Fingolimod Accord
Sphingosine 1-Phosphate Receptor Modulator for Multiple Sclerosis
Quick Facts About Fingolimod Accord
Key Takeaways About Fingolimod Accord
- First oral MS therapy: Fingolimod was the first oral disease-modifying treatment approved for relapsing-remitting multiple sclerosis, offering an alternative to injectable therapies
- First-dose cardiac monitoring required: You must be observed in a medical facility for at least 6 hours after taking the first dose due to potential heart rate slowing (bradycardia)
- Increased infection risk: Fingolimod lowers lymphocyte counts, increasing susceptibility to infections – report fever, flu-like symptoms, or any signs of infection to your doctor immediately
- Eye examinations needed: Macular oedema (swelling at the back of the eye) can occur, typically within the first 4 months – regular ophthalmological check-ups are essential
- Not safe in pregnancy: Fingolimod can cause birth defects and must not be used during pregnancy – effective contraception is required during treatment and for 2 months after stopping
What Is Fingolimod Accord and What Is It Used For?
Fingolimod Accord is an oral immunomodulatory medicine containing the active substance fingolimod. It is prescribed for adults and children aged 10 years and older to treat relapsing-remitting multiple sclerosis (RRMS), specifically in patients who have not responded adequately to other MS treatments or who have rapidly evolving severe disease.
Fingolimod Accord belongs to a class of drugs known as sphingosine 1-phosphate (S1P) receptor modulators. It was the first oral disease-modifying therapy approved for multiple sclerosis, marking a significant advancement in MS treatment when the originator product received approval from the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA). Fingolimod Accord is a generic equivalent manufactured by Accord Healthcare, offering the same therapeutic benefits as the original branded product.
What Is Multiple Sclerosis?
Multiple sclerosis (MS) is a chronic autoimmune disease affecting the central nervous system (CNS), which comprises the brain and spinal cord. In MS, the body's immune system mistakenly attacks myelin, the protective sheath that insulates nerve fibres. This process, called demyelination, disrupts the normal transmission of nerve signals, leading to a wide range of neurological symptoms. The World Health Organization (WHO) estimates that approximately 2.8 million people worldwide are living with MS.
Relapsing-remitting MS (RRMS) is the most common form, affecting approximately 85% of people diagnosed with MS. It is characterised by episodes of new or worsening neurological symptoms (relapses or attacks) followed by periods of partial or complete recovery (remissions). Common symptoms include difficulty walking, numbness or tingling, visual disturbances, fatigue, muscle spasticity, and balance problems. Over time, accumulated nerve damage can lead to progressive disability.
How Does Fingolimod Work?
Fingolimod works through a unique mechanism that distinguishes it from many other MS treatments. After being swallowed, fingolimod is converted in the body to its active form, fingolimod-phosphate, which binds to specific receptors called sphingosine 1-phosphate receptors (S1P1, S1P3, S1P4, and S1P5) on the surface of lymphocytes (a type of white blood cell).
By engaging these receptors, fingolimod causes lymphocytes to become trapped in lymph nodes – the small glands distributed throughout the body that are part of the immune system. This prevents the harmful, inflammation-causing lymphocytes from migrating through the bloodstream to the brain and spinal cord, where they would attack the myelin sheath. The result is a reduction in the inflammatory damage that drives MS relapses and disease progression.
Importantly, fingolimod does not destroy lymphocytes – it simply redirects their trafficking. When treatment is stopped, lymphocyte counts typically return to normal within one to two months as the cells are gradually released from the lymph nodes back into the circulation.
In the pivotal FREEDOMS and TRANSFORMS clinical trials, fingolimod 0.5 mg reduced the annualised relapse rate by approximately 54% compared with placebo and by 52% compared with intramuscular interferon beta-1a. It also significantly reduced the accumulation of new brain lesions seen on MRI and slowed disability progression over a 2-year study period.
What Should You Know Before Taking Fingolimod Accord?
