Read this Medication Guide before you start using GILENYA and
each time you get a refill. There may be new information. This
information does not take the place of talking with your doctor
about your medical condition or your treatment.
What is the most important information I should know about
GILENYA may cause serious side effects, including:
1. Slow Heart Rate (bradycardia or bradyarrhythmia) when you
start taking GILENYA. GILENYA can cause your heart rate to
slow down, especially after you take the first dose. Your heart
rate will usually slow down the most about 6 hours after you
take your first dose of GILENYA. You might feel dizzy or tired
or be aware of a slow or irregular heartbeat if your heart rate
slows down. Usually, if you experience these types of symptoms due to the slowing down of your heart rate, they will
occur during the first 6 hours after the first dose. Your doctor
will watch you for the first 6 hours after you take the first dose
to see if you have any serious side effects. Your slow heart rate
will usually return to normal within 1 month after you start taking GILENYA.
Call your doctor if at any time you have:
• a slow or irregular heartbeat
2. 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:
• body aches
3. 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.
It is not known if GILENYA is safe and effective in children under
What should I tell my doctor before taking GILENYA?
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 heart rate less than 55 beats a minute
• heart problems
• a history of 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
• eye problems, especially an inflammation of the eye called
• breathing problems
• 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 preg-
nant 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
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.
• 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
Know the medicines you take. Keep a list of your medicines with
you to show your doctor and pharmacist when you get a new
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
• Vaccines. Tell your doctor if you have been vaccinated within
1 month before you start taking GILENYA. You should not get cer-
tain 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