What is it and how is it used?

What Gilenya is

The active substance of Gilenya is fingolimod.

What Gilenya is used for

Gilenya is used in adults to treat relapsing-remitting multiple sclerosis (MS), more specifically in: Patients who have failed to respond despite treatment with beta-interferon (another MS treatment). or
Patients who have rapidly evolving severe MS.

Gilenya does not cure MS, but it helps to reduce the number of relapses and to slow down the progression of physical disabilities due to MS.

What is multiple sclerosis

MSis a long-term condition that affects the central nervous system (CNS), comprised of the brain and spinal cord. In MS inflammation destroys the protective sheath (called myelin) around the nerves in the CNS and stops the nerves from working properly. This is called demyelination.

Relapsing-remitting MS is characterised by repeated attacks (relapses) of nervous system symptoms that reflect inflammation within the CNS. Symptoms vary from patient to patient but typically involve walking difficulties, numbness, vision problems or disturbed balance. Symptoms of a relapse may disappear completely when the relapse is over, but some problems may remain.

How Gilenya works

Gilenya helps to protect against attacks on the CNS by the immune system by reducing the ability of some white blood cells (lymphocytes) to move freely within the body and by stopping them from reaching the brain and spinal cord. This limits nerve damage caused by MS.

Table of Contents
What do you have to consider before using it?
How is it used?
What are possible side effects?
How should it be stored?
Further information

What do you have to consider before using it?

Do not take Gilenya

  • if you have a lowered immune response (due to an immunodeficiency syndrome, a disease or to medicines that suppress the immune system).
  • if you have a severe active infection or active chronic infection such as hepatitis or tuberculosis.
  • if you have an active cancer (unless it is a type of skin cancer called basal cell carcinoma).
  • if you have severe liver problems.
  • if you are allergic (hypersensitive) to fingolimod or any of the other ingredients of Gilenya. If this applies to you , tell your doctor without taking Gilenya.

Take special care with Gilenya

Talk to your doctor before taking Gilenya:

  • if you are taking medicine for irregular heartbeat such as quinidine, disopyramide, amiodarone or sotalol.
  • if you have a slow resting heart rate (less than 55 beats per minute), if you are taking medicines (for example beta blockers) that slow your heart rate, if you have irregular or abnormal heart beat or a history of sudden loss of consciousness.
  • if you have any heart problems.
  • if you plan to get vaccinated.
  • if you have never had chickenpox.
  • if you have or have had visual disturbances or other signs of swelling in the central vision area (macula) at the back of the eye (a condition known as macular oedema, see below), inflammation or infection of the eye (uveitis), or if you have diabetes (which can cause eye problems).
  • if you have liver problems.
  • if you have high blood pressure that cannot be controlled by medicines.
  • if you have severe lung problems or smoker-s cough. If any of these applies to you, tell your doctor before taking Gilenya.

Slow heart rate (bradycardia) and irregular heartbeat: At the beginning of treatment, Gilenya causes the heart rate to slow down. As a result, you may feel dizzy or tired, or be consciously aware of your heartbeat, or your blood pressure may drop. If these effects are pronounced, tell your doctor, because you may need treatment right away. Gilenya can also cause an irregular heartbeat, especially after the first dose. Irregular heartbeat usually returns to normal in less than one day. Slow heart rate usually returns to normal within one month.

Your doctor will ask you to stay at the surgery or clinic for 6 hours after taking the first dose of Gilenya so that appropriate measures can be taken in the event of side effects that occur at the start of treatment. The same applies if you are resuming treatment after a break of more than two weeks.

If you have an irregular or abnormal heartbeat or a history of sudden loss of consciousness, your condition may worsen temporarily with Gilenya. If any of this applies to you, your doctor may check your heart before you start treatment with Gilenya.

The same applies if you have a slow heart rate (less than 55 beats per minute), or if you are taking medicines called beta blockers (which slow the heartbeat).

If you have never had chickenpox: If you have never had chickenpox, your doctor may want to check your immunity against the virus that causes it (varicella zoster virus). If you are not protected against the virus, you may need a vaccination before you start treatment with Gilenya. If this is the case, your doctor will delay the start of treatment with Gilenya by one month.