Fingolimod Accord has several important contraindications and precautions. You must not take it if you have an immunodeficiency syndrome, active severe infections, certain heart conditions, active cancer, severe liver disease, or if you are pregnant. Your doctor will conduct thorough assessments before prescribing this medicine.
Contraindications
Fingolimod Accord must not be used in the following situations. These are absolute contraindications, meaning the medicine should never be taken under these circumstances:
- Immunodeficiency: Patients with an immunodeficiency syndrome, whether caused by a congenital condition, disease, or immunosuppressive medication
- Progressive multifocal leukoencephalopathy (PML): Known or suspected PML, a rare but serious brain infection
- Active severe infections: Including active chronic infections such as hepatitis B, hepatitis C, or tuberculosis
- Active malignancies: Patients with known active cancers (excluding basal cell carcinoma of the skin)
- Severe liver impairment: Patients with Child-Pugh class C liver disease
- Recent cardiovascular events: Myocardial infarction, unstable angina, stroke, transient ischaemic attack (TIA), or certain types of heart failure within the preceding 6 months
- Cardiac arrhythmias: Certain types of irregular or abnormal heart rhythms, including patients whose ECG shows a prolonged QT interval prior to starting treatment
- Anti-arrhythmic medications: Concurrent use of Class Ia or Class III anti-arrhythmic drugs such as quinidine, disopyramide, amiodarone, or sotalol
- Pregnancy: Women who are pregnant or women of childbearing potential not using effective contraception
- Allergy: Known hypersensitivity to fingolimod or any of the excipients
Warnings and Precautions
Before starting Fingolimod Accord, your doctor will assess several important aspects of your health. Discuss the following conditions with your doctor, as additional monitoring or alternative treatment may be necessary:
Cardiac Effects – Bradycardia and Arrhythmias
One of the most clinically significant effects of fingolimod occurs at the start of treatment. After the first dose (or when increasing from a daily dose of 0.25 mg to 0.5 mg), fingolimod can cause a transient slowing of the heart rate (bradycardia) and, less commonly, irregular heart rhythms (arrhythmias). This effect is related to the drug's action on S1P receptors in the heart.
Because of this, you will be required to stay at a medical facility for at least 6 hours after taking the first dose for continuous monitoring of your heart rate, blood pressure, and ECG. If your heart rate is very slow, decreasing, or if your ECG shows significant abnormalities after the 6-hour period, monitoring may be extended – potentially overnight. The same monitoring protocol applies if treatment is interrupted for more than 2 weeks after at least one month of use, or for more than 1 week during the first month of treatment.
If you have a history of cardiac disease, heart failure, syncope (fainting), significant bradycardia, a history of second-degree or higher atrioventricular block, or if you are taking medications that lower heart rate (such as beta-blockers, verapamil, diltiazem, ivabradine, or digoxin), fingolimod may not be appropriate for you. A cardiology consultation is strongly recommended before initiating treatment.
Infections
Fingolimod reduces the number of circulating lymphocytes in the blood, which is its intended therapeutic effect. However, this also means your ability to fight infections is reduced. During treatment and for up to 2 months after stopping, you may be more susceptible to infections, which can be serious or life-threatening. Contact your doctor immediately if you develop symptoms of infection, including fever, feeling unwell, persistent cough, headache with stiff neck, light sensitivity, nausea, confusion, or seizures.
Before starting fingolimod, your doctor will check your varicella-zoster virus (chickenpox) immunity. If you have never had chickenpox and are not immune, vaccination is recommended at least one month before beginning treatment. Your doctor may also recommend screening and vaccination against human papillomavirus (HPV).
Progressive Multifocal Leukoencephalopathy (PML)
PML is a rare but potentially fatal brain infection caused by the JC virus. Cases of PML have been reported in patients treated with fingolimod. Your doctor will arrange a baseline MRI before starting treatment and periodic MRI scans during therapy to monitor for signs of PML. Symptoms of PML can resemble an MS relapse and may include changes in mood or behaviour, weakness on one side of the body, visual changes, confusion, or memory and speech difficulties. Report any new or worsening neurological symptoms to your doctor immediately.
