heat source such as hot water or microwave. 

● Do not shake the pre-filled pen. 

● Do not remove the yellow cap from the pre-filled pen yet. 

 

B. Inspect the SOLYMBIC pre-filled pen. 

 
Yellow cap on Window Medicine 

 

Make sure the medicine in the window is clear and colourless to slightly yellow. 

 

● Do not use the pre-filled pen if: 

 - The medicine is cloudy or discoloured, or contains flakes or particles. 
- Any part appears cracked or broken. 
- The pre-filled pen has been dropped on a hard surface. 
- The yellow cap is missing or not securely attached. 
- The expiration date printed on the label has passed. 

In all cases, use a new pre-filled pen. 

 

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96 

C. Gather all materials needed for your injection. 

Wash your hands thoroughly with soap and water. 

On a clean, well-lit work surface, place a new, pre-filled pen. 

 

You will also need these additional items, as they are not included in the carton: 

● Alcohol wipes 

● Cotton ball or gauze pad 

● Plaster 

● Sharps disposal container 

 

  
 

D. Prepare and clean your injection site. 

 
Belly 

Thigh 

 

You can use: 

● Your thigh 

● Belly, except for a 2-inch (5 centimetre) area right around your belly button 

 

Clean your injection site with an alcohol wipe. Let your skin dry. 

● Do not touch this area again before injecting. 

● If you want to use the same injection site, make sure it is not the same spot on the injection 

site you used for a previous injection. 

 - Do not inject into areas where the skin is tender, bruised, red, or hard. Avoid injecting 
into areas with scars or stretch marks. 

● If you have psoriasis, you should avoid injecting directly into raised, thick, red, or scaly skin 

patch or lesion. 

 

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Step 2: Get ready 

 

E. Pull the yellow cap straight off when you are ready to inject. 

 

It is normal to see a drop of liquid at the end of the needle or yellow safety guard. 

● Do not twist or bend the yellow cap. 

● Do not put the yellow cap back onto the pre-filled pen. 

● Do not remove the yellow cap from the pre-filled pen until you are ready to inject. 

 

F. Stretch or pinch your injection site to create a firm surface. 

Stretch method 

 

Stretch the skin firmly by moving your thumb and fingers in opposite directions, creating an area 

about 2 inches (5 centimetres) wide. 

OR 

Pinch method 

 

Pinch the skin firmly between your thumb and fingers, creating an area about 2 inches (5 

centimetres) wide. 

Important: Keep the skin stretched or pinched while injecting. 

 

Step 3: Inject 

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98 

 

G. Hold the stretch or pinch. With the yellow cap off, place the pre-filled pen on your skin at 

90 degrees. 

 

Important: Do not touch the blue start button yet. 

 

H. Firmly push the pre-filled pen down onto the skin until it stops moving. 

   

 

 

 

Important: You must push all the way down but do not touch the blue start button until you are 

ready to inject. 

 

I. When you are ready to inject, press the blue start button. 

 

 

“Click” 

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99 

J. Keep pushing down on your skin. Your injection could take about 10 seconds. 

     

~10s  

 

 

The window turns yellow  

When the injection is done 

 Note: After you remove the pre-filled pen from your  

skin, the needle will be automatically covered. 

Important: When you remove the pre-filled pen, if the window has not turned yellow, or if it looks 

like the medicine is still injecting, this means you have not received a full dose. Call your doctor 

immediately. 
 

 

“Click” 

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100 

Step 4: Finish 

 

K. Discard the used pre-filled pen and the yellow cap. 

 

● Put the used pre-filled pen in a sharps disposal container immediately after use. Do not throw 

away (dispose of) the pre-filled pen in your household waste. 

● Talk with your doctor or pharmacist about proper disposal. There may be local guidelines for 

disposal. 

● Do not reuse the pre-filled pen. 

● Do not recycle the pre-filled pen or sharps disposal container or throw them into the household 

waste. 

Important: Always keep the sharps disposal container out of the sight and reach of children. 

 

L. Examine the injection site. 

If there is blood, press a cotton ball or gauze pad on your injection site. Do not rub the injection site. 

Apply a plaster if needed. 