Infections: Gilenya lowers the white blood cell count (particularly the lymphocyte count). White blood cells fight infection. While you are taking Gilenya (and for up to 2 months after you stop taking it), you may get infections more easily. Any infection that you already have may get worse. Infections could be serious and life-threatening. If you think you have an infection, have fever, or feel like you have the flu, call your doctor right away.

Macular oedema: Before you start Gilenya, if you have or have had visual disturbances or other signs of swelling in the central vision area (macula) at the back of the eye, inflammation or infection of the eye (uveitis) or diabetes, your doctor may want you to undergo an eye examination.

Your doctor may want you to undergo an eye examination 3 to 4 months after starting Gilenya treatment.

The macula is a small area of the retina at the back of the eye which enables you to see shapes, colours, and details clearly and sharply. Gilenya may cause swelling in the macula, a condition that is known as macular oedema. The swelling usually happens in the first 4 months of Gilenya treatment.

Your chance of developing macular oedema is higher if you have diabetes or have had an inflammation of the eye called uveitis. In these cases your doctor will want you to undergo regular eye examinations in order to detect macular oedema.

If you have had macular oedema, talk to your doctor before you resume treatment with Gilenya.

Macular oedema can cause some of the same vision symptoms as an MS attack (optic neuritis). Early on, there may not be any symptoms. Be sure to tell your doctor about any changes in your vision. Your doctor may want you to undergo an eye examination, especially if:

  • the centre of your vision gets blurry or has shadows;
  • you develop a blind spot in the centre of your vision;
  • you have problems seeing colours or fine detail.

Liver function tests: If you have severe liver problems, you should not take Gilenya.Gilenya may cause abnormal results of liver function tests. You will probably not notice any symptoms but if you notice yellowing of your skin or the whites of your eyes, abnormal darkening of the urine or unexplained nausea and vomiting, tell your doctor straight away.

If you get any of these symptoms after starting Gilenya, tell your doctor straight away.

During the first six months of treatment your doctor will request blood tests to monitor your liver function. If your test results indicate a problem with your liver you may have to interrupt treatment with Gilenya.

High blood pressure

As Gilenya causes a slight elevation of blood pressure, your doctor may want to check your blood pressure regularly.

Lung problems

Gilenya has a slight effect on the lung function. Patients with severe lung problems or with smoker-s cough may have a higher chance of developing side effects.

Blood count

The desired effect of Gilenya treatment is to reduce the amount of white blood cells in your blood. This will usually go back to normal within 2 months of stopping treatment. If you need to have any blood tests, tell the doctor that you are taking Gilenya. Otherwise, it may not be possible for the doctor to understand the results of the test, and for certain types of blood test your doctor may need to take more blood than usual.

Before you start Gilenya, your doctor will confirm whether you have enough white blood cells in your blood and may want to repeat a check regularly. In case you do not have enough white blood cells, you may have to interrupt treatment with Gilenya.

Elderly

Experience with Gilenya in elderly patients (over 65 years) is limited. Talk to your doctor if you have any concerns.

Use in children

Gilenya is not intended to be used in children and adolescents below 18 years old as it has not been studied in MS patients below 18 years old.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Tell your doctor if you are taking any of the following medicines:
- Medicines that suppress or modulate the immune system, including other medicines used to treat MS, such as beta interferon, glatiramer acetate, natalizumab or mitoxantrone. You must not use Gilenya together with such medicines as this could intensify the effect on the immune system (see also ?Do not take Gilenya-).
- Vaccines. During and for up to 2 months after treatment with Gilenya, you should not be given certain types of vaccine (live attenuated vaccines) as they could trigger the infection that they were supposed to prevent. Other vaccines may not work as well as usual if given during this period.
- Medicines that slow the heartbeat (for example beta blockers, such as atenolol). Use of Gilenya together with such medicines could intensify the effect on heartbeat in the first days after starting Gilenya.
- Medicines for irregular heartbeat, such as quinidine, disopyramide, amiodarone or sotalol. Your doctor may decide not to prescribe Gilenya if you are taking such a medicine because it could intensify the effect on irregular heartbeat.
- Other medicines: protease inhibitors, anti-infectives such as ketoconazole, azole antifungals, clarithromycin or telithromycin.

Pregnancy and breast-feeding

Before you start treatment with Gilenya your doctor may ask you to do a pregnancy test in order to ensure that you are not pregnant. You should avoid becoming pregnant while taking Gilenya or in the two months after you stop taking it because there is a risk of harm to the baby. Talk with your doctor about reliable methods of birth control that you should use during treatment and for 2 months after you stop treatment.

