Skyrizi
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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 
 
Skyrizi 75 mg solution for injection in pre-filled syringe 
 
 
2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
 
Each pre-filled syringe contains 75 mg risankizumab in 0.83 ml solution. 
 
Risankizumab is a humanised immunoglobulin G1 (IgG1) monoclonal antibody selective to the 
interleukin (IL)-23 protein produced in Chinese Hamster Ovary cells using recombinant DNA 
technology. 
 
Excipients with known effect 
 
This medicinal product contains 68.0 mg sorbitol per 150 mg dose. 
 
This medicinal product contains less than 1 mmol sodium (23 mg) per 150 mg dose, that is to say 
essentially ‘sodium free’. 
 
For the full list of excipients, see section 6.1. 
 
 
3. PHARMACEUTICAL FORM 
 
Solution for injection (injection). 
 
The solution is colourless to slightly yellow and clear to slightly opalescent. 
 
 
4. CLINICAL PARTICULARS 
 
4.1 Therapeutic indications 
 
Skyrizi is indicated for the treatment of moderate to severe plaque psoriasis in adults who are 
candidates for systemic therapy. 
 
4.2 Posology and method of administration 
 
Skyrizi is intended for use under the guidance and supervision of a physician experienced in the 
diagnosis and treatment of psoriasis. 
 
Posology 
 
The recommended dose is 150 mg (two 75 mg injections) administered by subcutaneous injection at 
week 0, week 4, and every 12 weeks thereafter. 
 
Consideration should be given to discontinuing treatment in patients who have shown no response 
after 16 weeks of treatment. Some patients with initial partial response may subsequently improve 
with continued treatment beyond 16 weeks. 
 



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Missed dose 
 
If a dose is missed, the dose should be administered as soon as possible. Thereafter, dosing should be 
resumed at the regular scheduled time. 
 
Special populations 
 
Elderly (aged 65 years and over) 
 
No dose adjustment is required (see section 5.2). 
There is limited information in subjects aged ≥65 years. 
 
Renal or hepatic impairment 
 
No specific studies were conducted to assess the effect of hepatic or renal impairment on the 
pharmacokinetics of Skyrizi. These conditions are generally not expected to have any significant 
impact on the pharmacokinetics of monoclonal antibodies and no dose adjustments are considered 
necessary (see section 5.2). 
 
Paediatric population 
 
The safety and efficacy of Skyrizi in children and adolescents aged 6 to 18 years have not yet been 
established. No data are available. 
 
There is no relevant use of Skyrizi in children aged below 6 years for the indication of moderate to 
severe plaque psoriasis. 
 
Overweight patients  
 
No dose adjustment is required (see section 5.2). 
 
Method of administration  
 
Skyrizi is administered by subcutaneous injection. For each dose, the injections should be 
administered at different anatomic locations (such as thighs or abdomen), and not into areas where the 
skin is tender, bruised, erythematous, indurated or affected by psoriasis. Administration of Skyrizi in 
the upper, outer arm may only be performed by a healthcare professional or caregiver.  
 
Patients may self-inject Skyrizi after training in subcutaneous injection technique. Patients should be 
instructed to inject 2 pre-filled syringes for the full 150 mg dose and to read the ‘Instructions for use’ 
provided in the package leaflet before administration. 
 
4.3 Contraindications  
 
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. 
 
Clinically important active infections (e.g. active tuberculosis, see section 4.4). 
 
4.4 Special warnings and precautions for use 
 
Traceability 
 
In order to improve the traceability of biological medicinal products, the name and the batch number 
of the administered product should be clearly recorded. 
 



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Infections 
 
Risankizumab may increase the risk of infection. 
 
In patients with a chronic infection, a history of recurrent infection, or known risk factors for infection, 
risankizumab should be used with caution. Treatment with risankizumab should not be initiated in 
patients with any clinically important active infection until the infection resolves or is adequately 
treated. 
 
Patients treated with risankizumab should be instructed to seek medical advice if signs or symptoms of 
clinically important chronic or acute infection occur. If a patient develops such an infection or is not 
responding to standard therapy for the infection, the patient should be closely monitored and 
risankizumab should not be administered until the infection resolves. 
  
Tuberculosis 
 
Prior to initiating treatment with risankizumab, patients should be evaluated for tuberculosis (TB) 
infection. Patients receiving risankizumab should be monitored for signs and symptoms of active TB. 
Anti-TB therapy should be considered prior to initiating risankizumab in patients with a past history of 
latent or active TB in whom an adequate course of treatment cannot be confirmed. 
 
Immunisations  
 
Prior to initiating therapy with risankizumab, completion of all appropriate immunisations should be 
considered according to current immunisation guidelines. If a patient has received live vaccination 
(viral or bacterial), it is recommended to wait at least 4 weeks prior to starting treatment with 
risankizumab. Patients treated with risankizumab should not receive live vaccines during treatment 
and for at least 21 weeks after treatment (see section 5.2).  
 
Hypersensitivity 
 
If a serious hypersensivity reaction occurs, administration of risankizumab should be discontinued 
immediately and appropriate therapy initiated. 
 
Excipients with known effect 
 
This medicinal product contains 68.0 mg sorbitol per 150 mg dose. 
The additive effect of concomitantly administered products containing sorbitol (or fructose) and 
dietary intake of sorbitol (or fructose) should be taken into account. 
 
This medicinal product contains less than 1 mmol sodium (23 mg) per 150 mg dose, that is to say 
essentially ‘sodium free’. 
 
4.5 Interaction with other medicinal products and other forms of interaction 
 
Risankizumab is not expected to undergo metabolism by hepatic enzymes or renal elimination. Drug 
interactions between risankizumab and inhibitors, inducers, or substrates of drug metabolising 
enzymes are not expected and no dose adjustment is needed (see section 5.2). 
 
Concomitant immunosuppressive therapy or phototherapy 
 
The safety and efficacy of risankizumab in combination with immunosuppressants, including 
biologics, or phototherapy have not been evaluated. 
 



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4.6 Fertility, pregnancy and lactation 
 
Women of childbearing potential 
 
Women of childbearing potential should use an effective method of contraception during treatment 
and for at least 21 weeks after treatment. 
 
Pregnancy 
 
There are no or limited amount of data (less than 300 pregnancy outcomes) from the use of 
risankizumab in pregnant women. Animal studies do not indicate direct or indirect harmful effects 
with respect to reproductive toxicity. As a precautionary measure, it is preferable to avoid the use of 
risankizumab during pregnancy. 
 
Breast-feeding 
 
It is unknown whether risankizumab is excreted in human milk. Human IgGs are known to be excreted 
in breast milk during the first few days after birth, which decreases to low concentrations soon 
afterwards; consequently, a risk to the breast-fed infant cannot be excluded during this short period. A 
decision should be made whether to discontinue/abstain from risankizumab therapy, taking into 
account the benefit of breast-feeding to the child and the benefit of risankizumab therapy to the 
woman. 
 
Fertility 
 
The effect of risankizumab on human fertility has not been evaluated. Animal studies do not indicate 
direct or indirect harmful effects with respect to fertility. 
 
4.7 Effects on ability to drive and use machines 
 
Risankizumab has no or negligible influence on the ability to drive and use machines. 
 
4.8 Undesirable effects 
 
Summary of the safety profile 
 
The most frequently reported adverse reactions were upper respiratory infections, which occurred in 
13% of patients. 
 
Tabulated list of adverse reactions 
 
Adverse reactions for risankizumab from clinical studies (Table 1) are listed by MedDRA system 
organ class and are based on the following convention: 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 very rare (< 1/10,000). 
 