 

 

 

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	SUMMARY OF PRODUCT CHARACTERISTICS
	A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE
	B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
	C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
	D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
	A. LABELLING
	B. PACKAGE LEAFLET
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{'Title': '2. what you need to know before you use solymbic', 'Section_Content': 'do not use solymbic: - if you are allergic to adalimumab or any of the other ingredients of this medicine (listed in section 6). - if you have a severe infection, including active tuberculosis (see "warnings and precautions"). it is important that you tell your doctor if you have symptoms of infections, e.g. fever, wounds, feeling tired, dental problems. - if you have moderate or severe heart failure. it is important to tell your doctor if you have had or have a serious heart condition (see "warnings and precautions"). warnings and precautions talk to your doctor or pharmacist before using solymbic: - if you experience allergic reactions with symptoms such as chest tightness, wheezing, dizziness, swelling or rash do not inject more solymbic and contact your doctor immediately since, in rare cases, these reactions can be life threatening. - if you have an infection, including long-term or localised infection (for example, leg ulcer) consult your doctor before starting solymbic. if you are unsure, please contact your doctor. - you might get infections more easily while you are receiving solymbic treatment. this risk may increase if your lung function is impaired. these infections may be serious and include tuberculosis, infections caused by viruses, fungi, parasites or bacteria, or other opportunistic infections and sepsis that may, in rare cases, be life-threatening. it is important to tell your 65 doctor if you get symptoms such as fever, wounds, feeling tired or dental problems. your doctor may recommend temporary discontinuation of solymbic. - as cases of tuberculosis have been reported in patients treated with adalimumab, your doctor will check you for signs and symptoms of tuberculosis before starting solymbic. this will include a thorough medical evaluation including your medical history and appropriate screening tests (for example chest x-ray and a tuberculin test). the conduct and results of these tests should be recorded on your patient alert card. it is very important that you tell your doctor if you have ever had tuberculosis, or if you have been in close contact with someone who has had tuberculosis. tuberculosis can develop during therapy even if you have received preventative treatment for tuberculosis. if symptoms of tuberculosis (persistent cough, weight loss, listlessness, mild fever), or any other infection appear during or after therapy, tell your doctor immediately. - advise your doctor if you reside or travel in regions where fungal infections such as histoplasmosis coccidioidomycosis or blastomycosis are endemic. - advise your doctor if you have a history of recurrent infections or other conditions that increase the risk of infections. - advise your doctor if you are a carrier of the hepatitis b virus (hbv), if you have active hbv or if you think you might be at risk of contracting hbv. your doctor should test you for hbv. solymbic can cause reactivation of hbv in people who carry this virus. in some rare cases, especially if you are taking other medicines that suppress the immune system, reactivation of hbv can be life-threatening. - if you are over 65 years you may be more susceptible to infections while taking solymbic. you and your doctor should pay special attention to signs of infection while you are being treated with solymbic. it is important to tell your doctor if you get symptoms of infections, such as fever, wounds, feeling tired or dental problems. - if you are about to undergo surgery or dental procedures please inform your doctor that you are taking solymbic. your doctor may recommend temporary discontinuation of solymbic. - if you have or develop demyelinating disease such as multiple sclerosis, your doctor will decide if you should receive or continue to receive solymbic. tell your doctor immediately if you experience symptoms like changes in your vision, weakness in your arms or legs or numbness or tingling in any part of your body. - certain vaccines may cause infections and should not be given while receiving solymbic. please check with your doctor before you receive any vaccines. it is recommended that children, if possible, be