Fingolimod is an active pharmaceutical ingredient in the Sphingosine-1-Phosphate (S1p) Receptor Modulators group (L04AE). The information below is compiled per regulator from the product labels on record, with direct links to the original documents.
GBOfficial regulatory label· revised April 17, 2026[1]
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.
How to take
GB
CACanada· Health Canada
9 products
Uses
CAOfficial regulatory label· revised March 22, 2025[2]
ASN-Fingolimod (fingolimod hydrochloride) is indicated as monotherapy for the treatment of patients with the relapsing-remitting form of multiple sclerosis (MS) to reduce the frequency of clinical exacerbations and to delay the progression of physical disability.
ASN- Fingolimod is generally recommended in MS patients who have had an inadequate response to, or are unable to tolerate, one or more therapies for multiple sclerosis. ASN-Fingolimod should only be prescribed by neurologists who are experienced in the treatment of multiple sclerosis, and are knowledgeable of the efficacy and safety profile of fingolimod and are able to discuss benefits/risks with patients.
Pediatrics (< 18 years of age):
EUEuropean Union· EMA
3 products
Uses
EUOfficial regulatory label· revised March 2, 2026[3]
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.
How to take
EU
USUnited States· FDA
2 products
Uses
USOfficial regulatory label· revised March 27, 2026[4]
1 INDICATIONS AND USAGE Fingolimod capsules are indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in patients 10 years of age and older.
Fingolimod capsules are a sphingosine 1-phosphate receptor modulator indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in patients 10 years of age and older.
( 1 )
How to take
Drug interactions
Known interactions involving Fingolimod. Select one for details. This list is informational and not a complete interaction checker.
Showing 240 of 449. Type above to find a specific drug.
Interaction data compiled from DDInter (academic, CC-BY). Severity classification only - this is not a complete interaction checker and not medical advice.
[1]MHRA (UK) · PL506740010 · revised April 17, 2026
[2]Health Canada (DPD) · 02500914 · revised March 22, 2025
[3]European Medicines Agency · EMEA/H/C/005191 · revised March 2, 2026
[4]FDA DailyMed · 0f638feb-6986-41… · revised March 27, 2026 [PDF]
[5]OpenFDA adverse-event reports (US), 12 months ending June 4, 2026.
Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.
The treatment should be initiated and supervised by a physician experienced in multiple sclerosis. 5 mg capsule taken orally once daily. 25 mg capsule taken orally once daily. 5 mg Capsules, Hard are not suitable for paediatric patients with body weight ≤ 40 kg.
For these patients other medicinal products that contain fingolimod available on the market should be used. 5 mg capsule taken orally once daily. 5 mg capsules. 5 mg daily dose, it is recommended to repeat the same first dose monitoring as for treatment initiation.
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.
4). 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.
3). 2). Paediatric population The safety and efficacy of fingolimod in children aged below 10 years have not yet been established. No data are available. 1). Method of administration This medicinal product is for oral use. 2). The capsules should always be swallowed intact, without opening them.
This is not medical advice. Consult a qualified healthcare professional.
Side effects & warnings
GBOfficial regulatory label· Adverse reactions· revised April 17, 2026[1]
0%). Tabulated list of adverse reactions Adverse reactions reported in clinical trials and derived from post-marketing experience via spontaneous case reports or literature cases are shown below. 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).
Within each frequency grouping, adverse reactions are presented in the order of decreasing seriousness.
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 Not known: Hypersensitivity reactions, including rash, urticaria and angioedema upon treatment initiation*** Immune reconstitution inflammatory syndrome (IRIS)** 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*** Hepatobiliary disorders Not known: Acute hepatic failure*** 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 alanine transaminase, gamma glutamyltransferase, aspartate transaminase) Common: Weight decreased*** Blood triglycerides increased Uncommon: Neutrophil count decreased * The frequency category was based on an estimated exposure of approximately 10 000 patients to fingolimod in all clinical trials.
4). 5 mg in all clinical trials. 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.
5 mg dose. g. g. g. 4). 4). 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.
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 treatment. 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.
6% without a history of uveitis). 4). 5 mg and 5 mg resulted in a 2-fold increase in the incidence of macular oedema. Bradyarrhythmia Initiation of 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 […]
GBOfficial regulatory label· Warnings and precautions· revised April 17, 2026[1]
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 capsules.
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. 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 capsules.
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 treatment depending on duration of the interruption and time since start of treatment.
This is not medical advice. Consult a qualified healthcare professional.
Who should not take it
GBOfficial regulatory label· Contraindications· revised April 17, 2026[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).
4). - Severe active infections, active chronic infections (hepatitis, tuberculosis). - Active malignancies. - Severe liver impairment (Child-Pugh class C). 4). 4). 4). 4). 6). 1.
This is not medical advice. Consult a qualified healthcare professional.
ASN-Fingolimod is not indicated in patients below 18 years of age.
Geriatrics (> 65 years of age):
Clinical studies of fingolimod did not include sufficient numbers of patients aged 65 years and over to determine whether the safety and efficacy of fingolimod differs in elderly patients compared to younger patients. Physicians who choose to treat geriatric patients should consider that treatment with ASN-Fingolimod in the context of a greater frequency of reduced hepatic, renal, immune, pulmonary and cardiovascular function, other concomitant diseases and concomitant drug therapy warrants caution and may necessitate additional or more frequent monitoring (see CONTRAINDICATIONS and WARNINGS AND PRECAUTIONS).
