Fingolimod Accord
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  ANNEX I 
 

SUMMARY OF PRODUCT CHARACTERISTICS 
  



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1. NAME OF THE MEDICINAL PRODUCT 
 
Fingolimod Accord 0.5 mg hard capsules 
 
 
2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
 
Fingolimod Accord 0.5 mg hard capsules 
 
Each capsule contains fingolimod hydrochloride equivalent to 0.5 mg fingolimod. 
 
For the full list of excipients, see section 6.1. 
 
 
3. PHARMACEUTICAL FORM 
 
Hard capsule (capsule) 
 
Bright yellow opaque/white opaque size “3” hard gelatin capsule imprinted with “FO 0.5 mg” on the 
cap and two radial bands on the capsule body with yellow ink containing white to off-white powder. 
Each capsule is approximately 15.8 mm in length. 
 
 
4. CLINICAL PARTICULARS 
 
4.1 Therapeutic indications 
 
Fingolimod Accord is indicated as single disease modifying therapy in highly active relapsing 
remitting multiple sclerosis for the following groups of adult patients and paediatric patients aged 
10 years and older: 
 
- Patients with highly active disease despite a full and adequate course of treatment with at least 

one disease modifying therapy (for exceptions and information about washout periods see 
sections 4.4 and 5.1). 

or 
- Patients with rapidly evolving severe relapsing remitting multiple sclerosis defined by 2 or more 

disabling relapses in one year, and with 1 or more Gadolinium enhancing lesions on brain MRI 
or a significant increase in T2 lesion load as compared to a previous recent MRI. 

 
4.2 Posology and method of administration 
 
The treatment should be initiated and supervised by a physician experienced in multiple sclerosis. 
 
Posology 
 
In adults, the recommended dose of Fingolimod Accord is one 0.5 mg capsule taken orally once daily. 
 
In paediatric patients (10 years of age and above), the recommended dose is dependent on body 
weight. 
- Paediatric patients with body weight ≤40 kg: one 0.25 mg capsule taken orally once daily. 
- Paediatric patients with body weight >40 kg: one 0.5 mg capsule taken orally once daily. 
 
Paediatric patients who start on 0.25 mg capsules and subsequently reach a stable body weight above 
40 kg should be switched to 0.5 mg capsules. 
 
When switching from a 0.25 mg to a 0.5 mg daily dose, it is recommended to repeat the same first 
dose monitoring as for treatment initiation. 



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Fingolimod Accord is not available in 0.25 mg strength. For this dosage, other medicinal products that 
contain fingolimod available on the market should be used. 
 
Fingolimod Accord can be taken with or without food. 
 
The capsules should always be swallowed intact, without opening them. 
 
The same first dose monitoring as for treatment initiation is recommended when treatment is 
interrupted for: 
- 1 day or more during the first 2 weeks of treatment. 
- more than 7 days during weeks 3 and 4 of treatment. 
- more than 2 weeks after one month of treatment. 
 
If the treatment interruption is of shorter duration than the above, the treatment should be continued 
with the next dose as planned (see section 4.4). 
 
Special populations 
 
Elderly population 
Fingolimod should be used with caution in patients aged 65 years and over due to insufficient data on 
safety and efficacy (see section 5.2). 
 
Renal impairment 
Fingolimod was not studied in patients with renal impairment in the multiple sclerosis pivotal studies. 
Based on clinical pharmacology studies, no dose adjustments are needed in patients with mild to 
severe renal impairment. 
 
Hepatic impairment 
Fingolimod must not be used in patients with severe hepatic impairment (Child-Pugh class C) (see 
section 4.3). Although no dose adjustments are needed in patients with mild or moderate hepatic 
impairment, caution should be exercised when initiating treatment in these patients (see sections 
4.4 and 5.2). 
 
Paediatric population  
The safety and efficacy of fingolimod in children aged below 10 years have not yet been established. 
No data are available. 
 
There are very limited data available in children between 10–12 years old (see sections 4.4, 4.8 and 
5.1). 
 
Method of administration 
 
This medicinal product is for oral use. 
 
4.3 Contraindications 
 
-  Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. 
- Immunodeficiency syndrome. 
- Patients with increased risk for opportunistic infections, including immunocompromised 

patients (including those currently receiving immunosuppressive therapies or those 
immunocompromised by prior therapies). 

- Severe active infections, active chronic infections (hepatitis, tuberculosis). 
- Active malignancies. 
- Severe liver impairment (Child-Pugh class C). 



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- Patients who in the previous 6 months had myocardial infarction (MI), unstable angina pectoris, 
stroke/transient ischaemic attack (TIA), decompensated heart failure (requiring inpatient 
treatment), or New York Heart Association (NYHA) class III/IV heart failure (see section 4.4). 

- Patients with severe cardiac arrhythmias requiring anti-arrhythmic treatment with class Ia or 
class III anti-arrhythmic medicinal products (see section 4.4). 

- Patients with second-degree Mobitz type II atrioventricular (AV) block or third-degree AV 
block, or sick-sinus syndrome, if they do not wear a pacemaker (see section 4.4). 

- Patients with a baseline QTc interval ≥ 500 msec (see section 4.4). 
- During pregnancy and in women of childbearing potential not using effective contraception (see 

sections 4.4 and 4.6). 
 
4.4 Special warnings and precautions for use 
 
Bradyarrhythmia  
 
Initiation of Fingolimod Accord treatment results in a transient decrease in heart rate and may also be 
associated with atrioventricular conduction delays, including the occurrence of isolated reports of 
transient, spontaneously resolving complete AV block (see sections 4.8 and 5.1). 
 
After the first dose, the decline in heart rate starts within one hour, and is maximal within 6 hours. 
This post-dose effect persists over the following days, although usually to a milder extent, and usually 
abates over the next weeks. With continued administration, the average heart rate returns towards 
baseline within one month. However, individual patients may not return to baseline heart rate by the 
end of the first month. Conduction abnormalities were typically transient and asymptomatic. They 
usually did not require treatment and resolved within the first 24 hours on treatment. If necessary, the 
decrease in heart rate induced by fingolimod can be reversed by parenteral doses of atropine or 
isoprenaline. 
 
All patients should have an ECG and blood pressure measurement performed prior to and 6 hours after 
the first dose of Fingolimod Accord. All patients should be monitored for a period of 6 hours for signs 
and symptoms of bradycardia with hourly heart rate and blood pressure measurement. Continuous 
(real time) ECG monitoring during this 6-hour period is recommended. 
 
The same precautions as for the first dose are recommended when patients are switched from the 
0.25 mg to the 0.5 mg daily dose. 
 
Should post-dose bradyarrhythmia-related symptoms occur, appropriate clinical management should 
be initiated and monitoring should be continued until the symptoms have resolved. Should a patient 
require pharmacological intervention during the first-dose monitoring, overnight monitoring in a 
medical facility should be instituted and the first-dose monitoring should be repeated after the second 
dose of Fingolimod Accord. 
 
If the heart rate at 6 hours is the lowest since the first dose was administered (suggesting that the 
maximum pharmacodynamic effect on the heart may not yet be manifest), monitoring should be 
extended by at least 2 hours and until heart rate increases again. Additionally, if after 6 hours, the heart 
rate is <45 bpm in adults, <55 bpm in paediatric patients aged 12 years and above, or <60 bpm in 
paediatric patients aged 10 to below 12 years, or the ECG shows new onset second degree or higher 
grade AV block or a QTc interval ≥500 msec, extended monitoring (at least overnight monitoring), 
should be performed, and until the findings have resolved. The occurrence at any time of third degree 
AV block should also lead to extended monitoring (at least overnight monitoring). 
 
The effects on heart rate and atrioventricular conduction may recur on re-introduction of Fingolimod 
Accord treatment depending on duration of the interruption and time since start of Fingolimod Accord 
treatment. The same first dose monitoring as for treatment initiation is recommended when treatment 
is interrupted for: 
- 1 day or more during the first 2 weeks of treatment. 
- more than 7 days during weeks 3 and 4 of treatment. 



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- more than 2 weeks after one month of treatment. 
If the treatment interruption is of shorter duration than the above, the treatment should be continued 
with the next dose as planned. 
 
Very rare cases of T-wave inversion have been reported in adult patients treated with fingolimod. In 
case of T-wave inversion, the prescriber should ensure that there are no associated myocardial 
ischaemia signs or symptoms. If myocardial ischaemia is suspected, it is recommended to seek advice 
from a cardiologist. 
 
Due to the risk of serious rhythm disturbances or significant bradycardia, Fingolimod Accord should 
not be used in patients with sino-atrial heart block, a history of symptomatic bradycardia, recurrent 
syncope or cardiac arrest, or in patients with significant QT prolongation (QTc>470 msec [adult 
female], QTc >460 msec [paediatric female] or >450 msec [adult and paediatric male]), uncontrolled 
hypertension or severe sleep apnoea (see also section 4.3). In such patients, treatment with Fingolimod 
Accord should be considered only if the anticipated benefits outweigh the potential risks, and advice 
from a cardiologist sought prior to initiation of treatment in order to determine the most appropriate 
monitoring. At least overnight extended monitoring is recommended for treatment initiation (see also 
section 4.5). 
 
Fingolimod has not been studied in patients with arrhythmias requiring treatment with class Ia (e.g. 
quinidine, disopyramide) or class III (e.g. amiodarone, sotalol) antiarrhythmic medicinal products. 
Class Ia and class III antiarrhythmic medicinal products have been associated with cases of torsades de 
pointes in patients with bradycardia (see section 4.3). 
 
Experience with fingolimod is limited in patients receiving concurrent therapy with beta blockers, 
heart-rate-lowering calcium channel blockers (such as verapamil or diltiazem), or other substances 
which may decrease heart rate (e.g. ivabradine, digoxin, anticholinesteratic agents or pilocarpine). 
Since the initiation of Fingolimod Accord treatment is also associated with slowing of the heart rate 
(see also section 4.8, Bradyarrhythmia), concomitant use of these substances during Fingolimod 
Accord initiation may be associated with severe bradycardia and heart block. Because of the potential 
additive effect on heart rate treatment with Fingolimod Accord should not be initiated in patients who 
are concurrently treated with these substances (see also section 4.5). In such patients, treatment with 
Fingolimod Accord should be considered only if the anticipated benefits outweigh the potential risks. 
If treatment with Fingolimod Accord is considered, advice from a cardiologist should be sought 
regarding the switch to non heart-rate lowering medicinal products prior to initiation of treatment. If 
the heart-rate-lowering medication cannot be stopped, cardiologist’s advice should be sought to 
determine appropriate first dose monitoring, at least overnight extended monitoring is recommended 
(see also section 4.5). 
 
QT interval 
 
In a thorough QT interval study of doses of 1.25 or 2.5 mg fingolimod at steady-state, when a negative 
chronotropic effect of fingolimod was still present, fingolimod treatment resulted in a prolongation of 
QTcI, with the upper limit of the 90% CI ≤13.0 ms. There is no dose- or exposure-response 
relationship of fingolimod and QTcI prolongation. There is no consistent signal of increased incidence 
of QTcI outliers, either absolute or change from baseline, associated with fingolimod treatment. 
 
The clinical relevance of this finding is unknown. In the multiple sclerosis studies, clinically relevant 
effects on prolongation of the QTc-interval have not been observed but patients at risk for QT 
prolongation were not included in clinical studies. 
 
Medicinal products that may prolong QTc interval are best avoided in patients with relevant risk 
factors, for example, hypokalaemia or congenital QT prolongation. 
 
Immunosuppressive effects 
 



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Fingolimod has an immunosuppressive effect that predisposes patients to an infection risk, including 
opportunistic infections that can be fatal, and increases the risk of developing lymphomas and other 
malignancies, particularly those of the skin. Physicians should carefully monitor patients, especially 
those with concurrent conditions or known factors, such as previous immunosuppressive therapy. If 
this risk is suspected, discontinuation of treatment should be considered by the physician on a case-by-
case basis (see also section 4.4 “Infections” and “Cutaneous neoplasms” and section 4.8 
“Lymphomas”). 
 
Infections 
 
A core pharmacodynamic effect of Fingolimod Accord is a dose-dependent reduction of the peripheral 
lymphocyte count to 20-30% of baseline values. This is due to the reversible sequestration of 
lymphocytes in lymphoid tissues (see section 5.1). 
 
Before initiating treatment with Fingolimod Accord, a recent complete blood count (CBC) (i.e. within 
6 months or after discontinuation of prior therapy) should be available. Assessments of CBC are also 
recommended periodically during treatment, at month 3 and at least yearly thereafter, and in case of 
signs of infection. Absolute lymphocyte count <0.2x109/l, if confirmed, should lead to treatment 
interruption until recovery, because in clinical studies, fingolimod treatment was interrupted in 
patients with absolute lymphocyte count <0.2x109/l. 
 
Initiation of treatment with Fingolimod Accord should be delayed in patients with severe active 
infection until resolution. 
 
Patients need to be assessed for their immunity to varicella (chickenpox) prior to Fingolimod Accord 
treatment. It is recommended that patients without a health care professional confirmed history of 
chickenpox or documentation of a full course of vaccination with varicella vaccine undergo antibody 
testing to varicella zoster virus (VZV) before initiating Fingolimod Accord therapy. A full course of 
vaccination for antibody-negative patients with varicella vaccine is recommended prior to 
commencing treatment with Fingolimod Accord (see section 4.8). Initiation of treatment with 
Fingolimod Accord should be postponed for 1 month to allow full effect of vaccination to occur. 
 
The immune system effects of Fingolimod Accord may increase the risk of infections, including 
opportunistic infections (see section 4.8). Effective diagnostic and therapeutic strategies should be 
employed in patients with symptoms of infection while on therapy. When evaluating a patient with a 
suspected infection that could be serious, referral to a physician experienced in treating infections 
should be considered. During treatment, patients receiving Fingolimod Accord should be instructed to 
report promptly symptoms of infection to their physician. 
 
Suspension of Fingolimod Accord should be considered if a patient develops a serious infection and 
consideration of benefit-risk should be undertaken prior to re-initiation of therapy. 
 
Cases of cryptococcal meningitis (a fungal infection), sometimes fatal, have been reported in the post-
marketing setting after approximately 2-3 years of treatment, although an exact relationship with the 
duration of treatment is unknown (see section 4.8). Patients with symptoms and signs consistent with 
cryptococcal meningitis (e.g. headache accompanied by mental changes such as confusion, 
hallucinations, and/or personality changes) should undergo prompt diagnostic evaluation. If 
cryptococcal meningitis is diagnosed, fingolimod should be suspended and appropriate treatment 
should be initiated. A multidisciplinary consultation (i.e. infectious disease specialist) should be 
undertaken if re-initiation of fingolimod is warranted. 
 
Progressive multifocal leukoencephalopathy (PML) has been reported under fingolimod treatment 
since marketing authorisation (see section 4.8). PML is an opportunistic infection caused by John 
Cunningham virus (JCV), which may be fatal or result in severe disability. Cases of PML have 
occurred after approximately 2-3 years of monotherapy treatment without previous exposure to 
natalizumab. Although the estimated risk appears to increase with cumulative exposure over time, an 
exact relationship with the duration of treatment is unknown. Additional PML cases have occurred in 



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patients who had been treated previously with natalizumab, which has a known association with PML. 
PML can only occur in the presence of a JCV infection. If JCV testing is undertaken, it should be 
considered that the influence of lymphopenia on the accuracy of anti-JCV antibody testing has not 
been studied in fingolimod-treated patients. It should also be noted that a negative anti-JCV antibody 
test does not preclude the possibility of subsequent JCV infection. Before initiating treatment with 
fingolimod, a baseline MRI should be available (usually within 3 months) as a reference. MRI 
findings may be apparent before clinical signs or symptoms. During routine MRI (in accordance with 
national and local recommendations), physicians should pay attention to PML suggestive lesions. MRI 
may be considered as part of increased vigilance in patients considered at increased risk of PML. 
Cases of asymptomatic PML based on MRI findings and positive JCV DNA in the cerebrospinal fluid 
have been reported in patients treated with fingolimod. If PML is suspected, MRI should be performed 
immediately for diagnostic purposes and treatment with fingolimod should be suspended until PML 
has been excluded. 
 
Human papilloma virus (HPV) infection, including papilloma, dysplasia, warts and HPV-related 
cancer, has been reported under treatment with fingolimod in the post-marketing setting. Due to the 
immunosuppressive properties of fingolimod, vaccination against HPV should be considered prior to 
treatment initiation with fingolimod taking into account vaccination recommendations. Cancer 
screening, including Pap test, is recommended as per standard of care. 
 
Elimination of fingolimod following discontinuation of therapy may take up to two months and 
vigilance for infection should therefore be continued throughout this period. Patients should be 
instructed to report symptoms of infection up to 2 months after discontinuation of fingolimod. 
 
Macular oedema 
 
Macular oedema with or without visual symptoms has been reported in 0.5% of patients treated with 
fingolimod 0.5 mg, occurring predominantly in the first 3-4 months of therapy (see section 4.8). An 
ophthalmological evaluation is therefore recommended at 3-4 months after treatment initiation. If 
patients report visual disturbances at any time while on therapy, evaluation of the fundus, including 
the macula, should be carried out. 
 