Macular Oedema
Fingolimod can cause swelling of the macula, the part of the retina responsible for sharp central vision. This condition, known as macular oedema, typically occurs within the first 4 months of treatment and may cause blurred vision, shadows, or a blind spot in the centre of your visual field. An ophthalmological examination is recommended 3 to 4 months after starting treatment. Patients with diabetes or a history of uveitis (eye inflammation) are at higher risk and require more frequent eye examinations.
Liver Function
Fingolimod can affect liver function, and elevations in liver enzymes have been reported. Your doctor will check your liver function through blood tests before starting treatment, at months 1, 3, 6, 9, and 12 during the first year, and periodically thereafter. Seek immediate medical attention if you notice yellowing of your skin or the whites of your eyes, unusually dark urine, right-sided abdominal pain, unexplained nausea, vomiting, or loss of appetite.
Skin Cancer
An increased risk of basal cell carcinoma (BCC), squamous cell carcinoma, melanoma, and Merkel cell carcinoma has been reported in patients treated with fingolimod. A dermatological examination is recommended before starting treatment and annually during treatment. Limit your exposure to sunlight and ultraviolet (UV) radiation, wear protective clothing, and use high-factor sunscreen regularly.
Blood Pressure
Fingolimod may cause a mild increase in blood pressure. Your doctor should monitor your blood pressure regularly during treatment and ensure any hypertension is adequately managed with medication.
Posterior Reversible Encephalopathy Syndrome (PRES)
Rare cases of PRES have been reported in MS patients treated with fingolimod. Symptoms include sudden severe headache, confusion, seizures, and visual disturbances. Seek immediate medical attention if you experience these symptoms, as PRES requires prompt treatment and discontinuation of fingolimod.
Pregnancy and Breastfeeding
Fingolimod Accord must not be used during pregnancy. Animal studies and post-marketing data have shown that fingolimod can cause harm to the developing foetus. The rate of congenital malformations in infants exposed to fingolimod during pregnancy is approximately twice that observed in the general population (where the background rate is approximately 2–3%). The most commonly reported malformations include cardiac, renal, and musculoskeletal defects.
Before starting treatment, a pregnancy test is required to confirm you are not pregnant. You must use effective contraception during treatment and for at least 2 months after stopping fingolimod, as the drug remains active in the body for up to 2 months after the last dose. Your doctor will provide information about the risks and counselling about appropriate contraceptive methods. If you become pregnant while taking fingolimod, inform your doctor immediately so that treatment can be discontinued and appropriate prenatal care arranged.
Breastfeeding is not recommended during treatment with Fingolimod Accord, as fingolimod may pass into breast milk and could cause serious adverse effects in the nursing infant.
Switching from Other MS Treatments
If you are switching from another disease-modifying therapy, your doctor will consider an appropriate washout period to minimise the risk of additive immunosuppressive effects. When switching from natalizumab, a waiting period of 2–3 months is typically required. For teriflunomide, your doctor may recommend an accelerated elimination procedure. Switching from alemtuzumab requires careful evaluation due to the prolonged immunosuppressive effects of that medication.
How Does Fingolimod Accord Interact with Other Drugs?
Fingolimod has important drug interactions, particularly with medicines that affect heart rate or rhythm, immunosuppressive agents, certain antifungals, and enzyme-inducing drugs. Some combinations are contraindicated while others require careful monitoring or dose adjustment.
Informing your doctor about all medications you are currently taking or have recently taken is essential before starting Fingolimod Accord. Drug interactions can alter the effectiveness of fingolimod, increase the risk of adverse effects, or create dangerous combinations.
| Interacting Drug | Category | Risk / Effect | Action Required |
|---|---|---|---|
| Quinidine, disopyramide, amiodarone, sotalol | Class Ia/III anti-arrhythmics | Additive risk of cardiac arrhythmias and QT prolongation | Contraindicated – do not use together |
| Beta-blockers (e.g. atenolol, metoprolol) | Heart rate-lowering agents | Additive bradycardia, especially during first days of treatment | Cardiology assessment required; consider switching to alternative |
| Verapamil, diltiazem | Non-dihydropyridine CCBs | Enhanced heart rate reduction | Cardiology assessment required; overnight monitoring may be needed |
| Ivabradine, digoxin | Heart rate-lowering agents | Additive bradycardic effects | Cardiology assessment; consider alternative medications |
| Natalizumab, alemtuzumab, mitoxantrone | MS immunotherapies | Additive immunosuppression; increased infection risk | Do not use concurrently; observe appropriate washout periods |
| Corticosteroids (long-term) | Immunosuppressants | Potential additive immunosuppressive effect | Use with caution; monitor for infections |
| Live attenuated vaccines | Vaccines | Risk of vaccine-related infection; reduced vaccine efficacy | Avoid during treatment and for 2 months after stopping |
| Ketoconazole, clarithromycin, telithromycin | Strong CYP3A4 / CYP4F2 inhibitors | May increase fingolimod exposure | Use with caution; monitor for adverse effects |
| Carbamazepine, rifampicin, phenobarbital, phenytoin | Strong enzyme inducers | May reduce fingolimod efficacy by lowering blood levels | Use with caution; consider alternative treatment |
| St John's wort (Hypericum perforatum) | Herbal enzyme inducer | May reduce fingolimod efficacy | Avoid concomitant use |
Inactivated vaccines may have reduced effectiveness during fingolimod treatment. If vaccination is needed, discuss timing with your doctor. Avoid live attenuated vaccines (such as MMR, varicella, yellow fever) during treatment and for at least 2 months after stopping fingolimod, as they could cause the infection they are meant to prevent.
What Is the Correct Dosage of Fingolimod Accord?
The recommended dose for adults is one 0.5 mg capsule taken once daily by mouth. For children and adolescents aged 10 and older, the dose depends on body weight: 0.25 mg daily for those weighing 40 kg or less, and 0.5 mg daily for those weighing more than 40 kg. Treatment must be supervised by a neurologist experienced in MS management.
Fingolimod Accord should always be taken exactly as prescribed by your doctor. Treatment is initiated and monitored by a specialist physician experienced in the management of multiple sclerosis. The capsules should be swallowed whole with a glass of water and can be taken with or without food. Taking your dose at the same time each day will help you remember to take it consistently.
Adults
Standard Adult Dose
One 0.5 mg hard capsule taken once daily by mouth. Do not exceed the recommended dose. There is no need for dose adjustment based on age, sex, or ethnicity. No dose adjustment is required for patients with mild to moderate renal impairment or mild to moderate hepatic impairment.
Children and Adolescents (Aged 10 Years and Older)
Paediatric Dosing
The dose for children and adolescents is determined by body weight:
- Body weight ≤ 40 kg: One 0.25 mg capsule once daily
- Body weight > 40 kg: One 0.5 mg capsule once daily
Children who start on the 0.25 mg dose and subsequently reach a stable body weight above 40 kg will be instructed by their doctor to switch to the 0.5 mg dose. In this case, the first-dose monitoring procedure should be repeated. Fingolimod has not been studied in children under 10 years of age and should not be used in this age group.
Note: Fingolimod Accord 0.5 mg hard capsules are not suitable for children and adolescents weighing 40 kg or less. Other fingolimod products in the 0.25 mg strength are available for this purpose.
| Patient Group | Daily Dose | Special Considerations |
|---|---|---|
| Adults | 0.5 mg once daily | First-dose cardiac monitoring required for 6 hours |
| Children/adolescents ≤ 40 kg | 0.25 mg once daily | Use 0.25 mg formulation; first-dose monitoring required |
| Children/adolescents > 40 kg | 0.5 mg once daily | Repeat first-dose monitoring if switching from 0.25 mg |
| Elderly (> 65 years) | 0.5 mg once daily | Limited experience; use with caution |
| Hepatic impairment (mild–moderate) | 0.5 mg once daily | No dose adjustment required; severe impairment is contraindicated |
| Renal impairment | 0.5 mg once daily | No dose adjustment required |
Missed Dose
The appropriate action when a dose is missed depends on how long you have been taking fingolimod:
- First month of treatment (less than 1 month): If you miss one dose for an entire day, contact your doctor before taking the next dose. Your doctor may decide to observe you when you take the next dose, as the first-dose cardiac effects may recur.
- After one month – missed for 2 weeks or less: Take the next dose as planned at the regular time. No re-initiation monitoring is needed.
- After one month – missed for more than 2 weeks: Contact your doctor before resuming. First-dose monitoring will need to be repeated as the cardiac effects of the initial dose can reappear.
Never take a double dose to make up for a missed one.
Overdose
If you have taken too much Fingolimod Accord, contact your doctor or emergency services immediately. Overdose may result in severe bradycardia. In clinical trials, doses up to 40 times the recommended dose were associated with significant heart rate reduction requiring medical intervention.
Stopping Treatment
Abruptly discontinuing fingolimod can cause a severe rebound of MS disease activity, with symptoms potentially becoming worse than they were before or during treatment. Fingolimod remains in the body for up to 2 months after the last dose, and lymphocyte counts may remain low during this period. Always consult your doctor before stopping treatment, as careful planning and monitoring are needed for the transition to alternative therapy.
After stopping fingolimod, you may need to wait 6–8 weeks before starting a new MS treatment. If you resume fingolimod more than 2 weeks after stopping, the first-dose cardiac monitoring protocol must be repeated.
What Are the Side Effects of Fingolimod Accord?
Like all medicines, Fingolimod Accord can cause side effects, although not everyone experiences them. The most common side effects include influenza viral infections, sinusitis, headache, cough, diarrhoea, back pain, and elevated liver enzymes. Serious but less common side effects include bradycardia, macular oedema, serious infections, and certain types of cancer.
Understanding the frequency of side effects helps you and your doctor weigh the benefits and risks of treatment. Side effects are classified according to how commonly they occur. If you experience any side effects, particularly those listed as serious, contact your doctor promptly.
Very Common
- Influenza viral infections (fatigue, chills, sore throat, muscle pain, fever)
- Sinusitis (pressure or pain in cheeks and forehead)
- Headache
- Cough
- Diarrhoea
- Back pain
- Elevated liver enzyme levels (shown on blood tests)
Common
- Herpes virus infections (shingles) with blisters, burning, itching or pain
- Bronchitis with cough, chest discomfort, fever
- Tinea versicolor (ringworm, a fungal skin infection)
- Slow heart rate (bradycardia) and irregular heartbeat
- Basal cell carcinoma (a type of skin cancer)
- Low white blood cell count (lymphopenia, leucopenia)
- Dizziness, migraine
- Blurred vision
- Hypertension (mildly elevated blood pressure)
- Shortness of breath (dyspnoea)
- Eczema (itchy, red, burning skin rash), hair loss (alopecia)
- Muscle pain, joint pain
- Depression, anxiety
- Weakness (asthenia)
- Elevated blood triglyceride levels
- Weight loss
Uncommon
- Pneumonia (fever, cough, difficulty breathing)
- Macular oedema (swelling at the back of the eye causing visual disturbances)
- Decreased platelet count (increased risk of bleeding or bruising)
- Malignant melanoma (a type of skin cancer)
- Low neutrophil count (neutropenia)
- Nausea, depressed mood
- Seizures (more common in children/adolescents than adults)
Rare and Very Rare
- Posterior reversible encephalopathy syndrome (PRES) – sudden severe headache, confusion, seizures, visual disturbances
- Lymphoma (cancer affecting the lymphatic system)
- Squamous cell carcinoma (a type of skin cancer)
- Abnormal ECG (T-wave inversion) – very rare
- Kaposi's sarcoma (tumour associated with human herpesvirus 8) – very rare
Serious Side Effects Requiring Immediate Medical Attention
The following side effects, while not all common, can be serious or life-threatening. Contact your doctor or seek emergency medical attention immediately if you experience any of these:
- Signs of liver injury: Yellowing of the skin or whites of the eyes (jaundice), unusually dark urine, right-sided abdominal pain, nausea, vomiting, or loss of appetite
- Signs of serious infection: High fever, severe flu-like symptoms, headache with stiff neck and light sensitivity, confusion, or seizures (which may indicate meningitis or encephalitis)
- Signs of PML: Progressive weakness on one side of the body, visual changes, confusion, personality changes, or speech difficulties
- Severe allergic reactions: Skin rash, hives, swelling of the lips, tongue, or face (most likely to occur on the first day of treatment)
- Signs of skin cancer: New or changing moles, shiny pearly bumps, non-healing sores, or flesh-coloured painless lumps
- Immune reconstitution inflammatory syndrome (IRIS): Worsening of neurological symptoms after stopping fingolimod, caused by the immune system reactivating
- Cryptococcal infections: Headache with stiff neck, light sensitivity, nausea, or confusion (symptoms of cryptococcal meningitis)
- Autoimmune haemolytic anaemia: Unusual fatigue, pale skin, shortness of breath, dark-coloured urine
After discontinuing Fingolimod Accord, symptoms of MS may return and can sometimes be more severe than before or during treatment (rebound effect). Your doctor will monitor you closely during the transition period and determine when it is safe to begin alternative MS therapy.
How Should You Store Fingolimod Accord?
Store Fingolimod Accord at or below 25°C (77°F). Keep the capsules in their original blister packaging until ready to take. Store out of the sight and reach of children.
Proper storage of your medication is important to ensure it remains effective and safe to use throughout its shelf life. Follow these storage guidelines:
- Store at a temperature not exceeding 25°C (77°F)
- Keep the capsules in their original blister pack to protect from moisture
- Do not use after the expiry date printed on the carton and blister pack (the expiry date refers to the last day of that month)
- Do not use the package if it is damaged or shows signs of tampering
- Keep out of the sight and reach of children
Do not dispose of medicines via household waste or wastewater. Ask your pharmacist how to dispose of medicines no longer needed. These measures help protect the environment.
What Does Fingolimod Accord Contain?
Each Fingolimod Accord 0.5 mg hard capsule contains 0.5 mg of fingolimod (as hydrochloride) as the active ingredient, along with several inactive excipients that make up the capsule shell and contents.
Active Ingredient
Each hard capsule contains 0.5 mg fingolimod (as fingolimod hydrochloride). Fingolimod hydrochloride is a white to off-white powder that is the salt form of the active substance used for pharmaceutical formulation.
Inactive Ingredients (Excipients)
- Capsule contents: 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)
Appearance
Fingolimod Accord 0.5 mg is a clear yellow opaque / white opaque hard gelatin capsule (size “3”) approximately 15.8 mm in length, printed with “FO 0.5 mg” in black ink on the cap. The capsule contains a white to off-white powder.
Pack Sizes
Fingolimod Accord is available in PVC/PVDC/aluminium blister packs containing 7, 28, or 98 hard capsules, and in unit-dose blisters containing 7 × 1, 28 × 1, or 98 × 1 hard capsules. Not all pack sizes may be marketed in your country.
The marketing authorisation holder is Accord Healthcare S.L.U., Barcelona, Spain.
Frequently Asked Questions About Fingolimod Accord
Fingolimod Accord is used to treat relapsing-remitting multiple sclerosis (RRMS) in adults and children aged 10 years and older. It is specifically indicated for patients who have not responded adequately to at least one other disease-modifying therapy, or who have rapidly evolving severe MS. It helps reduce the frequency of relapses and slows the progression of physical disability caused by the disease.
Fingolimod can temporarily slow the heart rate (bradycardia) and cause irregular heartbeats after the first dose. This effect is due to the drug's action on sphingosine 1-phosphate receptors in cardiac tissue. During the 6-hour observation period, your heart rate, blood pressure, and ECG are monitored to ensure these effects do not become clinically significant. If abnormalities are detected, monitoring may be extended overnight. This first-dose monitoring is a standard safety precaution and is required by regulatory authorities worldwide.
No. Fingolimod must not be taken together with other immunosuppressive or immunomodulatory MS treatments such as beta-interferon, glatiramer acetate, natalizumab, mitoxantrone, teriflunomide, dimethyl fumarate, or alemtuzumab. Combining these medications with fingolimod can excessively suppress the immune system and significantly increase the risk of serious infections. If you are switching from one of these treatments, your doctor will determine the appropriate waiting period before starting fingolimod.
No. Fingolimod must not be used during pregnancy because it can cause birth defects. Studies have shown that the rate of congenital malformations in babies exposed to fingolimod during pregnancy is approximately double the background rate in the general population. The most commonly reported defects affect the heart, kidneys, and musculoskeletal system. Women of childbearing potential must use effective contraception during treatment and for at least 2 months after stopping fingolimod. A pregnancy test is required before starting treatment.
Fingolimod has a long elimination half-life of 6–9 days, which means it remains active in the body for approximately 2 months (about 6–8 weeks) after the last dose. During this period, its effects on the immune system persist – lymphocyte counts remain reduced and you may still be more susceptible to infections. This is why effective contraception must continue for 2 months after stopping, and why your doctor may recommend waiting 6–8 weeks before starting a new MS treatment.
The action you should take depends on how long you have been on treatment. If you are in the first month and miss an entire day, contact your doctor before taking the next dose – they may want to observe you due to possible cardiac effects. If you have been taking fingolimod for at least a month and missed 2 weeks or less, simply take the next dose at the usual time. If you have missed more than 2 weeks, contact your doctor – you will need to undergo first-dose cardiac monitoring again. Never take a double dose to compensate for a missed one.
References
- European Medicines Agency (EMA). Fingolimod – Summary of Product Characteristics. European public assessment report (EPAR). Available at: www.ema.europa.eu. Last updated 2025.
- Kappos L, Radue EW, O'Connor P, et al. A placebo-controlled trial of oral fingolimod in relapsing multiple sclerosis (FREEDOMS study). N Engl J Med. 2010;362(5):387–401. doi:10.1056/NEJMoa0909494
- Cohen JA, Barkhof F, Comi G, et al. Oral fingolimod or intramuscular interferon for relapsing multiple sclerosis (TRANSFORMS study). N Engl J Med. 2010;362(5):402–415. doi:10.1056/NEJMoa0907839
- Chitnis T, Arnold DL, Banwell B, et al. Trial of fingolimod versus interferon beta-1a in pediatric multiple sclerosis (PARADIGMS). N Engl J Med. 2018;379(11):1017–1027. doi:10.1056/NEJMoa1800149
- Montalban X, Gold R, Thompson AJ, et al. ECTRIMS/EAN guideline on the pharmacological treatment of people with multiple sclerosis. Mult Scler. 2018;24(2):96–120. doi:10.1177/1352458517751049
- Rae-Grant A, Day GS, Marrie RA, et al. Practice guideline recommendations summary: Disease-modifying therapies for adults with multiple sclerosis. Neurology. 2018;90(17):777–788. doi:10.1212/WNL.0000000000005347
- World Health Organization (WHO). Atlas of MS 2020: Mapping Multiple Sclerosis Around the World. Available at: www.who.int.
- British National Formulary (BNF). Fingolimod – Indications, dose, contra-indications, side-effects, interactions. bnf.nice.org.uk. Accessed January 2026.
Editorial Team
Medical Content
Written by iMedic Medical Editorial Team – specialists in neurology, neuroimmunology, and clinical pharmacology with documented academic background and clinical experience in multiple sclerosis management.
Medical Review
Reviewed by iMedic Medical Review Board – independent panel of board-certified neurologists and pharmacologists who verify all content against current EMA, AAN, and ECTRIMS/EAN guidelines.
Evidence standard: All medical claims in this article are supported by Level 1A evidence (systematic reviews and meta-analyses of randomised controlled trials) or current international clinical guidelines. Content follows the GRADE evidence framework and is reviewed at least annually. Last fact-check: .