If you do become pregnant while taking Gilenya, stop taking the medicine and tell your doctor straight away. You and your doctor will decide what is best for you and your baby.

You should not breast-feed while you are taking Gilenya. Gilenya can pass into breast milk and there is a risk of serious side effects for the baby.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

Your doctor will tell you whether your illness allows you to drive vehicles and use machines safely. Gilenya is not expected to have an influence on your ability to drive and use machines.

However, at initiation of treatment you will have to stay at the doctor-s surgery or clinic for 6 hours after taking the first dose of Gilenya. Your ability to drive and use machines may be impaired during and potentially after this time period.

How is it used?

Treatment with Gilenya will be overseen by a doctor who is experienced in the treatment of multiple sclerosis.

Always take Gilenya exactly as your doctor has told you. You should check with your doctor if you are not sure.

The dose is one capsule per day. Take Gilenya once a day with a glass of water. Gilenya can be taken with or without food.

Taking Gilenya at the same time each day will help you remember when to take your medicine.

Do not exceed the recommended dose.

Your doctor may switch you directly from beta interferon to Gilenya if there are no signs of abnormalities caused by your previous treatment. Your doctor may have to do a blood test in order to exclude such abnormalities. After stopping natalizumab you may have to wait for 2-3 months before starting treatment with Gilenya.

If you have questions about how long to take Gilenya, talk to your doctor or your pharmacist.

If you take more Gilenya than you should

If you have taken too much Gilenya, call your doctor straight away.

If you forget to take Gilenya

If you forget to take a dose, take the next dose as planned. Do not take a double dose to make up for a forgotten dose.

If you stop taking Gilenya

Do not stop taking Gilenya or change your dose without talking to your doctor first.

Gilenya will stay in your body for up to 2 months after you stop taking it. Your white blood cell count (lymphocyte count) may also remain low during this time and the side effects described in this leaflet may still occur. After stopping Gilenya you may have to wait for 6-8 weeks before starting a new MS treatment.

If you have to restart Gilenya more than 2 weeks after you stop taking it, the effect on heart rate normally seen when treatment is first started may re-occur. Talk to your doctor to check if you need to take the first capsule in the doctor-s surgery or clinic.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

What are possible side effects?

Like all medicines, Gilenya can cause side effects, although not everybody gets them.

Side effects may occur with certain frequencies, which are defined as follows:

Very common affects more than 1 user in 10 Common affects 1 to 10 users in 100 Uncommon affects 1 to 10 users in 1,000 Rare affects 1 to 10 users in 10,000 Very rare affects less than 1 user in 10,000 Not known frequency cannot be estimated from the available data.

Some side effects could be or could become serious

Common:

  • Cough with phlegm, chest discomfort, fever (signs of lung disorders)
  • Feeling sick with nausea, vomiting, diarrhoea (signs of bowel problems)
  • Herpes virus infection (shingles or herpes zoster) with symptoms such as blisters, burning, itching or pain around the mouth or genitals. Other symptoms may be fever and weakness in the early stages of infection, followed by numbness, itching, and red patches or blisters on the face or trunk
  • Slow heartbeat (bradycardia), irregular heart rhythm

Uncommon:

  • Pneumonia with symptoms such as fever, cough, difficulty breathing
  • Macular oedema (swelling in the central vision area of the retina at the back of the eye) with symptoms such as shadows or blind spot in the centre of the vision, blurred vision, problems seeing colours or details If you experience any of these, tell your doctor straight away.

Other side effects
Very common

  • Infection from flu virus with symptoms such as tiredness, chills, sore throat, aching in the joints or muscles, fever
  • Headache
  • Diarrhoea
  • Back pain
  • Cough
  • Increase in blood levels of a liver enzyme (ALT)
Common

  • Feeling of pressure or pain in the cheeks and forehead (sinusitis)
  • Fungal infections affecting the skin, hair or nails (ringworm)
  • Dizziness
  • Tingling or numbness
  • Severe headache often accompanied by nausea, vomiting and sensitivity to light (signs of migraine)
  • Low level of white blood cells (lymphocytes, leucocytes)
  • Weakness
  • Itchy, red, burning rash (signs of eczema)
  • Hair loss
  • Itching
  • Weight loss
  • Breathlessness
  • Depression
  • Eye pain
  • Blurred vision (see also the section on macular oedema under ?Some side effects could be or could become serious?)
  • Hypertension (Gilenya may cause a mild increase in blood pressure)
  • Increase in blood levels of hepatic enzymes
  • Increase in blood levels of certain lipids (triglycerides)
Uncommon

  • Low level of certain white blood cells (neutrophils)
  • Depressed mood
Rare

  • Blood vessel disorders
  • Nervous system disorders
  • Cancer of the lymphatic system (lymphoma)

If any of these affects you severely, tell your doctor

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

How should it be stored?

