•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 plan to become pregnant. GILENYA may harm your unborn baby. Talk to your doctor if you are pregnant or are planning to become pregnant.
•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.

For more information, you can call the GILENYA Pregnancy Registry at 1-877-598-7237 or visit www.gilenyapregnancyregistry.com.

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

Know the medicines you take. Keep a list of your medicines with you to show your doctor and pharmacist when you get a new medicine.

Using GILENYA and other medicines together may affect each other causing serious side effects.

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) by mouth
Ask your doctor or pharmacist for a list of these medicines if you are not sure.

How should I take GILENYA?

•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 "What is the most important information I should know about GILENYA?"

•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.
What are possible side effects of GILENYA?

GILENYA can cause serious side effects.

See "What is the most important information I should know about GILENYA?"

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