Patients with history of uveitis and patients with diabetes mellitus are at increased risk of macular 
oedema (see section 4.8). Fingolimod has not been studied in multiple sclerosis patients with 
concomitant diabetes mellitus. It is recommended that multiple sclerosis patients with diabetes 
mellitus or a history of uveitis undergo an ophthalmological evaluation prior to initiating therapy and 
have follow-up evaluations while receiving therapy. 
 
Continuation of fingolimod in patients with macular oedema has not been evaluated. It is 
recommended that Fingolimod Accord be discontinued if a patient develops macular oedema. A 
decision on whether or not Fingolimod Accord therapy should be re-initiated after resolution of 
macular oedema needs to take into account the potential benefits and risks for the individual patient. 
 
Liver function 
 
Increased hepatic enzymes, in particular alanine aminotransaminase (ALT) but also gamma 
glutamyltransferase (GGT) and aspartate transaminase (AST) have been reported in multiple sclerosis 
patients treated with fingolimod. In clinical trials, elevations 3-fold the upper limit of normal (ULN) or 
greater in ALT occurred in 8.0% of adult patients treated with fingolimod 0.5 mg compared to 1.9% of 
placebo patients. Elevations 5-fold the ULN occurred in 1.8% of patients on fingolimod and 0.9% of 
patients on placebo. In clinical trials, fingolimod was discontinued if the elevation exceeded 5 times 
the ULN. Recurrence of liver transaminase elevations occurred with rechallenge in some patients, 
supporting a relationship to fingolimod. In clinical studies, transaminase elevations occurred at any 
time during treatment although the majority occurred within the first 12 months. Serum transaminase 
levels returned to normal within approximately 2 months after discontinuation of fingolimod. 
 



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Fingolimod has not been studied in patients with severe pre-existing hepatic injury (Child-Pugh class 
C) and should not be used in these patients (see section 4.3). 
 
Due to the immunosuppressive properties of fingolimod, initiation of treatment should be delayed in 
patients with active viral hepatitis until resolution. 
 
Recent (i.e. within last 6 months) transaminase and bilirubin levels should be available before 
initiation of treatment with Fingolimod Accord. In the absence of clinical symptoms, liver 
transaminases should be monitored at months 1, 3, 6, 9 and 12 on therapy and periodically thereafter. 
If liver transaminases rise above 5 times the ULN, more frequent monitoring should be instituted, 
including serum bilirubin and alkaline phosphatase (ALP) measurement. With repeated confirmation 
of liver transaminases above 5 times the ULN, treatment with Fingolimod Accord should be 
interrupted and only re-commenced once liver transaminase values have normalised. 
 
Patients who develop symptoms suggestive of hepatic dysfunction, such as unexplained nausea, 
vomiting, abdominal pain, fatigue, anorexia, or jaundice and/or dark urine, should have liver enzymes 
checked and Fingolimod Accord should be discontinued if significant liver injury is confirmed (for 
example liver transaminase levels greater than 5-fold the ULN and/or serum bilirubin elevations). 
Resumption of therapy will be dependent on whether or not another cause of liver injury is determined 
and on the benefits to patient of resuming therapy versus the risks of recurrence of liver dysfunction. 
 
Although there are no data to establish that patients with pre-existing liver disease are at increased risk 
of developing elevated liver function tests when taking fingolimod, caution in the use of Fingolimod 
Accord should be exercised in patients with a history of significant liver disease. 
 
Interference with serological testing  
 
Since fingolimod reduces blood lymphocyte counts via re-distribution in secondary lymphoid organs, 
peripheral blood lymphocyte counts cannot be utilised to evaluate the lymphocyte subset status of a 
patient treated with Fingolimod Accord. Laboratory tests involving the use of circulating mononuclear 
cells require larger blood volumes due to reduction in the number of circulating lymphocytes. 
 
Blood pressure effects  
 
Patients with hypertension uncontrolled by medication were excluded from participation in 
premarketing clinical trials and special care is indicated if patients with uncontrolled hypertension are 
treated with Fingolimod Accord. 
 
In MS clinical trials, patients treated with fingolimod 0.5 mg had an average increase of approximately 
3 mmHg in systolic pressure, and approximately 1 mmHg in diastolic pressure, first detected 
approximately 1 month after treatment initiation, and persisting with continued treatment. In the two-
year placebo-controlled study, hypertension was reported as an adverse event in 6.5% of patients on 
fingolimod 0.5 mg and in 3.3% of patients on placebo. Therefore, blood pressure should be regularly 
monitored during treatment with Fingolimod Accord. 
 
Respiratory effects  
 
Minor dose-dependent reductions in values for forced expiratory volume (FEV1) and diffusion 
capacity for carbon monoxide (DLCO) were observed with fingolimod treatment starting at month 1 
and remaining stable thereafter. Fingolimod Accord should be used with caution in patients with 
severe respiratory disease, pulmonary fibrosis and chronic obstructive pulmonary disease (see also 
section 4.8). 
 
Posterior reversible encephalopathy syndrome 
 
Rare cases of posterior reversible encephalopathy syndrome (PRES) have been reported at the 0.5 mg 
dose in clinical trials and in the post-marketing setting (see section 4.8). Symptoms reported included 



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sudden onset of severe headache, nausea, vomiting, altered mental status, visual disturbances and 
seizure. Symptoms of PRES are usually reversible but may evolve into ischaemic stroke or cerebral 
haemorrhage. Delay in diagnosis and treatment may lead to permanent neurological sequelae. If PRES 
is suspected, Fingolimod Accord should be discontinued. 
 
Prior treatment with immunosuppressive or immunomodulatory therapies 
 
There have been no studies performed to evaluate the efficacy and safety of fingolimod when 
switching patients from teriflunomide, dimethyl fumarate or alemtuzumab treatment to fingolimod. 
When switching patients from another disease modifying therapy to Fingolimod Accord, the half-life 
and mode of action of the other therapy must be considered in order to avoid an additive immune 
effect whilst at the same time minimising the risk of disease reactivation. A CBC is recommended 
prior to initiating Fingolimod Accord to ensure that immune effects of the previous therapy (i.e. 
cytopenia) have resolved. 
 
Fingolimod Accord can generally be started immediately after discontinuation of interferon or 
glatiramer acetate. 
 
For dimethyl fumarate, the washout period should be sufficient for CBC to recover before treatment 
with Fingolimod Accord is started. 
 
Due to the long half-life of natalizumab, elimination usually takes up to 2-3 months following 
discontinuation. Teriflunomide is also eliminated slowly from the plasma. Without an accelerated 
elimination procedure, clearance of teriflunomide from plasma can take from several months up to 
2 years. An accelerated elimination procedure as defined in the teriflunomide summary of product 
characteristics is recommended or alternatively washout period should not be shorter than 3.5 months. 
Caution regarding potential concomitant immune effects is required when switching patients from 
natalizumab or teriflunomide to Fingolimod Accord. 
 
Alemtuzumab has profound and prolonged immunosuppressive effects. As the actual duration of these 
effects is unknown, initiating treatment with Fingolimod Accord after alemtuzumab is not 
recommended unless the benefits of such treatment clearly outweigh the risks for the individual 
patient. 
 
A decision to use prolonged concomitant treatment with corticosteroids should be taken after careful 
consideration. 
 
Co-administration with potent CYP450 inducers 
 
The combination of fingolimod with potent CYP450 inducers should be used with caution. 
Concomitant administration with St John’s wort is not recommended (see section 4.5). 
 
Malignancies 
 
Cutaneous malignancies 
Basal cell carcinoma (BCC) and other cutaneous neoplasms, including malignant melanoma, 
squamous cell carcinoma, Kaposi’s sarcoma and Merkel cell carcinoma, have been reported in patients 
receiving fingolimod (see section 4.8). Vigilance for skin lesions is warranted and a medical 
evaluation of the skin is recommended at initiation, and then every 6 to 12 months taking into 
consideration clinical judgement. The patient should be referred to a dermatologist in case suspicious 
lesions are detected. 
 
Since there is a potential risk of malignant skin growths, patients treated with fingolimod should be 
cautioned against exposure to sunlight without protection. These patients should not receive 
concomitant phototherapy with UV-B-radiation or PUVA-photochemotherapy. 
 
Lymphomas 



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There have been cases of lymphoma in clinical studies and the post-marketing setting (see section 
4.8). The cases reported were heterogeneous in nature, mainly non-Hodgkin’s lymphoma, including 
B-cell and T-cell lymphomas. Cases of cutaneous T-cell lymphoma (mycosis fungoides) have been 
observed. A fatal case of Epstein-Barr virus (EBV) positive B-cell lymphoma has also been observed. 
If lymphoma is suspected, Fingolimod Accord should be discontinued. 
 
Women of childbearing potential  
 
Due to risk to the foetus, fingolimod is contraindicated during pregnancy and in women of 
childbearing potential not using effective contraception. Before initiation of treatment, women of 
childbearing potential must be informed of this risk to the foetus, must have a negative pregnancy test 
and must use effective contraception during treatment and for 2 months after treatment discontinuation 
(see sections 4.3 and 4.6 and the information contained in the Physician Information Pack). 
 
Tumefactive lesions 
 
Rare cases of tumefactive lesions associated with MS relapse were reported in the post-marketing 
setting. In case of severe relapses, MRI should be performed to exclude tumefactive lesions. 
Discontinuation of Fingolimod Accord should be considered by the physician on a case-by-case basis 
taking into account individual benefits and risks. 
 
Return of disease activity (rebound) after fingolimod discontinuation 
 
In the post-marketing setting, severe exacerbation of disease has been observed rarely in some patients 
stopping fingolimod. This has generally been observed within 12 weeks after stopping fingolimod, but 
has also been reported up to 24 weeks after fingolimod discontinuation. Caution is therefore indicated 
when stopping fingolimod therapy. If discontinuation of fingolimod is deemed necessary, the 
possibility of recurrence of exceptionally high disease activity should be considered and patients 
should be monitored for relevant signs and symptoms and appropriate treatment initiated as required 
(see “Stopping therapy” below). 
 
Stopping therapy 
 
If a decision is made to stop treatment with Fingolimod Accord a 6 week interval without therapy is 
needed, based on half-life, to clear fingolimod from the circulation (see section 5.2). Lymphocyte 
counts progressively return to normal range within 1-2 months of stopping therapy in most patients 
(see section 5.1) although full recovery can take significantly longer in some patients. Starting other 
therapies during this interval will result in concomitant exposure to fingolimod. Use of 
immunosuppressants soon after the discontinuation of Fingolimod Accord may lead to an additive 
effect on the immune system and caution is therefore indicated. 
 
Caution is also indicated when stopping fingolimod therapy due to the risk of a rebound (see “Return 
of disease activity (rebound) after fingolimod discontinuation” above). If discontinuation of 
Fingolimod Accord is deemed necessary, patients should be monitored during this time for relevant 
signs of a possible rebound. 
 
Paediatric population 
 
The safety profile in paediatric patients is similar to that in adults and the warnings and precautions for 
adults therefore also apply to paediatric patients. 
 
In particular, the following should be noted when prescribing Fingolimod Accord to paediatric 
patients: 
- Precautions should be followed at the time of the first dose (see “Bradyarrhythmia” above). The 

same precautions as for the first dose are recommended when patients are switched from the 
0.25 mg to the 0.5 mg daily dose. 



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- In the controlled paediatric trial D2311, cases of seizures, anxiety, depressed mood and 
depression have been reported with a higher incidence in patients treated with fingolimod 
compared to patients treated with interferon beta-1a. Caution is required in this subgroup 
population (see “Paediatric population” in section 4.8). 

- Mild isolated bilirubin increases have been noted in paediatric patients on fingolimod. 
- It is recommended that paediatric patients complete all immunisations in accordance with 

current immunisation guidelines before starting Fingolimod Accord therapy (see “Infections” 
above). 

- There are very limited data available in children between 10–12 years old, less than 40 kg or at 
Tanner stage <2 (see sections 4.8 and 5.1). Caution is required in these subgroups due to very 
limited knowledge available from the clinical study. 

- Long-term safety data in the paediatric population are not available. 
 
4.5 Interaction with other medicinal products and other forms of interaction 
 
Anti-neoplastic, immunomodulatory or immunosuppressive therapies 
 
Anti-neoplastic, immunomodulatory or immunosuppressive therapies should not be co-administered 
due to the risk of additive immune system effects (see sections 4.3 and 4.4). 
 
Caution should also be exercised when switching patients from long-acting therapies with immune 
effects such as natalizumab, teriflunomide or mitoxantrone (see section 4.4). In multiple sclerosis 
clinical studies the concomitant treatment of relapses with a short course of corticosteroids was not 
associated with an increased rate of infection. 
 
Vaccination  
 
During and for up to two months after treatment with Fingolimod Accord vaccination may be less 
effective. The use of live attenuated vaccines may carry a risk of infections and should therefore be 
avoided (see sections 4.4 and 4.8). 
 
Bradycardia-inducing substances 
 
Fingolimod has been studied in combination with atenolol and diltiazem. When fingolimod was used 
with atenolol in an interaction study in healthy volunteers, there was an additional 15% reduction of 
heart rate at fingolimod treatment initiation, an effect not seen with diltiazem. Treatment with 
Fingolimod Accord should not be initiated in patients receiving beta blockers, or other substances 
which may decrease heart rate, such as class Ia and III antiarrhythmics, calcium channel blockers 
(such as verapamil or diltiazem), ivabradine, digoxin, anticholinesteratic agents or pilocarpine because 
of the potential additive effects on heart rate (see sections 4.4 and 4.8). If treatment with Fingolimod 
Accord is considered in such patients, advice from a cardiologist should be sought regarding the 
switch to non heart-rate lowering medicinal products or appropriate monitoring for treatment 
initiation, at least overnight monitoring is recommended, if the heart-rate-lowering medication cannot 
be stopped. 
 
Pharmacokinetic interactions of other substances on fingolimod 
 
Fingolimod is metabolised mainly by CYP4F2. Other enzymes like CYP3A4 may also contribute to 
its metabolism, notably in the case of strong induction of CYP3A4. Potent inhibitors of transporter 
proteins are not expected to influence fingolimod disposition. Co-administration of fingolimod with 
ketoconazole resulted in a 1.7-fold increase in fingolimod and fingolimod phosphate exposure (AUC) 
by inhibition of CYP4F2. Caution should be exercised with substances that may inhibit CYP3A4 
(protease inhibitors, azole antifungals, some macrolides such as clarithromycin or telithromycin). 
 
Co-administration of carbamazepine 600 mg twice daily at steady-state and a single dose of 
fingolimod 2 mg reduced the AUC of fingolimod and its metabolite by approximately 40%. Other 
strong CYP3A4 enzyme inducers, for example rifampicin, phenobarbital, phenytoin, efavirenz and St. 



12  

John’s Wort, may reduce the AUC of fingolimod and its metabolite at least to this extent. As this 
could potentially impair the efficacy, their co-administration should be used with caution. 
Concomitant administration with St. John’s Wort is however not recommended (see section 4.4). 
 
Pharmacokinetic interactions of fingolimod on other substances 
 
Fingolimod is unlikely to interact with substances mainly cleared by the CYP450 enzymes or by 
substrates of the main transporter proteins. 
 
Co-administration of fingolimod with ciclosporin did not elicit any change in the ciclosporin or 
fingolimod exposure. Therefore, fingolimod is not expected to alter the pharmacokinetics of medicinal 
products that are CYP3A4 substrates. 
 
Co-administration of fingolimod with oral contraceptives (ethinylestradiol and levonorgestrel) did not 
elicit any change in oral contraceptive exposure. No interaction studies have been performed with oral 
contraceptives containing other progestagens, however an effect of fingolimod on their exposure is not 
expected. 
 
4.6 Fertility, pregnancy and lactation 
 
Women of childbearing potential / Contraception in females 
 
Fingolimod is contraindicated in women of childbearing potential not using effective contraception 
(see section 4.3). Therefore, before initiation of treatment in women of childbearing potential, a 
negative pregnancy test result must be available and counselling should be provided regarding the 
serious risk to the foetus. Women of childbearing potential must use effective contraception during 
treatment and for 2 months after discontinuation of Fingolimod Accord, since fingolimod takes 
approximately 2 months to eliminate from the body after treatment discontinuation (see section 4.4). 
 
Specific measures are also included in the Physician Information Pack. These measures must be 
implemented before fingolimod is prescribed to female patients and during treatment. 
 
When stopping fingolimod therapy for planning a pregnancy the possible return of disease activity 
should be considered (see section 4.4). 
 
Pregnancy 
 
Based on human experience, post-marketing data suggest that use of fingolimod is associated with a 2-
fold increased risk of major congenital malformations when administered during pregnancy compared 
with the rate observed in the general population (2-3%; EUROCAT). 
The following major malformations were most frequently reported: 
- Congenital heart disease such as atrial and ventricular septal defects, tetralogy of Fallot 
- Renal abnormalities 
- Musculoskeletal abnormalities 
 
There are no data on the effects of fingolimod on labour and delivery. 
 
Animal studies have shown reproductive toxicity including foetal loss and organ defects, notably 
persistent truncus arteriosus and ventricular septal defect (see section 5.3). Furthermore, the receptor 
affected by fingolimod (sphingosine 1-phosphate receptor) is known to be involved in vascular 
formation during embryogenesis. 
 
