Gilenya

Gilenya is a prescription medication used to treat relapsing forms of multiple sclerosis (MS). Gilenya belongs to a group of drugs called sphingosine l-phosphate receptor modulators. Although the exact way it works is unknown, it may work by decreasing the activity of certain cells of the immune system.

This medication comes in capsule form and is taken once a day, with or without food.

Common side effects include headache, flu, diarrhea, and back pain.

Gilenya is a prescription medicine used to treat relapsing forms of multiple sclerosis (MS) in adults and children 10 years of age and older. 

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• Novartis Pharmaceuticals Corporation

Gilenya can cause serious side effects. See "Drug Precautions".    

The most common side effects of Gilenya include:

• headache
• flu
• diarrhea
• back and stomach pain
• abnormal liver tests
• pain in the arms or legs
• inflammation of the sinuses
• cough

Tell your doctor if you have any side effect that bothers you or that does not go away.

These are not all of the possible side effects of Gilenya. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• Medicines for:
  • heart problems or
  • high blood pressure or
  • other medicines that may lower your heart rate or change your heart rhythm
• Vaccines. Tell your doctor if you have been vaccinated within 1 month before you start taking Gilenya. You should not get certain vaccines while you take Gilenya and for at least 2 months after you stop taking Gilenya. If you take certain vaccines, you may get the infection the vaccine should have prevented. Vaccines may not work as well when given during Gilenya treatment.
• Medicines that could raise your chance of getting infections, such as medicines to treat cancer or to control your immune system.
• Ketoconazole (an antifungal drug) when taken by mouth

This is not a complete list of Gilenya drug interactions. Ask your doctor or pharmacist for more information.

• Gilenya may cause serious side effects, including:

Slow heart rate (bradycardia or bradyarrhythmia) when you start taking Gilenya. This medication can cause your heart rate to slow down, especially after you take your first dose. You will have a test to check the electrical activity of your heart (ECG) before you take your first dose of Gilenya.

You should stay in a medical facility for at least 6 hours after you take your first dose of Gilenya.

After you take your first dose of Gilenya:

• Your pulse and blood pressure should be checked every hour.
• You should be watched by a healthcare professional to see if you have any serious side effects. If your heart rate slows down too much, you may have symptoms such as:
  • dizziness
  • tiredness
  • feeling like your heart is beating slowly or skipping beats
• If you have any of the symptoms of slow heart rate, they will usually happen during the first 6 hours after your first dose of Gilenya. Symptoms can happen up to 24 hours after you take your first Gilenya dose.
• 6 hours after you take your first dose of Gilenya you will have another ECG. If your ECG shows any heart problems or if your heart rate is still too low or continues to decrease, you will continue to be watched.
• If you have any serious side effects after your first dose of Gilenya, especially those that require treatment with other medicines, you will stay in the medical facility to be watched overnight. You will also be watched for any serious side effects for at least 6 hours after you take your second dose of Gilenya the next day.
• If you have certain types of heart problems, or if you are taking certain types of medicines that can affect your heart, you will be watched overnight after you take your first dose of Gilenya.

Your slow heart rate will usually return to normal within 1 month after you start taking Gilenya.

Call your doctor or go to the nearest emergency room right away if you have any symptoms of slow heart rate.

Infections. Gilenya can increase your risk of serious infections. Gilenya lowers the number of white blood cells (lymphocytes) in your blood. This will usually go back to normal within 2 months of stopping treatment. Your doctor may do a blood test before you start taking Gilenya. Call your doctor right away if you have any of these symptoms of an infection:

• fever
• tiredness
• body aches
• chills
• nausea
• vomiting

Rare Brain Infection (progressive multifocal leukoencephalopathy (PML)). PML is a rare and serious brain infection that usually leads to death or severe disability. 

If PML happens, it usually happens in people with weakened immune systems but has happened in people who do not have weakened immune systems.

Symptoms of PML get worse over days to weeks. Call your doctor right away if you have any new or worsening symptoms of PML, that have lasted several days, including:

• weakness on 1 side of your body
• loss of coordination in your arms and legs
• decreased strength
• problems with balance
• changes in your vision
• changes in your thinking or memory/confusion
• changes in your personality

Do not stop taking Gilenya without first discussing any questions or concerns with your health care professionals. 

A problem with your vision called macular edema. Macular edema can cause some of the same vision symptoms as an MS attack (optic neuritis). You may not notice any symptoms with macular edema. Macular edema usually starts in the first 3 to 4 months after you start taking Gilenya. Your doctor should test your vision before you start taking Gilenya and 3 to 4 months after you start taking Gilenya, or any time you notice vision changes during treatment with Gilenya. Your risk of macular edema may be higher if you have diabetes or have had an inflammation of your eye called uveitis.