brought up to date with all immunisations in agreement with current immunisation guidelines prior to initiating solymbic therapy. if you received solymbic while you were pregnant, your baby may be at higher risk for getting such an infection for up to approximately five months after the last dose you received during pregnancy. it is important that you tell your baby\'s doctors and other health care professionals about your solymbic use during your pregnancy so they can decide when your baby should receive any vaccine. - if you have mild heart failure and you are being treated with solymbic, your heart failure status must be closely monitored by your doctor. it is important to tell your doctor if you have had or have a serious heart condition. if you develop new or worsening symptoms of heart failure (e.g. shortness of breath, or swelling of your feet), you must contact your doctor immediately. - in some patients the body may fail to produce enough of the blood cells that help your body fight infections or help you to stop bleeding. if you develop a fever that does not go away, 66 bruise or bleed very easily or look very pale, call your doctor right away. your doctor may decide to stop treatment. - there have been very rare cases of certain kinds of cancer in children and adult patients taking adalimumab or other tnf blockers. people with more serious rheumatoid arthritis that have had the disease for a long time may have a higher than average risk of getting lymphoma (a type of cancer that affects the lymph system), and leukaemia (a type of cancer that affects the blood and bone marrow). if you take solymbic the risk of getting lymphoma, leukaemia, or other cancers may increase. on rare occasions, a specific and severe type of lymphoma has been observed in some patients taking adalimumab. some of those patients were also treated with azathioprine or 6-mercaptopurine. tell your doctor if you are taking azathioprine or 6-mercaptopurine with solymbic. in addition, cases of non-melanoma skin cancer have been observed in patients taking adalimumab. if new skin lesions appear during or after therapy or if existing lesions change appearance, tell your doctor. - there have been cases of cancers other than lymphoma in patients with a specific type of lung disease called chronic obstructive pulmonary disease (copd) treated with another tnf blocker. if you have copd, or are a heavy smoker, you should discuss with your doctor whether treatment with a tnf blocker is appropriate for you. the needle cover of the pre-filled syringe is made from dry natural rubber (a derivative of latex), which may cause allergic reactions. in order to improve the traceability of this medicine, your doctor or pharmacist should record the tradename and the lot number of the product you have been given in your patient file. you may also wish to make a note of these details in case you are asked for this information in the future. children and adolescents - vaccinations: if possible children should be up to date with all vaccinations before using solymbic. - do not use the 20 mg or 40 mg pre-filled syringe if doses other than 20 mg or 40 mg are recommended. other medicines and solymbic tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. solymbic can be taken together with methotrexate or certain disease-modifying anti-rheumatic agents (sulfasalazine, hydroxychloroquine, leflunomide and injectable gold preparations), steroids or pain medications including non-steroidal anti-inflammatory drugs (nsaids). you should not take solymbic with medicines containing the active substance, anakinra or abatacept. if you have questions, please ask your doctor. pregnancy and breast-feeding the effects of solymbic in pregnant women are not known and so the use of solymbic in pregnant women is not recommended. you are advised to avoid becoming pregnant and must use adequate contraception while using solymbic and for at least 5 months after the last solymbic treatment. if you become pregnant, you should consult your doctor. it is not known whether solymbic passes into breast milk. if you are a breast-feeding mother, you should stop breast-feeding during solymbic treatment and for at least 5 months after the last solymbic treatment. if you received solymbic during your 67 pregnancy, your baby may have a higher risk for getting an infection. it is important that you tell your baby\'s doctors and other health care professionals about your solymbic use during your pregnancy before the baby receives any vaccine (for more information see section on vaccination). if you think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. driving