Consequently, fingolimod is contraindicated during pregnancy (see section 4.3). Fingolimod should be 
stopped 2 months before planning a pregnancy (see section 4.4). If a woman becomes pregnant during 
treatment, fingolimod must be discontinued. Medical advice should be given regarding the risk of 
harmful effects to the foetus associated with treatment and ultrasonography examinations should be 
performed. 



13  

 
Breast-feeding 
 
Fingolimod is excreted in milk of treated animals during lactation (see section 5.3). Due to the 
potential for serious adverse reactions to fingolimod in nursing infants, women receiving Fingolimod 
Accord should not breastfeed. 
 
Fertility 
 
Data from preclinical studies do not suggest that fingolimod would be associated with an increased 
risk of reduced fertility (see section 5.3). 
 
4.7 Effects on ability to drive and use machines 
 
Fingolimod Accord has no or negligible influence on the ability to drive and use machines. 
 
However, dizziness or drowsiness may occasionally occur when initiating therapy with Fingolimod 
Accord. On initiation of Fingolimod Accord treatment it is recommended that patients be observed for 
a period of 6 hours (see section 4.4, Bradyarrhythmia). 
 
4.8 Undesirable effects  
 
Summary of the safety profile 
 
Adverse reactions reported with fingolimod 0.5 mg in Studies D2301 (FREEDOMS) and D2309 
(FREEDOMS II) are shown below. Adverse reactions derived from post-marketing experience with 
fingolimod via spontaneous case reports or literature cases are also reported. Frequencies were defined 
using 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); very rare (<1/10,000); not known (cannot be 
estimated from the available data). 
 
Tabulated list of adverse reactions 
 

Infections and infestations 
Very common: Influenza 

Sinusitis 
Common: Herpes viral infections 

Bronchitis 
Tinea versicolor 

Uncommon: Pneumonia 
Not known: Progressive multifocal leukoencephalopathy (PML)** 

Cryptococcal infections** 
Neoplasms benign, malignant and unspecified (incl cysts and polyps) 
Common: Basal cell carcinoma 
Uncommon: Malignant melanoma**** 
Rare: Lymphoma*** 

Squamous cell carcinoma**** 
Very rare: Kaposi’s sarcoma**** 
Not known: Merkel cell carcinoma*** 
Blood and lymphatic system disorders 
Common: Lymphopenia 

Leucopenia 
Uncommon: Thrombocytopenia 
Not known: Autoimmune haemolytic anaemia*** 

Peripheral oedema*** 
Immune system disorders 



14  

Not known: Hypersensitivity reactions, including rash, urticaria and angioedema upon 
treatment initiation*** 

Psychiatric disorders 
Common: Depression 
Uncommon: Depressed mood 
Nervous system disorders 
Very common: Headache 
Common: Dizziness 

Migraine 
Uncommon: Seizure 
Rare: Posterior reversible encephalopathy syndrome (PRES)* 
Not known Severe exacerbation of disease after fingolimod discontinuation*** 
Eye disorders 
Common: Vision blurred 
Uncommon: Macular oedema 
Cardiac disorders 
Common: Bradycardia 

Atrioventricular block 
Very rare: T-wave inversion*** 
Vascular disorders 
Common: Hypertension 
Respiratory, thoracic and mediastinal disorders
Very common: Cough 
Common: Dyspnoea 
Gastrointestinal disorders 
Very common: Diarrhoea 
Uncommon: Nausea*** 
Skin and subcutaneous tissue disorders 
Common: Eczema 

Alopecia 
Pruritus 

Musculoskeletal and connective tissue disorders 
Very common: Back pain 
Common: Myalgia 

Arthralgia 
General disorders and administration site conditions
Common: Asthenia 
Investigations 
Very common: Hepatic enzyme increased (increased ALT, Gamma glutamyltransferase, 

Aspartate transaminase) 
Common:  Weight decreased*** 

Blood triglycerides increased 
Uncommon: Neutrophil count decreased 
* Not reported in Studies FREEDOMS, FREEDOMS II and TRANSFORMS. The frequency category 

was based on an estimated exposure of approximately 10,000 patients to fingolimod in all clinical 
trials. 

** PML and cryptococcal infections (including cases of cryptococcal meningitis) have been reported in 
the post-marketing setting (see section 4.4). 

*** Adverse drug reactions from spontaneous reports and literature 
**** The frequency category and risk assessment were based on an estimated exposure of more than 

24,000 patients to fingolimod 0.5 mg in all clinical trials. 
 
Description of selected adverse reactions 
 
Infections 



15  

In multiple sclerosis clinical studies the overall rate of infections (65.1%) at the 0.5 mg dose was 
similar to placebo. However, lower respiratory tract infections, primarily bronchitis and to a lesser 
extent herpes infection and pneumonia were more common in fingolimod-treated patients. 
 
Some cases of disseminated herpes infection, including fatal cases, have been reported even at the 
0.5 mg dose. 
 
In the post-marketing setting, cases of infections with opportunistic pathogens, such as viral (e.g. 
varicella zoster virus [VZV], John Cunningham virus [JCV] causing Progressive Multifocal 
Leukoencephalopathy, herpes simplex virus [HSV]), fungal (e.g. cryptococci including cryptococcal 
meningitis) or bacterial (e.g. atypical mycobacterium), have been reported, some of which have been 
fatal (see section 4.4). 
 
Human papilloma virus (HPV) infection, including papilloma, dysplasia, warts and HPV-related 
cancer, has been reported under treatment with fingolimod in the post-marketing setting. Due to the 
immunosuppressive properties of fingolimod, vaccination against HPV should be considered prior to 
treatment initiation with fingolimod taking into account vaccination recommendations. Cancer 
screening, including Pap test, is recommended as per standard of care. 
 
Macular oedema 
In multiple sclerosis clinical studies macular oedema occurred in 0.5% of patients treated with the 
recommended dose of 0.5 mg and 1.1% of patients treated with the higher dose of 1.25 mg. The 
majority of cases occurred within the first 3-4 months of therapy. Some patients presented with blurred 
vision or decreased visual acuity, but others were asymptomatic and diagnosed on routine 
ophthalmological examination. The macular oedema generally improved or resolved spontaneously 
after discontinuation of fingolimod. The risk of recurrence after re-challenge has not been evaluated. 
 
Macular oedema incidence is increased in multiple sclerosis patients with a history of uveitis (17% 
with a history of uveitis vs. 0.6% without a history of uveitis). Fingolimod has not been studied in 
multiple sclerosis patients with diabetes mellitus, a disease which is associated with an increased risk 
for macular oedema (see section 4.4). In renal transplant clinical studies in which patients with 
diabetes mellitus were included, therapy with fingolimod 2.5 mg and 5 mg resulted in a 2-fold increase 
in the incidence of macular oedema. 
 
Bradyarrhythmia  
Initiation of fingolimod treatment results in a transient decrease in heart rate and may also be 
associated with atrioventricular conduction delays. In multiple sclerosis clinical studies the maximal 
decline in heart rate was seen within 6 hours after treatment initiation, with declines in mean heart rate 
of 12-13 beats per minute for fingolimod 0.5 mg. Heart rate below 40 beats per minute in adults, and 
below 50 beats per minute in paediatric patients, was rarely observed in patients on fingolimod 0.5 mg. 
The average heart rate returned towards baseline within 1 month of chronic treatment. Bradycardia 
was generally asymptomatic but some patients experienced mild to moderate symptoms, including 
hypotension, dizziness, fatigue and/or palpitations, which resolved within the first 24 hours after 
treatment initiation (see also sections 4.4 and 5.1). 
  
In multiple sclerosis clinical studies first-degree atrioventricular block (prolonged PR interval on 
ECG) was detected after treatment initiation in adult and paediatric patients. In adult clinical trials it 
occurred in 4.7% of patients on fingolimod 0.5 mg, in 2.8% of patients on intramuscular interferon 
beta-1a, and in 1.6% of patients on placebo. Second-degree atrioventricular block was detected in less 
than 0.2% adult patients on fingolimod 0.5 mg. In the post-marketing setting, isolated reports of 
transient, spontaneously resolving complete AV block have been observed during the six hour 
monitoring period following the first dose of fingolimod. The patients recovered spontaneously. The 
conduction abnormalities observed both in clinical trials and post-marketing were typically transient, 
asymptomatic and resolved within the first 24 hours after treatment initiation. Although most patients 
did not require medical intervention, one patient on fingolimod 0.5 mg received isoprenaline for 
asymptomatic second-degree Mobitz I atrioventricular block. 
 



16  

In the post-marketing setting, isolated delayed onset events, including transient asystole and 
unexplained death, have occurred within 24 hours of the first dose. These cases have been confounded 
by concomitant medicinal products and/or pre-existing disease. The relationship of such events to 
fingolimod is uncertain. 
 
Blood pressure 
In multiple sclerosis clinical studies fingolimod 0.5 mg was associated with an average increase of 
approximately 3 mmHg in systolic pressure and approximately 1 mmHg in diastolic pressure, 
manifesting approximately 1 month after treatment initiation. This increase persisted with continued 
treatment. Hypertension was reported in 6.5% of patients on fingolimod 0.5 mg and in 3.3% of 
patients on placebo. In the post-marketing setting, cases of hypertension have been reported within the 
first month of treatment initiation and on the first day of treatment that may require treatment with 
antihypertensive agents or discontinuation of fingolimod (see also section 4.4, Blood pressure effects). 
 
Liver function 
Increased hepatic enzymes have been reported in adult and paediatric multiple sclerosis patients 
treated with fingolimod. In clinical studies 8.0% and 1.8% of adult patients treated with fingolimod 
0.5 mg experienced an asymptomatic elevation in serum levels of ALT of ≥3x ULN (upper limit of 
normal) and ≥5x ULN, respectively. Recurrence of liver transaminase elevations has occurred upon re-
challenge in some patients, supporting a relationship to the medicinal product. In clinical studies, 
transaminase elevations occurred at any time during treatment although the majority occurred within 
the first 12 months. ALT levels returned to normal within approximately 2 months after 
discontinuation of fingolimod. In a small number of patients (N=10 on 1.25 mg, N=2 on 0.5 mg) who 
experienced ALT elevations ≥5x ULN and who continued on fingolimod therapy, the ALT levels 
returned to normal within approximately 5 months (see also section 4.4, Liver function). 
 
Nervous system disorders 
In clinical studies, rare events involving the nervous system occurred in patients treated with 
fingolimod at higher doses (1.25 or 5.0 mg) including ischaemic and haemorrhagic strokes and 
neurological atypical disorders, such as acute disseminated encephalomyelitis (ADEM)-like events. 
 
Cases of seizures, including status epilepticus, have been reported with the use of fingolimod in 
clinical studies and in the post-marketing setting. 
 
Vascular disorders 
Rare cases of peripheral arterial occlusive disease occurred in patients treated with fingolimod at 
higher doses (1.25 mg). 
 
Respiratory system 
Minor dose-dependent reductions in values for forced expiratory volume (FEV1) and diffusion 
capacity for carbon monoxide (DLCO) were observed with fingolimod treatment starting at month 1 
and remaining stable thereafter. At month 24, the reduction from baseline values in percentage of 
predicted FEV1 was 2.7% for fingolimod 0.5 mg and 1.2% for placebo, a difference that resolved after 
treatment discontinuation. For DLCO the reductions at month 24 were 3.3% for fingolimod 0.5 mg 
and 2.7% for placebo. 
 
Lymphomas 
There have been cases of lymphoma of different varieties, in both clinical studies and the post-
marketing setting, including a fatal case of Epstein-Barr virus (EBV) positive B-cell lymphoma. The 
incidence of non-Hodgkin’s lymphoma (B-cell and T-cell) cases was higher in clinical trials than 
expected in the general population. Some T-cell lymphoma cases were also reported in the 
post-marketing setting, including cases of cutaneous T-cell lymphoma (mycosis fungoides). 
 
Haemophagocytic syndrome 
Very rare cases of haemophagocytic syndrome (HPS) with fatal outcome have been reported in 
patients treated with fingolimod in the context of an infection. HPS is a rare condition that has been 
described in association with infections, immunosuppression and a variety of autoimmune diseases. 



17  

 
Paediatric population 
 
In the controlled paediatric trial D2311 (see section 5.1), the safety profile in paediatric patients (10 to 
below 18 years of age) receiving fingolimod 0.25 mg or 0.5 mg daily was overall similar to that seen 
in adult patients. There were, nevertheless, more neurological and psychiatric disorders observed in 
the study. Caution is needed in this subgroup due to very limited knowledge available from the clinical 
study. 
 
In the paediatric study, cases of seizures were reported in 5.6% of fingolimod-treated patients and 
0.9% of interferon beta-1a-treated patients. 
 
Depression and anxiety are known to occur with increased frequency in the multiple sclerosis 
population. Depression and anxiety have also been reported in paediatric patients treated with 
fingolimod. 
 
Mild isolated bilirubin increases have been noted in paediatric patients on fingolimod. 
 
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 
 
Single doses up to 80 times the recommended dose (0.5 mg) were well tolerated in healthy adult 
volunteers. At 40 mg, 5 of 6 subjects reported mild chest tightness or discomfort which was clinically 
consistent with small airway reactivity. 
 
Fingolimod can induce bradycardia upon treatment initiation. The decline in heart rate usually starts 
within one hour of the first dose, and is steepest within 6 hours. The negative chronotropic effect of 
fingolimod persists beyond 6 hours and progressively attenuates over subsequent days of treatment 
(see section 4.4 for details). There have been reports of slow atrioventricular conduction, with isolated 
reports of transient, spontaneously resolving complete AV block (see sections 4.4 and 4.8). 
 
If the overdose constitutes first exposure to fingolimod, it is important to monitor patients with a 
continuous (real time) ECG and hourly measurement of heart rate and blood pressure, at least during 
the first 6 hours (see section 4.4). 
 
Additionally, if after 6 hours the heart rate is <45 bpm in adults, <55 bpm in paediatric patients aged 
12 years and above, or <60 bpm in paediatric patients aged 10 years to below 12 years, or if the ECG 
at 6 hours after the first dose shows second degree or higher AV block, or if it shows a QTc interval 
≥500 msec, monitoring should be extended at least for overnight and until the findings have resolved. 
The occurrence at any time of third degree AV block should also lead to extended monitoring 
including overnight monitoring. 
 
Neither dialysis nor plasma exchange results in removal of fingolimod from the body. 
 
 
5. PHARMACOLOGICAL PROPERTIES 
 
5.1 Pharmacodynamic properties 
 
Pharmacotherapeutic group: Immunosuppressants, selective immunosuppressants, ATC code: 
L04AA27 



18  

 
Mechanism of action 
 
Fingolimod is a sphingosine 1-phosphate receptor modulator. Fingolimod is metabolised by 
sphingosine kinase to the active metabolite fingolimod phosphate. Fingolimod phosphate binds at low 
nanomolar concentrations to sphingosine 1-phosphate (S1P) receptor 1 located on lymphocytes, and 
readily crosses the blood-brain barrier to bind to S1P receptor 1 located on neural cells in the central 
nervous system (CNS). By acting as a functional antagonist of S1P receptors on lymphocytes, 
fingolimod phosphate blocks the capacity of lymphocytes to egress from lymph nodes, causing a 
redistribution, rather than depletion, of lymphocytes. Animal studies have shown that this 
redistribution reduces the infiltration of pathogenic lymphocytes, including pro-inflammatory 
Th17 cells, into the CNS, where they would be involved in nerve inflammation and nervous tissue 
damage. Animal studies and in vitro experiments indicate that fingolimod may also act via interaction 
with S1P receptors on neural cells. 
 
Pharmacodynamic effects 
 
Within 4-6 hours after the first dose of fingolimod 0.5 mg, the lymphocyte count decreases to 
approximately 75% of baseline in peripheral blood. With continued daily dosing, the lymphocyte 
count continues to decrease over a two-week period, reaching a minimal count of approximately 
500 cells/microlitre or approximately 30% of baseline. Eighteen percent of patients reached a minimal 
count below 200 cells/microlitre on at least one occasion. Low lymphocyte counts are maintained with 
chronic daily dosing. The majority of T and B lymphocytes regularly traffic through lymphoid organs 
and these are the cells mainly affected by fingolimod. Approximately 15-20% of T lymphocytes have 
an effector memory phenotype, cells that are important for peripheral immune surveillance. Since this 
lymphocyte subset typically does not traffic to lymphoid organs it is not affected by fingolimod. 
Peripheral lymphocyte count increases are evident within days of stopping fingolimod treatment and 
typically normal counts are reached within one to two months. Chronic fingolimod dosing leads to a 
mild decrease in the neutrophil count to approximately 80% of baseline. Monocytes are unaffected by 
fingolimod. 
 
Fingolimod causes a transient reduction in heart rate and decrease in atrioventricular conduction at 
treatment initiation (see sections 4.4 and 4.8). The maximal decline in heart rate is seen within 6 hours 
post dose, with 70% of the negative chronotropic effect achieved on the first day. With continued 
administration heart rate returns to baseline within one month. The decrease in heart rate induced by 
fingolimod can be reversed by parenteral doses of atropine or isoprenaline. Inhaled salmeterol has also 
been shown to have a modest positive chronotropic effect. With initiation of fingolimod treatment 
there is an increase in atrial premature contractions, but there is no increased rate of atrial 
fibrillation/flutter or ventricular arrhythmias or ectopy. Fingolimod treatment is not associated with a 
decrease in cardiac output. Autonomic responses of the heart, including diurnal variation of heart rate 
and response to exercise are not affected by fingolimod treatment. 
 