Page 4 of
Who should not take it
CAOfficial regulatory label· Contraindications· revised March 22, 2025[2]
Patients who are hypersensitive to fingolimod or to any ingredient in the formulation of ASN- Fingolimod (fingolimod hydrochloride) or component of the container. For a complete listing, see the DOSAGE FORMS, COMPOSITION AND PACKAGING section of the product monograph.
g. g. immunodeficiency syndrome). , hepatitis, tuberculosis). Patients with known active malignancies, except for patients with basal cell carcinoma. Patients with severe hepatic impairment (Child-Pugh Class C) (see WARNINGS AND PRECAUTIONS, Special Populations; WARNINGS AND PRECAUTIONS, Hepatic/Biliary/Pancreatic; and ACTION AND CLINICAL PHARMACOLOGY, Pharmacokinetics-Special Populations and Conditions).
Patients who in the last 6 months had myocardial infarction, unstable angina pectoris, stroke/transient ischemic attack, decompensated heart failure (requiring inpatient treatment), or New York Heart Association Class III/IV heart failure.
Patients with severe cardiac arrhythmias requiring anti-arrhythmic treatment with Class Ia or Class III anti-arrhythmic drugs (see WARNINGS AND PRECAUTIONS). Patients with second-degree Mobitz type II atrioventricular (AV) block or third-degree AV block, or sick-sinus syndrome, if they do not have a pacemaker (see WARNINGS AND PRECAUTIONS).
Patients with a baseline QTc interval ≥500 msec (see WARNINGS AND PRECAUTIONS). Women (including female adolescents) who are pregnant or of childbearing potential not using effective contraception (see WARNINGS AND PRECAUTIONS).
Pregnancy must be excluded before start of treatment as ASN-Fingolimod may cause fetal harm. WARNINGS AND PRECAUTIONS Page 5 of 64 Varicella vaccination There have been very rare fatal cases of varicella zoster virus (VZV) infections in patients taking fingolimod (at recommended dose or higher doses used in clinical trials).
These patients received prolonged concomitant corticosteroid use (more than 5 days) for treatment of multiple sclerosis relapses. Patients need to be assessed for their immunity to varicella (chickenpox) prior to ASN-Fingolimod 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 ASN-Fingolimod therapy.
A full course of vaccination for antibody- negative patients with varicella vaccine is recommended (if not contraindicated) prior to commencing treatment with ASN-Fingolimod. If vaccinated, treatment with ASN-Fingolimod should only be initiated 1 month after the patient has been vaccinated to allow full effect of vaccination to occur (see WARNINGS AND PRECAUTIONS, Herpetic infections).
SUMMARY OF IMPORTANT PRECAUTIONS TO BE TAKEN PRIOR TO INITIATING AND DURING TREATMENT WITH ASN-Fingolimod Refer to the WARNINGS AND PRECAUTIONS – Immune, Cardiovascular, Ophthalmologic, Hepatic/Biliary/Pancreatic, Special Populations, DRUG INTERACTIONS, and TOXICOLOGY sections for more complete information.
ASN-Fingolimod should be used under the supervision of a neurologist experienced in the treatment of multiple sclerosis and familiar with the safety and efficacy of fingolimod capsules. All patients should have an electrocardiogram (ECG) performed prior to the first dose and 6 hours after the first dose.
Patients should be monitored closely for signs and symptoms of bradyarrhythmia, with hourly pulse and blood pressure measurements, for at least 6 hours after the first dose. Immune system effects Fingolimod reduces circulating lymphocyte counts to 20-30% of baseline values via reversible retention in lymphoid organs and may increase the risk of infections.
Delay the start of ASN-Fingolimod in patients with severe active infection until resolved. e. within 6 months or after discontinuation of prior therapy) result is available. Instruct patients to promptly report symptoms of infection during treatment and for two months after discontinuation.
Check varicella-zoster virus (VZV) antibody status before starting therapy if there is no health care professional confirmed history of chicken pox or vaccination with varicella vaccine; if negative, vaccination is recommended, with a delay in treatment initiation for 1 month after vaccination to allow full effect of vaccination to occur.
Co-administration of anti-neoplastic, immunosuppressive or immune-modulating therapies is not recommended due to the risk of additive immune system effects. Cardiovascular effects Page 6 of 64 Initiation of fingolimod treatment results in reversible heart rate decrease and has also been associated with atrioventricular (AV) conduction delays, including isolated cases of spontaneously resolving complete AV block (see WARNINGS AND PRECAUTIONS, Bradyarrhythmia; ADVERSE REACTIONS Post Market Adverse Events).
g. hypokalemia, hypomagnesemia or congenital QT prolongation), due to the risk of serious cardiac rhythm disturbances. ASN-Fingolimod should not be used in patients with a history of cardiac arrest, uncontrolled hypertension or severe untreated sleep apnea since significant bradycardia may be […]
This is not medical advice. Consult a qualified healthcare professional.
