Capsules de fingolimod
Gilenya
Revu par Sid DajaniDernière mise à jour par Michael Stewart, MRPharmSDernière mise à jour 9 nov. 2023
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Note de l'auteur clinique : Michael Stewart 25/01/2021: the Medicines and Healthcare products Regulatory Agency (MHRA) has issued new advice for doctors and patients following reports of serious liver injury in a small number of people taking fingolimod. Your doctor will arrange for regular blood tests during your treatment to monitor your liver function. Seek urgent medical attention if you develop any symptoms or signs of liver injury, such as feeling sick (nausea) or being sick (vomiting), tiredness, abdominal (tummy) pain, yellow skin or eyes, or dark urine.
Note de l'auteur clinique : Michael Stewart 23/9/2019: the Medicines and Healthcare products Regulatory Agency (MHRA) has issued a new warning regarding an increased risk of birth defects if fingolimod is taken during pregnancy. Pregnant women should not take fingolimod. Women of childbearing potential must use effective contraception during treatment with fingolimod and for two months afterwards. Speak with your doctor if you are planning to become pregnant or think you may be pregnant whilst taking fingolimod.
Fingolimod is a treatment for relapsing-remitting multiple sclerosis (MS) in adults.
Take one (500 microgram) capsule every day.
Side-effects include a slow heart rate at first, an increased risk of infection, and eye problems.
About fingolimod
Type de médicament | An immunomodulating medicine |
Utilisé pour | Relapsing-remitting multiple sclerosis (MS) in adults and in children aged 10 years or older |
Aussi appelé | Gilenya® |
Disponible sous forme de | Capsules |
Sclérose en plaques (SEP) is a condition which affects the brain and spinal cord. The protective cover around nerves in the brain and spinal cord is damaged in people with MS, and this stops the nerves from working as they should. Most people with MS have the relapsing-remitting form of the disease where symptoms come and go in episodes. A 'relapse' occurs when an episode of symptoms develops. The symptoms last for a period of time and then ease, or 'remit'. Further relapses occur from time to time, with periods of remission in between.
Fingolimod works by interfering with your immune system, because it is believed that this is responsible for causing the damage to the nerves. Fingolimod reduces the access of certain white blood cells to the brain and spinal cord, and this reduces the number of relapses in some people. Fingolimod does not cure MS, and it is not a suitable treatment for everyone. It will be prescribed for you by a specialist and your treatment will be closely monitored.
Before taking fingolimod
Some medicines are not suitable for people with certain conditions, and sometimes a medicine may only be used if extra care is taken. For these reasons, before you start taking fingolimod it is important that your doctor knows:
Si vous êtes enceinte ou si vous allaitez.
If you have a condition which affects your immune system.
Si on vous a dit que vous avez un rythme cardiaque irrégulier.
If you have any other heart problem, including angina pain or if you have had a heart attack in the past.
If you have blood vessel disease or if you have had a stroke or transient ischaemic attack (TIA) in the past.
Si vous avez un problème avec le fonctionnement de votre foie.
If you have any problems with your lungs or breathing.
If you are currently unwell, or have an infection or a high temperature (fever).
If you have been told you have cancer.
Si vous avez déjà eu une réaction allergique à un médicament.
Si vous prenez d'autres médicaments. Cela inclut tous les médicaments que vous prenez et qui sont disponibles à l'achat sans ordonnance, ainsi que les médicaments à base de plantes et les médecines complémentaires.
Note de l'auteur clinique (Michael Stewart) 18/12/2017: this leaflet has been updated to reflect a recent drug safety update from MHRA which issued additional advice for healthcare professionals with regard to patients with heart arrhythmias and other heart problems.
How to take fingolimod
Before you start this treatment, read the manufacturer's printed information leaflet from inside your pack. It will give you more information about fingolimod and will provide you with a full list of the side-effects which you may experience from taking it.
You will be asked to take your first dose of fingolimod in a clinic where you can be observed. This is because it can slow your heart rate at first, and your doctor will want to check for this.
Take fingolimod exactly as your doctor tells you to. Take one capsule a day. Try to take your doses at the same time of day each day, as this will help you to remember to take fingolimod regularly.
Swallow the capsule with a drink of water. You can take fingolimod before or after meals.
Your doctor will give you instructions in case you forget to take a dose. You must follow the directions your doctor gives to you, but as a guide, the usual recommendation is that if you have been taking fingolimod for less than a month and you miss a dose, you should speak with your doctor avant you take the next dose.
Tirer le meilleur parti de votre traitement
Remember to keep all your regular appointments with your doctor. This is so your doctor can check on your progress. You will need to have regular blood tests and skin and eye checks during the treatment.
Fingolimod can harm an unborn child so you must avoid getting pregnant while you are taking it. Make sure you have discussed with your doctor which types of contraception are suitable for you and your partner. You must use effective contraception during treatment and for two months afterwards. If you are a woman and want to have a family, discuss this with your doctor so that you can be given advice from a specialist before you become pregnant.
If you are due to have any vaccinations, it is very important that the person treating you knows that you are taking this medicine. This is because fingolimod will make some vaccines less effective, and also because you will be at risk of getting an infection from some vaccines.
Fingolimod can cause your skin to become more sensitive to sunlight than normal. Protect your skin from sunlight even on bright but cloudy days and do not use sunbeds. Let your doctor know straightaway if you notice any changes to your skin.
Can fingolimod cause problems?