S1P4 could partially contribute to the effect but was not the main receptor responsible for the 
lymphoid depletion. The mechanism of action of bradycardia and vasoconstriction were also studied in 
vitro in guinea pigs and isolated rabbit aorta and coronary artery. It was concluded that bradycardia 
could be mediated primarily by activation of inward-rectifying potassium channel or G-protein 
activated inwardly rectifying K+ channel (IKACh/GIRK) and that vasoconstriction seems to be 
mediated by a Rho kinase and calcium dependent mechanism. 
 
Fingolimod treatment with single or multiple doses of 0.5 and 1.25 mg for two weeks is not associated 
with a detectable increase in airway resistance as measured by FEV1 and forced expiratory flow rate 
(FEF) 25-75. However, single fingolimod doses ≥5 mg (10-fold the recommended dose) are associated 
with a dose-dependent increase in airway resistance. Fingolimod treatment with multiple doses of 0.5, 
1.25, or 5 mg is not associated with impaired oxygenation or oxygen desaturation with exercise or an 
increase in airway responsiveness to methacholine. Subjects on fingolimod treatment have a normal 
bronchodilator response to inhaled beta-agonists. 
 



19  

Clinical efficacy and safety 
 
The efficacy of fingolimod has been demonstrated in two studies which evaluated once-daily doses of 
fingolimod 0.5 mg and 1.25 mg in adult patients with relapsing-remitting multiple sclerosis (RRMS). 
Both studies included adult patients who had experienced ≥2 relapses in the prior 2 years or ≥1 relapse 
during the prior year. Expanded Disability Status Score (EDSS) was between 0 and 5.5. A third study 
targeting the same adult patient population was completed after registration of fingolimod. 
 
Study D2301 (FREEDOMS) was a 2-year randomised, double-blind, placebo-controlled Phase III 
study of 1,272 patients (n=425 on 0.5 mg, 429 on 1.25 mg, 418 on placebo). Median values for 
baseline characteristics were: age 37 years, disease duration 6.7 years, and EDSS score 2.0. Outcome 
results are shown in Table 1. There were no significant differences between the 0.5 mg and the 
1.25 mg doses as regards either endpoint. 
 
Table 1 Study D2301 (FREEDOMS): main results 
 

 Fingolimod 
0.5 mg 

Placebo 
 

Clinical endpoints   
Annualised relapse rate (primary endpoint) 0.18** 0.40  
Percentage of patients remaining relapse-free at 
24 months 

70%** 46% 

Proportion with 3-month Confirmed Disability 
Progression† 
Hazard ratio (95% CI) 

17% 
 
0.70 (0.52, 0.96)* 

24% 

MRI endpoints    
Median (mean) number of new or enlarging T2 
lesions over 24 months 

0.0 (2.5)** 5.0 (9.8) 

Median (mean) number of Gd-enhancing lesions 
at month 24 

0.0 (0.2)** 0.0 (1.1) 

Median (mean) % change in brain volume over 
24 months 

-0.7 (-0.8)** -1.0 (-1.3) 

† Disability progression defined as 1-point increase in EDSS confirmed 3 months later 
** p<0.001, *p<0.05 compared to placebo 
All analyses of clinical endpoints were intent-to-treat. MRI analyses used evaluable dataset. 

 
Patients who completed the 24-month core FREEDOMS study could enter a dose-blinded extension 
study (D2301E1) and receive fingolimod. In total, 920 patients entered (n=331 continued on 0.5 mg, 
289 continued on 1.25 mg, 155 switched from placebo to 0.5 mg and 145 switched from placebo to 
1.25 mg). After 12 months (month 36), 856 patients (93%) were still enrolled. Between months 24 and 
36, the annualised relapse rate (ARR) for patients on fingolimod 0.5 mg in the core study who 
remained on 0.5 mg was 0.17 (0.21 in the core study). The ARR for patients who switched from 
placebo to fingolimod 0.5 mg was 0.22 (0.42 in the core study). 
 
Comparable results were shown in a replicate 2-year randomised, double-blind, placebo-controlled 
Phase III study on fingolimod in 1,083 patients (n=358 on 0.5 mg, 370 on 1.25 mg, 355 on placebo) 
with RRMS (D2309; FREEDOMS 2). Median values for baseline characteristics were: age 41 years, 
disease duration 8.9 years, EDSS score 2.5. 
 
Table 2 Study D2309 (FREEDOMS 2): main results 
 

 Fingolimod 
0.5 mg

Placebo 
 

Clinical endpoints 
Annualised relapse rate (primary endpoint) 0.21** 0.40 



20  

Percentage of patients remaining relapse-free at 
24 months 

71.5%** 52.7% 

Proportion with 3-month Confirmed Disability 
Progression† 
Hazard ratio (95% CI) 

25% 
 
0.83 (0.61, 1.12) 

29% 

MRI endpoints    
Median (mean) number of new or enlarging T2 
lesions over 24 months 

0.0 (2.3)** 4.0 (8.9) 

Median (mean) number of Gd-enhancing lesions 
at month 24 

0.0 (0.4)** 0.0 (1.2) 

Median (mean) % change in brain volume over 
24 months 

-0.71 (-0.86)** -1.02 (-1.28) 

† Disability progression defined as 1-point increase in EDSS confirmed 3 months later 
** p<0.001 compared to placebo 
All analyses of clinical endpoints were intent-to-treat. MRI analyses used evaluable dataset. 

 
Study D2302 (TRANSFORMS) was a 1-year randomised, double-blind, double-dummy, active 
(interferon beta-1a)-controlled Phase III study of 1,280 patients (n=429 on 0.5 mg, 420 on 1.25 mg, 
431 on interferon beta-1a, 30 μg by intramuscular injection once weekly). Median values for baseline 
characteristics were: age 36 years, disease duration 5.9 years, and EDSS score 2.0. Outcome results 
are shown in Table 3. There were no significant differences between the 0.5 mg and the 1.25 mg doses 
as regards study endpoints. 
 
Table 3 Study D2302 (TRANSFORMS): main results 
 

 Fingolimod 
0.5 mg  

Interferon beta-1a, 
30 μg 

Clinical endpoints   
Annualised relapse rate (primary endpoint) 0.16** 0.33 
Percentage of patients remaining relapse-free at 
12 months 

83%** 71% 

Proportion with 3-month Confirmed Disability  
Progression† 
Hazard ratio (95% CI) 

6% 
 
0.71 (0.42, 1.21)  

8% 

MRI endpoints    
Median (mean) number of new or enlarging T2 
lesions over 12 months 

0.0 (1.7)* 1.0 (2.6) 

Median (mean) number of Gd-enhancing lesions 
at 12 months 

0.0 (0.2)** 0.0 (0.5) 

Median (mean) % change in brain volume over 
12 months 

-0.2 (-0.3)** -0.4 (-0.5) 

† Disability progression defined as 1-point increase in EDSS confirmed 3 months later. 
* p<0.01,** p<0.001, compared to interferon beta-1a 
All analyses of clinical endpoints were intent-to-treat. MRI analyses used evaluable dataset. 

 
Patients who completed the 12-month core TRANSFORMS study could enter a dose-blinded 
extension (D2302E1) and receive fingolimod. In total, 1,030 patients entered, however, 3 of these 
patients did not receive treatment (n=356 continued on 0.5 mg, 330 continued on 1.25 mg, 167 
switched from interferon beta-1a to 0.5 mg and 174 from interferon beta-1a to 1.25 mg). After 
12 months (month 24), 882 patients (86%) were still enrolled. Between months 12 and 24, the ARR 
for patients on fingolimod 0.5 mg in the core study who remained on 0.5 mg was 0.20 (0.19 in the core 
study). The ARR for patients who switched from interferon beta-1a to fingolimod 0.5 mg was 0.33 
(0.48 in the core study). 
 



21  

Pooled results of Studies D2301 and D2302 showed a consistent and statistically significant reduction 
in annualised relapse rate compared to comparator in subgroups defined by gender, age, prior multiple 
sclerosis therapy, disease activity or disability levels at baseline. 
 
Further analyses of clinical trial data demonstrate consistent treatment effects in highly active 
subgroups of relapsing remitting multiple sclerosis patients. 
 
Paediatric population 
 
The efficacy and safety of once-daily doses of fingolimod 0.25 mg or 0.5 mg (dose selected based on 
body weight and exposure measurements) have been established in paediatric patients aged 10 to 
<18 years with relapsing-remitting multiple sclerosis. 
 
Study D2311 (PARADIGMS) was a double-blind, double-dummy, active-controlled study with 
flexible duration up to 24 months, with 215 patients 10 to <18 years old (n=107 on fingolimod, 108 on 
interferon beta-1a 30 μg by intramuscular injection once weekly). 
 
Median values for baseline characteristics were: age 16 years, median disease duration 1.5 years and 
EDSS score 1.5. The majority of patients were Tanner stage 2 or higher (94.4%) and were >40 kg 
(95.3%). Overall, 180 (84%) of patients completed the core phase on study drug (n=99 [92.5%] on 
fingolimod, 81 [75%] on interferon beta-1a). Outcome results are shown in Table 4. 
 
Table 4 Study D2311 (PARADIGMS): main results 
 

 Fingolimod 
0.25 mg or 0.5 mg 

Interferon beta-1a 
30 µg 

Clinical endpoints N=107 N=107# 
Annualised relapse rate (primary endpoint) 0.122** 0.675 
Percentage of patients remaining relapse-free at 
24 months 

85.7** 38.8 

MRI endpoints   
Annualised rate of the number of new or newly 
enlarging T2 lesions 

n=106 n=102 

Adjusted mean 4.393** 9.269 
Number of Gd-enhancing T1 lesions per scan up to 
month 24 

n=105 n=95 

Adjusted mean 0.436** 1.282 
Annualised rate of brain atrophy from baseline up to 
month 24 

n=96 n=89 

Least Square Mean -0.48* -0.80 
# One patient randomised to receive interferon beta-1a by intramuscular injection was unable to 

swallow the double-dummy medication and discontinued from study. The patient was excluded 
from the full analysis and safety set. 

* p<0.05, ** p<0.001, compared to interferon beta-1a. 
All analyses of clinical endpoints were on the full analysis set. 
 
5.2 Pharmacokinetic properties 
 
Pharmacokinetic data were obtained in healthy adult volunteers, in renal transplant adult patients and 
in multiple sclerosis adult patients. 
 
The pharmacologically active metabolite responsible for efficacy is fingolimod phosphate. 
 
Absorption 
 
Fingolimod absorption is slow (tmax of 12-16 hours) and extensive (≥85%). The apparent absolute 
oral bioavailability is 93% (95% confidence interval: 79-111%). Steady-state-blood concentrations are 



22  

reached within 1 to 2 months following once-daily administration and steady-state levels are 
approximately 10-fold greater than with the initial dose. 
 
Food intake does not alter Cmax or exposure (AUC) of fingolimod. Fingolimod phosphate Cmax was 
slightly decreased by 34% but AUC was unchanged. Therefore, Fingolimod Accord may be taken 
without regard to meals (see section 4.2). 
 
Distribution 
 
Fingolimod highly distributes in red blood cells, with the fraction in blood cells of 86%. Fingolimod 
phosphate has a smaller uptake in blood cells of <17%. Fingolimod and fingolimod phosphate are 
highly protein bound (>99%). 
 
Fingolimod is extensively distributed to body tissues with a volume of distribution of about 
1,200±260 litres. A study in four healthy subjects who received a single intravenous dose of a 
radioiodolabelled analogue of fingolimod demonstrated that fingolimod penetrates into the brain. In a 
study in 13 male multiple sclerosis patients who received fingolimod 0.5 mg/day, the mean amount of 
fingolimod (and fingolimod phosphate) in seminal ejaculate, at steady-state, was approximately 
10,000 times lower than the oral dose administered (0.5 mg). 
 
Biotransformation 
 
Fingolimod is transformed in humans by reversible stereoselective phosphorylation to the 
pharmacologically active (S)-enantiomer of fingolimod phosphate. Fingolimod is eliminated by 
oxidative biotransformation catalysed mainly via CYP4F2 and possibly other isoenzymes and 
subsequent fatty acid-like degradation to inactive metabolites. Formation of pharmacologically 
inactive non-polar ceramide analogues of fingolimod was also observed. The main enzyme involved in 
the metabolism of fingolimod is partially identified and may be either CYP4F2 or CYP3A4. 
 
Following single oral administration of [14C] fingolimod, the major fingolimod-related components in 
blood, as judged from their contribution to the AUC up to 34 days post dose of total radiolabelled 
components, are fingolimod itself (23%), fingolimod phosphate (10%), and inactive metabolites (M3 
carboxylic acid metabolite (8%), M29 ceramide metabolite (9%) and M30 ceramide metabolite (7%)). 
 
Elimination 
 
Fingolimod blood clearance is 6.3±2.3 l/h, and the average apparent terminal half-life (t1/2) is 6-
9 days. Blood levels of fingolimod and fingolimod phosphate decline in parallel in the terminal phase, 
leading to similar half-lives for both. 
 
After oral administration, about 81% of the dose is slowly excreted in the urine as inactive 
metabolites. Fingolimod and fingolimod phosphate are not excreted intact in urine but are the major 
components in the faeces, with amounts representing less than 2.5% of the dose each. After 34 days, 
the recovery of the administered dose is 89%. 
 
Linearity 
 
Fingolimod and fingolimod phosphate concentrations increase in an apparently dose proportional 
manner after multiple once-daily doses of 0.5 mg or 1.25 mg. 
 
Characteristics in specific groups of patients 
 
The pharmacokinetics of fingolimod and fingolimod phosphate do not differ in males and females, in 
patients of different ethnic origin, or in patients with mild to severe renal impairment. 
 
In subjects with mild, moderate, or severe hepatic impairment (Child-Pugh class A, B, and C), no 
change in fingolimod Cmax was observed, but fingolimod AUC was increased respectively by 12%, 



23  

44%, and 103%. In patients with severe hepatic impairment (Child-Pugh class C), fingolimod-
phosphate Cmax was decreased by 22% and AUC was not substantially changed. The 
pharmacokinetics of fingolimod-phosphate were not evaluated in patients with mild or moderate 
hepatic impairment. The apparent elimination half-life of fingolimod is unchanged in subjects with 
mild hepatic impairment, but is prolonged by about 50% in patients with moderate or severe hepatic 
impairment. 
 
Fingolimod should not be used in patients with severe hepatic impairment (Child-Pugh class C) (see 
section 4.3). Fingolimod should be introduced cautiously in mild and moderate hepatic impaired 
patients (see section 4.2). 
 
Clinical experience and pharmacokinetic information in patients aged above 65 years are limited. 
Fingolimod Accord should be used with caution in patients aged 65 years and over (see section 4.2). 
 
Paediatric population 
 
In paediatric patients (10 years of age and above), fingolimod-phosphate concentrations increase in an 
apparent dose proportional manner between 0.25 mg and 0.5 mg. 
 
Fingolimod-phosphate concentration at steady state is approximately 25% lower in paediatric patients 
(10 years of age and above) following daily administration of 0.25 mg or 0.5 mg fingolimod compared 
to the concentration in adult patients treated with fingolimod 0.5 mg once daily. 
 
There are no data available for paediatric patients below 10 years old. 
 
5.3 Preclinical safety data 
 
The preclinical safety profile of fingolimod was assessed in mice, rats, dogs and monkeys. The major 
target organs were the lymphoid system (lymphopenia and lymphoid atrophy), lungs (increased 
weight, smooth muscle hypertrophy at the bronchio-alveolar junction), and heart (negative 
chronotropic effect, increase in blood pressure, perivascular changes and myocardial degeneration) in 
several species; blood vessels (vasculopathy) in rats only at doses of 0.15 mg/kg and higher in a 2-year 
study, representing an approximate 4-fold margin based on the human systemic exposure (AUC) at a 
daily dose of 0.5 mg. 
 
No evidence of carcinogenicity was observed in a 2-year bioassay in rats at oral doses of fingolimod 
up to the maximally tolerated dose of 2.5 mg/kg, representing an approximate 50-fold margin based on 
human systemic exposure (AUC) at the 0.5 mg dose. However, in a 2-year mouse study, an increased 
incidence of malignant lymphoma was seen at doses of 0.25 mg/kg and higher, representing an 
approximate 6-fold margin based on the human systemic exposure (AUC) at a daily dose of 0.5 mg. 
 
Fingolimod was neither mutagenic nor clastogenic in animal studies. 
 
Fingolimod had no effect on sperm count/motility or on fertility in male and female rats up to the 
highest dose tested (10 mg/kg), representing an approximate 150-fold margin based on human 
systemic exposure (AUC) at a daily dose of 0.5 mg. 
 
Fingolimod was teratogenic in the rat when given at doses of 0.1 mg/kg or higher. Drug exposure in 
rats at this dose was similar to that in patients at the therapeutic dose (0.5 mg). The most common 
foetal visceral malformations included persistent truncus arteriosus and ventricular septum defect. The 
teratogenic potential in rabbits could not be fully assessed, however an increased embryo-foetal 
mortality was seen at doses of 1.5 mg/kg and higher, and a decrease in viable foetuses as well as foetal 
growth retardation was seen at 5 mg/kg. Drug exposure in rabbits at these doses was similar to that in 
patients. 
 



