sclerosis (MS). Discover your
number of relapses in the first once-daily* pill.
• 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 breast-feed, as it is not
known if GILENYA passes into breast milk. A
pregnancy registry is available for women who
become pregnant during GILENYA treatment.
Tell your doctor about all your medical conditions,
including if you had or now have an irregular
or abnormal heartbeat; a heart rate less than
55 beats a minute; heart problems; a history
of 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 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; 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.
Ask your doctor about the possibilities
with GILENYA—and if it’s right for you.
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 doctor’s office or clinic,
where you will be observed for 6 hours. If you stop
taking GILENYA for 2 weeks or more, you will need to
repeat this observation.
Please see Brief Summary of Important Product Information on the adjacent pages.