and using machines solymbic may have a minor influence on your ability to drive, cycle or use machines. room spinning sensation and vision disturbances may occur after taking solymbic. solymbic contains sodium this medicine contains less than 1 mmol of sodium (23 mg) per 0.8 ml dose, i.e. essentially \'sodium- free\'.', 'Entity_Recognition': [{'Text': 'solymbic', 'Type': 'PRODUCT_NAME', 'BeginOffset': 0, 'EndOffset': 0}, {'Text': 'allergic', 'Type': 'PROBLEM', 'BeginOffset': 34, 'EndOffset': 42}, {'Id': 6, 'BeginOffset': 46, 'EndOffset': 56, 'Score': 0.9796355962753296, 'Text': 'adalimumab', 'Category': 'MEDICATION', 'Type': 'GENERIC_NAME', 'Traits': []}, {'Text': 'this medicine', 'Type': 'TREATMENT', 'BeginOffset': 92, 'EndOffset': 105}, {'Text': 'a severe infection', 'Type': 'PROBLEM', 'BeginOffset': 143, 'EndOffset': 161}, {'Text': 'active tuberculosis', 'Type': 'PROBLEM', 'BeginOffset': 173, 'EndOffset': 192}, {'Text': 'symptoms', 'Type': 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{'Title': '3. how to use solymbic', 'Section_Content': "always use this medicine exactly as your doctor or pharmacist has told you. check with your doctor or pharmacist if you are not sure. adults with rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis or axial spondyloarthritis without radiographic evidence of ankylosing spondylitis solymbic is injected under the skin (subcutaneous use). the usual dose for adults with rheumatoid arthritis, ankylosing spondylitis, axial spondyloarthritis without radiographic evidence of ankylosing spondylitis, and for patients with psoriatic arthritis is 40 mg given every other week as a single dose. in rheumatoid arthritis, methotrexate is continued while using solymbic. if your doctor determines that methotrexate is inappropriate, solymbic can be given alone. if you have rheumatoid arthritis and you do not receive methotrexate with your solymbic therapy, your doctor may decide to give 40 mg every week. children with enthesitis-related arthritis the recommended dose of solymbic for patients with enthesitis-related arthritis, aged 6 to 17 years depends on the height and weight of the child. your child's doctor will tell you the correct dose to use. adults with psoriasis the usual dose for adults with psoriasis is an initial dose of 80 mg, followed by 40 mg given every other week starting one week after the initial dose. you should continue to inject solymbic for as long as your doctor has told you. depending on your response, your doctor may increase the dose frequency to 40 mg every week. children or adolescents with plaque psoriasis the recommended dose of solymbic for patients aged 4 to 17 years with plaque psoriasis depends on the weight of your child. solymbic should only be used in patients weighing either 23 to 28 kg or 47 kg and greater. your child's doctor will tell you the correct dose to use. adults with hidradenitis suppurativa 68 the usual dose regimen for hidradenitis suppurativa is an initial dose of 160 mg (as four 40 mg injections in one day or two 40 mg injections per day for two consecutive days), followed by an 80 mg dose (as two 40 mg injections on the same day) two weeks later. after two further weeks, continue with a dose of 40 mg every week. it is recommended that you use an antiseptic wash daily on the affected areas. adults with crohn's disease the usual dose regimen for crohn's disease is 80 mg initially followed by 40 mg every other week two weeks later. if a faster response is required, your doctor may prescribe an initial dose of 160 mg (as four 40 mg injections in one day or two 40 mg injections per day for two consecutive days), followed by 80 mg two weeks later, and thereafter as 40 mg every other week. depending on your response, your doctor may increase the dose frequency to 40 mg every week. children or adolescents with crohn's disease children or adolescents weighing less than 40 kg: the usual dose regimen is 40 mg initially followed by 20 mg two weeks later. if a faster response is required, your doctor may prescribe an initial dose of 80 mg (as two 40 mg injections in 1 day) followed by 40 mg two weeks later. thereafter, the usual dose is 20 mg every other week. depending on your response, your doctor may increase the dose frequency to 20 mg every week. children or adolescents weighing 40 kg or more: the usual dose regimen is 80 mg initially followed by 40 mg two weeks later. if a faster response is required, your doctor may prescribe an initial dose of 160 mg (as four 40 mg injections in 1 day or as two 40 mg injections per day for 2 consecutive days) followed by 