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Table 1:  List of adverse reactions in clinical studies 
 
System Organ Class Frequency Adverse Reactions 
Infections and 
infestations 
 

Very common Upper respiratory 
infectionsa 

Common Tinea infectionsb
Uncommon Folliculitis

Nervous system 
disorders 

Common Headachec

Skin and subcutaneous 
tissue disorders 

Common Pruritus 

General disorders and 
administration site 
conditions 

Common Fatigued
Injection site reactionse 

a  Includes: respiratory tract infection (viral, bacterial or unspecified), sinusitis 
(including acute), rhinitis, nasopharyngitis, pharyngitis (including viral), tonsillitis 

b Includes: tinea pedis, tinea cruris, body tinea, tinea versicolor, tinea manuum, 
onychomycosis 

c  Includes: headache, tension headache, sinus headache 
d  Includes: fatigue, asthenia 
e Includes: injection site bruising, erythema, haematoma, haemorrhage, irritation, 

pain, pruritus, reaction, swelling 
 
Description of selected adverse reactions 
 
Infections 
 
Over the entire psoriasis programme including long-term exposure to risankizumab, the rate of 
infections was 75.5 events per 100 subject-years. The majority of cases were non-serious and mild to 
moderate in severity and did not lead to discontinuation of risankizumab. The rate of serious infections 
was 1.7 events per 100 subject-years (see section 4.4). 
 
Immunogenicity 
 
As with all therapeutic proteins, there is the potential for immunogenicity with risankizumab. The 
detection of antibody formation is highly dependent on the sensitivity and specificity of the assay. 
 
For subjects treated with risankizumab at the recommended clinical dose for up to 52 weeks in 
psoriasis clinical trials, treatment-emergent anti-drug antibodies and neutralising antibodies were 
detected in 24% (263/1,079) and 14% (150/1,079) of evaluated subjects, respectively. 
 
For most subjects, antibodies to risankizumab including neutralising antibodies were not associated 
with changes in clinical response or safety. Among the few subjects (approximately 1%; 7/1,000 at 
week 16 and 6/598 at week 52) with high antibody titers (>128), clinical response appeared to be 
reduced. The incidence of injection site reactions is numerically higher in the anti-drug antibody-
positive compared with anti-drug antibody-negative groups over short-term (16 weeks: 2.7% vs 1.3%) 
and longer term treatment (>52 weeks: 5.0% vs 3.3%). The injection site reactions were all mild to 
moderate in severity, none were serious, and none led to discontinuation of risankizumab. 
 
Elderly 
 
There is limited safety information in subjects aged ≥65 years. 
 
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 



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professionals are asked to report any suspected adverse reactions via the national reporting system 
listed in Appendix V. 
 
4.9 Overdose 
 
In the event of overdose, it is recommended that the patient be monitored for any signs or symptoms 
of adverse reactions and appropriate symptomatic treatment be instituted immediately. 
 
 
5. PHARMACOLOGICAL PROPERTIES 
 
5.1  Pharmacodynamic properties 
 
Pharmacotherapeutic group: Immunosuppressants, interleukin inhibitors, ATC code: L04AC18 
 
Mechanism of action 
 
Risankizumab is a humanised immunoglobulin G1 (IgG1) monoclonal antibody that selectively binds 
with high affinity to the p19 subunit of human interleukin 23 (IL-23) cytokine without binding to IL-
12 and inhibits its interaction with the IL-23 receptor complex. IL-23 is a cytokine that is involved in 
inflammatory and immune responses. By blocking IL-23 from binding to its receptor, risankizumab 
inhibits IL-23-dependent cell signalling and release of proinflammatory cytokines.  
 
Pharmacodynamic effects 
 
In a study of subjects with psoriasis, expression of genes associated with the IL-23/IL-17 axis was 
decreased in the skin after single doses of risankizumab. Reductions in epidermal thickness, 
infiltration of inflammatory cells, and expression of psoriatic disease markers were also observed in 
psoriatic lesions. 
 
Clinical efficacy and safety 
 
The efficacy and safety of risankizumab was assessed in 2,109 subjects with moderate to severe 
plaque psoriasis in four multicentre, randomised, double-blind studies (ULTIMMA-1, ULTIMMA-2, 
IMMHANCE, and IMMVENT). Enrolled subjects were 18 years of age and older with plaque 
psoriasis who had a body surface area (BSA) involvement of ≥10%, a static Physician Global 
Assessment (sPGA) score of ≥3 in the overall assessment (plaque thickness/induration, erythema, and 
scaling) of psoriasis on a severity scale of 0 to 4, a Psoriasis Area and Severity Index (PASI) score 
≥12, and who were candidates for systemic therapy or phototherapy. 
 
Overall, subjects had a median baseline PASI score of 17.8, a median BSA of 20.0%, and a median 
baseline DLQI score of 13.0. Baseline sPGA score was severe in 19.3% of subjects and moderate in 
80.7% of subjects. A total of 9.8% of study subjects had a history of diagnosed psoriatic arthritis. 
 
Across all studies, 30.9% of subjects were naïve to any systemic therapy (including non-biologic and 
biologic), 38.1% had received prior phototherapy or photochemotherapy, 48.3% had received prior 
non‐biologic systemic therapy, 42.1% had received prior biologic therapy, and 23.7% had received at 
least one anti-TNF alpha agent for the treatment of psoriasis. 
 
ULTIMMA-1 and ULTIMMA-2 
 
ULTIMMA-1 and ULTIMMA-2 enrolled 997 subjects (598 randomised to risankizumab 150 mg, 199 
to ustekinumab 45 mg or 90 mg [according to baseline weight], and 200 to placebo). Subjects received 
treatment at week 0, week 4, and every 12 weeks thereafter. The two co-primary endpoints in 
ULTIMMA-1 and ULTIMMA-2 were the proportion of subjects who achieved 1) PASI 90 response 
and 2) sPGA score of clear or almost clear (sPGA 0 or 1) at week 16 versus placebo. The results for 
the co-primary and other endpoints are presented in Table 2 and Figure 1. 



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Table 2:  Efficacy and quality of life results in adults with plaque psoriasis in ULTIMMA-1 and 
ULTIMMA-2 
 ULTIMMA-1 ULTIMMA-2 
 Risankizumab  

(N=304) 
n (%) 

Ustekinumab
(N=100) 
n (%) 

Placebo 
(N=102) 
n (%) 

Risankizumab  
(N=294) 
n (%) 

Ustekinumab 
(N=99) 
n (%) 

Placebo 
(N=98) 
n (%) 

sPGA of clear or almost clear (0 or 1) 

   Week 16a 267 (87.8) 63 (63.0) 8 (7.8) 246 (83.7) 61 (61.6) 5 (5.1) 

   Week 52 262 (86.2) 54 (54.0) -- 245 (83.3) 54 (54.5) -- 
sPGA of clear (0) 
   Week 16 112 (36.8) 14 (14.0) 2 (2.0) 150 (51.0) 25 (25.3) 3 (3.1) 
   Week 52 175 (57.6) 21 (21.0) -- 175 (59.5) 30 (30.3) -- 
PASI 75 
   Week 12 264 (86.8) 70 (70.0) 10 (9.8) 261 (88.8) 69 (69.7) 8 (8.2) 
   Week 52 279 (91.8) 70 (70.0) -- 269 (91.5) 76 (76.8) -- 
PASI 90 
   Week 16a  229 (75.3) 42 (42.0) 5 (4.9) 220 (74.8) 47 (47.5) 2 (2.0) 
   Week 52 249 (81.9) 44 (44.0) -- 237 (80.6) 50 (50.5) -- 
PASI 100 
   Week 16 109 (35.9) 12 (12.0) 0 (0.0) 149 (50.7) 24 (24.2) 2 (2.0) 
   Week 52 171 (56.3) 21 (21.0) -- 175 (59.5) 30 (30.3) -- 
DLQI 0 or 1b 
   Week 16 200 (65.8) 43 (43.0) 8 (7.8) 196 (66.7) 46 (46.5) 4 (4.1) 
   Week 52 229 (75.3) 47 (47.0) -- 208 (70.7) 44 (44.4)  -- 
PSS 0 (symptom-free)c 
   Week 16 89 (29.3) 15 (15.0) 2 (2.0) 92 (31.3) 15 (15.2) 0 (0.0) 
   Week 52 173 (56.9) 30 (30.0) -- 160 (54.4) 30 (30.3) -- 
All comparisons of risankizumab versus ustekinumab and placebo achieved p<0.001 except for PASI 75 at 
week 52 in ULTIMMA-2 where p=0.001 
a  Co-primary endpoints versus placebo 
b No impact on health-related quality of life 
c Psoriasis Symptom Scale (PSS) of 0 means no symptoms of pain, itching, redness, and burning during the 
last 24 hours  
 



