number of relapses in the first once-daily* pill.
Your risk of macular edema may be higher if you
have diabetes or have had an inflammation of
your eye (uveitis). Call your doctor right away if
you have blurriness, shadows, or a blind spot in
the center of your vision; sensitivity to light; or
unusually colored vision.
• Breathing problems. Some patients have
shortness of breath. Call your doctor right
away if you have trouble breathing.
• Liver problems. Your doctor should do blood
tests to check your liver before you start
GILENYA. Call your doctor right away if you
have nausea, vomiting, stomach pain, loss of
appetite, tiredness, dark urine, or if your skin
or the whites of your eyes turn yellow.
• Increases in blood pressure (BP). BP should be
monitored during treatment.
GILENYA may harm your unborn baby. Talk to your
doctor if you are pregnant or planning to become
pregnant. Women who can become pregnant
should use effective birth control while on GILENYA,
and for at least 2 months after stopping. If you
become pregnant while taking GILENYA, or
within 2 months after stopping, tell your doctor
right away. Women who take GILENYA should
not breastfeed, as it is not known if GILENYA
passes into breast milk. A pregnancy registry is
available for women who become pregnant
during GILENYA treatment. Call 1-877-598-7237
or visit www.gilenyapregnancyregistry.com for
Tell your doctor about all your medical conditions,
including if you had or now have an irregular or
abnormal heartbeat; history of stroke or warning
stroke; heart problems; a history of repeated
fainting; a fever or infection, or if you are unable to
fight infections; eye problems; diabetes; breathing
or liver problems; or high blood pressure. Also tell
your doctor if you have had chicken pox or have
received the vaccine for chicken pox. Your doctor
may do a test for the chicken pox virus, and you
may need to get the vaccine for chicken pox and
wait 1 month before starting GILENYA.
Tell your doctor about all the medicines you take,
including medicines for heart problems or high
blood pressure or other medicines that may lower
your heart rate or change your heart rhythm;
medicines that could increase your chance of
infections, such as medicines to treat cancer or
control your immune system; or ketoconazole
(an antifungal) by mouth. If taken with GILENYA,
serious side effects may occur. You should not
get certain vaccines while taking GILENYA, and
for at least 2 months after stopping.
The most common side effects with GILENYA were
headache, flu, diarrhea, back pain, abnormal liver
tests, and cough.
You are encouraged to report negative side
effects of prescription drugs to the FDA. Visit
www.fda.gov/medwatch, or call 1-800-FDA-1088.
*GILENYA can result in a slow heart rate when first
taken. Your first dose will be given in a medical
facility where you will be watched for at least 6
hours. If you stop taking GILENYA for more than
14 days after your first month of treatment, you
will need to repeat this observation.
Please see Brief Summary of Important Product Information on next pages.