The treatment should be initiated and supervised by a physician experienced in multiple sclerosis. 5 mg capsule taken orally once daily. 25 mg capsule taken orally once daily. 5 mg capsule taken orally once daily. 5 mg capsules. 5 mg daily dose, it is recommended to repeat the same first dose monitoring as for treatment initiation.
25 mg strength. For this dosage, other medicinal products that contain fingolimod available on the market should be used. 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. 4). 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.
3). 2). Paediatric population The safety and efficacy of fingolimod in children aged below 10 years have not yet been established. No data are available. 1). Method of administration This medicinal product is for oral use. 2) The capsules should always be swallowed intact, without opening them.
This is not medical advice. Consult a qualified healthcare professional.
Side effects & warnings
EUOfficial regulatory label· Adverse reactions· revised March 2, 2026[3]
0%). Tabulated list of adverse reactions Adverse reactions reported in clinical trials and derived from post-marketing experience via spontaneous case reports or literature cases are shown below. 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).
Within each frequency grouping, adverse reactions are presented in the order of decreasing seriousness.
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 15 Not known: Hypersensitivity reactions, including rash, urticaria and angioedema upon treatment initiation*** Immune reconstitution inflammatory syndrome (IRIS)** 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*** Hepatobiliary disorders Not known: Acute hepatic failure*** 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 alanine transaminase, gamma glutamyltransferase, aspartate transaminase) Common: Weight decreased*** Blood triglycerides increased Uncommon: Neutrophil count decreased * The frequency category was based on an estimated exposure of approximately 10 000 patients to fingolimod in all clinical trials.
4). 5 mg in all clinical trials. 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.
5 mg dose. g. g. g. 4). 4). 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.
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 treatment. 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.
6% without a history of uveitis). 4). 5 mg and 5 mg resulted in a 2-fold increase in the incidence of macular oedema. Bradyarrhythmia Initiation of 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 […]
EUOfficial regulatory label· Warnings and precautions· revised March 2, 2026[3]
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. 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 treatment depending on duration of the interruption and time since start of treatment.
This is not medical advice. Consult a qualified healthcare professional.
Who should not take it
EUOfficial regulatory label· Contraindications· revised March 2, 2026[3]
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).
4). - Severe active infections, active chronic infections (hepatitis, tuberculosis). 4 - Active malignancies. - Severe liver impairment (Child-Pugh class C). 4). 4). 4). 4). 6).
This is not medical advice. Consult a qualified healthcare professional.
USOfficial regulatory label· revised March 27, 2026[4]
2 DOSAGE AND ADMINISTRATION · Assessments are required prior to initiating fingolimod capsules. 5 mg orally once daily, with or without food. 3 ) · First-Dose Monitoring (including reinitiation after discontinuation greater than 14 days and dose increases): o Observe all patients for bradycardia for at least 6 hours; monitor pulse and blood pressure hourly.
Electrocardiograms (ECGs) prior to dosing and at end of observation period required. 4 ) o Monitor until resolution if heart rate < 45 beats per minute (bpm) in adults, < 55 bpm in patients aged 12 years and above, or < 60 bpm in pediatric patients aged 10 to below 12 years, atrioventricular (AV) block, or if lowest postdose heart rate is at the end of the observation period.
4 ) o Monitor symptomatic bradycardia with ECG until resolved. Continue overnight if intervention is required; repeat first-dose monitoring for second dose. 4 ) o Observe patients overnight if at higher risk of symptomatic bradycardia, heart block, prolonged QTc interval, or if taking drugs with known risk of torsades de pointes.
1 )] . 5 )] . 6 )] . 5 )] . 4 )] . Skin Examination Obtain a baseline skin examination prior to or shortly after initiation of fingolimod. 12 )]. 4 )] . 2 )] . It is recommended that pediatric patients if possible, complete all immunizations in accordance with current immunization guidelines prior to initiating fingolimod therapy.
2 Important Administration Instructions Patients who initiate fingolimod and those who reinitiate treatment after discontinuation for longer than 14 days, require first-dose monitoring. 5)]. Fingolimod capsules can be taken with or without food.
5 mg orally once-daily. 5 mg are associated with a greater incidence of adverse reactions without additional benefit. 2 )]. Prior to dosing and at the end of the observation period, obtain an electrocardiogram (ECG) in all patients. First 6-Hour Monitoring Administer the first dose of fingolimod in a setting in which resources to appropriately manage symptomatic bradycardia are available.
Monitor all patients for 6 hours after the first dose for signs and symptoms of bradycardia with hourly pulse and blood pressure measurement. Additional Monitoring After 6-Hour Monitoring Continue monitoring until the abnormality resolves if any of the following is present (even in the absence of symptoms) after 6 hours: the heart rate 6 hours postdose is less than 45 beats per minute (bpm) in adults, less than 55 bpm in pediatric patients 12 years of age and older, or less than 60 bpm in pediatric patients 10 or 11 years of age; the heart rate 6 hours postdose is at the lowest value postdose suggesting that the maximum pharmacodynamic effect on the heart may not have occurred; the ECG 6 hours postdose shows new onset second degree or higher atrioventricular (AV) block.