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‐100

‐90

‐80

‐70

‐60

‐50

‐40

‐30

‐20

‐10

0

0 4 8 12 16 22 28 34 40 46 52

RZB

UST

PBO

Figure 1:  Time course of mean percent change from baseline of PASI in ULTIMMA-1 and 
ULTIMMA-2 

PA
SI

 P
er

ce
nt

 C
ha

ng
e 

fr
om

 B
as

el
in

e 
 

 Weeks 
RZB = risankizumab 
UST = ustekinumab 
PBO = placebo 
p<0.001 at each time point 

 
Examination of age, gender, race, body weight ≤130 kg, baseline PASI score, concurrent psoriatic 
arthritis, previous non-biologic systemic treatment, previous biologic treatment, and previous failure 
of a biologic did not identify differences in response to risankizumab among these subgroups. 
 
Improvements were observed in psoriasis involving the scalp, the nails, and the palms and soles at 
week 16 and week 52 in subjects treated with risankizumab. 



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Table 3:  Mean changes from baseline in NAPSI, PPASI, and PSSI 
 ULTIMMA-1 ULTIMMA-2 IMMHANCE 
 Risankizumab Placebo Risankizumab Placebo Risankizumab Placebo 
NAPSI: 
Change 
at Week 
16 (SE) 

N=178; 
-9.0 (1.17) 

N=56; 
2.1 (1.86) 

*** 

N=177; 
-7.5 (1.03) 

N=49; 
3.0 (1.76) 

*** 

N=235; 
-7.5 (0.89) 

N=58; 
2.5 

(1.70) 
*** 

PPASI: 
Change 
at Week 
16 (SE) 

N=95; 
-5.93 (0.324) 

 

N=34; 
-3.17 

(0.445) 
*** 

N=86; 
-7.24 (0.558) 

N=23; 
-3.74 

(1.025) 
** 

N=113; 
-7.39 (0.654) 

 

N=26; 
-0.27 

(1.339) 
*** 

PSSI: 
Change 
at Week 
16 (SE) 

N=267; 
-17.6 (0.47) 

N=92; 
-2.9 

(0.69) 
*** 

N=252; 
-18.4 (0.52) 

N=83; 
-4.6 

(0.82) 
*** 

N=357; 
-20.1 (0.40) 

N=88; 
-5.5 

(0.77) 
*** 

NAPSI: 
Change 
at Week 
52 (SE) 

N=178; 
-15.7 (0.94) - 

N=183; 
-16.7 (0.85) - - - 

PPASI: 
Change 
at Week 
52 (SE) 

N=95; 
-6.16 (0.296) 

 
- N=89; -8.35 (0.274) - - - 

PSSI: 
Change 
at Week 
52 (SE) 

N=269; 
-17.9 (0.34) - 

N=259; 
-18.8 (0.24) - - - 

Nail Psoriasis Severity Index (NAPSI), Palmoplantar Psoriasis Severity Index (PPASI), Psoriasis 
Scalp Severity Index (PSSI), and Standard Error (SE) 
** P < 0.01 comparing to risankizumab 
*** P < 0.001 comparing to risankizumab
 
Anxiety and depression, as measured by the Hospital Anxiety and Depression Scale (HADS), 
improved in the risankizumab group at week 16 compared with the placebo group. 
 
Maintenance of response 
 
In an integrated analysis of subjects receiving risankizumab in ULTIMMA-1 and ULTIMMA-2 for 
PASI 100 responders at week 16, 79.8% (206/258) of the subjects who continued on risankizumab 
maintained the response at week 52. For PASI 90 responders at week 16, 88.4% (398/450) of subjects 
maintained the response at week 52. 
 
The safety profile of risankizumab with up to 77 weeks of exposure was consistent with the profile 
observed up to 16 weeks. 
 
IMMHANCE  
 
IMMHANCE enrolled 507 subjects (407 randomised to risankizumab 150 mg and 100 to placebo). 
Subjects received treatment at week 0, week 4 and every 12 weeks thereafter. Subjects who were 
originally on risankizumab and had a sPGA response of clear or almost clear at week 28 were re-
randomised to continue risankizumab every 12 weeks or have treatment withdrawn. 
 
At week 16, risankizumab was superior to placebo on the co-primary endpoints of sPGA of clear or 
almost clear (83.5% risankizumab vs 7.0% placebo) and PASI 90 (73.2% risankizumab vs 2.0% 
placebo). 
 



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Of the 31 subjects from the IMMHANCE study with latent tuberculosis (TB) who did not receive 
prophylaxis during the study, none developed active TB during the mean follow-up of 55 weeks on 
risankizumab. 
 
Among subjects with sPGA of clear or almost clear at week 28 in IMMHANCE, 81.1% (90/111) of 
subjects re-randomised to continued treatment with risankizumab maintained this response at week 
104 compared to 7.1% (16/225) who were re-randomised to withdrawal from risankizumab. Of these 
subjects, 63.1% (70/111) of subjects re-randomised to continued treatment with risankizumab 
achieved a sPGA clear response at week 104 compared to 2.2% (5/225) who were re-randomised to 
withdrawal from risankizumab. 
 
IMMVENT 
 
IMMVENT enrolled 605 subjects (301 randomised to risankizumab and 304 to adalimumab). Subjects 
randomised to risankizumab received 150 mg of treatment at week 0, week 4 and every 12 weeks 
thereafter. Subjects randomised to adalimumab received 80 mg at week 0, 40 mg at week 1 and 40 mg 
every other week through week 15. Starting at week 16, subjects who were receiving adalimumab 
continued or switched treatment based on response: 
 <PASI 50 were switched to risankizumab 
 PASI 50 to <PASI 90 were re-randomised to either continue adalimumab or switch to 

risankizumab 
 PASI 90 continued to receive adalimumab 

 
Results are presented in Table 4. 
 
Table 4:  Efficacy and quality of life results at week 16 in adults with plaque psoriasis in 
IMMVENT 
 Risankizumab 

(N=301) 
n (%) 

Adalimumab 
(N=304) 
n (%) 

sPGA of clear or almost cleara 252 (83.7)  183 (60.2)  
PASI 75 273 (90.7)  218 (71.7)  
PASI 90a 218 (72.4)  144 (47.4)  
PASI 100 120 (39.9)  70 (23.0)  
DLQI 0 or 1b 198 (65.8) 148 (48.7) 
All comparisons achieved p<0.001  
a Co-primary endpoints 
b No impact on health-related quality of life 
 
For subjects who had PASI 50 to <PASI 90 with adalimumab at week 16 and were re-randomised, 
differences in PASI 90 response rates between switching to risankizumab and continuing adalimumab 
were noted 4 weeks after re-randomisation (49.1% vs 26.8%, respectively).  
 
Results 28 weeks after re-randomisation are presented in Table 5 and Figure 2. 
 



