Fingolimod capsules Gilenya
Clinical author's note: 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.
Clinical author's note: 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 of medicine | An immunomodulating medicine |
| Used for | Relapsing-remitting multiple sclerosis (MS) in adults and in children aged 10 years or older |
| Also called | Gilenya® |
| Available as | Capsules |
Multiple sclerosis (MS) 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:
- If you are pregnant or breastfeeding.
- If you have a condition which affects your immune system.
- If you have been told you have an irregular heart rhythm.
- 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.
- If you have a problem with the way your liver works.
- 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.
- If you have ever had an allergic reaction to a medicine.
- If you are taking any other medicines. This includes any medicines you are taking which are available to buy without a prescription, as well as herbal and complementary medicines.
Clinical author's note (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 before you take the next dose.
Getting the most from your treatment
- 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 | What can I do if I experience this? |
| 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 | Do not drive and do not use tools or machines while affected |
| 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 |
| Diarrhoea | Drink plenty of water |
| Low mood, skin problems | Speak with your doctor if troublesome |
| Slow heart rate, changes to some blood test results, blood pressure changes, weight loss | Your doctor will check for these |
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:
- Feeling sick (nausea) or being sick (vomiting)
- Tiredness
- Abdominal (tummy) pain
- 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
If you experience any other symptoms which you think may be due to the capsules, speak with your doctor or pharmacist for further advice.
Clinical author's note (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
- Keep all medicines out of the reach and sight of children.
- Store in a cool, dry place, away from direct heat and light.
Important information about all medicines
Never take more than the prescribed dose. If you suspect that you or someone else might have taken an overdose of this medicine, go to the accident and emergency department of your local hospital. Take the container with you, even if it is empty. If you are due to have an operation or dental treatment, tell the person carrying out the treatment which medicines you are taking. If you buy any medicines, always check with your doctor or a pharmacist that they are suitable for you to take. This medicine is for you. Never give it to other people even if their condition appears to be the same as yours. Do not keep out-of-date or unwanted medicines. Take them to your local pharmacy which will dispose of them for you. If you have any questions about this medicine ask your pharmacist. |
Further reading and references
Manufacturer's PIL, Gilenya® 0.25 mg and 0.5 mg hard capsules; Novartis Pharmaceuticals UK Ltd, The electronic Medicines Compendium. Dated May 2023.
Medicines Complete BNF 86th Edition; British Medical Association and Royal Pharmaceutical Society of Great Britain, London.