If postdose symptomatic bradycardia occurs, initiate appropriate management, begin continuous ECG monitoring, and continue monitoring until the symptoms have resolved if no pharmacological treatment is required. If pharmacological treatment is required, continue monitoring overnight and repeat 6-hour monitoring after the second dose.
Overnight Monitoring Continuous overnight ECG monitoring in a medical facility should be instituted: in patients that require pharmacologic intervention for symptomatic bradycardia. 5 )]. 4 )] . The same precautions (first-dose monitoring) as for initial dosing are applicable.
Within the first 2 weeks of treatment, first-dose procedures are recommended after interruption of 1 day or more; during Weeks 3 and 4 of treatment, first-dose procedures are recommended after treatment interruption of more than 7 days.
This is not medical advice. Consult a qualified healthcare professional.
Most-reported reactions to the US regulator (12 mo to June 4, 2026): 868 reports total. [5]
Multiple Sclerosis Relapse 102
Lymphopenia 79
Multiple Sclerosis 54
Headache 41
Drug Ineffective 39
Fatigue 35
Lymphocyte Count Decreased 35
Drug Intolerance 34
Gait Disturbance 28
Condition Aggravated 26
Disease Progression 26
Off Label Use 26
Side effects & warnings
USOfficial regulatory label· Adverse reactions· revised March 27, 2026[4]
14 )] Most common adverse reactions (incidence ≥10% and greater than placebo): Headache, liver transaminase elevation, diarrhea, cough, influenza, sinusitis, back pain, abdominal pain, and pain in extremity. gov/medwatch. 1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
5 mg. 5 mg in the 1-year active-controlled trial (Study 2). The overall exposure in the controlled trials was equivalent to 1,716 person-years . 5 mg. 5 mg was approximately 4,119 person-years. 5 mg were headache, liver transaminase elevation, diarrhea, cough, influenza, sinusitis, back pain, abdominal pain, and pain in extremity.
5% on placebo). Table 1 lists adverse reactions in clinical studies in adults that occurred in ≥ 1% of fingolimod-treated patients and ≥ 1% higher rate than for placebo. 5 mg N=783% Placebo N=773 % Infections Influenza 11 8 Sinusitis 11 8 Bronchitis 8 5 Herpes zoster 2 1 Tinea versicolor 2 ˂1 Cardiac disorders Bradycardia 3 1 Nervous system disorders Headache 25 24 Migraine 6 4 Gastrointestinal disorders Nausea 13 12 Diarrhea 13 10 Abdominal pain 11 10 General disorders and administration-site conditions Asthenia 2 1 Musculoskeletal and connective tissue disorders Back pain 10 9 Pain in extremity 10 7 Skin and subcutaneous tissue disorders Alopecia 3 2 Actinic keratosis 2 1 Investigations Liver transaminase elevations (ALT/GGT/AST) 15 4 Blood triglycerides increased 3 1 Respiratory, thoracic, and mediastinal disorders Cough 12 11 Dyspnea 9 7 Eye disorders Vision blurred 4 2 Vascular disorders Hypertension 8 4 Blood and lymphatic system disorders Lymphopenia 7 ˂1 Leukopenia 2 ˂1 Neoplasms benign, malignant, and unspecified (including cysts and polyps) Skin papilloma 3 2 Basal cell carcinoma 2 1 Abbreviations: ALT, alanine transaminase; AST, aspartate transferase; GGT, gamma-glutamyl transferase.
Adverse reactions of seizure, dizziness, pneumonia, eczema, and pruritus were also reported in Studies 1 and 3, but did not meet the reporting rate criteria for inclusion in Table 1 (difference was less than 1%). 5 mg in Study 2, the 1-year active-controlled (versus interferon beta-1a) study were generally similar to those in Studies 1 and 3.
25 mg to 5 mg) higher than recommended for use in MS. Similar events have been reported with fingolimod in the postmarketing setting although a causal relationship has not been established. 2 )]. 3% in placebo-treated patients. It is unknown whether these events were related to the effects of multiple sclerosis alone, to fingolimod, or to a combination of both.
5 mg daily was similar to that seen in adult patients. 4)]. 2 Postmarketing Experience The following adverse reactions have been identified during postapproval use of fingolimod. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
14 )]
USOfficial regulatory label· Warnings and precautions· revised March 27, 2026[4]
5 WARNINGS AND PRECAUTIONS • Infections: Fingolimod may increase the risk. Obtain a complete blood count (CBC) before initiating treatment. Monitor for infection during treatment and for 2 months after discontinuation. Do not start in patients with active infections.
2 ) • Progressive Multifocal Leukoencephalopathy (PML): Withhold fingolimod at the first sign or symptom suggestive of PML. 3 ) • Macular Edema : Increases the risk of macular edema. Obtain a baseline evaluation of the fundus, including the macula, near the start of treatment with fingolimod.
Conduct an evaluation of the fundus, including the macula, 3 to 4 months after treatment start, periodically while on therapy and any time there is a change in vision. Consider discontinuing fingolimod if macular edema develops. Diabetes mellitus and uveitis increase the risk.
4 ) • Liver Injury : Obtain liver enzyme results before initiation and periodically during treatment. Closely monitor patients with severe hepatic impairment. Discontinue if there is evidence of liver injury without other cause. 3 ) • Posterior Reversible Encephalopathy Syndrome (PRES): If suspected, discontinue fingolimod.