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Table 5:  Efficacy results 28 weeks after re-randomisation in IMMVENT 
 Switched to 

Risankizumab 
(N=53) 
n (%) 

Continued on 
Adalimumab 

(N=56) 
n (%) 

PASI 90 35 (66.0)  12 (21.4)  
PASI 100 21 (39.6)  4 (7.1)  
All comparisons achieved p<0.001  
 
Figure 2:  Time course of PASI 90 after re-randomisation in IMMVENT 

Pe
rc

en
t o

f S
ub

je
ct

s 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 Weeks After Re-Randomisation 
ADA/ADA: Subjects randomised to adalimumab and continued on adalimumab 
ADA/RZB: Subjects randomised to adalimumab and switched to risankizumab 
p<0.05 at week 4 and p<0.001 at each time point beginning at week 8 

 
In 270 patients who switched from adalimumab to risankizumab without a washout period, the safety 
profile of risankizumab was similar to that in patients who initiated risankizumab after wash out of any 
prior systemic therapies. 
 
Paediatric population 
 
The European Medicines Agency has deferred the obligation to submit the results of studies with 
risankizumab in one or more subsets of the paediatric population in the treatment of plaque psoriasis 
(see section 4.2 for information on paediatric use). 
 
5.2 Pharmacokinetic properties 
 
Absorption 
 
Risankizumab exhibited linear pharmacokinetics with dose-proportional increase in exposure across 
dose ranges of 18 to 300 mg and 0.25 to 1 mg/kg administered subcutaneously, and 200 to 1,200 mg 
and 0.01 to 5 mg/kg administered intravenously. 
 
Following subcutaneous dosing of risankizumab, peak plasma concentrations were achieved between 
3-14 days after dosing with an estimated absolute bioavailability of 89%. With dosing of 150 mg at 
week 0, week 4 and every 12 weeks thereafter, estimated steady-state peak and trough plasma 
concentrations are 12 and 2 µg/mL, respectively.  



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Distribution 
 
The mean (±standard deviation) steady-state volume of distribution (Vss) of risankizumab was 11.4 
(±2.7) L in Phase 3 studies in subjects with psoriasis, indicating that the distribution of risankizumab is 
primarily confined to the vascular and interstitial spaces. 
 
Biotransformation 
 
Therapeutic IgG monoclonal antibodies are typically degraded into small peptides and amino acids via 
catabolic pathways in the same manner as endogenous IgGs. Risankizumab is not expected to be 
metabolised by cytochrome P450 enzymes. 
 
Elimination 
 
The mean (±standard deviation) systemic clearance (CL) of risankizumab was 0.3 (±0.1) L/day in 
Phase 3 studies in subjects with psoriasis. The mean terminal elimination half-life of risankizumab 
ranged from 28 to 29 days in Phase 3 studies in subjects with psoriasis. 
 
As an IgG1 monoclonal antibody, risankizumab is not expected to be filtered by glomerular filtration 
in the kidneys or to be excreted as an intact molecule in the urine. 
 
Linearity/non-linearity 
 
Risankizumab exhibited linear pharmacokinetics with approximately dose-proportional increases in 
systemic exposure (Cmax and AUC) in the evaluated dose ranges of 18 to 300 mg or 0.25 to 1 mg/kg 
subcutaneous administration in healthy subjects or subjects with psoriasis. 
 
Drug interactions 
 
A drug interaction study was conducted in subjects with plaque psoriasis to assess the effect of 
repeated administration of risankizumab on the pharmacokinetics of cytochrome P450 (CYP) sensitive 
probe substrates. The exposure of caffeine (CYP1A2 substrate), warfarin (CYP2C9 substrate), 
omeprazole (CYP2C19 substrate), metoprolol (CYP2D6 substrate) and midazolam (CYP3A substrate) 
following risankizumab treatment were comparable to their exposures prior to risankizumab treatment, 
indicating no clinically meaningful drug interactions through these enzymes. 
 
Population pharmacokinetic analyses indicated that risankizumab exposure was not impacted by 
concomitant medications (metformin, atorvastatin, lisinopril, amlodipine, ibuprofen, acetylsalicylate 
and levothyroxine) used by some subjects with plaque psoriasis during the clinical studies. 
 
Special populations 
 
Paediatric patients 
 
The pharmacokinetics of risankizumab in paediatric subjects has not been established. 
 
Elderly patients 
 
Of the 2,234 subjects with plaque psoriasis exposed to risankizumab, 243 were 65 years or older and 
24 subjects were 75 years or older. No overall differences in risankizumab exposure were observed 
between older and younger subjects who received risankizumab. 
 
Patients with renal or hepatic impairment 
 
No specific studies have been conducted to determine the effect of renal or hepatic impairment on the 
pharmacokinetics of risankizumab. Based on population pharmacokinetic analyses, serum creatinine 



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levels, creatinine clearance, or hepatic function markers (ALT/AST/bilirubin) did not have a 
meaningful impact on risankizumab clearance in subjects with psoriasis. 
 
As an IgG1 monoclonal antibody, risankizumab is mainly eliminated via intracellular catabolism and 
is not expected to undergo metabolism via hepatic cytochrome P450 enzymes or renal elimination. 
 
Body weight 
 
Risankizumab clearance and volume of distribution increase as body weight increases which may 
result in reduced efficacy in subjects with high body weight (>130 kg). However, this observation is 
based on a limited number of subjects. No dose adjustment based on body weight is currently 
recommended. 
 
Gender or race 
 
The clearance of risankizumab was not significantly influenced by gender or race in adult subjects 
with plaque psoriasis. No clinically meaningful differences in risankizumab exposure were observed 
in Chinese or Japanese subjects compared to Caucasian subjects in a clinical pharmacokinetic study.  
 
5.3 Preclinical safety data 
 
Nonclinical data revealed no special hazard for humans based on repeat-dose toxicity studies including 
safety pharmacology evaluations, and a reproductive and developmental toxicity study in cynomolgus 
monkeys at doses of up to 50 mg/kg/week (producing exposures of about 70 times the clinical 
exposure at maximum recommended human dose [MRHD]). 
 
Mutagenicity and carcinogenicity studies have not been conducted with risankizumab. In a 26-week 
chronic toxicology study in cynomolgus monkeys at doses of up to 50 mg/kg/week (about 70 times the 
clinical exposure at the MRHD), there were no pre-neoplastic or neoplastic lesions observed and no 
adverse immunotoxicity or cardiovascular effects were noted . 
 
 
6. PHARMACEUTICAL PARTICULARS 
 
6.1 List of excipients 
 
Disodium succinate hexahydrate 
Succinic acid 
Sorbitol 
Polysorbate 20 
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 the pre-filled syringes in the outer carton in order to protect from light. 
 



15 

6.5 Nature and contents of container  
 
Pre-filled glass syringe with a fixed needle and needle cover, assembled in an automatic needle guard. 
Each pre-filled syringe contains 75 mg risankizumab in 0.83 ml. 
 
Skyrizi is available in packs containing 2 pre-filled syringes and 2 alcohol pads. 
 
6.6 Special precautions for disposal and other handling 
 
Before injecting, patients may remove the carton from the refrigerator and allow to reach room 
temperature out of direct sunlight (15 to 30 minutes) without removing the pre-filled syringes from the 
carton. 
 
Prior to use, a visual inspection of each pre-filled syringe is recommended. The solution should be 
colourless to slightly yellow and clear to slightly opalescent. It may contain a few translucent to white 
product-related particles. Skyrizi should not be used if the solution is cloudy or discoloured, or 
contains large particles. 
 
Two pre-filled syringes should be injected for the full 150 mg dose. Comprehensive instructions for 
use are provided in the package leaflet. 
 
Each pre-filled syringe is for single use only. 
  
Any unused medicinal product or waste material should be disposed of in accordance with local 
requirements. 
 
 
7. MARKETING AUTHORISATION HOLDER 
 
AbbVie Deutschland GmbH & Co. KG 
Knollstrasse 
67061 Ludwigshafen 
Germany 
 
 
8. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/19/1361/001 
 
 
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 
 
Date of first authorisation: 26 April 2019 
 
 
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. 
  