24  

In rats, F1 generation pup survival was decreased in the early postpartum period at doses that did not 
cause maternal toxicity. However, F1 body weights, development, behaviour, and fertility were not 
affected by treatment with fingolimod. 
 
Fingolimod was excreted in milk of treated animals during lactation at concentrations 2-fold to 3-fold 
higher than that found in maternal plasma. Fingolimod and its metabolites crossed the placental barrier 
in pregnant rabbits. 
 
Juvenile animal studies 
 
Results from two toxicity studies in juvenile rats showed slight effects on neurobehavioural response, 
delayed sexual maturation and a decreased immune response to repeated stimulations with keyhole 
limpet haemocyanin (KLH), which were not considered adverse. Overall, the treatment-related effects 
of fingolimod in juvenile animals were comparable to those seen in adult rats at similar dose levels, 
with the exception of changes in bone mineral density and neurobehavioural impairment (reduced 
auditory startle response) observed at doses of 1.5 mg/kg and higher in juvenile animals and the 
absence of smooth muscle hypertrophy in the lungs of the juvenile rats. 
 
 
6. PHARMACEUTICAL PARTICULARS 
 
6.1 List of excipients 
 
Capsule fill 
 
Pregelatinised starch 
Magnesium stearate 
 
Capsule shell 
 
Gelatin 
Titanium dioxide (E171) 
Yellow iron oxide (E172) 
 
Printing ink 
 
Shellac (E904) 
Propylene glycol (E1520) 
Potassium hydroxide 
Black iron oxide (E172) 
Yellow iron oxide (E172) 
 
6.2 Incompatibilities 
 
Not applicable. 
 
6.3 Shelf life 
 
3 years  
 
6.4 Special precautions for storage 
 
Store below 25°C. 
 
6.5 Nature and contents of container 
 
PVC/PVDC/aluminium blister packs containing 7, 28 or 98 hard capsules. 



25  

PVC/PVDC/aluminium perforated unit dose blister packs containing 7 x 1, 28 x 1 or 98 x 1 hard 
capsule. 
 
Not all pack sizes may be marketed. 
 
6.6 Special precautions for disposal 
 
Any unused medicinal product or waste material should be disposed of in accordance with local 
requirements. 
 
 
7. MARKETING AUTHORISATION HOLDER 
 
Accord Healthcare S.L.U. 
World Trade Center, Moll de Barcelona, s/n, 
Edifici Est, 6a Planta, 
08039 Barcelona, 
Spain 
 
 
8. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/20/1450/001-006 
 
 
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 
 
Date of first authorisation: 
 
 
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. 
  



26  

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
ANNEX II 

 
A. MANUFACTURER 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 



27  

A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE 
 
Name and address of the manufacturer responsible for batch release 
 
LABORATORI FUNDACIÓ DAU 
C/ C, 12-14 Pol. Ind. Zona Franca, Barcelona, 
08040 Barcelona, Spain 
 
Accord Healthcare Polska Sp. z.o.o. 
ul.Lutomierska 50, 
95-200, Pabianice, 
Poland 
 
Pharmadox Healthcare Limited 
KW20A Kordin Industrial Park, 
Paola PLA 3000, Malta 
 
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; 
 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. 

 



28  

 Additional risk minimisation measures 
 
Prior to launch of Fingolimod Accord 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 (NCA). 
 
The MAH shall ensure that in each Member State (MS) where Fingolimod Accord is marketed, all 
physicians who intend to prescribe Fingolimod Accord are provided with an updated Physician 
Information Pack, including: 
 

1. Summary of Product Characteristics (SmPC); 
2. Physician’s checklist for adult and pediatric patients, to consider prior to 

prescribing Fingolimod Accord, 
3. The Patient / Parent / Caregiver’s guide, to be provided to all patients, their parents (or 

legal representatives), and caregivers. 
4. The pregnancy-specific patient reminder card, to be provided to all patients, their parents 

(or legal representatives), and caregivers, as applicable. 
 
Physician’s checklist 
 
The physician’s checklist shall contain the following key messages: 
 
 Monitoring requirements at treatment initiation: 
Before first dose 

o Perform baseline ECG prior to the first dose of Fingolimod Accord; 
o Perform blood pressure measurement prior to the first dose of Fingolimod Accord; 
o Perform a liver function test prior to (within 6 months) treatment initiation; 
o Arrange ophthalmological assessment before starting Fingolimod Accord treatment in 

patients with diabetes mellitus or with a history of uveitis. 
o A negative pregnancy test result must be confirmed prior to starting treatment. 

 
Until 6 hours after first dose 

o Monitor the patient for 6 hours after the first dose of Fingolimod Accord has been 
administered for signs and symptoms of bradycardia, including hourly pulse and blood 
pressure checks. Continuous (real time) ECG monitoring is recommended; 

o Perform an ECG at the end of the 6-hour monitoring period. 
 
>6 to 8 hours after first dose 

o If, at the 6-hour time point, the heart rate is at the lowest value following the first dose, 
extend heart rate monitoring for at least 2 more hours and until the heart rate increases 
again. 

 
 Recommendation for re-initiating Fingolimod Accord therapy after treatment interruption: 

The same first dose monitoring as for treatment initiation is recommended when treatment is 
interrupted for: 
o One day or more during the first 2 weeks of treatment;  
o More than 7 days during weeks 3 and 4 of treatment;  
o More than 2 weeks after at least 1 month of treatment. 



29 
 

 Recommendation for overnight monitoring after the first dose (or if the first dose monitoring 
applies during treatment re-initiation): 
o Extend heart rate monitoring for at least overnight in a medical facility and until 

resolution of findings in patients requiring pharmacological intervention during 
monitoring at treatment initiation/re-initiation. Repeat the first dose monitoring after the 
second dose of Fingolimod Accord; 

o Extend heart rate monitoring for at least overnight in a medical facility and 
until resolution of findings in patients: 
 With third degree AV block occurring at any time; 
 Where at the 6-hour time point: 

a. Heart rate <45 bpm, <55 bpm in paediatric patients aged 12 years old 
and above, or <60 bpm in pediatric patients 10 to below 12 years of 
age; 

b. New onset second degree or higher AV block; 
c. QTc interval 500 msec. 

 
 Fingolimod Accord is contraindicated in patients with: 

o Known immunodeficiency syndrome; 
o Patients with increased risk for opportunistic infections, including 

immunocompromised patients (including those currently receiving immunosuppressive 
therapies or those immunocompromised by prior therapies); 

o Severe active infections, active chronic infections (hepatitis, tuberculosis); 
o Known active malignancies; 
o Severe liver impairment (Child-Pugh class C); 
o In the previous 6 months, myocardial infarction (MI), unstable angina pectoris, 

stroke/transient ischaemic attack (TIA), decompensated heart failure (requiring 
inpatient treatment), or New York Heart Association (NYHA) class III/IV heart failure; 

o Severe cardiac arrhythmias requiring anti-arrhythmic treatment with class Ia or class III 
anti-arrhythmic medicinal products; 

o Second-degree Mobitz type II atrioventricular (AV) block or third-degree AV block, or 
sick-sinus syndrome, if they do not wear a pacemaker; 

o Patients with a baseline QTc interval ≥500 msec; 
o Pregnant women and women of childbearing potential not using effective contraception; 
o Hypersensitivity to the active substance or to any of the excipients. 
 

 Fingolimod Accord is not recommended in patients with: 
o Sino-atrial heart block; 
o QTc prolongation >470 msec (adult females), QTc >460 msec (pediatric females) or >450 

msec (adult and pediatric males); 
o History of cardiac arrest; 
o Severe sleep apnea; 
o History of symptomatic bradycardia; 
o History of recurrent syncope; 
o Uncontrolled hypertension. 

 
If Fingolimod Accord treatment is considered in these patients anticipated benefits must outweigh 
potential risks and a cardiologist must be consulted to determine appropriate monitoring, at least 
overnight extended monitoring is recommended. 
 
 Fingolimod Accord is not recommended in patients concomitantly taking medicines known to 

decrease the heart rate. If Fingolimod Accord treatment is considered in these patients 
anticipated benefits must outweigh potential risks and a cardiologist must be consulted to 
switch to non heart-rate- lowering therapy or, if not possible, to determine appropriate 
monitoring. At least overnight extended monitoring is recommended. 
 

 Fingolimod Accord reduces peripheral blood lymphocyte counts. Peripheral lymphocyte count 



30 
 

(CBC) should be checked in all patients prior to initiation (within 6 months or after 
discontinuation of prior therapy) and monitored during treatment with Fingolimod Accord. 
Treatment should be interrupted if lymphocyte count is confirmed as <0.2x109/L. The 
approved dosing of 0.5 mg once daily (or 0.25 mg once daily in pediatric patients 10 years of 
age and above with a body weight of ≤40 kg) when restarting Fingolimod Accord should be 
administered. Other dosing regimens have not been approved. 
 

 Fingolimod Accord has an immunosuppressive effect that predisposes patients to an infection 
risk, including opportunistic infections that can be fatal, and increases the risk of developing 
lymphomas (including mycosis fungoides) and other malignancies, particularly those of the 
skin. Surveillance should include vigilance for both skin malignancies and mycosis 
fungoides. Physicians should carefully monitor patients, especially those with concurrent 
conditions or known factors, such as previous immunosuppressive therapy. If this risk is 
suspected, discontinuation of treatment should be considered by the physician on a case-by-
case basis. 

 
o Treatment initiation in patients with severe active infection should be delayed until the 

infection is resolved. Suspension of treatment during serious infections should be 
considered. Anti-neoplastic, immunomodulatory or immunosuppressive therapies 
should not be co-administered due to the risk of additive immune system effects. For 
the same reason, a decision to use prolonged concomitant treatment with 
corticosteroids should be taken after careful consideration. 

 
o Vigilance for basal cell carcinoma and other cutaneous neoplasms including malignant 

melanoma, squamous cell carcinoma, Kaposi’s sarcoma and Merkel cell carcinoma is 
recommended, with skin examination prior to treatment initiation and then every 6 to 
12 months taking into consideration clinical judgement. Patients should be referred to a 
dermatologist if suspicious lesions are detected. Caution patients against exposure to 
sunlight without protection. These patients should not receive concomitant 
phototherapy with UV-B-radiation or PUVA-photochemotherapy. 

 
 Patients should be instructed to report signs and symptoms of infections immediately to their 

prescriber during and for up to two months after treatment with Fingolimod Accord. 
 

o Prompt diagnostic evaluation should be performed in patient with symptoms and signs 
consistent with cryptococcal meningitis; appropriate treatment, if diagnosed, should be 
initiated. 

Reports of cryptococcal meningitis (sometimes fatal) have been received after approximately 2-3 
years of treatment, although an exact relationship with the duration of treatment is unknown. 
 

o Physicians should be vigilant for clinical symptoms or MRI findings suggestive of 
PML. If PML is suspected, treatment with Fingolimod Accord should be suspended 
until PML has been excluded. 

Cases of PML have occurred after approximately 2-3 years of monotherapy treatment although an 
exact relationship with the duration of treatment is unknown. 
 

o Specific recommendations regarding vaccination for patients initiating Fingolimod 
Accord treatment. Check varicella zoster virus (VZV) antibody status in patients 
without a healthcare professional confirmed history of chickenpox or documentation of 
a full course of varicella vaccination. If negative, a full course of vaccination with 
varicella vaccine is recommended and treatment initiation should be delayed for 1 
month to allow full effect of vaccination to occur. 

 
o Human papilloma virus (HPV) infection, including papilloma, dysplasia, warts and 

HPV- related cancer, has been reported in the post-marketing setting. Cancer 
screening, including Pap test, and vaccination for HPV-related cancer is recommended 



31 
 

for patients, as per standard of care. 
 
 A full ophthalmological assessment should be considered: 

o 3-4 months after starting Fingolimod Accord therapy for the early detection of visual 
impairment due to drug-induced macular oedema; 

o During treatment with Fingolimod Accord in patients with diabetes mellitus or with a 
history of uveitis. 

 
 Fingolimod Accord is teratogenic. It is contraindicated in women of childbearing potential 

(including female adolescents) not using effective contraception and in pregnant women. 
 

o A negative pregnancy test result must be confirmed prior to starting treatment, and it 
must be repeated at suitable intervals. 

 
o Women of child-bearing potential, including adolescent females, their parents (or legal 

representatives), and caregivers, should be counselled before treatment initiation and 
regularly thereafter about the serious risks of Fingolimod Accord to the foetus, 
facilitated by the pregnancy-specific patient reminder card. 

 
o Women of childbearing potential must use effective contraception during treatment and 

for two months following treatment discontinuation. 
 

o While on treatment, women must not become pregnant. If a woman becomes pregnant 
while on treatment, Fingolimod Accord must be discontinued. When stopping 
Fingolimod Accord therapy due to pregnancy or for planning a pregnancy, the possible 
return of disease activity should be considered. Medical advice should be given 
regarding the risk of harmful effects to the foetus associated with Fingolimod Accord 
treatment and ultrasonography examinations should be performed. 

 
o Fingolimod Accord must be stopped 2 months before planning a pregnancy. 

 
 Liver function should be monitored at months 1, 3, 6, 9 and 12 during Fingolimod Accord 

therapy and periodically thereafter; the approved dosing of 0.5 mg daily (or 0.25 mg once daily 
in pediatric patients 10 years of age and above with a body weight of ≤40 kg) should be 
administered. Other dosing regimens have not been approved. 

 
 In the post-marketing setting, severe exacerbation of disease has been observed rarely in some 

patients stopping Fingolimod Accord. The possibility of recurrence of exceptionally high disease 
activity should be considered. 

 
 Cases of seizure, including status epilepticus, have been reported. Physicians should be vigilant 

for seizures and especially in those patients with underlying conditions or with a pre-existing 
history or family history of epilepsy. 

 
 Physicians should reassess on an annual basis the benefit of Fingolimod Accord treatment versus 

risk in each patient, especially pediatric patients. 
 
 Physicians should provide patients/parents/caregivers with the patient/parents/caregiver guide 

and with the pregnancy-specific patient reminder card. 
 

The safety profile in pediatric patients is similar to adults and therefore the warnings and precautions 
in adults also apply for pediatric patients. 

Specifically with pediatric patients, physicians should also: 
o Assess Tanner staging and measure height and weight as per standard of care; 



32 
 

o Perform cardiovascular monitoring; 
o Take precautions when the first dose is administered / patients are switched from 0.25 to 

0.5 mg daily, due to the potential for bradyarrhythmia; 
o Monitor the patient for sign and symptoms of depression and anxiety; 
o Emphasize treatment compliance and misuse to patients, especially about treatment 

interruption and the importance of repeating cardiovascular monitoring; 
o Emphasize Fingolimod Accord immunosuppressive effects; 
o Consider a complete vaccination schedule before starting Fingolimod Accord; 
o Provide guidance on seizure monitoring. 

 
Patient / Parent / Caregiver guide 
 
The patient/parents/caregiver guide shall contain the following key messages: 
 What Fingolimod Accord is and how it works; 
 What multiple sclerosis is; 
 Patients should read the package leaflet thoroughly before starting treatment and should keep it in 

case they need to refer to it again during treatment; 
 Importance of reporting adverse reactions; 
 Patients should have a baseline ECG and blood pressure measurement prior to receiving the first 

dose of Fingolimod Accord; 
 Heart rate should be monitored for 6 or more hours after the first dose of Fingolimod Accord, 

including hourly pulse and blood pressure checks. Patients may be monitored with continuous 
ECG during the first 6 hours. An ECG at 6 hours should also be performed and, in some 
circumstances, monitoring may involve an overnight stay; 

 Patients should call their doctor in case of treatment interruption as the first dose monitoring may 
need to be repeated, depending on duration of interruption and time since starting of Fingolimod 
Accord treatment; 

 Patients should report immediately symptoms indicating low heart rate (such as dizziness, 
vertigo, nausea or palpitations) after the first dose of Fingolimod Accord; 

 Fingolimod Accord is not recommended in patients with cardiac disease or those taking 
medicines concomitantly known to decrease heart rate, and they should tell any doctor they see 
that they are being treated with Fingolimod Accord; 

 Signs and symptoms of infection, which should be immediately reported to the prescriber 
physician during and up to two months after Fingolimod Accord treatment; 

 The need to undergo cancer screening, including Pap test, and vaccination for HPV-related 
cancer, as per standard of care, will be assessed by the prescriber physician; 

 Any symptoms of visual impairment should be reported immediately to the prescriber during and 
for up to two months after the end of treatment with Fingolimod Accord; 

 Fingolimod Accord is teratogenic. Women of child-bearing potential, including adolescent 
females, should: 
o Be informed before treatment initiation and regularly thereafter by their physician about 

Fingolimod Accord serious risks to the foetus, and about the contraindication in 
pregnant women and in women of childbearing potential not using effective 
contraception, facilitated by the pregnancy-specific patient reminder card; 

o Have a negative pregnancy test before starting Fingolimod Accord; 
o Be using effective contraception during and for at least two months following 

discontinuation of Fingolimod Accord treatment; 
o Report immediately to the prescribing physician any (intended or unintended) 

pregnancy during and up to two months following discontinuation of Fingolimod 
Accord treatment; 

 A liver function test should be performed prior to treatment initiation; liver function monitoring 
should be performed at months 1, 3, 6, 9 and 12 during Fingolimod Accord therapy, and 
periodically thereafter; 

 Skin cancers have been reported in multiple sclerosis patients treated with Fingolimod Accord. 
Patients should inform their doctor immediately if any skin nodules (e.g., shiny, pearly nodules), 



33 
 

patches or open sores that do not heal within weeks are noted. Symptoms of skin cancer may 
include abnormal growth or changes of skin tissue (e.g., unusual moles) with a change in color, 
shape or size over time; 

 Seizure may occur. The doctor should be informed about a pre-existing history or family history 
of epilepsy; 

 Stopping Fingolimod Accord therapy may result in return of disease activity. The prescribing 
physician should decide whether and how the patient should be monitored after stopping 
Fingolimod Accord. 

