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 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:
• 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
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.
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.
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
What is GILENYA?
GILENYA is a prescription medicine used to treat relapsing forms
of multiple sclerosis (MS) in adults. GILENYA can decrease the
number of MS flare-ups (relapses). GILENYA does not cure MS,
but it can help slow down the physical problems that MS causes.
It is not known if GILENYA is safe and effective in children under
Who should not take GILENYA?
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.
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 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
• 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 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