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?”
Serious side effects include:
• 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
• tiredness
• your skin or the whites of your eyes turn yellow
• dark urine
The most common side effects of GILENYA include:
• headache
• flu
• diarrhea
• back pain
• abnormal liver tests
• cough
Tell your doctor if you have any side effect that bothers you or
that does not go away.