16 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX II 
 
A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND 

MANUFACTURER(S) 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 
 

 



17 

A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND 
MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE 
 
Name and address of the manufacturer(s) of the biological active substance(s) 
 
Boehringer Ingelheim Pharma GmbH & Co. KG 
Birkendorfer Str. 65 
88397 Biberach a.d.R. 
GERMANY 
 
Name and address of the manufacturer(s) responsible for batch release 
 
AbbVie S.r.l. 
148, Pontina Km 52 snc 
04011 
Campoverde di Aprilia (LT) 
ITALY 
 
 
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 (PSURs) 
 
The requirements for submission of PSURs 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. 
The marketing authorisation holder (MAH) shall submit the first PSUR for this product within 6 
months following authorisation. 
 
 
D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND 
EFFECTIVE USE OF THE MEDICINAL PRODUCT 
 
 Risk management plan (RMP) 
 
The marketing authorisation holder (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; 
 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. 

  



18 

 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX III 
 

LABELLING AND PACKAGE LEAFLET 
  



19 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

A. LABELLING 
  



20 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
OUTER CARTON 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Skyrizi 75 mg solution for injection in pre-filled syringe 
risankizumab 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
One pre-filled syringe contains 75 mg risankizumab. 
 
 
3. LIST OF EXCIPIENTS 
 
Excipients: disodium succinate hexahydrate, succinic acid, sorbitol, polysorbate 20 and water for 
injections. See leaflet for further information 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
solution for injection 
2 pre-filled syringes 
2 alcohol pads 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
 
Subcutaneous use 
 
For single use only. 
 
Open here 
 
For more information and support on Skyrizi go to www.skyrizi.eu or scan this code. 
 
 
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 
 
 
8. EXPIRY DATE 
 
EXP 
 



21 

 
9. SPECIAL STORAGE CONDITIONS 
 
Store in a refrigerator. Do not freeze. 
 
Keep the pre-filled syringes in the outer 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 
 
AbbVie Deutschland GmbH & Co. KG 
Knollstrasse 
67061 Ludwigshafen 
Germany 
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/19/1361/001 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
skyrizi 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC 
SN 
NN 
  



22 

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 
 
BLISTER 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Skyrizi 75 mg solution for injection in pre-filled syringe 
risankizumab 
 
 
2. NAME OF THE MARKETING AUTHORISATION HOLDER 
 
AbbVie (as logo) 
 
 
3. EXPIRY DATE 
 
EXP  
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. OTHER 
 
For subcutaneous use 
 
PC 



23 

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
LABEL 
 
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 
 
Skyrizi 75 mg injection 
risankizumab 
SC 
 
 
2. METHOD OF ADMINISTRATION 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
 
6. OTHER 
  



24 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

B. PACKAGE LEAFLET 
 
 



25 

Package leaflet: Information for the patient 
 

Skyrizi 75 mg solution for injection in pre-filled syringe 
risankizumab 

 
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. 
- If you have any further questions, ask your doctor, pharmacist or nurse. 
- 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, pharmacist or nurse. This includes any possible 

side effects not listed in this leaflet. See section 4. 
 
What is in this leaflet 
 
1. What Skyrizi is and what it is used for 
2. What you need to know before you use Skyrizi 
3. How to use Skyrizi 
4. Possible side effects  
5. How to store Skyrizi 
6. Contents of the pack and other information 
7. Instructions for use 
 
 
1. What Skyrizi is and what it is used for 
 
Skyrizi contains the active substance risankizumab. 
 
Skyrizi is used to treat adults with moderate to severe plaque psoriasis. 
 
How Skyrizi works 
This medicine works by stopping a protein in the body called ‘IL-23’, which causes inflammation. It 
reduces the inflammation. It also reduces symptoms of psoriasis such as burning, itching, pain, redness 
and scaling. 
 
 
2. What you need to know before you use Skyrizi 
 
Do not use Skyrizi 
 if you are allergic to risankizumab or any of the other ingredients of this medicine (listed in 

section 6). 
 if you have an infection, including active tuberculosis, which your doctor thinks is important. 

 
Warnings and precautions 
Talk to your doctor, pharmacist or nurse before and during the use of Skyrizi: 
 if you currently have an infection or if you have an infection that keeps coming back.   
 if you have tuberculosis (TB).  
 if you have recently received or plan to receive an immunisation (vaccine). You should not be 

given certain types of vaccines while using Skyrizi. 
 



26 

Allergic reactions 
Tell your doctor or seek medical help immediately if you notice any signs of an allergic reaction while 
you are taking Skyrizi such as: 
 difficulty breathing or swallowing 
 swelling of the face, lips, tongue or throat 
 severe itching of the skin, with a red rash or raised bumps 
 
Children and adolescents 
Skyrizi is not recommended for children and adolescents under 18 years of age. This is because 
Skyrizi has not been studied in this age group. 
 
Other medicines and Skyrizi 
Tell your doctor, pharmacist or nurse: 
 if you are using, have recently used or might use any other medicines. 
 if you have recently had or are going to have a vaccination. You should not be given certain 

types of vaccines while using Skyrizi. 
 
If you are not sure, talk to your doctor, pharmacist or nurse before and during the use of Skyrizi. 
 
Pregnancy, contraception and breast-feeding 
If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for 
advice before using this medicine. This is because it is not known how this medicine will affect the 
baby. 
 
If you are a woman who can become pregnant, you should use contraception while using this medicine 
and for at least 21 weeks after your last dose of Skyrizi. 
 
If you are breast-feeding or are planning to breast-feed, talk to your doctor before using this medicine. 
 
Driving and using machines 
Skyrizi is not likely to affect your driving and use of machines. 
 
Skyrizi contains sorbitol and sodium 
This medicine contains 68 mg sorbitol per 150 mg dose. 
 
This medicine contains less than 1 mmol sodium (23 mg) per 150 mg dose, that is to say essentially 
‘sodium-free’. 
 
 
3. How to use Skyrizi 
 
Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor 
or pharmacist if you are not sure. 
 
This medicine is given as 2 injections under your skin (called ‘subcutaneous injections’).   
 
How much Skyrizi to use 
 
The dose is 150 mg given as two 75 mg injections. 
 
 How much? When?
1st dose 150 mg (two 75 mg injections) When your doctor tells you 
2nd dose  150 mg (two 75 mg injections) 4 weeks after 1st dose
Further doses 150 mg (two 75 mg injections) Every 12 weeks starting after 2nd dose 

 



27 

You and your doctor, pharmacist or nurse will decide if you should inject this medicine yourself. Do 
not inject yourself with this medicine unless you have been trained by your doctor, pharmacist or 
nurse. A caregiver may also give your injections after they have been trained. 
 
Read section 7 ‘Instructions for use’ at the end of this leaflet before injecting Skyrizi yourself. 
 
If you use more Skyrizi than you should 
If you have used more Skyrizi than you should or the dose has been given sooner than prescribed, talk 
to your doctor.   
 
If you forget to use Skyrizi 
If you forget to use Skyrizi, inject a dose as soon as you remember. Talk to your doctor if you are not 
sure what to do.  
 
If you stop using Skyrizi 
Do not stop using Skyrizi without talking to your doctor first. If you stop treatment, your symptoms 
may come back. 
 
If you have any further questions on the use of this medicine, ask your doctor, pharmacist, or nurse. 
 
 
4. Possible side effects 
 
Like all medicines, this medicine can cause side effects, although not everybody gets them. 
 
Serious side effects 
Talk to your doctor or get medical help immediately if you have symptoms of a serious infection such 
as:  
 fever, flu-like symptoms, night sweats 
 feeling tired or short of breath, cough which will not go away 
 warm, red and painful skin, or a painful skin rash with blisters 
 
Your doctor will decide if you can keep using Skyrizi. 
 