 
Specifically for Pediatric patients: 
 
The following should be considered: 
 Physicians should assess Tanner staging and measure height and weight as per standard of care; 
 Precautions should be taken during the first dose of Fingolimod Accord and when patients are 

switched from 0.25 to 0.5 mg daily; 
 Depression and anxiety are known to occur with increased frequency in the multiple sclerosis 

population and have been reported also in pediatric patients treated with Fingolimod Accord; 
 Cardiac monitoring guidance; 
 Patients should ensure medication compliance and avoid misuse, especially treatment 

interruption, and repeat cardiac monitoring; 
 Signs and symptoms of infection; 
 Seizure monitoring guidance. 
 
Pregnancy-specific patient reminder card 
 
The pregnancy-specific patient reminder card shall contain the following key messages: 
 Fingolimod Accord is contraindicated during pregnancy and in women of childbearing potential 

not using effective contraception. 
 Doctors will provide counselling before treatment initiation and regularly thereafter regarding the 

teratogenic risk of Fingolimod Accord and required actions to minimise this risk. 
 Patients must use effective contraception while taking Fingolimod Accord. 
 A pregnancy test must be carried out and negative results verified by the doctor before starting 

treatment. It must be repeated at suitable intervals. 
 Patients will be informed by their doctor of the need for effective contraception while on 

treatment and for 2 months after discontinuation. 
 Doctors will provide counselling in the event of pregnancy and evaluation of the outcome of any 

pregnancy. 
 While on treatment, women must not become pregnant. If a woman becomes pregnant or wants 

to become pregnant, Fingolimod Accord must be discontinued. 
 Patients should inform their doctor straight away if there is worsening of multiple sclerosis after 

stopping treatment with Fingolimod Accord. 
  



34 
 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
ANNEX III 

 
LABELLING AND PACKAGE LEAFLET 

  



35 
 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

A. LABELLING 
  



36 
 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
CARTON OF UNIT PACK 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Fingolimod Accord 0.5 mg hard capsules 
fingolimod 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each capsule contains 0.5 mg fingolimod (as hydrochloride). 
 
 
3. LIST OF EXCIPIENTS 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
7 hard capsules 
28 hard capsules 
98 hard capsules 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
Oral use. 
Swallow each capsule whole. 
 
 
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 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Store below 25°C. 
 
 



37 
 

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 
 
Accord Healthcare S.L.U. 
World Trade Center, Moll de Barcelona, s/n, 
Edifici Est, 6a Planta, 
08039 Barcelona, 
Spain 
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/20/1450/001 
EU/1/20/1450/002 
EU/1/20/1450/003 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Fingolimod Accord 0.5 mg 
 
 
17. UNIQUE IDENTIFIER - 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC 
SN 
NN 
  



38 
 

 
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 
 
BLISTERS FOR UNIT PACK 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Fingolimod Accord 0.5 mg capsules 
fingolimod 
 
 
2. NAME OF THE MARKETING AUTHORISATION HOLDER 
 
Accord 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. OTHER 
 
 
  



39 
 

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
CARTON OF UNIT PACK CONTAINING SINGLE-UNIT-DOSE BLISTERS 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Fingolimod Accord 0.5 mg hard capsules 
fingolimod 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each capsule contains 0.5 mg fingolimod (as hydrochloride). 
 
 
3. LIST OF EXCIPIENTS 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
7 x 1 hard capsule. 
28 x 1 hard capsule. 
98 x 1 hard capsule. 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
Oral use.  
Swallow each capsule whole. 
 
 
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 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Store below 25°C. 
 
 



40 
 

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 
 
Accord Healthcare S.L.U. 
World Trade Center, Moll de Barcelona, s/n, 
Edifici Est, 6a Planta, 
08039 Barcelona, 
Spain 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/20/1450/004 
EU/1/20/1450/005 
EU/1/20/1450/006 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Fingolimod Accord 0.5 mg 
 
 
17. UNIQUE IDENTIFIER - 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC  
SN  
NN 
 
 



41 
 

 
 
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 
 
SINGLE-UNIT-DOSE BLISTERS  
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Fingolimod Accord 0.5 mg capsules 
fingolimod 
 
 
2. NAME OF THE MARKETING AUTHORISATION HOLDER 
 
Accord 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. OTHER 
 
 
  



42 
 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

B. PACKAGE LEAFLET 
  



43 
 

Package leaflet: Information for the user 
 

Fingolimod Accord 0.5 mg hard capsules 
fingolimod 

 
Read all of this leaflet carefully before you start taking 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 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 Fingolimod Accord is and what it is used for 
2. What you need to know before you take Fingolimod Accord 
3. How to take Fingolimod Accord 
4. Possible side effects 
5. How to store Fingolimod Accord 
6. Contents of the pack and other information 
 
 
1. What Fingolimod Accord is and what it is used for 
 
What Fingolimod Accord is 
The active substance of Fingolimod Accord is fingolimod. 
 
What Fingolimod Accord is used for 
Fingolimod Accord is used in adults and in children and adolescents (10 years of age and above) to 
treat relapsing-remitting multiple sclerosis (MS), more specifically in: 
- Patients who have failed to respond despite treatment with an MS treatment. 
or 
- Patients who have rapidly evolving severe MS. 
 
Fingolimod Accord does not cure MS, but it helps to reduce the number of relapses and to slow down 
the progression of physical disabilities due to MS. 
 
What is multiple sclerosis 
MS is a long-term condition that affects the central nervous system (CNS), comprised of the brain and 
spinal cord. In MS inflammation destroys the protective sheath (called myelin) around the nerves in 
the CNS and stops the nerves from working properly. This is called demyelination. 
 
Relapsing-remitting MS is characterised by repeated attacks (relapses) of nervous system symptoms 
that reflect inflammation within the CNS. Symptoms vary from patient to patient but typically involve 
walking difficulties, numbness, vision problems or disturbed balance. Symptoms of a relapse may 
disappear completely when the relapse is over, but some problems may remain. 
 
How Fingolimod Accord works 
Fingolimod Accord helps to protect against attacks on the CNS by the immune system by reducing the 
ability of some white blood cells (lymphocytes) to move freely within the body and by stopping them 
from reaching the brain and spinal cord. This limits nerve damage caused by MS. Fingolimod Accord 
also reduces some of the immune reactions of your body. 
 
 
2. What you need to know before you take Fingolimod Accord 



44 
 

 
Do not take Fingolimod Accord 
- if you have a lowered immune response (due to an immunodeficiency syndrome, a disease or 

to medicines that suppress the immune system). 
- if you have a severe active infection or active chronic infection such as hepatitis or 

tuberculosis. 
- if you have an active cancer. 
- if you have severe liver problems. 
- if, in the last 6 months, you have had heart attack, angina, stroke or warning of a stroke or 

certain types of heart failure. 
- if you have certain types of irregular or abnormal heartbeat (arrhythmia), including patients 

in whom the electrocardiogram (ECG) shows prolonged QT interval before starting Fingolimod 
Accord. 

- if you are taking or have recently taken medicine for irregular heartbeat such as quinidine, 
disopyramide, amiodarone or sotalol. 

- If you are pregnant or a woman of childbearing potential not using effective contraception. 
- if you are allergic to fingolimod or any of the other ingredients of this medicine (listed in 

section 6). 
If this applies to you, tell your doctor without taking Fingolimod Accord. 
 
Warnings and precautions 
Talk to your doctor before taking Fingolimod Accord: 
- if you have severe breathing problems during sleep (severe sleep apnoea). 
- if you have been told you have an abnormal electrocardiogram.  
- if you suffer from symptoms of slow heart rate (e.g. dizziness, nausea, or palpitations). 
- if you are taking or have recently taken medicines that slow your heart rate (such as beta 

blockers, verapamil, diltiazem or ivabradine, digoxin, anticholinesteratic agents or pilocarpine). 
- if you have a history of sudden loss of consciousness or fainting (syncope). 
- if you plan to get vaccinated. 
- if you have never had chickenpox. 
- if you have or have had visual disturbances or other signs of swelling in the central vision 

area (macula) at the back of the eye (a condition known as macular oedema, see below), 
inflammation or infection of the eye (uveitis), or if you have diabetes (which can cause eye 
problems). 

- if you have liver problems. 
- if you have high blood pressure that cannot be controlled by medicines. 
- if you have severe lung problems or smoker’s cough. 
If any of these applies to you, tell your doctor before taking Fingolimod Accord. 
 
Slow heart rate (bradycardia) and irregular heartbeat 
At the beginning of treatment or after taking the first dose of 0.5 mg when you switch from a 0.25 mg 
daily dose, Fingolimod Accord causes the heart rate to slow down. As a result, you may feel dizzy or 
tired, or be consciously aware of your heartbeat, or your blood pressure may drop. If these effects are 
pronounced, tell your doctor, because you may need treatment right away. Fingolimod Accord 
can also cause an irregular heartbeat, especially after the first dose. Irregular heartbeat usually returns 
to normal in less than one day. Slow heart rate usually returns to normal within one month. 
 
Your doctor will ask you to stay at the surgery or clinic for at least 6 hours, with hourly pulse and 
blood pressure measurements, after taking the first dose of Fingolimod Accord or after taking the first 
dose of 0.5 mg when you switch from a 0.25 mg daily dose, so that appropriate measures can be taken 
in the event of side effects that occur at the start of treatment. You should have an electrocardiogram 
performed prior to the first dose of Fingolimod Accord and after the 6-hour monitoring period. Your 
doctor may monitor your electrocardiogram continuously during that time. If after the 6-hour period 
you have a very slow or decreasing heart rate, or if your electrocardiogram shows abnormalities, you 



45 
 

may need to be monitored for a longer period (at least 2 more hours and possibly overnight) until these 
have resolved. The same may apply if you are resuming Fingolimod Accord after a break in treatment, 
depending on both how long the break was and how long you had been taking Fingolimod Accord 
before the break. 
 
If you have, or if you are at risk for, an irregular or abnormal heartbeat, if your electrocardiogram is 
abnormal, or if you have heart disease or heart failure, Fingolimod Accord may not be appropriate for 
you. 
 
If you have a history of sudden loss of consciousness or decreased heart rate, Fingolimod Accord may 
not be appropriate for you. You will be evaluated by a cardiologist (heart specialist) to advise how you 
should start treatment with Fingolimod Accord, including overnight monitoring. 
 
If you are taking medicines that can cause your heart rate to decrease, Fingolimod Accord may not be 
appropriate for you. You will need to be evaluated by a cardiologist, who will check whether you can 
be switched to alternative medicine that does not decrease your heart rate in order to allow treatment 
with-Fingolimod Accord. If such a switch is impossible, the cardiologist will advise how you should 
start treatment with Fingolimod Accord, including overnight monitoring. 
 
If you have never had chickenpox 
If you have never had chickenpox, your doctor will check your immunity against the virus that causes 
it (varicella zoster virus). If you are not protected against the virus, you may need a vaccination before 
you start treatment with Fingolimod Accord. If this is the case, your doctor will delay the start of 
treatment with Fingolimod Accord until one month after the full course of vaccination is completed. 
 
Infections 
Fingolimod Accord lowers the white blood cell count (particularly the lymphocyte count). White 
blood cells fight infection. While you are taking Fingolimod Accord (and for up to 2 months after you 
stop taking it), you may get infections more easily. Any infection that you already have may get 
worse. Infections could be serious and life-threatening. If you think you have an infection, have fever, 
feel like you have the flu, or have a headache accompanied by stiff neck, sensitivity to light, nausea, 
and/or confusion (these may be caused by a fungal infection and may be symptoms of meningitis), 
contact your doctor straight away, because it could be serious and life-threatening. If you believe your 
MS is getting worse (e.g. weakness or visual changes) or if you notice any new symptoms, talk to your 
doctor straight away, because these may be the symptoms of a rare brain disorder caused by infection 
and called progressive multifocal leukoencephalopathy (PML). PML is a serious condition that may 
lead to severe disability or death. Your doctor will consider performing an MRI scan to evaluate this 
condition and will decide whether you need to stop taking Fingolimod Accord. 
 
Human papilloma virus (HPV) infection, including papilloma, dysplasia, warts and HPV-related 
cancer, has been reported in patients treated with Fingolimod Accord. Your doctor will consider 
whether you need to have a vaccination against HPV before starting treatment. If you are a woman, 
your doctor will also recommend HPV screening. 
 
Macular oedema  
Before you start Fingolimod Accord, if you have or have had visual disturbances or other signs of 
swelling in the central vision area (macula) at the back of the eye, inflammation or infection of the eye 
(uveitis) or diabetes, your doctor may want you to undergo an eye examination. 
 
Your doctor may want you to undergo an eye examination 3 to 4 months after starting Fingolimod 
Accord treatment. 
 
The macula is a small area of the retina at the back of the eye which enables you to see shapes, 
colours, and details clearly and sharply. Fingolimod Accord may cause swelling in the macula, a 
condition that is known as macular oedema. The swelling usually happens in the first 4 months of 
Fingolimod Accord treatment. 
 



46 
 

Your chance of developing macular oedema is higher if you have diabetes or have had an 
inflammation of the eye called uveitis. In these cases your doctor will want you to undergo regular eye 
examinations in order to detect macular oedema. 
 
If you have had macular oedema, talk to your doctor before you resume treatment with Fingolimod 
Accord. 
 
Macular oedema can cause some of the same vision symptoms as an MS attack (optic neuritis). Early 
on, there may not be any symptoms. Be sure to tell your doctor about any changes in your vision. Your 
doctor may want you to undergo an eye examination, especially if: 
- the centre of your vision gets blurry or has shadows; 
- you develop a blind spot in the centre of your vision; 
- you have problems seeing colours or fine detail. 
 
Liver function tests 
If you have severe liver problems, you should not take Fingolimod Accord. Fingolimod Accord may 
affect your liver function. You will probably not notice any symptoms but if you notice yellowing of 
your skin or the whites of your eyes, abnormally dark urine or unexplained nausea and vomiting, tell 
your doctor straight away. 
 
If you get any of these symptoms after starting Fingolimod Accord, tell your doctor straight away. 
 
During the first twelve months of treatment your doctor will request blood tests to monitor your liver 
function. If your test results indicate a problem with your liver you may have to interrupt treatment 
with Fingolimod Accord. 
 
High blood pressure 
As Fingolimod Accord causes a slight elevation of blood pressure, your doctor may want to check 
your blood pressure regularly. 
 
Lung problems 
Fingolimod Accord has a slight effect on the lung function. Patients with severe lung problems or with 
smoker’s cough may have a higher chance of developing side effects. 
 
Blood count 
The desired effect of Fingolimod Accord treatment is to reduce the amount of white blood cells in 
your blood. This will usually go back to normal within 2 months of stopping treatment. If you need to 
have any blood tests, tell the doctor that you are taking Fingolimod Accord. Otherwise, it may not be 
possible for the doctor to understand the results of the test, and for certain types of blood test your 
doctor may need to take more blood than usual. 
 
Before you start Fingolimod Accord, your doctor will confirm whether you have enough white blood 
cells in your blood and may want to repeat a check regularly. In case you do not have enough white 
blood cells, you may have to interrupt treatment with Fingolimod Accord. 
 
Posterior reversible encephalopathy syndrome (PRES) 
A condition called posterior reversible encephalopathy syndrome (PRES) has been rarely reported in 
MS patients treated with Fingolimod Accord. Symptoms may include sudden onset of severe 
headache, confusion, seizures and vision changes. Tell your doctor straight away if you experience 
any of these symptoms during your treatment with Fingolimod Accord, because it could be serious. 
 
Cancer 
Skin cancers have been reported in MS patients treated with Fingolimod Accord. Talk to your doctor 
straight away if you notice any skin nodules (e.g. shiny pearly nodules), patches or open sores that do 
not heal within weeks. Symptoms of skin cancer may include abnormal growth or changes of skin 
tissue (e.g. unusual moles) with a change in colour, shape or size over time. Before you start 



47 
 

Fingolimod Accord, a skin examination is required to check whether you have any skin nodules. Your 
doctor will also carry out regular skin examinations during your treatment with Fingolimod Accord. If 
you develop problems with your skin, your doctor may refer you to a dermatologist, who after 
consultation may decide that it is important for you to be seen on a regular basis. 
 
A type of cancer of the lymphatic system (lymphoma) has been reported in MS patients treated with 
Fingolimod Accord. 
 
Exposure to the sun and protection against the sun 
Fingolimod weakens your immune system. This increases your risk of developing cancers, in 
particular skin cancers. You should limit your exposure to the sun and UV rays by: 
- wearing appropriate protective clothing. 
- regularly applying sunscreen with a high degree of UV protection. 
 