Along with their useful effects, most medicines can cause unwanted side-effects although not everyone experiences them. The table below contains some of the most common ones associated with fingolimod. You will find a full list in the manufacturer's information leaflet supplied with your medicine. The unwanted effects often improve as your body adjusts to the new medicine, but speak with your doctor or pharmacist if any of the following continue or become troublesome.
Common fingolimod side-effects | Que puis-je faire si je ressens cela ? |
Infections (in particular nose, throat and lung infections), cough | Let your doctor know if you notice any signs of infection |
Feeling dizzy or tired, blurred vision | Ne conduisez pas et n'utilisez pas d'outils ou de machines lorsque vous êtes affecté |
Headache, back pain | Ask your doctor or pharmacist to recommend a suitable painkiller. If the headache is sudden or severe, speak with your doctor straightaway |
Diarrhée | Buvez beaucoup d'eau |
Low mood, skin problems | Parlez avec votre médecin si cela pose problème |
Slow heart rate, changes to some blood test results, blood pressure changes, weight loss | Votre médecin vérifiera ces éléments |
Important : There have been rare reports of serious liver injury in a small number of people taking fingolimod. Your doctor will arrange for blood tests during your treatment, however, seek urgent medical attention if you develop a combination of the following symptoms:
Se sentir malade (nausée) ou être malade (vomissements)
Fatigue
Douleur abdominale (ventre)
Yellowing skin or eyes, or dark urine.
You should also let your doctor know immediately if you experience any signs of infection such as:
Headache or neck stiffness
Rash or high temperature (fever)
Oversensitivity to light
Si vous ressentez d'autres symptômes que vous pensez être dus aux capsules, consultez votre médecin ou votre pharmacien pour obtenir des conseils supplémentaires.
Note de l'auteur clinique (Michael Stewart) 25/01/2021: this leaflet has been updated to reflect drug safety updates from the MHRA regarding serious liver injury, pregnancy, sensitivity to UV light and signs of infection.
How to store fingolimod
Gardez tous les médicaments hors de la portée et de la vue des enfants.
Conserver dans un endroit frais et sec, à l'abri de la chaleur directe et de la lumière.
Informations importantes sur tous les médicaments
Informations importantes sur tous les médicaments
Ne prenez jamais plus que la dose prescrite. Si vous soupçonnez que vous ou quelqu'un d'autre avez pris une surdose de ce médicament, rendez-vous au service des urgences de votre hôpital local. Emportez le contenant avec vous, même s'il est vide.
Si vous devez subir une opération ou un traitement dentaire, informez la personne qui effectue le traitement des médicaments que vous prenez.
If you buy any medicines, always check with your doctor or a pharmacist that they are suitable for you to take.
Ce médicament est pour vous. Ne le donnez jamais à d'autres personnes, même si leur état semble être le même que le vôtre.
Ne conservez pas de médicaments périmés ou indésirables. Apportez-les à votre pharmacie locale qui s'en débarrassera pour vous.
Si vous avez des questions concernant ce médicament, demandez à votre pharmacien.
MHRA - Signaler des réactions indésirables
Signalez les effets secondaires suspectés des médicaments, vaccins, cigarettes électroniques, incidents liés aux dispositifs médicaux, produits défectueux ou falsifiés (contrefaits) à l'Agence de Régulation des Médicaments et Produits de Santé pour garantir une utilisation sûre et efficace.
Questions fréquemment posées
What is the purpose of the initial observation period when starting fingolimod?
You will be asked to take your first dose of fingolimod in a clinic where you can be observed. This is because the medicine can slow your heart rate at first, and your doctor will want to check for this.
How long do I need to use contraception after stopping fingolimod?
You must use effective contraception during treatment and for two months after you stop taking fingolimod, as it can harm an unborn child.
Are there specific symptoms I should watch out for that might indicate a serious liver problem while on fingolimod?
Yes, you should seek urgent medical attention if you develop a combination of feeling or being sick, tiredness, abdominal pain, yellowing skin or eyes, or dark urine. These can be signs of a serious liver injury.
What should I do if I forget to take a dose of fingolimod, especially if I've just started the treatment?
If you have been taking fingolimod for less than a month and you miss a dose, you should speak with your doctor before you take the next dose. For guidelines on missed doses after a longer period, follow your doctor's specific instructions.
Does fingolimod affect how my skin reacts to sunlight?
Yes, fingolimod can make your skin more sensitive to sunlight than usual. It's important to protect your skin from the sun, even on cloudy days, and avoid using sunbeds. You should also let your doctor know if you notice any changes to your skin.
Lectures complémentaires et références
- Manufacturer's PIL, Gilenya® 0.25 mg and 0.5 mg hard capsules; Novartis Pharmaceuticals UK Ltd, The electronic Medicines Compendium. Dated May 2023.
- Médicaments Complets BNF 89e Édition; Association Médicale Britannique et Société Royale Pharmaceutique de Grande-Bretagne, Londres.
À propos du critique

Sid Dajani
Sultan Dajani a obtenu son diplôme à la London School of Pharmacy en 1994 et est devenu le plus jeune membre élu du conseil de la Royal Pharmaceutical Society depuis sa fondation en 1842.
Historique de l'article
Article également disponible en Anglais, Allemand, Espagnol, Français, Italien, Portugais, Hindi, Hébreu, Arabe, and Suédois.
Prochaine révision prévue : 8 nov. 2026
9 nov. 2023 | Dernière version
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