Other side effects 
Tell your doctor, pharmacist or nurse if you get any of the following side effects 
 
Very common: may affect more than 1 in 10 people  
 upper respiratory infections with symptoms such as sore throat and stuffy nose 
 
Common: may affect up to 1 in 10 people 
 feeling tired 
 fungal skin infection 
 injection site reactions (such as redness or pain) 
 itching 
 headache 
 
Uncommon: may affect up to 1 in 100 people  
 small raised red bumps on the skin 
 
Reporting of side effects 
If you get any side effects, talk to your doctor, pharmacist, or nurse. 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. 
 



28 

 
5. How to store Skyrizi 
 
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 syringe label and outer carton 
after ‘EXP’. 
 
Store in a refrigerator (2°C - 8°C). Do not freeze. 
 
Keep the pre-filled syringes in the original carton in order to protect from light. 
 
Do not use this medicine if the liquid is cloudy or contains flakes or large particles. 
 
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. 
 
 
6. Contents of the pack and other information 
 
What Skyrizi contains  
- The active substance is risankizumab. Each pre-filled syringe contains 75 mg of risankizumab 

in 0.83 ml solution. 
- The other ingredients are disodium succinate hexahydrate, succinic acid, sorbitol, polysorbate 

20 and water for injections. 
 

What Skyrizi looks like and contents of the pack 
Skyrizi is a clear and colourless to slightly yellow liquid in a pre-filled syringe with needle guard. The 
liquid may contain tiny white or clear particles. 
 
Each pack contains 2 pre-filled syringes and 2 alcohol pads. 
 
Marketing Authorisation Holder 
 
AbbVie Deutschland GmbH & Co. KG 
Knollstrasse 
67061 Ludwigshafen 
Germany 
 
Manufacturer 
 
AbbVie S.r.l.  
04011 Campoverde di Aprilia  
(Latina)  
Italy 
 
For any information about this medicine, please contact the local representative of the Marketing 
Authorisation Holder: 
 
België/Belgique/Belgien 
AbbVie SA 
Tél/Tel: +32 10  477811 

Lietuva 
AbbVie UAB  
Tel: +370 5 205 3023 



29 

 
България 
АбВи ЕООД 
Тел:+359 2 90 30 430 

 
Luxembourg/Luxemburg 
AbbVie SA 
Belgique/Belgien 
Tél/Tel: +32 10 477811 

 
Česká republika 
AbbVie s.r.o.  
Tel: +420 233 098 111 

 
Magyarország 
AbbVie Kft. 
Tel:+36 1 455 8600 

 
Danmark 
AbbVie A/S 
Tlf: +45 72 30-20-28 

 
Malta 
V.J.Salomone Pharma Limited  
Tel: +356 22983201 

 
Deutschland 
AbbVie Deutschland GmbH & Co. KG 
Tel: 00800 222843 33 (gebührenfrei) 
Tel: +49 (0) 611 / 1720-0 

 
Nederland 
AbbVie B.V. 
Tel:  +31 (0)88 322 2843 

 
Eesti 
AbbVie Biopharmaceuticals GmbH Eesti filiaal  
Tel: +372 623 1011 

 
Norge 
AbbVie AS 
Tlf: +47 67 81 80 00 

 
Ελλάδα 
AbbVie ΦΑΡΜΑΚΕΥΤΙΚΗ Α.Ε. 
Τηλ: +30 214 4165 555 

 
Österreich 
AbbVie GmbH  
Tel: +43 1 20589-0 

 
España 
AbbVie Spain, S.L.U. 
Tel:  +34 91 384 09 10 

 
Polska 
AbbVie Polska Sp. z o.o. 
Tel: +48 22 372 78 00  

 
France 
AbbVie 
Tél: +33 (0) 1 45 60 13 00 

 
Portugal 
AbbVie, Lda.  
Tel: +351 (0)21 1908400 

 
Hrvatska  
AbbVie d.o.o. 
Tel: + 385 (0)1 5625 501 

 
România 
AbbVie S.R.L. 
Tel: +40 21 529 30 35 

 
Ireland 
AbbVie Limited  
Tel: +353 (0)1 4287900 

 
Slovenija 
AbbVie Biofarmacevtska družba d.o.o. 
Tel: +386 (1)32 08 060 

 
Ísland 
Vistor hf. 
Tel: +354 535 7000 

 
Slovenská republika 
AbbVie s.r.o. 
Tel: +421 2 5050 0777 

 
Italia 
AbbVie S.r.l.  
Tel: +39 06 928921 

 
Suomi/Finland 
AbbVie Oy  
Puh/Tel:  +358 (0)10 2411 200 

 
Κύπρος 
Lifepharma (Z.A.M.) Ltd 
Τηλ: +357 22 34 74 40 

 
Sverige 
AbbVie AB 
Tel:  +46 (0)8 684 44 600 



30 

 
Latvija 
AbbVie SIA  
Tel: +371 67605000 

 
United Kingdom 
AbbVie Ltd  
Tel: +44 (0)1628 561090 

 
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.  
 
Detailed and updated information on this product is available by scanning the QR code included below 
or on the outer carton with a smartphone. The same information is also available at the following 
URL: 
www.skyrizi.eu 
 
QR code to be included 
 
To listen to or request a copy of this leaflet in <Braille>, <large print> or <audio>, please contact the 
local representative of the Marketing Authorisation Holder. 
 
 
7.  Instructions for use 

 
Please read all of section 7 before using Skyrizi 

 
                Plunger rod          Finger grip                 Needle cover 

 
                                                          Body of syringe 
 

Important information to know before you inject Skyrizi 
 You should receive training on how to inject Skyrizi before giving an injection. Talk to your 

doctor, pharmacist or nurse if you need help 
 Mark the dates on your calendar so you know when to inject Skyrizi 
 Keep Skyrizi in the original carton to protect the medicine from light until it is time to use it 
 Do not inject if the liquid is cloudy or contains flakes or large particles. The liquid should look 

clear to slightly yellow and may contain tiny white or clear particles 
 Do not shake the syringe 
 Wait to remove the needle cover until just before the injection 
 



31 

Return this medicine to the pharmacy 
 if the expiry date (EXP) has passed 
 if the liquid has ever been frozen (even if thawed) 
 if the syringe has been dropped or damaged 
 if the syringe paper tray cover is broken or missing 
 
For a more comfortable injection: Take the carton out of the refrigerator and leave it at room 
temperature, out of direct sunlight, for 15 to 30 minutes before injecting.  
 Skyrizi should not be warmed in any other way (for example, in a microwave or in hot water) 
 Keep the syringes in the carton until ready to inject 

 
Follow the steps below each time you use Skyrizi 

 
STEP 1 
 

Place the following items on a clean, flat 
surface: 
 2 pre-filled syringes and 2 alcohol pads 

(included in the carton) 
 2 cotton balls or gauze pads (not included 

in the carton) 
 Special disposal container (not included in 

the carton) 
 
Wash and dry your hands. 
 
Start with one syringe for the first injection. 
 
For a full dose, 2 injections are required, 
one after the other. 

STEP 2 
 
Areas to inject 

 
   Areas to inject 

Choose from these 3 areas to inject: 
 front of left thigh 
 front of right thigh 
 your belly (abdomen) at least 5 cm 

from your belly button (navel) 
 
For the second syringe, inject at least 3 cm 
away from the first injection. Do not inject 
into the same place. 
 
Before each injection, wipe where you will 
inject in a circular motion with an alcohol 
pad. 

 Do not touch or blow on the 
injection site after it is cleaned. 
Allow the skin to dry before 
injecting  

 Do not inject through clothes 
 Do not inject into skin that is sore, 

bruised, red, hard, scarred, or has 
stretch marks 

 Do not inject into areas affected by 
psoriasis 



32 

STEP 3 
 

 
      Check liquid 

Hold the syringe with the covered needle 
pointing down, as shown. 
 
Check the liquid in the syringe. 
 