6 ) • Respiratory Effects: Evaluate when clinically indicated. 7 ) • Fetal Risk: May cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and to use an effective method of contraception during treatment and for 2 months after stopping fingolimod.
3 ) • Severe Increase in Disability After Stopping Fingolimod : Monitor for development of severe increase in disability following discontinuation and begin appropriate treatment as needed. 9 ) • Tumefactive MS : Consider when severe MS relapse occurs during treatment or after discontinuation.
Obtain imaging and begin treatment as needed. 10) • Increased Blood Pressure (BP): Monitor BP in adult and pediatric patients during treatment. 11 ) • Malignancies: Skin examination prior to or shortly after the start of treatment and periodically thereafter is recommended.
Suspicious skin lesions should be evaluated. 4 ) ]. Reduction in Heart Rate After the first dose of fingolimod, the heart rate decrease starts within an hour. On Day 1, the maximum decline in heart rate generally occurs within 6 hours and recovers, although not to baseline levels, by 8 to 10 hours postdose.
This is not medical advice. Consult a qualified healthcare professional.
Who should not take it
USOfficial regulatory label· Contraindications· revised March 27, 2026[4]
1 )] a baseline QTc interval ≥500 msec cardiac arrhythmias requiring anti-arrhythmic treatment with Class Ia or Class III anti-arrhythmic drugs had a hypersensitivity reaction to fingolimod or any of the excipients in fingolimod capsules.
14 )]. Recent myocardial infarction, unstable angina, stroke, transient ischemic attack (TIA), decompensated heart failure with hospitalization, or Class III/IV heart failure. ( 4 ) History of Mobitz Type II 2 nd degree or 3 rd degree AV block or sick sinus syndrome, unless patient has a pacemaker.
( 4 ) Baseline QTc interval ≥500 msec. ( 4 ) Cardiac arrhythmias requiring anti-arrhythmic treatment with Class Ia or Class III anti-arrhythmic drugs. ( 4 ) Hypersensitivity to fingolimod or its excipients. ( 4 )
This is not medical advice. Consult a qualified healthcare professional.
2). 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.
3). In such patients, treatment with Fingolimod capsules 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.
5). g. g. amiodarone, sotalol) antiarrhythmic medicinal products. 3). g. ivabradine, digoxin, anticholinesteratic agents or pilocarpine). 8, Bradyarrhythmia), concomitant use of these substances during treatment initiation may be associated with severe bradycardia and heart block.
5). In such patients, treatment with Fingolimod capsules should be considered only if the anticipated benefits outweigh the potential risks. If treatment with Fingolimod capsules is considered, advice from a cardiologist should be sought regarding the switch to non heart-rate lowering medicinal products prior to initiation of treatment.
5). 5 mg fingolimod at steady-state, when a negative chronotropic effect of fingolimod was still […]
2). 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.
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.
5). g. g. amiodarone, sotalol) antiarrhythmic medicinal products. 3). g. ivabradine, digoxin, anticholinesteratic agents or pilocarpine). 8, Bradyarrhythmia), concomitant use of these substances during treatment initiation may be associated with severe bradycardia and heart block.
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.
5). 5 mg fingolimod at steady-state, when a negative chronotropic effect of fingolimod was still present, fingolimod […]
Because of physiological diurnal variation, there is a second period of heart rate decrease within 24 hours after the first dose. In some patients, heart rate decrease during the second period is more pronounced than the decrease observed in the first 6 hours.
Heart rates below 40 bpm in adults, and below 50 bpm in pediatric patients occurred rarely. 1% of patients on placebo. Patients who experienced bradycardia were generally asymptomatic, but some patients experienced hypotension, dizziness, fatigue, palpitations, and/or chest pain that usually resolved within the first 24 hours on treatment.
, ischemic heart disease, history of myocardial infarction, congestive heart failure, history of cardiac arrest, cerebrovascular disease, uncontrolled hypertension, history of symptomatic bradycardia, history of recurrent syncope, severe untreated sleep apnea, AV block, sinoatrial heart block) may poorly tolerate the fingolimod-induced bradycardia, or experience serious rhythm disturbances after the first dose of fingolimod.
Prior to treatment with fingolimod, these patients should have a cardiac evaluation by a physician appropriately trained to conduct such evaluation, and if treated with fingolimod, should be monitored overnight with continuous ECG in a medical facility after the first dose.
, citalopram, chlorpromazine, haloperidol, methadone, erythromycin) should be monitored overnight with continuous ECG in a medical facility. Following the second dose, a further decrease in heart rate may occur when compared to the heart rate prior to the second dose, but this change is of a smaller magnitude than that observed following the first dose.
With continued dosing, the heart rate returns to baseline within 1 month of chronic treatment. Clinical data indicate effects of fingolimod on heart rate are maximal after the first dose although milder effects on heart rate may persist for, on average, 2 to 4 weeks after initiation of therapy at which time heart rate generally returns to baseline.