Unusual brain lesions associated with MS relapse 
Rare cases of unusually large brain lesions associated with MS relapse have been reported in patients 
treated with Fingolimod Accord. In case of severe relapse, your doctor will consider performing MRI 
to evaluate this condition and will decide whether you need to stop taking Fingolimod Accord. 
 
Switch from other treatments to Fingolimod Accord 
Your doctor may switch you directly from beta interferon, glatiramer acetate or dimethyl fumarate to 
Fingolimod Accord if there are no signs of abnormalities caused by your previous treatment. Your 
doctor may have to do a blood test in order to exclude such abnormalities. After stopping natalizumab 
you may have to wait for 2-3 months before starting treatment with Fingolimod Accord. To switch 
from teriflunomide, your doctor may advise you to wait for a certain time or to go through an 
accelerated elimination procedure. If you have been treated with alemtuzumab, a thorough evaluation 
and discussion with your doctor is required to decide if Fingolimod Accord is appropriate for you. 
 
Women of childbearing potential 
If used during pregnancy, Fingolimod Accord can harm the unborn baby. Before you start treatment 
with Fingolimod Accord your doctor will explain the risk to you and ask you to do a pregnancy test in 
order to ensure that you are not pregnant. Your doctor will give you a card which explains why you 
should not become pregnant while taking Fingolimod Accord. It also explains what you should do to 
avoid becoming pregnant while you are taking Fingolimod Accord. You must use effective 
contraception during treatment and for 2 months after stopping treatment (see section “Pregnancy and 
breastfeeding”). 
 
Worsening of MS after stopping Fingolimod Accord treatment 
Do not stop taking Fingolimod Accord or change your dose without talking to your doctor first. 
 
Tell your doctor straight away if you think your MS is getting worse after you have stopped treatment 
with Fingolimod Accord. This could be serious (see “If you stop taking Fingolimod Accord” in 
section 3, and also section 4, “Possible side effects”). 
 
Elderly 
Experience with Fingolimod Accord in elderly patients (over 65 years) is limited. Talk to your doctor 
if you have any concerns. 
 
Children and adolescents 
Fingolimod Accord is not intended for use in children below 10 years old as it has not been studied in 
MS patients in this age group. 
 
The warnings and precautions listed above also apply to children and adolescents. The following 
information is particularly important for children and adolescents and their caregivers: 



48 
 

- Before you start Fingolimod Accord, your doctor will check your vaccination status. If you have 
not had certain vaccinations, it may be necessary for you to be given them before Fingolimod 
Accord can be started. 

- The first time you take Fingolimod Accord, or when you switch from a 0.25 mg daily dose to a 
0.5 mg daily dose, your doctor will monitor your heart rate and heartbeat (see “Slow heart rate 
(bradycardia) and irregular heartbeat” above). 

- If you experience convulsions or fits before or whilst taking Fingolimod Accord, let your doctor 
know. 

- If you suffer from depression or anxiety or if you become depressed or anxious while you are 
taking Fingolimod Accord, let your doctor know. You may need to be monitored more closely. 

 
Other medicines and Fingolimod Accord 
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other 
medicines. Tell your doctor if you are taking any of the following medicines: 
 Medicines that suppress or modulate the immune system, including other medicines used 

to treat MS, such as beta interferon, glatiramer acetate, natalizumab, mitoxantrone, 
teriflunomide, dimethyl fumarate or alemtuzumab. You must not use Fingolimod Accord 
together with such medicines as this could intensify the effect on the immune system (see also 
‘Do not take Fingolimod Accord’). 

 Corticosteroids, due to a possible added effect on the immune system. 
 Vaccines. If you need to receive a vaccine, seek your doctor’s advice first. During and for up to 

2 months after treatment with Fingolimod Accord, you should not receive certain types of 
vaccine (live attenuated vaccines) as they could trigger the infection that they were supposed to 
prevent. Other vaccines may not work as well as usual if given during this period. 

 Medicines that slow the heartbeat (for example beta blockers, such as atenolol). Use of 
Fingolimod Accord together with such medicines could intensify the effect on heartbeat in the 
first days after starting Fingolimod Accord. 

 Medicines for irregular heartbeat, such as quinidine, disopyramide, amiodarone or sotalol. 
You must not use Fingolimod Accord if you are taking such a medicine because it could 
intensify the effect on irregular heartbeat (see also ‘Do not take Fingolimod Accord’). 

 Other medicines: 
o protease inhibitors, anti-infectives such as ketoconazole, azole antifungals, clarithromycin or 

telithromycin. 
o carbamazepine, rifampicine, phenobarbital, phenytoin, efavirenz or St. John’s Wort (potential 

risk of reduced efficacy of Fingolimod Accord). 
 
Pregnancy and breast-feeding 
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask 
your doctor for advice before taking this medicine. 
 
Pregnancy 
Do not use Fingolimod Accord during pregnancy, if you are trying to become pregnant or if you are a 
woman who could become pregnant and you are not using effective contraception. If Fingolimod 
Accord is used during pregnancy, there is a risk of harm to the unborn baby. The rate of congenital 
malformations observed in babies exposed to Fingolimod Accord during pregnancy is about 2 times 
the rate observed in the general population (in whom the rate of congenital malformations is about 
2-3%). The most frequently reported malformations included cardiac, renal and musculoskeletal 
malformations. 
 
Therefore, if you are a woman of childbearing potential: 
- before you start treatment with Fingolimod Accord your doctor will inform you about the risk to 

an unborn baby and ask you to do a pregnancy test in order to ensure that you are not pregnant, 
and, 



49 
 

- you must use effective contraception while taking Fingolimod Accord and for two months after 
you stop taking it to avoid becoming pregnant. Talk to your doctor about reliable methods of 
contraception. 

 
Your doctor will give you a card which explains why you should not become pregnant while taking 
Fingolimod Accord. 
 
If you do become pregnant while taking Fingolimod Accord, tell your doctor straight away. Your 
doctor will decide to stop treatment (see “If you stop taking Fingolimod Accord” in section 3, and also 
section 4, “Possible side effects”). Specialised pre-natal monitoring will be performed. 
 
Breast-feeding 
You should not breast-feed while you are taking Fingolimod Accord. Fingolimod Accord can pass 
into breast milk and there is a risk of serious side effects for the baby. 
 
Driving and using machines 
Your doctor will tell you whether your illness allows you to drive vehicles, including a bicycle, and 
use machines safely. Fingolimod Accord is not expected to have an influence on your ability to drive 
and use machines. 
 
However, at initiation of treatment you will have to stay at the doctor’s surgery or clinic for 6 hours 
after taking the first dose of Fingolimod Accord. Your ability to drive and use machines may be 
impaired during and potentially after this time period. 
 
 
3. How to take Fingolimod Accord 
 
Treatment with Fingolimod Accord will be overseen by a doctor who is experienced in the treatment 
of multiple sclerosis. 
 
Always take this medicine exactly as your doctor has told you. Check with your doctor if you are not 
sure. 
 
The recommended dose is: 
 
Adults: 
The dose is one 0.5 mg capsule per day. 
 
Children and adolescents (10 years of age and above): 
The dose depends on body weight. 
 Children and adolescents with body weight equal to or below 40 kg: one 0.25 mg capsule per 

day. 
 Children and adolescents with body weight above 40 kg: one 0.5 mg capsule per day. 
Children and adolescents who start on one 0.25 mg capsule per day and later reach a stable body 
weight above 40 kg will be instructed by their doctor to switch to one 0.5 mg capsule per day. In this 
case, it is recommended to repeat the first-dose observation period. 
 
Fingolimod Accord is only available as 0.5 mg hard capsules which are not suitable for children and 
adolescents with a body weight equal to or below 40 kg.  
Other fingolimod-containing medicines are available in 0.25 mg strength. 
Ask your doctor or pharmacist. 
 
Do not exceed the recommended dose. 
 
Fingolimod Accord is for oral use. 
 



50 
 

Take Fingolimod Accord once a day with a glass of water. Fingolimod Accord capsules should always 
be swallowed intact, without opening them. Fingolimod Accord can be taken with or without food.  
Taking Fingolimod Accord at the same time each day will help you remember when to take your 
medicine. 
 
If you have questions about how long to take Fingolimod Accord, talk to your doctor or your 
pharmacist. 
 
If you take more Fingolimod Accord than you should 
If you have taken too much Fingolimod Accord, call your doctor straight away. 
 
If you forget to take Fingolimod Accord 
If you have been taking Fingolimod Accord for less than 1 month and you forget to take 1 dose for a 
whole day, call your doctor before you take the next dose. Your doctor may decide to keep you under 
observation at the time you take the next dose. 
 
If you have been taking Fingolimod Accord for at least 1 month and have forgotten to take your 
treatment for more than 2 weeks, call your doctor before you take the next dose. Your doctor may 
decide to keep you under observation at the time you take the next dose. However, if you have 
forgotten to take your treatment for up to 2 weeks, you can take the next dose as planned. 
 
Never take a double dose to make up for a forgotten dose. 
 
If you stop taking Fingolimod Accord 
Do not stop taking Fingolimod Accord or change your dose without talking to your doctor first. 
 
Fingolimod Accord will stay in your body for up to 2 months after you stop taking it. Your white 
blood cell count (lymphocyte count) may also remain low during this time and the side effects 
described in this leaflet may still occur. After stopping Fingolimod Accord you may have to wait for 
6-8 weeks before starting a new MS treatment. 
 
If you have to restart Fingolimod Accord more than 2 weeks after you stop taking it, the effect on 
heart rate normally seen when treatment is first started may re-occur and you will need to be 
monitored at the doctor’s surgery or clinic for re-initiation of treatment. Do not restart Fingolimod 
Accord after stopping it for more than two weeks without seeking advice from your doctor. 
 
Your doctor will decide whether and how you need to be monitored after stopping Fingolimod 
Accord. Tell your doctor straight away if you think your MS is getting worse after you have stopped 
treatment with Fingolimod Accord. This could be serious. 
 
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. 
 
Some side effects could be or could become serious 
Common (may affect up to 1 in 10 people) 
- Coughing with phlegm, chest discomfort, fever (signs of lung disorders) 
- Herpes virus infection (shingles or herpes zoster) with symptoms such as blisters, burning, 

itching or pain of the skin, typically on the upper body or the face. Other symptoms may be 
fever and weakness in the early stages of infection, followed by numbness, itching or red 
patches with severe pain 

- Slow heartbeat (bradycardia), irregular heart rhythm 



51 
 

- A type of skin cancer called basal cell carcinoma (BCC) which often appears as a pearly nodule, 
although it can also take other forms 

- Depression and anxiety are known to occur with increased frequency in the MS population and 
have also been reported in paediatric patients treated with Fingolimod Accord. 

- Weight loss 
 
Uncommon (may affect up to 1 in 100 people) 
- Pneumonia with symptoms such as fever, cough, difficulty breathing 
- Macular oedema (swelling in the central vision area of the retina at the back of the eye) with 

symptoms such as shadows or blind spot in the centre of the vision, blurred vision, problems 
seeing colours or details 

- Reduction in blood platelets which increases risk of bleeding or bruising 
- Malignant melanoma (a type of skin cancer which usually develops from an unusual mole). 

Possible signs of melanoma include moles which may change size, shape, elevation or colour 
over time, or new moles. The moles may itch, bleed or ulcerate 

- Convulsion, fits (more frequent in children and adolescents than in adults) 
 
Rare (may affect up to 1 in 1,000 people) 
- A condition called posterior reversible encephalopathy syndrome (PRES). Symptoms may 

include sudden onset of severe headache, confusion, seizures and/or vision disturbances 
- Lymphoma (a type of cancer that affects the lymph system) 
- Squamous cell carcinoma: a type of skin cancer which may present as a firm red nodule, a sore 

with crust, or a new sore on an existing scar 
 
Very rare (may affect up to 1 in 10,000 people) 
- Electrocardiogram anomaly (T-wave inversion) 
- Tumour related to infection with human herpes virus 8 (Kaposi’s sarcoma) 
 
Not known (frequency cannot be estimated from the available data) 
- Allergic reactions, including symptoms of rash or itchy hives, swelling of lips, tongue or face, 

which are more likely to occur on the day you start Fingolimod Accord treatment 
- Risk of a rare brain infection called progressive multifocal leukoencephalopathy (PML). The 

symptoms of PML may be similar to an MS relapse. Symptoms might also arise that you might 
not become aware of by yourself, such as changes in mood or behaviour, memory lapses, speech 
and communication difficulties, which your doctor may need to investigate further to rule out 
PML. Therefore, if you believe your MS is getting worse or if you or those close to you notice 
any new or unusual symptoms, it is very important that you speak to your doctor as soon as 
possible 

- Cryptococcal infections (a type of fungal infection), including cryptococcal meningitis with 
symptoms such as headache accompanied by stiff neck, sensitivity to light, nausea, and/or 
confusion 

- Merkel cell carcinoma (a type of skin cancer). Possible signs of Merkel cell carcinoma include 
flesh-coloured or bluish-red, painless nodule, often on the face, head or neck. Merkel cell 
carcinoma can also present as a firm painless nodule or mass. Long-term exposure to the sun 
and a weak immune system can affect the risk of developing Merkel cell carcinoma 

- After Fingolimod Accord treatment is stopped, symptoms of MS can return and may become 
worse than they were before or during treatment. 

- Autoimmune form of anaemia (decreased amount of red blood cells) where red blood cells are 
destroyed (autoimmune haemolytic anaemia). 

 
If you experience any of these, tell your doctor straight away. 
 
Other side effects  
Very common (may affect more than 1 in 10 people) 



52 
 

- Infection from flu virus with symptoms such as tiredness, chills, sore throat, aching in the joints 
or muscles, fever 

- Feeling of pressure or pain in the cheeks and forehead (sinusitis) 
- Headache 
- Diarrhoea 
- Back pain 
- Blood testing showing higher levels of liver enzymes 
- Cough 
 
Common (may affect up to 1 in 10 people) 
- Ringworm, a fungal infection of the skin (tinea versicolor) 
- Dizziness 
- Severe headache often accompanied by nausea, vomiting and sensitivity to light (migraine) 
- Low level of white blood cells (lymphocytes, leucocytes) 
- Weakness 
- Itchy, red, burning rash (eczema) 
- Itching  
- Blood fat (triglycerides) level increased 
- Hair loss 
- Breathlessness 
- Depression 
- Blurred vision (see also the section on macular oedema under “Some side effects could be or 

could become serious”) 
- Hypertension (Fingolimod Accord may cause a mild increase in blood pressure) 
- Muscle pain 
- Joint pain 
 
Uncommon (may affect up to 1 in 100 people) 
- Low level of certain white blood cells (neutrophils) 
- Depressed mood 
- Nausea 
 
Rare (may affect up to 1 in 1,000 people) 
- Cancer of the lymphatic system (lymphoma) 
 
Not known (frequency cannot be estimated from the available data) 
- Peripheral swelling 
 
If any of these affects you severely, tell your doctor. 
 
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 Fingolimod Accord 
 
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 carton and blister foil after 
“EXP”. The expiry date refers to the last day of that month. 
 
Store below 25°C. 



53 
 

Do not use any pack that is damaged or shows signs of tampering. 
 
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 to protect the environment. 
 
 
6. Contents of the pack and other information 
 
What Fingolimod Accord contains 
- The active substance is fingolimod. 
- Each capsule contains 0.5 mg fingolimod (as hydrochloride). 
- The other ingredients are: 

Capsule fill: Pregelatinised starch, magnesium stearate. 
Capsule shell: gelatin, titanium dioxide (E171), yellow iron oxide (E172). 
Printing ink: shellac (E904), propylene glycol (E1520), potassium hydroxide, black iron oxide 
(E172), yellow iron oxide (E172). 

 
What Fingolimod Accord looks like and contents of the pack 
 
Bright yellow opaque/white opaque size “3” hard gelatin capsule imprinted with “FO 0.5 mg” on the 
cap and two radial bands on the capsule body with yellow ink containing white to off-white powder. 
Each capsule is approximately 15.8 mm in length. 
 
Fingolimod Accord is available in PVC/PVDC/aluminium blister packs containing 7, 28 or 98 hard 
capsules. 
PVC/PVDC/aluminium perforated unit dose blister packs containing 7 x 1, 28 x 1 or 98 x 1 hard 
capsule. 
 
Not all pack sizes may be marketed. 
 
Marketing Authorisation Holder 
 
Accord Healthcare S.L.U. 
World Trade Center, Moll de Barcelona, s/n, 
Edifici Est, 6a Planta, 
08039 Barcelona, 
Spain 
 
Manufacturer 
LABORATORI FUNDACIÓ DAU 
C/ C, 12-14 Pol. Ind. Zona Franca, Barcelona, 
08040 Barcelona, Spain 
 
Accord Healthcare Polska Sp. z.o.o. 
ul.Lutomierska 50, 
95-200, Pabianice, 
Poland 
 
Pharmadox Healthcare Limited 
KW20A Kordin Industrial Park, 
Paola PLA 3000, Malta 
 
This leaflet was last revised in {MM/YYYY} 
 
Other sources of information 
Detailed information on this medicine is available on the European Medicines Agency website: 
http://www.ema.europa.eu. 