 It is normal to see bubbles in the window 
 The liquid should look clear to slightly 

yellow and may contain tiny white or clear 
particles 

 Do not use if the liquid is cloudy or 
contains flakes or large particles 

STEP 4 
 

Removing the needle cover: 
 
 Hold the syringe in one hand between the 

finger grip and needle cover 
 With the other hand, gently pull the needle 

cover straight off 
 Do not hold or pull the plunger rod when 

removing the needle cover 
 You may see a drop of liquid at the end of 

the needle. This is normal 
 Throw away the needle cover  
 Do not touch the needle with your fingers 

or let the needle touch anything 

STEP 5 
 

 
 

Hold the body of the syringe in one hand 
between the thumb and index finger, like you 
would a pencil. 
 
Gently pinch the area of cleaned skin with 
your other hand and hold it firmly. 
 
Insert the needle all the way into the skin at 
about a 45-degree angle using a quick, short 
movement. Keep the syringe steady at the 
same angle. 



33 

STEP 6 
 

 
      Needle guard 

Slowly push the plunger rod all the way in 
until all of the liquid is injected. 
 
Pull the needle out of the skin while keeping 
the syringe at the same angle. 
 
Slowly take your thumb off the plunger rod. 
The needle will then be covered by the 
needle guard. 
 
 The needle guard will not activate unless 

all the liquid is injected 
 Speak to your doctor, pharmacist or nurse 

if you think you have not given a full dose 
 

Press a cotton ball or gauze pad where you 
have injected and hold for 10 seconds. 
 
Do not rub the skin where you have injected. 
You may have slight bleeding from where 
you injected. This is normal 

STEP 7 
 

 
2 Injections Required 

For a full dose, two injections are needed, 
one after the other. 
 
 Repeat Steps 2 through 6 with the second 

syringe 
 Inject the second syringe straight after the 

first injection but at least 3 cm away from 
the first injection 

STEP 8  
 

Throw away used syringes in a special 
disposal container straight after use. 
 
 Do not throw away used syringes in the 

household waste 
 Your doctor, pharmacist or nurse will tell 

you how to return the full special disposal 
container 

 

 