Keep out of the reach and sight of children.
Do not use Gilenya after the expiry date which is stated on the carton and blister foil after ?EXP?. The expiry date refers to the last day of the month.
Do not store above 30ºC.
Store in the original package in order to protect from moisture.
Do not use any pack that is damaged or shows signs of tampering.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

Further information

What Gilenya contains

  • The active substance is fingolimod. Each capsule contains 0.5 mg fingolimod (as hydrochloride).
  • The other ingredients are: Capsule core: magnesium stearate, mannitol Capsule shell: yellow iron oxide (E172), titanium dioxide (E171), gelatin Printing ink:shellac (E904), dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, purified water, strong ammonia solution, potassium hydroxide, black iron oxide (E172), yellow iron oxide (E172), titanium dioxide (E171), dimethicone

What Gilenya looks like and contents of the pack

Gilenya 0.5 mg hard capsules have a white opaque body and bright yellow opaque cap. ?FTY0.5mg? is imprinted on the cap with black ink and two bands are imprinted on the body with yellow ink.

Gilenya is available in packs containing 7 or 28 capsules or in multipacks containing 84 capsules (3 packs of 28 capsules). Not all pack sizes may be marketed in your country.

Marketing Authorisation Holder

Novartis Europharm Limited
Wimblehurst Road
Horsham
West Sussex, RH12 5AB
United Kingdom

Manufacturer

Novartis Pharma GmbH
Roonstrasse 25
90429 Nuremberg
Germany

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

BelgiëBelgiqueBelgien Novartis Pharma N.V. TélTel 32 2 246 16 11 LuxembourgLuxemburg Novartis Pharma N.V. TélTel 32 2 246 16 11

Novartis Pharma Services Inc. . 359 2 489 98 28 Magyarország Novartis Hungária Kft. Pharma Tel. 36 1 457 65 00

eská republika Novartis s.r.o. Tel 420 225 775 111 Malta Novartis Pharma Services Inc. Tel 356 2298 3217

Danmark Novartis Healthcare AS Tlf 45 39 16 84 00 Nederland Novartis Pharma B.V. Tel 31 26 37 82 111

Deutschland Novartis Pharma GmbH Tel 49 911 273 0 Norge Novartis Norge AS Tlf 47 23 05 20 00

Eesti Novartis Pharma Services Inc. Tel 372 66 30 810 Österreich Novartis Pharma GmbH Tel 43 1 86 6570

Novartis Hellas A.E.B.E. 30 210 281 17 12 Polska Novartis Poland Sp. z o.o. Tel. 48 22 375 4888

España Novartis Farmacéutica, S.A. Tel 34 93 306 42 00 Portugal Novartis Farma - Produtos Farmacêuticos, S.A. Tel 351 21 000 8600

France Novartis Pharma S.A.S. Tél 33 1 55 47 66 00 România Novartis Pharma Services Romania SRL Tel 40 21 31299 01

Ireland Novartis Ireland Limited Tel 353 1 260 12 55 Slovenija Novartis Pharma Services Inc. Tel 386 1 300 75 50

Ísland Vistor hf. Sími 354 535 7000 Slovenská republika Novartis Slovakia s.r.o. Tel 421 2 5542 5439

Italia Novartis Farma S.p.A. Tel 39 02 96 54 1 SuomiFinland Novartis Finland Oy PuhTel 358 010 6133 200

Novartis Pharma Services Inc. 357 22 690 690 Sverige Novartis Sverige AB Tel 46 8 732 32 00

Latvija Novartis Pharma Services Inc. Tel 371 67 887 070 United Kingdom Novartis Pharmaceuticals UK Ltd. Tel 44 1276 698370

Lietuva
Novartis Pharma Services Inc.
Tel: +370 5 269 16 50

This leaflet was last approved in

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