LENYA, 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 GILENYA.
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:
•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 is not known if GILENYA is safe and effective in children under age 18.
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 befo