80 mg two weeks later. thereafter, the usual dose is 40 mg every other week. depending on your response, your doctor may increase the dose frequency to 40 mg every week. adults with ulcerative colitis the usual solymbic dose for adults with ulcerative colitis is 160 mg initially (dose can be administered as four 40 mg injections in one day or as two 40 mg injections per day for two consecutive days) followed by 80 mg two weeks later, then 40 mg every other week. depending on your response, your doctor may increase the dose to 40 mg every week. adults with non-infectious uveitis the usual dose for adults with non-infectious uveitis is an initial dose of 80 mg, followed by 40 mg given every other week starting one week after the initial dose. you should continue to inject solymbic for as long as your doctor has told you. in non-infectious uveitis, corticosteroids or other medicines that influence the immune system may be continued while using solymbic. solymbic can also be given alone. method and route of administration solymbic is administered by injection under the skin (subcutaneous injection). if you use more solymbic than you should 69 if you accidentally inject solymbic more frequently than told to by your doctor or pharmacist, you should call your doctor or pharmacist and tell him/her that you have taken more. always take the outer carton of this medicine with you, even if it is empty. if you forget to use solymbic if you forget to give yourself an injection, you should inject it as soon as you remember. then take your next dose as you would have on your originally scheduled day, had you not forgotten a dose. if you stop using solymbic the decision to stop using solymbic should be discussed with your doctor. your symptoms may return upon discontinuation. if you have any further questions on the use of this medicine, ask your doctor or pharmacist.", 'Entity_Recognition': [{'Text': 'solymbic', 'Type': 'PRODUCT_NAME', 'BeginOffset': 0, 'EndOffset': 0}, {'Text': 'this medicine', 'Type': 'TREATMENT', 'BeginOffset': 11, 'EndOffset': 24}, {'Id': 26, 'BeginOffset': 146, 'EndOffset': 166, 'Score': 0.88294917345047, 'Text': 'rheumatoid arthritis', 'Category': 'MEDICAL_CONDITION', 'Type': 'DX_NAME', 'Traits': [{'Name': 'DIAGNOSIS', 'Score': 0.9669777154922485}]}, {'Id': 27, 'BeginOffset': 168, 'EndOffset': 187, 'Score': 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{'Title': '4. possible side effects', 'Section_Content': "like all medicines, this medicine can cause side effects, although not everybody gets them. most side effects are mild to moderate. however, some may be serious and require treatment. side effects may occur at least up to 4 months after the last solymbic injection. tell your doctor immediately if you notice any of the following: severe rash, hives or other signs of allergic reaction; swollen face, hands, feet; trouble breathing, swallowing; shortness of breath with exertion or upon lying down or swelling of the feet. tell your doctor as soon as possible if you notice any of the following: signs of infection such as fever, feeling sick, wounds, dental problems, burning on urination; feeling weak or tired; coughing; tingling; numbness; double vision; arm or leg weakness; a bump or open sore that doesn't heal; signs and symptoms suggestive of blood disorders such as persistent fever, bruising, bleeding, paleness. the symptoms described above can be signs of the below listed side effects, which have been observed with adalimumab: very common side effects (may affect more than 1 in 10 people): injection site reactions (including pain, swelling, redness or itching); respiratory tract infections (including cold, runny nose, sinus infection, pneumonia); headache; abdominal pain; nausea and vomiting; rash; musculoskeletal pain. common side effects (may affect up to 1 in 10 people): serious infections (including blood poisoning and influenza); skin infections (including cellulitis and shingles); 70 ear infections; oral infections (including tooth infections and cold sores); reproductive tract infections; urinary tract infection; fungal infections; joint infections; benign tumours; skin cancer; allergic reactions (including seasonal allergy); dehydration; mood swings (including depression); anxiety; difficulty sleeping; sensation disorders such as tingling, prickling or numbness; migraine; nerve root compression (including low back pain and leg pain); vision disturbances; eye inflammation; inflammation of the eye lid and eye swelling; vertigo; sensation of heart beating rapidly; high blood pressure; flushing; haematoma; cough; asthma; shortness