Physicians should continue to be alert to patient reports of cardiac symptoms. Atrioventricular Blocks Initiation of fingolimod treatment has resulted in transient AV conduction delays. 6% of patients on placebo. In a study of 697 patients with available 24-hour Holter monitoring data after their first dose (N=351 receiving fingolimod and N=346 on placebo), second-degree AV blocks (Mobitz Types I [Wenckebach] or 2:1 AV blocks) occurred in 4% (N=14) of patients receiving fingolimod and 2% (N=7) of patients on placebo.
Of the 14 patients receiving fingolimod, 7 patients had 2:1 AV block (5 patients within the first 6 hours postdose and 2 patients after 6 hours postdose). All second-degree AV blocks on placebo were Mobitz Type I and occurred after the first 12 hours postdose.
The conduction abnormalities were usually transient and asymptomatic, and resolved within the first 24 hours on treatment, but they occasionally required treatment with atropine or isoproterenol. Postmarketing Experience In the postmarketing setting, third-degree AV block and AV block with junctional escape have been observed during the first-dose 6-hour observation period with fingolimod.
Isolated delayed onset events, including transient asystole and unexplained death, have occurred within 24 hours of the first dose. These events were confounded by concomitant medications and/or preexisting disease, and the relationship to fingolimod is uncertain.
Cases of syncope were also reported after the first dose of fingolimod capsules. 2 Infections Risk of Infections Fingolimod causes a dose-dependent reduction in peripheral lymphocyte count to 20% to 30% of baseline values because of reversible sequestration of lymphocytes in lymphoid tissues.
2 ) ] . Life-threatening and fatal infections have occurred in association with fingolimod. , within 6 months or after discontinuation of prior therapy) should be available. Consider suspending treatment with fingolimod if a patient develops a serious infection, and reassess the benefits and risks prior to reinitiation of therapy.
Because the elimination of fingolimod after discontinuation may take up to 2 months, continue monitoring for infections throughout this period. Instruct patients receiving fingolimod to report symptoms of infections to a physician. Patients with active acute or chronic infections should not start treatment until the infection(s) is resolved.
In MS placebo-controlled trials in adult patients, the overall rate of infections (72%) with fingolimod was similar to placebo. However, bronchitis, herpes zoster, influenza, sinusitis, and pneumonia were more common in fingolimod -treated patients.
6% in the placebo group. , atypical mycobacteria) have been reported with fingolimod. Patients with symptoms and signs consistent with any of these infections should undergo prompt diagnostic evaluation and appropriate treatment. 5 mg and 7% on placebo.
Two patients died of herpetic infections during controlled trials. One death was due to disseminated primary herpes zoster and the other was to herpes simplex encephalitis. 5 mg dose) and had received high-dose corticosteroid therapy to treat suspected MS relapses.
Serious, life-threatening events of disseminated varicella zoster and herpes simplex infections, including cases of encephalitis and multiorgan failure, have occurred with fingolimod in the postmarketing setting. Include disseminated herpetic infections in the differential diagnosis of patients who are receiving fingolimod and present with an atypical MS relapse or multiorgan failure.
Cases of Kaposi's sarcoma have been reported in the postmarketing setting. Kaposi's sarcoma is an angioproliferative disorder that is associated with infection with human herpes virus 8 (HHV-8). Patients with symptoms or signs consistent with Kaposi's sarcoma should be referred for prompt diagnostic evaluation and management.
Cryptococcal Infections Cryptococcal infections, including cases of fatal cryptococcal meningitis and disseminated cryptococcal infections, have been reported with fingolimod in the postmarketing setting. Cryptococcal infections have generally occurred after approximately 2 years of fingolimod treatment, but may occur earlier.
The relationship between the risk of cryptococcal infection and the duration of treatment is unknown. Patients with symptoms and signs consistent with a cryptococcal infection should undergo prompt diagnostic evaluation and treatment.
Prior and Concomitant Treatment with Antineoplastic, Immunosuppressive, or Immune-Modulating Therapies In clinical studies, patients who received fingolimod did not receive concomitant treatment with antineoplastic, noncorticosteroid immunosuppressive, or immune-modulating therapies used for treatment of MS.
4 )] . When switching to fingolimod from immune-modulating or immunosuppressive medications, consider the duration of their effects and their mode of action to avoid unintended additive immunosuppressive effects. Varicella Zoster Virus Antibody Testing/Vaccination Patients without a healthcare professional confirmed history of chickenpox or without documentation of a full course of vaccination against VZV should be tested for antibodies to VZV before initiating fingolimod.
4 )]. Human Papilloma Virus Infection Human papilloma virus (HPV) infections, including papilloma, dysplasia, warts, and HPV-related cancer, have been reported in patients treated with fingolimod in the postmarketing setting. Vaccination against HPV should be considered prior to treatment initiation with fingolimod, taking into account vaccination recommendations.
Cancer screening, including Papanicolaou (Pap) test, is recommended as per standard of care for patients using an immunosuppressive therapy. 3 Progressive Multifocal Leukoencephalopathy Cases of progressive multifocal leukoencephalopathy (PML) have occurred in patients with MS who received fingolimod in the postmarketing setting.
PML is an opportunistic viral infection of the brain caused by the JC virus (JCV) that typically only occurs in patients who are immunocompromised, and that usually leads to death or severe disability. PML has occurred in patients who had not been treated previously with natalizumab, which has a known association with PML, were not taking any other immunosuppressive or immunomodulatory medications concomitantly, and did not have any ongoing systemic medical conditions resulting in compromised immune system function.