	SUMMARY OF PRODUCT CHARACTERISTICS
	A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) ANDMANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
	B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
	C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETINGAUTHORISATION
	D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE ANDEFFECTIVE USE OF THE MEDICINAL PRODUCT
	A. LABELLING
	B. PACKAGE LEAFLET
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{'Title': '2. what you need to know before you use skyrizi', 'Section_Content': "do not use skyrizi if you are allergic to risankizumab or any of the other ingredients of this medicine (listed in section 6). if you have an infection, including active tuberculosis, which your doctor thinks is important. warnings and precautions talk to your doctor, pharmacist or nurse before and during the use of skyrizi: if you currently have an infection or if you have an infection that keeps coming back. if you have tuberculosis (tb). if you have recently received or plan to receive an immunisation (vaccine). you should not be given certain types of vaccines while using skyrizi. allergic reactions tell your doctor or seek medical help immediately if you notice any signs of an allergic reaction while you are taking skyrizi such as: difficulty breathing or swallowing swelling of the face, lips, tongue or throat severe itching of the skin, with a red rash or raised bumps children and adolescents skyrizi is not recommended for children and adolescents under 18 years of age. this is because skyrizi has not been studied in this age group. other medicines and skyrizi tell your doctor, pharmacist or nurse: if you are using, have recently used or might use any other medicines. if you have recently had or are going to have a vaccination. you should not be given certain types of vaccines while using skyrizi. if you are not sure, talk to your doctor, pharmacist or nurse before and during the use of skyrizi. pregnancy, contraception and breast-feeding if you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice before using this medicine. this is because it is not known how this medicine will affect the baby. if you are a woman who can become pregnant, you should use contraception while using this medicine and for at least 21 weeks after your last dose of skyrizi. if you are breast-feeding or are planning to breast-feed, talk to your doctor before using this medicine. driving and using machines skyrizi is not likely to affect your driving and use of machines. skyrizi contains sorbitol and sodium this medicine contains 68 mg sorbitol per 150 mg dose. this medicine contains less than 1 mmol sodium (23 mg) per 150 mg dose, that is to say essentially 'sodium-free'.", 'Entity_Recognition': [{'Text': 'skyrizi', 'Type': 'PRODUCT_NAME', 'BeginOffset': 0, 'EndOffset': 0}, {'Id': 5, 'BeginOffset': 11, 'EndOffset': 18, 'Score': 0.7887539267539978, 'Text': 'skyrizi', 'Category': 'MEDICATION', 'Type': 'BRAND_NAME', 'Traits': [{'Name': 'NEGATION', 'Score': 0.805378258228302}]}, {'Text': 'allergic', 'Type': 'PROBLEM', 'BeginOffset': 30, 'EndOffset': 38}, {'Id': 6, 'BeginOffset': 42, 'EndOffset': 54, 'Score': 0.9582822322845459, 'Text': 'risankizumab', 'Category': 'MEDICATION', 'Type': 'GENERIC_NAME', 'Traits': [{'Name': 'NEGATION', 'Score': 0.43558722734451294}]}, {'Text': 'this medicine', 'Type': 'TREATMENT', 'BeginOffset': 90, 'EndOffset': 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{'Title': '3. how to use skyrizi', '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. this medicine is given as 2 injections under your skin (called 'subcutaneous injections'). how much skyrizi to use the dose is 150 mg given as two 75 mg injections. how much? when? 1st dose 150 mg (two 75 mg injections) when your doctor tells you 2nd dose 150 mg (two 75 mg injections) 4 weeks after 1st dose further doses 150 mg (two 75 mg injections) every 12 weeks starting after 2nd dose 27 you and your doctor, pharmacist or nurse will decide if you should inject this medicine yourself. do not inject yourself with this medicine unless you have been trained by your doctor, pharmacist or nurse. a caregiver may also give your injections after they have been trained. read section 7 'instructions for use' at the end of this leaflet before injecting skyrizi yourself. if you use more skyrizi than you should if you have used more skyrizi than you should or the dose has been given sooner than prescribed, talk to your doctor. if you forget to use skyrizi if you forget to use skyrizi, inject a dose as soon as you remember. talk to your doctor if you are not sure what to do. if you stop using skyrizi do not stop using skyrizi without talking to your doctor first. if you stop treatment, your symptoms may come back. if you have any further questions on the use of this medicine, ask your doctor, pharmacist, or nurse.", 'Entity_Recognition': [{'Text': 'skyrizi', 'Type': 'PRODUCT_NAME', 'BeginOffset': 0, 'EndOffset': 0}, {'Text': 'this medicine', 'Type': 'TREATMENT', 'BeginOffset': 11, 'EndOffset': 24}, {'Text': 'this medicine', 'Type': 'TREATMENT', 'BeginOffset': 134, 'EndOffset': 147}, {'Text': '2', 'Type': 'NUMBER', 'BeginOffset': 160, 'EndOffset': 161}, {'Id': 20, 'BeginOffset': 162, 'EndOffset': 172, 'Score': 0.19977876543998718, 'Text': 'injections', 'Category': 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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. serious side effects talk to your doctor or get medical help immediately if you have symptoms of a serious infection such as: fever, flu-like symptoms, night sweats feeling tired or short of breath, cough which will not go away warm, red and painful skin, or a painful skin rash with blisters your doctor will decide if you can keep using skyrizi. other side effects tell your doctor, pharmacist or nurse if you get any of the following side effects very common: may affect more than 1 in 10 people upper respiratory infections with symptoms such as sore throat and stuffy nose common: may affect up to 1 in 10 people feeling tired fungal skin infection injection site reactions (such as redness or pain) itching headache uncommon: may affect up to 1 in 100 people small raised red bumps on the skin reporting of side effects if you get any side effects, talk to your doctor, pharmacist, or nurse. 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': 'skyrizi', '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': 11, 'BeginOffset': 44, 'EndOffset': 56, 'Score': 0.9657506942749023, 'Text': 'side effects', 'Category': 'MEDICAL_CONDITION', 'Type': 'DX_NAME', 'Traits': [{'Name': 'SYMPTOM', 'Score': 0.7874408960342407}]}, {'Text': 'serious side effects', 'Type': 'PROBLEM', 'BeginOffset': 92, 'EndOffset': 112}, {'Text': 'symptoms', 'Type': 'PROBLEM', 'BeginOffset': 177, 'EndOffset': 185}, {'Text': 'a serious 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{'Title': '5. how to store skyrizi', '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 syringe label and outer carton after 'exp'. store in a refrigerator (2 - 8). do not freeze. keep the pre-filled syringes in the original carton in order to protect from light. do not use this medicine if the liquid is cloudy or contains flakes or large particles. 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': 'skyrizi', 'Type': 'PRODUCT_NAME', 'BeginOffset': 0, 'EndOffset': 0}, {'Text': 'this medicine', 'Type': 'TREATMENT', 'BeginOffset': 70, 'EndOffset': 83}, {'Text': 'the pre-filled syringes', 'Type': 'TREATMENT', 'BeginOffset': 226, 'EndOffset': 249}, {'Text': 'the original carton', 'Type': 'TREATMENT', 'BeginOffset': 253, 'EndOffset': 272}, {'Text': 'this medicine', 'Type': 'TREATMENT', 'BeginOffset': 316, 'EndOffset': 329}, {'Text': 'cloudy', 'Type': 'PROBLEM', 'BeginOffset': 347, 'EndOffset': 353}, {'Text': 'large particles', 'Type': 'PROBLEM', 'BeginOffset': 376, 'EndOffset': 391}]}
{'Title': '6. contents of the pack and other information', 'Section_Content': 'what skyrizi contains - the active substance is risankizumab. each pre-filled syringe contains 75 mg of risankizumab in 0.83 ml solution. - the other ingredients are disodium succinate hexahydrate, succinic acid, sorbitol, polysorbate 20 and water for injections. what skyrizi looks like and contents of the pack skyrizi is a clear and colourless to slightly yellow liquid in a pre-filled syringe with needle guard. the liquid may contain tiny white or clear particles. each pack contains 2 pre-filled syringes and 2 alcohol pads.', 'Entity_Recognition': [{'Text': 'skyrizi', 'Type': 'PRODUCT_NAME', 'BeginOffset': 0, 'EndOffset': 0}, {'Id': 0, 'BeginOffset': 48, 'EndOffset': 60, 'Score': 0.9841517210006714, 'Text': 'risankizumab', 'Category': 'MEDICATION', 'Type': 'GENERIC_NAME', 'Traits': [], 'Attributes': [{'Type': 'FORM', 'Score': 0.42756542563438416, 'RelationshipScore': 0.9934884309768677, 'RelationshipType': 'FORM', 'Id': 1, 'BeginOffset': 67, 'EndOffset': 94, 'Text': 'pre-filled syringe contains', 'Category': 'MEDICATION', 'Traits': []}]}, {'Text': 'each pre-filled syringe', 'Type': 'TREATMENT', 'BeginOffset': 62, 'EndOffset': 85}, {'Text': '75', 'Type': 'NUMBER', 'BeginOffset': 95, 'EndOffset': 97}, {'Id': 3, 'BeginOffset': 104, 'EndOffset': 116, 'Score': 0.9493979811668396, 'Text': 'risankizumab', 'Category': 'MEDICATION', 'Type': 'GENERIC_NAME', 'Traits': [], 'Attributes': [{'Type': 'FORM', 'Score': 0.42756542563438416, 'RelationshipScore': 0.8833158016204834, 'RelationshipType': 'FORM', 'Id': 1, 'BeginOffset': 67, 'EndOffset': 94, 'Text': 'pre-filled syringe contains', 'Category': 'MEDICATION', 'Traits': []}, {'Type': 'DOSAGE', 'Score': 0.9767340421676636, 'RelationshipScore': 0.9999960660934448, 'RelationshipType': 'DOSAGE', 'Id': 2, 'BeginOffset': 95, 'EndOffset': 100, 'Text': '75 mg', 'Category': 'MEDICATION', 'Traits': []}, {'Type': 'STRENGTH', 'Score': 0.5691222548484802, 'RelationshipScore': 0.9948503375053406, 'RelationshipType': 'STRENGTH', 'Id': 4, 'BeginOffset': 120, 'EndOffset': 127, 'Text': '0.83 ml', 'Category': 'MEDICATION', 'Traits': []}, {'Type': 'FORM', 'Score': 0.9725430607795715, 'RelationshipScore': 0.9997944235801697, 'RelationshipType': 'FORM', 'Id': 5, 'BeginOffset': 128, 'EndOffset': 136, 'Text': 'solution', 'Category': 'MEDICATION', 'Traits': []}]}, {'Text': '0.83', 'Type': 'NUMBER', 'BeginOffset': 120, 'EndOffset': 124}, {'Id': 6, 'BeginOffset': 166, 'EndOffset': 196, 'Score': 0.9919443130493164, 'Text': 'disodium succinate hexahydrate', 'Category': 'MEDICATION', 'Type': 'GENERIC_NAME', 'Traits': [], 'Attributes': [{'Type': 'STRENGTH', 'Score': 0.5691222548484802, 'RelationshipScore': 0.9696229100227356, 'RelationshipType': 'STRENGTH', 'Id': 4, 'BeginOffset': 120, 'EndOffset': 127, 'Text': '0.83 ml', 'Category': 'MEDICATION', 'Traits': []}]}, {'Id': 7, 'BeginOffset': 198, 'EndOffset': 211, 'Score': 0.9983543157577515, 'Text': 'succinic acid', 'Category': 'MEDICATION', 'Type': 'GENERIC_NAME', 'Traits': []}, {'Id': 8, 'BeginOffset': 213, 'EndOffset': 221, 'Score': 0.9199740886688232, 'Text': 'sorbitol', 'Category': 'MEDICATION', 'Type': 'GENERIC_NAME', 'Traits': []}, {'Id': 9, 'BeginOffset': 223, 'EndOffset': 234, 'Score': 0.5416322350502014, 'Text': 'polysorbate', 'Category': 'MEDICATION', 'Type': 'GENERIC_NAME', 'Traits': [], 'Attributes': [{'Type': 'STRENGTH', 'Score': 0.27132290601730347, 'RelationshipScore': 0.9809276461601257, 'RelationshipType': 'STRENGTH', 'Id': 10, 'BeginOffset': 235, 'EndOffset': 237, 'Text': '20', 'Category': 'MEDICATION', 'Traits': []}, {'Type': 'ROUTE_OR_MODE', 'Score': 0.3435990810394287, 'RelationshipScore': 0.9945600628852844, 'RelationshipType': 'ROUTE_OR_MODE', 'Id': 11, 'BeginOffset': 252, 'EndOffset': 262, 'Text': 'injections', 'Category': 'MEDICATION', 'Traits': []}]}, {'Text': '20', 'Type': 'NUMBER', 'BeginOffset': 235, 'EndOffset': 237}, {'Text': 'injections', 'Type': 'TREATMENT', 'BeginOffset': 252, 'EndOffset': 262}, {'Text': 'slightly yellow liquid', 'Type': 'PROBLEM', 'BeginOffset': 350, 'EndOffset': 372}, {'Text': 'tiny white or clear particles', 'Type': 'PROBLEM', 'BeginOffset': 439, 'EndOffset': 468}, {'Text': 'each pack', 'Type': 'TREATMENT', 'BeginOffset': 470, 'EndOffset': 479}, {'Text': '2 pre-filled syringes', 'Type': 'TREATMENT', 'BeginOffset': 489, 'EndOffset': 510}, {'Text': '2 alcohol pads', 'Type': 'TREATMENT', 'BeginOffset': 515, 'EndOffset': 529}]}