of breath; gastrointestinal bleeding; dyspepsia (indigestion, bloating, heart burn); acid reflux disease; sicca syndrome (including dry eyes and dry mouth); itching; itchy rash; bruising; inflammation of the skin (such as eczema); breaking of finger nails and toe nails; increased sweating; hair loss; new onset or worsening of psoriasis; muscle spasms; blood in urine; kidney problems; chest pain; oedema; fever; reduction in blood platelets which increases risk of bleeding or bruising; impaired healing. uncommon side effects (may affect up to 1 in 100 people): opportunistic infections (which include tuberculosis and other infections that occur when resistance to disease is lowered); neurological infections (including viral meningitis); eye infections; bacterial infections; diverticulitis (inflammation and infection of the large intestine); cancer; 71 cancer that affects the lymph system; melanoma; immune disorders that could affect the lungs, skin and lymph nodes (most commonly presenting as sarcoidosis); vasculitis (inflammation of blood vessels); tremor; neuropathy; stroke; double vision; hearing loss, buzzing; sensation of heart beating irregularly such as skipped beats; heart problems that can cause shortness of breath or ankle swelling; heart attack; a sac in the wall of a major artery, inflammation and clot of a vein, blockage of a blood vessel; lung diseases causing shortness of breath (including inflammation); pulmonary embolism (blockage in an artery of the lung); pleural effusion (abnormal collection of fluid in the pleural space); inflammation of the pancreas which causes severe pain in the abdomen and back; difficulty in swallowing; facial oedema; gallbladder inflammation, gallbladder stones; fatty liver; night sweats; scar; abnormal muscle breakdown; systemic lupus erythematosus (including inflammation of skin, heart, lung, joints and other organ systems); sleep interruptions; impotence; inflammations. rare side effects (may affect up to 1 in 1,000 people): leukaemia (cancer affecting the blood and bone marrow); severe allergic reaction with shock; multiple sclerosis; nerve disorders (such as eye nerve inflammation and guillain-barré syndrome that may cause muscle weakness, abnormal sensations, tingling in the arms and upper body); heart stops pumping; pulmonary fibrosis (scarring of the lung); intestinal perforation; hepatitis; reactivation of hepatitis b; autoimmune hepatitis (inflammation of the liver caused by the body's own immune system); cutaneous vasculitis (inflammation of blood vessels in the skin); stevens-johnson syndrome (early symptoms include malaise, fever, headache and rash); facial oedema associated with allergic reactions; erythema multiforme (inflammatory skin rash); lupus-like syndrome. not known (frequency cannot be estimated from available data): hepatosplenic t-cell lymphoma (a rare blood cancer that is often fatal); merkel cell carcinoma (a type of skin cancer); liver failure; worsening of a condition called dermatomyositis (seen as a skin rash accompanying muscle weakness). some side effects observed with adalimumab may not have symptoms and may only be discovered through blood tests. these include: very common side effects (may affect more than 1 in 10 people): low blood measurements for white blood cells; low blood measurements for red blood cells; increased lipids in the blood; elevated liver enzymes. common side effects (may affect up to 1 in 10 people): high blood measurements for white blood cells; low blood measurements for platelets; increased uric acid in the blood; abnormal blood measurements for sodium; low blood measurements for calcium; low blood measurements for phosphate; high blood sugar; high blood measurements for lactate dehydrogenase; autoantibodies present in the blood. rare side effects (may affect up to 1 in 1,000 people): low blood measurements for white blood cells, red blood cells and platelet count. not known (frequency cannot be estimated from available data): liver failure. reporting of side effects if you get any side effects, talk to your doctor or pharmacist. this includes any possible side effects not listed in this leaflet. you can also report side effects directly via the national reporting system listed in appendix v. by reporting side effects you can help provide more information on the safety of this medicine.", 'Entity_Recognition': [{'Text': 'solymbic', 'Type': 'PRODUCT_NAME', 'BeginOffset': 0, 'EndOffset': 0}, {'Text': 'all medicines', 'Type': 'TREATMENT', 'BeginOffset': 5, 'EndOffset': 18}, {'Text': 'this medicine', 'Type': 'TREATMENT', 'BeginOffset': 20, 'EndOffset': 33}, {'Id': 