Longer treatment duration increases the risk of PML in fingolimod-treated patients; the majority of cases have occurred in patients treated with fingolimod for at least 18 months. At the first sign or symptom suggestive of PML, withhold fingolimod and perform an appropriate diagnostic evaluation.
Typical symptoms associated with PML are diverse, progress over days to weeks, and include progressive weakness on one side of the body or clumsiness of limbs, disturbance of vision, and changes in thinking, memory, and orientation leading to confusion and personality changes.
Magnetic resonance imaging (MRI) findings may be apparent before clinical signs or symptoms. Cases of PML, diagnosed based on MRI findings and the detection of JCV DNA in the cerebrospinal fluid in the absence of clinical signs or symptoms specific to PML, have been reported in patients treated with MS medications associated with PML, including fingolimod.
Many of these patients subsequently became symptomatic with PML. Therefore, monitoring with MRI for signs that may be consistent with PML may be useful, and any suspicious findings should lead to further investigation to allow for an early diagnosis of PML, if present.
Lower PML-related mortality and morbidity have been reported following discontinuation of another MS medication associated with PML in patients with PML who were initially asymptomatic compared to patients with PML who had characteristic clinical signs and symptoms at diagnosis.
It is not known whether these differences are due to early detection and discontinuation of MS treatment or due to differences in disease in these patients. If PML is confirmed, treatment with fingolimod should be discontinued. Immune reconstitution inflammatory syndrome (IRIS) has been reported in patients treated with S1P receptor modulators, including fingolimod, who developed PML and subsequently discontinued treatment.
IRIS presents as a clinical decline in the patient’s condition that may be rapid, can lead to serious neurological complications or death, and is often associated with characteristic changes on MRI. The time to onset of IRIS in patients with PML was generally within a few months after S1P receptor modulator discontinuation.
Monitoring for development of IRIS and appropriate treatment of the associated inflammation should be undertaken. 4 Macular Edema S1P receptor modulators, including fingolimod, have been associated with an increased risk of macular edema.
Obtain a baseline evaluation of the fundus, including the macula, near the start of treatment with fingolimod. Perform an examination of the fundus, including the macula, 3 to 4 months after starting treatment, periodically while on therapy, and any time there is a change in vision.
A dose-dependent increase in the risk of macular edema occurred in the fingolimod clinical development program. 4% of patients (3/773) treated with placebo. Macular edema occurred predominantly during the first 3 to 4 months of therapy.
These clinical trials excluded patients with diabetes mellitus, a known risk factor for macular edema (see below Macular Edema in Patients with History of Uveitis or Diabetes Mellitus). Symptoms of macular edema included blurred vision and decreased visual acuity.
Routine ophthalmological examination detected macular edema in some patients with no visual symptoms. Macular edema generally partially or completely resolved with or without treatment after drug discontinuation. Some patients had residual visual acuity loss even after resolution of macular edema.
Macular edema has also been reported in patients taking fingolimod in the postmarketing setting, usually within the first 6 months of treatment. Continuation of fingolimod in patients who develop macular edema has not been evaluated.
, 6 months) can lead to permanent visual loss. Consider discontinuing fingolimod if macular edema develops; this decision should include an assessment of the potential benefits and risks for the individual patient. The risk of recurrence after rechallenge has not been evaluated.
Macular Edema in Patients with History of Uveitis or Diabetes Mellitus Patients with a history of uveitis and patients with diabetes mellitus are at increased risk of macular edema during fingolimod therapy. 6%, respectively). Fingolimod has not been tested in MS patients with diabetes mellitus.
5 Liver Injury Clinically significant liver injury has occurred in patients treated with fingolimod in the postmarketing setting. Signs of liver injury, including markedly elevated serum hepatic enzymes and elevated total bilirubin, have occurred as early as ten days after the first dose and have also been reported after prolonged use.
Cases of acute liver failure requiring liver transplant have been reported. 5 mg and 3% of patients on placebo. 5% of patients on fingolimod and 1% of patients on placebo. The majority of elevations occurred within 6 to 9 months. In clinical trials, fingolimod was discontinued if the elevation exceeded 5 times the ULN.
Serum transaminase levels returned to normal within approximately 2 months after discontinuation of fingolimod. Recurrence of liver transaminase elevations occurred with rechallenge in some patients. Prior to starting treatment with fingolimod (within 6 months), obtain serum transaminases (ALT and AST) and total bilirubin levels.
Obtain transaminase levels and total bilirubin levels periodically until two months after fingolimod discontinuation. Patients should be monitored for signs and symptoms of any hepatic injury. Measure liver transaminase and bilirubin levels promptly in patients who report symptoms that may indicate liver injury, including new or worsening fatigue, anorexia, right upper abdominal discomfort, dark urine, or jaundice.
In this clinical context, if the patient is found to have an alanine aminotransferase (ALT) greater than three times the reference range with serum total bilirubin greater than two times the reference range, treatment with fingolimod should be interrupted.
