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Important Questions to Ask Your Doctor About Multiple Sclerosis

  1. What course of multiple sclerosis do you think I have?
  2. What additional symptoms could I develop?
  3. How can I better manage symptoms at home?
  4. What drug(s) should I take to treat my MS?
  5. How will I know if the drugs are working?
  6. What side effects should I expect, and how should I respond to them?
  7. Is there anything else I can do to cope with worsening symptoms?
  8. What do you recommend for treating the symptoms of my MS (like muscle spasms or pain)?
  9. What types of lifestyle changes, exercise, or physical therapy can be helpful for me?
  10. Where can I find more information about MS?
  11. Where can I find information about clinical trials?
  12. Are there any local support groups?

 

Learn About Relapsing Multiple Sclerosis (MS) Treatment with GILENYA
Missi L. is a GILENYA guide and a paid Novartis spokesperson.
12/11 GYA-1113714

Indication

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.

Important Safety Information

GILENYA may cause serious side effects such as:

  • Slow heart rate, especially about 6 hours after your first dose. If your heart rate slows down, you might feel dizzy or tired, or be aware of a slow or irregular heartbeat. Your doctor will watch you for the first 6 hours after your first dose for any serious side effects. If you experience slow heart rate, it will usually return to normal within 1 month. Call your doctor if at any time you have dizziness, tiredness, or a slow or irregular heartbeat. If you stop taking GILENYA for 2 weeks or more, you will need to repeat this observation.
  • GILENYA may cause serious side effects such as increased 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 GILENYA. Your doctor may do a blood test before you start GILENYA. Increased risk of infection was seen with doses higher than the approved dose (0.5 mg). Two patients died who took higher-dose GILENYA (1.25 mg) combined with high-dose steroids. