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fingolimod

Gilenya · ATC code L04AE01

Brand names: Gilenya, Areleptan, Chantico, Inzolfi, Fingod, Gaxenim, Golpimec, Lognif, Finimod, Myelitu

Key facts
Active substance
fingolimod
Drug class
Immunosuppressive drug
ATC code
L04AE01
Authorisation
centrally authorised across the EU (EMA)
Dosage forms
Gilenya 0.25 mg hard capsules / Gilenya 0.5 mg hard capsules
Marketing authorisation holder
Novartis Europharm Limited
Information as of
2026-10-28

Key facts

Fingolimod is a sphingosine 1-phosphate receptor modulator used as disease-modifying therapy for highly active relapsing remitting multiple sclerosis in adults and children aged 10 years and older (Gilenya).

What it is used for

  • Highly active relapsing remitting multiple sclerosis despite a full and adequate course of at least one disease-modifying therapy.
  • Rapidly evolving severe relapsing remitting multiple sclerosis (2 or more disabling relapses in one year with gadolinium-enhancing lesions or a significant increase in T2 lesion load on MRI).

Dosing

  • Adults: 0.5 mg orally once daily, with or without food; swallow capsules intact.
  • Children aged 10 years and above: ≤40 kg 0.25 mg, >40 kg 0.5 mg once daily.
  • First-dose monitoring (ECG and blood pressure before and 6 hours after the first dose, hourly heart rate and blood pressure) is repeated when switching from 0.25 mg to 0.5 mg and after treatment interruptions (e.g. 1 day or more during the first 2 weeks).
  • No dose adjustment in renal impairment; severe hepatic impairment (Child-Pugh C): contraindicated; caution from 65 years.

Contraindications

  • Immunodeficiency syndrome, increased risk of opportunistic infections, suspected or confirmed PML.
  • Severe active infections, active chronic infections (hepatitis, tuberculosis), active malignancies.
  • Severe liver impairment (Child-Pugh class C).
  • In the previous 6 months myocardial infarction, unstable angina, stroke/TIA, decompensated heart failure or NYHA class III/IV heart failure; severe arrhythmias requiring class Ia or III anti-arrhythmics; second-degree Mobitz type II or third-degree AV block or sick-sinus syndrome without a pacemaker; QTc ≥ 500 msec.
  • Pregnancy and women of childbearing potential not using effective contraception; hypersensitivity.

Important warnings

  • Bradyarrhythmia: heart rate decline starts within one hour of the first dose and is maximal within 6 hours; monitor for 6 hours, continuous ECG recommended.
  • Infections including PML, cryptococcal and herpes infections; check blood count and varicella antibody status before starting.
  • Macular oedema (0.5% of patients), mainly in the first 3-4 months; ophthalmological evaluation at 3-4 months recommended.
  • Hepatic enzyme increases and acute hepatic failure have been reported; monitor for skin cancers (e.g. basal cell carcinoma, melanoma).
  • Severe exacerbation of disease has been observed rarely after stopping.

Side effects

  • Most frequent at 0.5 mg: headache (24.5%), hepatic enzyme increased (15.2%), diarrhoea (12.6%), cough (12.3%), influenza (11.4%), sinusitis (10.9%) and back pain (10.0%).
  • Common: herpes viral infections, bronchitis, basal cell carcinoma, lymphopenia, bradycardia, AV block, hypertension, dyspnoea.
  • Rare or frequency not known: lymphoma, PML, cryptococcal infections, acute hepatic failure.

Interactions

  • Anti-neoplastic, immunomodulatory or immunosuppressive therapies should not be co-administered.
  • Do not start in patients on beta blockers or other heart-rate-lowering substances (e.g. class Ia and III antiarrhythmics, verapamil, diltiazem, ivabradine, digoxin).
  • Vaccination may be less effective during and for up to two months after treatment; avoid live attenuated vaccines.

Pregnancy and breastfeeding

  • Contraindicated in pregnancy; a negative pregnancy test is required before starting; effective contraception during and for 2 months after treatment.
  • Women receiving fingolimod should not breastfeed.

Summary of the official product information, written with AI on 2026-10-29. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.

Full official text →

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For patients

Package leaflet, verbatim

This product has no separate US patient information.

Authorisation and brand names by country

Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.

EU – centrally authorised (all member states)

Source: European Medicines Agency (EMA), product information

Austria

  • AreleptanPharmaselect International Beteiligungs Gmbh · 1 register entry
  • ChanticoG.L. Pharma Gmbh · 1 register entry
  • FingolimodStada Arzneimittel Gmbh, 1a Pharma Gmbh, Neuraxpharm Arzneimittel Gmbh, Pharmaselect International Beteiligungs Gmbh, Ratiopharm Arzneimittel Vertriebs-Gmbh, Genericon Pharma Gesellschaft M.B.H., Tillomed Pharma Gmbh, +pharma Arzneimittel Gmbh, Devatis Gmbh, Zentiva, K.S., Biocon Pharma Malta I Limited, Reddy Holding Gmbh, Hcs Bvba · 15 register entries
  • InzolfiSandoz Gmbh · 1 register entry

Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-29

Germany

  • FingodTad Pharma Gmbh · 1 register entry
  • Fingolimod123 Acurae Pharma Gmbh, Neuraxpharm Arzneimittel Gmbh, Bluepharma Indústria Farmacêutica S.A., Medochemie Ltd., Pharmathen S.A., Ratiopharm Gmbh, Hec Pharm Gmbh, Sigillata Limited, Medical Valley Invest Ab, Bluefish Pharmaceuticals Ab, Glenmark Arzneimittel Gmbh, Tillomed Pharma Gmbh, Devatis Gmbh, Heumann Pharma Gmbh & Co. Generica Kg, Holsten Pharma Gmbh, Laboratorios Liconsa S.A., Towa Pharmaceutical S.A., Viatris Germany Gmbh, Vivanta Generics S.R.O., Zentiva Pharma Gmbh, Amarox Pharma Gmbh, Ascend Gmbh, Biocon Pharma Malta I Limited, Koanaa Healthcare Spain S.L., Olpha As, Puren Pharma Gmbh & Co. Kg, Stadapharm Gmbh, Betapharm Arzneimittel Gmbh, Denk Pharma Gmbh & Co. Kg, Abz-Pharma Gmbh, Basics Gmbh, Aliud Pharma Gmbh · 34 register entries
  • GaxenimBausch Health Ireland Limited · 1 register entry
  • GolpimecNeuraxpharm Arzneimittel Gmbh · 1 register entry
  • LognifRatiopharm Gmbh · 2 register entries

Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-29

Turkey

  • FinimodTEVA PHARMA İLAÇ SAN.VE TİC. A.Ş. · 2 register entries
  • MyelituONKO İLAÇ SAN. VE TİC. A.Ş. · 1 register entry

Source: TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, as of 2026-10-16

Brand names in 28 more European countries
Belgium
Fingolimod Ab, Fingolimod Eg, Fingolimod Fresenius Kabi, Fingolimod Krka, Inzolfi
Bulgaria
Chantico, Inzolfi, Арелептан, Бонаксон, Гаксеним, Ефигало, Лумента, Финголимод Devatis, Финголимод Зентива, Финголимод Медокеми, Финголимод Рихтер, Финголимод Рнт
Croatia
Areleptan, Arlesias, Efigalo, Fingolimod Alpha-Medical, Fingolimod Stada, Fingolimod Teva
Cyprus
Fingolimod Adelco, Fingolimod Remedica, Fingolimod Sandoz, Fingolimod Sapiens, Fingolimod Stada, Fingolimod Tecnigen, Finrina, Lognif
Czechia
Areleptan, Bonaxon, Chantico, Efigalo, Fimodigo, Fingolimod +pharma, Fingolimod Fmk, Fingolimod Fresenius Kabi, Fingolimod Glenmark, Fingolimod Medochemie, Fingolimod Msn, Fingolimod Olpha, Fingolimod Reddy, Fingolimod Richter, Fingolimod Sandoz, Fingolimod Stada, Fingolimod Zentiva, Gaxenim, Golpimec, Lognif
Denmark
Areleptan, Bonaxon, Fingolimod, Finrina, Gaxenim, Golpimec
Estonia
Chantico, Efigalo, Fingolimod Msn, Fingolimod Norameda, Fingolimod Olpha, Fingolimod Remedica, Fingolimod Richter, Fingolimod Zentiva
Finland
Fingolimod, Gaxenim, Golpimec
France
Fingolimod Arrow, Fingolimod Benta, Fingolimod Bgr, Fingolimod Biogaran, Fingolimod Edest Intas Third Party Sales, Fingolimod Eg, Fingolimod Evolugen, Fingolimod Hcs, Fingolimod Koanaa, Fingolimod Laboratorios Liconsa, Fingolimod Liconsa, Fingolimod Olpha, Fingolimod Pharmaki, Fingolimod Pharmathen, Fingolimod Sandoz, Fingolimod Synthon, Fingolimod Teva, Fingolimod Viatris Pharma, Fingolimod Viatris Sante, Fingolimod Zentiva, Fingolimod Zydus
Greece
Fingolimod Adelco, Fingolimod Medochemie, Fingolimod Pharmathen, Fingolimod Rafarm, Fingolimod Stada, Fingolya, Finrina, Ginolimod, Lognif
Hungary
Bonaxon, Chantico, Efigalo, Fimodigo, Fingolimod Msn, Fingolimod Onkogen, Fingolimod Q Pharma, Fingolimod Richter, Fingolimod Stada, Gaxenim, Limoda, Lognif
Iceland
Fingolimod, Gilenya
Ireland
Fingolimod Clonmel, Fingolimod Flynn Pharma, Fingolimod Krka, Fingolimod Msn, Fingolimod Rowa Pharmaceuticals, Fingolimod Rowex, Fingolimod Teva, Fingolimod Tillomed
Italy
Fingolimod Aurobindo, Fingolimod Dr. Reddy’s, Fingolimod Eg, Fingolimod Hcs, Fingolimod Koanaa, Fingolimod Liconsa, Fingolimod Mylan Italia, Fingolimod Olpha, Fingolimod Pharmathen, Fingolimod Sandoz, Fingolimod Sun, Fingolimod Tillomed, Fingolimod Towa, Fingolimod Vivanta, Fingolimod Zentiva, Gaxenim, Golpimec, Inzolfi, Lognif, Mulfinya, Naegoti
Latvia
Bonaxon, Chantico, Efigalo, Fingolimod Msn, Fingolimod Norameda, Fingolimod Olpha, Fingolimod Zentiva
Liechtenstein
Fingolimod Accord, Fingolimod Mylan, Gilenya
Lithuania
Chantico, Efigalo, Fingolimod Msn, Fingolimod Norameda, Fingolimod Olpha, Fingolimod Remedica, Fingolimod Richter, Fingolimod Zentiva
Luxembourg
Fingolimod Eg, Fingolimod Ratiopharm
Malta
Fingolimod Denk, Fingolimod Remedica, Fingolimod Sandoz, Fingolimod Tillomed
Netherlands
Chantico, Fenoxa, Fimodigo Vipharm, Fingolimod, Inzolfi
Norway
Areleptan, Fingolimod Accord, Fingolimod Devatis, Fingolimod Fresenius Kabi, Fingolimod Krka, Fingolimod Medical Valley, Fingolimod Mylan, Fingolimod Orion, Fingolimod Pharmathen, Fingolimod Reddy, Fingolimod Sandoz, Fingolimod Stada, Fingolimod Teva, Fingolimod Tillomed, Fingolimod Zentiva, Gilenya, Golpimec
Poland
Bonaxon, Chantico, Efigalo, Fenoxa, Fimodigo, Fingolimod, Gaxenim, Golpimec, Inzolfi
Portugal
Bluesar, Fingolimod Bluefish, Fingolimod Bluepharma, Fingolimod Farmoz, Fingolimod Generis, Fingolimod Krka, Fingolimod Medochemie, Fingolimod Pharmakern, Fingolimod Pharmathen, Fingolimod Reddy, Fingolimod Sandoz, Fingolimod Stada, Fingolimod Tecnigen, Fingolimod Teva, Fingolimod Tillomed, Fingolimod Towa, Fingolimod Urgher, Fingolimod Zentiva, Inzolfi
Romania
Fingolimod Dr. Reddys, Fingolimod Msn, Fingolimod Richter, Fingolimod Zentiva
Slovakia
Areleptan, Bonaxon, Chantico, Efigalo, Fimodigo, Fingolimod Glenmark, Fingolimod Msn, Fingolimod Olpha, Fingolimod Reddy, Fingolimod Richter, Fingolimod Sandoz, Fingolimod Stada Arzneimittel Ag, Fingolimod Zentiva, Gaxenim, Golpimec, Lognif
Slovenia
Areleptan, Arlesias, Efigalo, Fingolimod Stada, Fingolimod Teva, Inzolfi
Spain
Fingolimod, Gaxenim, Lognif
Sweden
Areleptan, Fingolimod Amarox, Fingolimod Avansor, Fingolimod Devatis, Fingolimod Glenmark, Fingolimod Krka, Fingolimod Medical Valley, Fingolimod Orion, Fingolimod Reddy, Fingolimod Stada, Fingolimod Teva, Fingolimod Tillomed, Fingolimod Zentiva, Gaxenim, Golpimec

EMA – Article 57 product data (EU/EEA), 2026-10-29

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Sources

  1. European Medicines Agency. Gilenya – EPAR, Product Information. 2026-10-28. https://www.ema.europa.eu/en/documents/product-information/gilenya-epar-product-information_en.pdf
  2. EMA – Article 57 product data (EU/EEA), 2026-10-29. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
  3. EMA – Article 57 product data (EU/EEA), 2026-10-29. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
  4. TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, 2026-10-16. https://www.titck.gov.tr/dinamikmodul/85
  5. Wikidata (CC0): ATC L04AE.

Editorial: Medelix editorial team · last updated 2026-10-28 · How these pages are made · Report an error

Source: European Medicines Agency (EMA), product information. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.