23, 'BeginOffset': 44, 'EndOffset': 56, 'Score': 0.9641301035881042, 'Text': 'side effects', 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{'Title': '5. how to store solymbic', 'Section_Content': 'keep this medicine out of the sight and reach of children. do not use this medicine after the expiry date which is stated on the label and carton after exp. the expiry date refers to the last day of that month. store in a refrigerator (2c 8c). do not freeze. store in the original carton in order to protect from light. a single solymbic pre-filled syringe may be stored at temperatures up to a maximum of 25 for a period of up to 14 days. the pre-filled syringe must be protected from light, and discarded if not used within the 14-day period. do not throw away any medicines via wastewater or household waste. ask your pharmacist how to throw away medicines you no longer use. these measures will help protect the environment.', 'Entity_Recognition': [{'Text': 'solymbic', 'Type': 'PRODUCT_NAME', 'BeginOffset': 0, 'EndOffset': 0}, {'Text': 'this medicine', 'Type': 'TREATMENT', 'BeginOffset': 70, 'EndOffset': 83}, {'Text': 'a single solymbic pre-filled syringe', 'Type': 'TREATMENT', 'BeginOffset': 320, 'EndOffset': 356}, {'Text': '25', 'Type': 'NUMBER', 'BeginOffset': 406, 'EndOffset': 408}, {'Text': '14', 'Type': 'NUMBER', 'BeginOffset': 431, 'EndOffset': 433}, {'Text': 'the pre-filled syringe', 'Type': 'TREATMENT', 'BeginOffset': 440, 'EndOffset': 462}, {'Text': '14', 'Type': 'NUMBER', 'BeginOffset': 530, 'EndOffset': 532}]}
{'Title': '6. contents of the pack and other information', 'Section_Content': 'what solymbic contains - the active substance is adalimumab. each pre-filled syringe contains 20 mg of adalimumab in 0.4 ml of solution or 40 mg of adalimumab in 0.8 ml of solution. - the other ingredients are glacial acetic acid, sucrose, polysorbate 80, sodium hydroxide and water for injection. what solymbic looks like and contents of the pack solymbic is a clear and colourless to slightly yellow solution. each pack contains 1 single-use 20 mg pre-filled syringe (with yellow plunger rod). each pack contains 1, 2, 4 or 6 single-use 40 mg pre-filled syringes (with blue plunger rod).', 'Entity_Recognition': [{'Text': 'solymbic', 'Type': 'PRODUCT_NAME', 'BeginOffset': 0, 'EndOffset': 0}, {'Id': 0, 'BeginOffset': 49, 'EndOffset': 59, 'Score': 0.9894786477088928, 'Text': 'adalimumab', 'Category': 'MEDICATION', 'Type': 'GENERIC_NAME', 'Traits': [], 'Attributes': [{'Type': 'FORM', 'Score': 0.4237994849681854, 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{'Type': 'DOSAGE', 'Score': 0.8351287841796875, 'RelationshipScore': 0.9255297183990479, 'RelationshipType': 'DOSAGE', 'Id': 4, 'BeginOffset': 117, 'EndOffset': 123, 'Text': '0.4 ml', 'Category': 'MEDICATION', 'Traits': []}, {'Type': 'FORM', 'Score': 0.984997034072876, 'RelationshipScore': 0.9538276791572571, 'RelationshipType': 'FORM', 'Id': 5, 'BeginOffset': 127, 'EndOffset': 135, 'Text': 'solution', 'Category': 'MEDICATION', 'Traits': []}]}, {'Text': '0.4', 'Type': 'NUMBER', 'BeginOffset': 117, 'EndOffset': 120}, {'Text': '40', 'Type': 'NUMBER', 'BeginOffset': 139, 'EndOffset': 141}, {'Id': 7, 'BeginOffset': 148, 'EndOffset': 158, 'Score': 0.9887070655822754, 'Text': 'adalimumab', 'Category': 'MEDICATION', 'Type': 'GENERIC_NAME', 'Traits': [], 'Attributes': [{'Type': 'DOSAGE', 'Score': 0.8351287841796875, 'RelationshipScore': 0.92750084400177, 'RelationshipType': 'DOSAGE', 'Id': 4, 'BeginOffset': 117, 'EndOffset': 123, 'Text': '0.4 ml', 'Category': 'MEDICATION', 'Traits': []}, {'Type': 'FORM', 'Score': 0.984997034072876, 'RelationshipScore': 0.9781227707862854, 'RelationshipType': 'FORM', 'Id': 5, 'BeginOffset': 127, 'EndOffset': 135, 'Text': 'solution', 'Category': 'MEDICATION', 'Traits': []}, {'Type': 'DOSAGE', 'Score': 0.9071652889251709, 'RelationshipScore': 0.9999338388442993, 'RelationshipType': 'DOSAGE', 'Id': 6, 'BeginOffset': 139, 'EndOffset': 144, 'Text': '40 mg', 'Category': 'MEDICATION', 'Traits': []}, {'Type': 'DOSAGE', 'Score': 0.893244743347168, 'RelationshipScore': 0.8321431875228882, 'RelationshipType': 'DOSAGE', 'Id': 8, 'BeginOffset': 162, 'EndOffset': 168, 'Text': '0.8 ml', 'Category': 'MEDICATION', 'Traits': []}, {'Type': 'FORM', 'Score': 0.9109216928482056, 'RelationshipScore': 0.934687077999115, 'RelationshipType': 'FORM', 'Id': 9, 'BeginOffset': 172, 'EndOffset': 180, 'Text': 'solution', 'Category': 'MEDICATION', 'Traits': []}]}, {'Text': '0.8', 'Type': 'NUMBER', 'BeginOffset': 162, 'EndOffset': 165}, {'Id': 10, 'BeginOffset': 210, 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