	SUMMARY OF PRODUCT CHARACTERISTICS
	A. MANUFACTURER 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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characterised by repeated attacks (relapses) of nervous system symptoms that reflect inflammation within the cns. symptoms vary from patient to patient but typically involve walking difficulties, numbness, vision problems or disturbed balance. symptoms of a relapse may disappear completely when the relapse is over, but some problems may remain. how fingolimod accord works fingolimod accord helps to protect against attacks on the cns by the immune system by reducing the ability of some white blood cells (lymphocytes) to move freely within the body and by stopping them from reaching the brain and spinal cord. this limits nerve damage caused by ms. fingolimod accord also reduces some of the immune reactions of your body.', 'Entity_Recognition': [{'Text': 'fingolimod accord', 'Type': 'PRODUCT_NAME', 'BeginOffset': 0, 'EndOffset': 0}, {'Id': 16, 'BeginOffset': 50, 'EndOffset': 60, 'Score': 0.6258694529533386, 'Text': 'fingolimod', 'Category': 'MEDICATION', 'Type': 'GENERIC_NAME', 'Traits': 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{'Title': '3. how to take fingolimod accord', 'Section_Content': "treatment with fingolimod accord will be overseen by a doctor who is experienced in the treatment of multiple sclerosis. always take this medicine exactly as your doctor has told you. check with your doctor if you are not sure. the recommended dose is: adults: the dose is one 0.5 mg capsule per day. children and adolescents (10 years of age and above): the dose depends on body weight. children and adolescents with body weight equal to or below 40 kg: one 0.25 mg capsule per day. children and adolescents with body weight above 40 kg: one 0.5 mg capsule per day. children and adolescents who start on one 0.25 mg capsule per day and later reach a stable body weight above 40 kg will be instructed by their doctor to switch to one 0.5 mg capsule per day. in this case, it is recommended to repeat the first-dose observation period. fingolimod accord is only available as 0.5 mg hard capsules which are not suitable for children and adolescents with a body weight equal to or below 40 kg. other fingolimod-containing medicines are available in 0.25 mg strength. ask your doctor or pharmacist. do not exceed the recommended dose. fingolimod accord is for oral use. take fingolimod accord once a day with a glass of water. fingolimod accord capsules should always be swallowed intact, without opening them. fingolimod accord can be taken with or without food. taking fingolimod accord at the same time each day will help you remember when to take your medicine. if you have questions about how long to take fingolimod accord, talk to your doctor or your pharmacist. if you take more fingolimod accord than you should if you have taken too much fingolimod accord, call your doctor straight away. if you forget to take fingolimod accord if you have been taking fingolimod accord for less than 1 month and you forget to take 1 dose for a whole day, call your doctor before you take the next dose. your doctor may decide to keep you under observation at the time you take the next dose. if you have been taking fingolimod accord for at least 1 month and have forgotten to take your treatment for more than 2 weeks, call your doctor before you take the next dose. your doctor may decide to keep you under observation at the time you take the next dose. however, if you have forgotten to take your treatment for up to 2 weeks, you can take the next dose as planned. never take a double dose to make up for a forgotten dose. if you stop taking fingolimod accord do not stop taking fingolimod accord or change your dose without talking to your doctor first. fingolimod accord will stay in your body for up to 2 months after you stop taking it. your white blood cell count (lymphocyte count) may also remain low during this time and the side effects described in this leaflet may still occur. after stopping fingolimod accord you may have to wait for 6-8 weeks before starting a new ms treatment. if you have to restart fingolimod accord more than 2 weeks after you stop taking it, the effect on heart rate normally seen when treatment is first started may re-occur and you will need to be monitored at the doctor's surgery or clinic for re-initiation of treatment. do not restart fingolimod accord after stopping it for more than two weeks without seeking advice from your doctor. your doctor will decide whether and how you need to be monitored after stopping fingolimod accord. tell your doctor straight away if you think your ms is getting worse after you have stopped treatment with fingolimod accord. this could be serious. if you have any further questions on the use of this medicine, ask your doctor or pharmacist.", 'Entity_Recognition': [{'Text': 'fingolimod accord', 'Type': 'PRODUCT_NAME', 'BeginOffset': 0, 'EndOffset': 0}, {'Text': 'treatment', 'Type': 'TREATMENT', 'BeginOffset': 0, 'EndOffset': 9}, {'Id': 0, 'BeginOffset': 15, 'EndOffset': 25, 'Score': 0.573483407497406, 'Text': 'fingolimod', 'Category': 'MEDICATION', 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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. some side effects could be or could become serious common (may affect up to 1 in 10 people) - coughing with phlegm, chest discomfort, fever (signs of lung disorders) - herpes virus infection (shingles or herpes zoster) with symptoms such as blisters, burning, itching or pain of the skin, typically on the upper body or the face. other symptoms may be fever and weakness in the early stages of infection, followed by numbness, itching or red patches with severe pain - slow heartbeat (bradycardia), irregular heart rhythm 51 - a type of skin cancer called basal cell carcinoma (bcc) which often appears as a pearly nodule, although it can also take other forms - depression and anxiety are known to occur with increased frequency in the ms population and have also been reported in paediatric patients treated with fingolimod accord. - weight loss uncommon (may affect up to 1 in 100 people) - pneumonia with symptoms such as fever, cough, difficulty breathing - macular oedema (swelling in the central vision area of the retina at the back of the eye) with symptoms such as shadows or blind spot in the centre of the vision, blurred vision, problems seeing colours or details - reduction in blood platelets which increases risk of bleeding or bruising - malignant melanoma (a type of skin cancer which usually develops from an unusual mole). possible signs of melanoma include moles which may change size, shape, elevation or colour over time, or new moles. the moles may itch, bleed or ulcerate - convulsion, fits (more frequent in children and adolescents than in adults) rare (may affect up to 1 in 1,000 people) - a condition called posterior reversible encephalopathy syndrome (pres). symptoms may include sudden onset of severe headache, confusion, seizures and/or vision disturbances - lymphoma (a type of cancer that affects the lymph system) - squamous cell carcinoma: a type of skin cancer which may present as a firm red nodule, a sore with crust, or a new sore on an existing scar very rare (may affect up to 1 in 10,000 people) - electrocardiogram anomaly (t-wave inversion) - tumour related to infection with human herpes virus 8 (kaposi\'s sarcoma) not known (frequency cannot be estimated from the available data) - allergic reactions, including symptoms of rash or itchy hives, swelling of lips, tongue or face, which are more likely to occur on the day you start fingolimod accord treatment - risk of a rare brain infection called progressive multifocal leukoencephalopathy (pml). the symptoms of pml may be similar to an ms relapse. symptoms might also arise that you might not become aware of by yourself, such as changes in mood or behaviour, memory lapses, speech and communication difficulties, which your doctor may need to investigate further to rule out pml. therefore, if you believe your ms is getting worse or if you or those close to you notice any new or unusual symptoms, it is very important that you speak to your doctor as soon as possible - cryptococcal infections (a type of fungal infection), including cryptococcal meningitis with symptoms such as headache accompanied by stiff neck, sensitivity to light, nausea, and/or confusion - merkel cell carcinoma (a type of skin cancer). possible signs of merkel cell carcinoma include flesh-coloured or bluish-red, painless nodule, often on the face, head or neck. merkel cell carcinoma can also present as a firm painless nodule or mass. long-term exposure to the sun and a weak immune system can affect the risk of developing merkel cell carcinoma - after fingolimod accord treatment is stopped, symptoms of ms can return and may become worse than they were before or during treatment. - autoimmune form of anaemia (decreased amount of red blood cells) where red blood cells are destroyed (autoimmune haemolytic anaemia). if you experience any of these, tell your doctor straight away. other side effects very common (may affect more than 1 in 10 people) 52 - infection from flu virus with symptoms such as tiredness, chills, sore throat, aching in the joints or muscles, fever - feeling of pressure or pain in the cheeks and forehead (sinusitis) - headache - diarrhoea - back pain - blood testing showing higher levels of liver enzymes - cough common (may affect up to 1 in 10 people) - ringworm, a fungal infection of the skin (tinea versicolor) - dizziness - severe headache often accompanied by nausea, vomiting and sensitivity to light (migraine) - low level of white blood cells (lymphocytes, leucocytes) - weakness - itchy, red, burning rash (eczema) - itching - blood fat (triglycerides) level increased - hair loss - breathlessness - depression - blurred vision (see also the section on macular oedema under "some side effects could be or could become serious") - hypertension (fingolimod accord may cause a mild increase in blood pressure) - muscle pain - joint pain uncommon (may affect up to 1 in 100 people) - low level of certain white blood cells (neutrophils) - depressed mood - nausea rare (may affect up to 1 in 1,000 people) - cancer of the lymphatic system (lymphoma) not known (frequency cannot be estimated from the available data) - peripheral swelling if any of these affects you severely, tell your doctor. 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': 'fingolimod accord', 'Type': 'PRODUCT_NAME', 'BeginOffset': 0, 'EndOffset': 0}, {'Text': 'all medicines', 'Type': 'TREATMENT', 'BeginOffset': 5, 'EndOffset': 18}, {'Text': 'this medicine', 'Type': 'TREATMENT', 'BeginOffset': 20, 'EndOffset': 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'Category': 'MEDICAL_CONDITION', 'Type': 'DX_NAME', 'Traits': [{'Name': 'SYMPTOM', 'Score': 0.7010800838470459}]}, {'Id': 194, 'BeginOffset': 5552, 'EndOffset': 5563, 'Score': 0.35775163769721985, 'Text': 'appendix v.', 'Category': 'MEDICAL_CONDITION', 'Type': 'DX_NAME', 'Traits': [{'Name': 'SYMPTOM', 'Score': 0.6154013872146606}]}, {'Id': 195, 'BeginOffset': 5577, 'EndOffset': 5589, 'Score': 0.8531802296638489, 'Text': 'side effects', 'Category': 'MEDICAL_CONDITION', 'Type': 'DX_NAME', 'Traits': [{'Name': 'SYMPTOM', 'Score': 0.738497257232666}]}, {'Text': 'this medicine', 'Type': 'TREATMENT', 'BeginOffset': 5645, 'EndOffset': 5658}]}
{'Title': '5. how to store fingolimod accord', '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 carton and blister foil after "exp". the expiry date refers to the last day of that month. store below 25. do not use any pack that is damaged or shows signs of tampering. 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 to protect the environment.', 'Entity_Recognition': [{'Text': 'fingolimod accord', 'Type': 'PRODUCT_NAME', 'BeginOffset': 0, 'EndOffset': 0}, {'Text': 'this medicine', 'Type': 'TREATMENT', 'BeginOffset': 70, 'EndOffset': 83}, {'Text': '25.', 'Type': 'NUMBER', 'BeginOffset': 232, 'EndOffset': 235}, {'Text': 'any pack', 'Type': 'TREATMENT', 'BeginOffset': 247, 'EndOffset': 255}, {'Text': 'these measures', 'Type': 'TREATMENT', 'BeginOffset': 435, 'EndOffset': 449}]}
{'Title': '6. contents of the pack and other information', 'Section_Content': 'what fingolimod accord contains - the active substance is fingolimod. - each capsule contains 0.5 mg fingolimod (as hydrochloride). - the other ingredients are: capsule fill: pregelatinised starch, magnesium stearate. capsule shell: gelatin, titanium dioxide (e171), yellow iron oxide (e172). printing ink: shellac (e904), propylene glycol (e1520), potassium hydroxide, black iron oxide (e172), yellow iron oxide (e172). what fingolimod accord looks like and contents of the pack bright yellow opaque/white opaque size "3" hard gelatin capsule imprinted with "fo 0.5 mg" on the cap and two radial bands on the capsule body with yellow ink containing white to off-white powder. each capsule is approximately 15.8 mm in length. fingolimod accord is available in pvc/pvdc/aluminium blister packs containing 7, 28 or 98 hard capsules. pvc/pvdc/aluminium perforated unit dose blister packs containing 7 x 1, 28 x 1 or 98 x 1 hard capsule. not all pack sizes may be marketed.', 'Entity_Recognition': [{'Text': 'fingolimod accord', 'Type': 'PRODUCT_NAME', 'BeginOffset': 0, 'EndOffset': 0}, {'Id': 1, 'BeginOffset': 58, 'EndOffset': 68, 'Score': 0.858161449432373, 'Text': 'fingolimod', 'Category': 'MEDICATION', 'Type': 'GENERIC_NAME', 'Traits': [], 'Attributes': [{'Type': 'FORM', 'Score': 0.4282362759113312, 'RelationshipScore': 0.9997580647468567, 'RelationshipType': 'FORM', 'Id': 2, 'BeginOffset': 77, 'EndOffset': 84, 'Text': 'capsule', 'Category': 'MEDICATION', 'Traits': []}, {'Type': 'DOSAGE', 'Score': 0.8419494032859802, 'RelationshipScore': 0.9511471390724182, 'RelationshipType': 'DOSAGE', 'Id': 3, 'BeginOffset': 94, 'EndOffset': 100, 'Text': '0.5 mg', 'Category': 'MEDICATION', 'Traits': []}]}, {'Text': 'each capsule', 'Type': 'TREATMENT', 'BeginOffset': 72, 'EndOffset': 84}, {'Text': '0.5 mg fingolimod (as hydrochloride)', 'Type': 'TREATMENT', 'BeginOffset': 94, 'EndOffset': 130}, {'Text': 'pregelatinised starch', 'Type': 'TREATMENT', 'BeginOffset': 175, 'EndOffset': 196}, {'Id': 6, 'BeginOffset': 198, 'EndOffset': 216, 'Score': 0.9872205853462219, 'Text': 'magnesium stearate', 'Category': 'MEDICATION', 'Type': 'GENERIC_NAME', 'Traits': []}, {'Text': 'gelatin, titanium dioxide', 'Type': 'TREATMENT', 'BeginOffset': 233, 'EndOffset': 258}, {'Id': 8, 'BeginOffset': 267, 'EndOffset': 284, 'Score': 0.3684917092323303, 'Text': 'yellow iron oxide', 'Category': 'MEDICATION', 'Type': 'GENERIC_NAME', 'Traits': []}, {'Text': 'propylene glycol (e', 'Type': 'TREATMENT', 'BeginOffset': 323, 'EndOffset': 342}, {'Id': 10, 'BeginOffset': 349, 'EndOffset': 368, 'Score': 0.9967036843299866, 'Text': 'potassium hydroxide', 'Category': 'MEDICATION', 'Type': 'GENERIC_NAME', 'Traits': []}, {'Id': 11, 'BeginOffset': 370, 'EndOffset': 386, 'Score': 0.9843938946723938, 'Text': 'black iron oxide', 'Category': 'MEDICATION', 'Type': 'GENERIC_NAME', 'Traits': []}, {'Text': 'yellow iron oxide', 'Type': 'TREATMENT', 'BeginOffset': 395, 'EndOffset': 412}, {'Text': 'bright yellow opaque/white opaque size', 'Type': 'PROBLEM', 'BeginOffset': 480, 'EndOffset': 518}, {'Text': 'hard gelatin capsule', 'Type': 'TREATMENT', 'BeginOffset': 523, 'EndOffset': 543}, {'Text': '0.5', 'Type': 'NUMBER', 'BeginOffset': 563, 'EndOffset': 566}, {'Text': 'the cap', 'Type': 'TREATMENT', 'BeginOffset': 574, 'EndOffset': 581}, {'Text': 'two radial bands', 'Type': 'TREATMENT', 'BeginOffset': 586, 'EndOffset': 602}, {'Id': 0, 'BeginOffset': 610, 'EndOffset': 622, 'Score': 0.5799968242645264, 'Text': 'capsule body', 'Category': 'ANATOMY', 'Type': 'SYSTEM_ORGAN_SITE', 'Traits': []}, {'Text': 'yellow ink', 'Type': 'PROBLEM', 'BeginOffset': 628, 'EndOffset': 638}, {'Text': '15.8', 'Type': 'NUMBER', 'BeginOffset': 707, 'EndOffset': 711}, {'Text': 'pvc/pvdc/aluminium blister packs', 'Type': 'TREATMENT', 'BeginOffset': 760, 'EndOffset': 792}, {'Text': '7', 'Type': 'NUMBER', 'BeginOffset': 804, 'EndOffset': 805}, {'Text': '28', 'Type': 'NUMBER', 'BeginOffset': 807, 'EndOffset': 809}, {'Text': '98', 'Type': 'NUMBER', 'BeginOffset': 813, 'EndOffset': 815}, {'Text': 'pvc', 'Type': 'TREATMENT', 'BeginOffset': 831, 'EndOffset': 834}, {'Text': 'pvdc', 'Type': 'TREATMENT', 'BeginOffset': 835, 'EndOffset': 839}, {'Text': 'aluminium perforated unit dose blister packs', 'Type': 'TREATMENT', 'BeginOffset': 840, 'EndOffset': 884}, {'Text': '7', 'Type': 'NUMBER', 'BeginOffset': 896, 'EndOffset': 897}, {'Text': '1', 'Type': 'NUMBER', 'BeginOffset': 900, 'EndOffset': 901}, {'Text': '28', 'Type': 'NUMBER', 'BeginOffset': 903, 'EndOffset': 905}, {'Text': '1', 'Type': 'NUMBER', 'BeginOffset': 908, 'EndOffset': 909}, {'Text': '98', 'Type': 'NUMBER', 'BeginOffset': 913, 'EndOffset': 915}, {'Text': '1', 'Type': 'NUMBER', 'BeginOffset': 918, 'EndOffset': 919}]}