ed on animal studies, GILENYA may cause fetal harm. Discuss with women of childbearing age whether they are pregnant, might be pregnant or are trying to become pregnant. Advise women of childbearing age of the need for effective contraception during GILENYA treatment and for two months after stopping GILENYA. Advise the patient that if she should nevertheless become pregnant, she should immediately inform her physician.
17.8 Persistence of GILENYA effects after drug discontinuationAdvise patients that GILENYA remains in the blood and continues to have effects, including decreased blood lymphocyte counts, for up to two months following the last dose.
T2011-104
MEDICATION GUIDE
GILENYA™ (je-LEN-yah)
(fingolimod)
capsules
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?
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:
dizziness
tiredness
a slow or irregular heartbeat
2.Infections. GILENYA can increase your risk of serious infections. GILENYAlowers 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:
fever
tiredness
body aches
chills
nausea
vomiting
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