Treatment should not be resumed if a plausible alternative etiology for the signs and symptoms cannot be established, because these patients are at risk for severe drug-induced liver injury. 3 ) ]. 6 Posterior Reversible Encephalopathy Syndrome There have been rare cases of posterior reversible encephalopathy syndrome (PRES) reported in adult patients receiving fingolimod.
Symptoms reported included sudden onset of severe headache, altered mental status, visual disturbances, and seizure. Symptoms of PRES are usually reversible but may evolve into ischemic stroke or cerebral hemorrhage. Delay in diagnosis and treatment may lead to permanent neurological sequelae.
If PRES is suspected, fingolimod should be discontinued. 7 Respiratory Effects Dose-dependent reductions in forced expiratory volume over 1 second (FEV1) and diffusion lung capacity for carbon monoxide (DLCO) were observed in patients treated with fingolimod as early as 1 month after treatment initiation.
0% for placebo. 5% for placebo. The changes in FEV1 appear to be reversible after treatment discontinuation. There is insufficient information to determine the reversibility of the decrease of DLCO after drug discontinuation. 5 mg and 7% of patients receiving placebo.
Several patients discontinued fingolimod because of unexplained dyspnea during the extension (uncontrolled) studies. Fingolimod has not been tested in MS patients with compromised respiratory function. Spirometric evaluation of respiratory function and evaluation of DLCO should be performed during therapy with fingolimod if clinically indicated.
8 Fetal Risk Fingolimod may cause fetal harm when administered to a pregnant woman. In animal reproduction studies conducted in rats and rabbits, developmental toxicity was observed with administration of fingolimod at doses less than the recommended human dose.
Available observational pregnancy registry data suggest that use of fingolimod is associated with an increased prevalence of major birth defects in comparison to the general population. Advise pregnant women and females of reproductive potential of the potential risk to a fetus.
3 )]. 9 Severe Increase in Disability After Stopping Fingolimod Severe increase in disability accompanied by multiple new lesions on MRI has been reported after discontinuation of fingolimod in the postmarketing setting. Patients in most of these reported cases did not return to the functional status they had before stopping fingolimod.
The increase in disability generally occurred within 12 weeks after stopping fingolimod, but was reported up to 24 weeks after fingolimod discontinuation. Monitor patients for development of severe increase in disability following discontinuation of fingolimod and begin appropriate treatment as needed.
3)]. 10 Tumefactive Multiple Sclerosis MS relapses with tumefactive demyelinating lesions on imaging have been observed during fingolimod therapy and after fingolimod discontinuation in the postmarketing setting. Most reported cases of tumefactive MS in patients receiving fingolimod have occurred within the first 9 months after fingolimod initiation, but tumefactive MS may occur at any point during treatment.
Cases of tumefactive MS have also been reported within the first 4 months after fingolimod discontinuation. Tumefactive MS should be considered when a severe MS relapse occurs during fingolimod treatment, especially during initiation, or after discontinuation of fingolimod, prompting imaging evaluation and initiation of appropriate treatment.
11 Increased Blood Pressure Increases in blood pressure have been observed in patients treated with fingolimod. 5 mg had an average increase over placebo of approximately 3 mmHg in systolic pressure, and approximately 2 mmHg in diastolic pressure, first detected after approximately 1 month of treatment initiation, and persisting with continued treatment.
5 mg and in 4% of patients on placebo. Monitor blood pressure (BP) in adult and pediatric patients during treatment with fingolimod. 12 Malignancies Cutaneous Malignancies The risk of cutaneous malignancies (including basal cell carcinoma (BCC), squamous cell carcinoma (SCC) and melanoma) is increased in patients treated with S1P receptor modulators.
Use of fingolimod has been associated with an increased risk of BCC and melanoma. 1 )] . 2 )], and Merkel cell carcinoma have been reported with fingolimod in the postmarketing setting. Skin examinations are recommended prior to or shortly after the start of treatment and periodically thereafter for all patients, particularly those with risk factors for skin cancer.
Providers and patients are advised to monitor for suspicious skin lesions. If a suspicious skin lesion is observed, it should be promptly evaluated. As usual for patients with increased risk for skin cancer, exposure to sunlight and ultraviolet light should be limited by wearing protective clothing and using a sunscreen with a high protection factor.
Concomitant phototherapy with UV-B radiation or PUVA photochemotherapy is not recommended in patients taking fingolimod. Lymphoma Cases of lymphoma, including both T-cell and B-cell types and CNS lymphoma, have occurred in patients receiving Fingolimod.
The reporting rate of non-Hodgkin lymphoma with Fingolimod is greater than that expected in the general population adjusted by age, gender, and region. Cutaneous T-cell lymphoma (including mycosis fungoides) has also been reported with Fingolimod in the postmarketing setting.
13 Immune System Effects Following Fingolimod Discontinuation Fingolimod remains in the blood and has pharmacodynamic effects, including decreased lymphocyte counts, for up to 2 months following the last dose of fingolimod. 2 ) ]. 4 ) ].
14 Hypersensitivity Reactions Hypersensitivity reactions, including rash, urticaria, and angioedema have been reported with fingolimod in the postmarketing setting. Fingolimod is contraindicated in patients with history of hypersensitivity to fingolimod or any of its excipients [see Contraindications ( 4 )].