Call your doctor right away if you have any of the following:

• blurriness or shadows in the center of your vision
• a blind spot in the center of your vision 
• sensitivity to light
• unusually colored (tinted) vision

Breathing Problems. Some people who take Gilenya have shortness of breath. Call your doctor right away if you have trouble breathing.

Liver problems. Gilenya may cause liver problems. Your doctor should do blood tests to check your liver before you start taking Gilenya. Call your doctor right away if you have any of the following symptoms of liver problems: 

• nausea
• vomiting
• stomach pain 
• loss of appetite
• tiredness
• your skin or the whites of your eyes turn yellow
• dark urine 

Types of skin cancer called basal cell carcinoma (BCC) and melanoma. Tell your doctor if you have any changes in the appearance of your skin.

Increased blood pressure. Your doctor will monitor your blood pressure. 

Swelling and narrowing of the blood vessels in your brain. Call your doctor right away if you have any of the following symptoms:

• sudden severe headache
• sudden confusion
• sudden loss of vision or other changes in your vision
• seizure

Do not take Gilenya if you:

• have had a heart attack, unstable angina, stroke or warning stroke or certain types of heart failure in the last 6 months
• have certain types of irregular or abnormal heartbeat (arrhythmia), including patients in whom a heart finding called prolonged QT is seen on ECG before starting Gilenya 
• are taking certain medicines that change your heart rhythm

If any of the above situations apply to you, tell your doctor.

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Gilenya, there are no specific foods that you must exclude from your diet when receiving this medication.

Before you take Gilenya, tell your doctor about all your medical conditions, including if you had or now have:

• an irregular or abnormal heartbeat (arrhythmia)
• a history of stroke or warning stroke 
• heart problems, including heart attack or angina
• a history of repeated fainting (syncope)
• a fever or infection, or you are unable to fight infections. Tell your doctor if you have had chicken pox or have received the vaccine for chicken pox. Your doctor may do a blood test for chicken pox virus. You may need to get the vaccine for chicken pox and then wait 1 month before you start taking Gilenya.
• eye problems, especially an inflammation of the eye called uveitis.
• diabetes
• breathing problems, including during your sleep
• liver problems
• high blood pressure
• are pregnant or breastfeeding

Tell your doctor if you are allergic to Gilenya or to any of its ingredients. 

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant. Gilenya may harm your unborn baby.

• Tell your doctor right away if you become pregnant while taking Gilenya or if you become pregnant within 2 months after you stop taking Gilenya.
• If you are a female who can become pregnant, you should use effective birth control during your treatment with Gilenya and for at least 2 months after you stop taking Gilenya.

Pregnancy Registry: There is a registry for women who become pregnant during treatment with Gilenya. If you become pregnant while taking Gilenya, talk to your doctor about registering with the Gilenya Pregnancy Registry. The purpose of this registry is to collect information about your health and your baby’s health.

Tell your doctor if you are breastfeeding or plan to breastfeed. It is not known if Gilenya passes into your breast milk. You and your doctor should decide if you will take Gilenya or breastfeed. You should not do both.

• Your first dose of Gilenya will be given in a medical facility where you will be watched for at least 6 hours after your first dose of Gilenya. See "Drug Precautions".
• Take Gilenya exactly as your doctor tells you to take it. 
• Take Gilenya 1 time each day. 
• Take Gilenya with or without food.
• Do not stop taking Gilenya without talking with your doctor first.
• If you start Gilenya again after stopping for 2 weeks or more, you will start taking Gilenya again in your doctor’s office or clinic.

Call your doctor right away if you miss a dose of Gilenya.

• You may need to be observed by a healthcare professional for at least 6 hours when you take your next dose.
• If you need to be observed by a healthcare professional when you take your next dose of Gilenya you will have:
  • an ECG before you take your dose
  • hourly pulse and blood pressure measurements after you take the dose
  • an ECG 6 hours after your dose

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

Adults and pediatric patients (10 years of age and older) weighing more than 40 kg: The recommended dose of Gilenya (fingolimod) is 0.5 mg orally once daily.

Pediatric patients (10 years of age and above) weighing less than or equal to 40 kg: The recommended dose of Gilenya (fingolimod) is 0.25 mg orally once-daily.

If you take too much Gilenya, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

If Gilenya is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if an overdose is suspected, seek emergency medical attention.

• Store Gilenya in the original blister pack in a dry place. 
• Store Gilenya at room temperature between 59°F to 86°F (15°C to 30°C). 
• Keep Gilenya and all medicines out of the reach of children.