What is Gilenya? Uses, warnings & side effects

How to take Gilenya

• Your doctor will tell you how much medicine to use. Do not use more than directed. Your doctor will give you the first dose of this medicine. You may need to stay in the hospital or clinic for at least 6 hours after the first dose to check for unwanted effects.

• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.

• Missed dose: If you missed a dose, call your doctor or pharmacist for instructions.

• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.

• Missed dose: If you missed a dose, call your doctor or pharmacist for instructions.

• Your doctor will tell you how much medicine to use. Do not use more than directed. Your doctor will give you the first dose of this medicine. You may need to stay in the hospital or clinic for at least 6 hours after the first dose to check for unwanted effects.

• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

What to do if you miss a dose of Gilenya

Gilenya contraindications - Who shouldn't take Gilenya?

• This medicine is not right for everyone. Do not use it if you had an allergic reaction to fingolimod.

Gilenya warnings

• It is not safe to take this medicine during pregnancy. It could harm an unborn baby. Tell your doctor right away if you become pregnant. Use effective birth control to prevent pregnancy during treatment with this medicine and for 2 months after your last dose.

• Tell your doctor if you are breastfeeding, or if you have kidney disease, liver disease, diabetes, any type of infection or an infection that keeps coming back, or a history of uveitis (swelling in the eye).

• This medicine may cause slow or uneven heartbeat. Because of this side effect, tell your doctor about any heart or circulation problems you have, including heart disease, high blood pressure, heart attack, stroke, heart failure, heart block, angina, or other rhythm problems (including sick sinus syndrome or long QT). Also tell your doctor if you have sleep apnea or a history of repeated fainting.

• This medicine may cause the following problems:Macular edema (swelling in the eye)Progressive multifocal leukoencephalopathy (PML, a brain infection that can be life-threatening)Posterior reversible encephalopathy syndrome (swelling in the brain)Lung or breathing problemsLiver problemsHigh blood pressureIncreased risk of skin cancer (including basal cell carcinoma, melanoma) or lymphoma

• This medicine may cause a severe increase in disability (including worsening of MS symptoms) for at least 12 to 24 weeks after stopping the medicine. Talk to your doctor if you have concerns about this.

• This medicine lowers the number of white blood cells. This weakens your immune system, so you may get infections more easily. Wash your hands often. Avoid people who are sick. Reported infections include bronchitis, pneumonia, varicella zoster, or herpes simplex, which could be life-threatening. This risk could last up to 2 months after you stop fingolimod treatment.

• Do not stop using this medicine and then start it again without talking first to your doctor. Your heartbeat may need to be monitored.

• This medicine may make your skin more sensitive to sunlight. Wear sunscreen. Do not use sunlamps or tanning beds.

• Tell any doctor or dentist who treats you that you are using this medicine. This medicine may affect certain medical test results.

• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.

• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Gilenya interactions & what to avoid when taking Gilenya

• Do not use fingolimod if you also use medicine for heart rhythm problems.

• Some medicines can affect how fingolimod works. Tell your doctor if you are using any of the following:Chlorpromazine, citalopram, erythromycin, haloperidol, ketoconazole, methadone, mitoxantrone, natalizumab, teriflunomideBeta-blocker medicine or other medicine that affects your heart or blood pressure (including digoxin, diltiazem, verapamil)Steroid medicine (including dexamethasone, hydrocortisone, methylprednisolone, prednisolone, prednisone)

• This medicine may interfere with vaccines. Ask your doctor before you get a flu shot or any other vaccines. Avoid receiving live vaccines during treatment with this medicine and for 2 months after the last dose.

• This medicine may cause the following problems:Macular edema (swelling in the eye)Liver problemsProgressive multifocal leukoencephalopathy (PML, a brain infection that can be life-threatening)Posterior reversible encephalopathy syndrome (swelling in the brain)Basal cell carcinoma (skin cancer)

• Do not stop taking this medicine and then start again without talking to your doctor. Your heartbeat may need to be monitored.

• Your doctor will check your progress and the effects of this medicine at regular visits. Keep all appointments.

• Keep all medicine out of the reach of children. Never share your medicine with anyone.

• This medicine lowers the number of white blood cells. This weakens your immune system, so you may get infections more easily. Wash your hands often. Avoid people who are sick. Reported infections include bronchitis, pneumonia, varicella zoster, or herpes simplex. This risk could last up to 2 months after you stop fingolimod treatment.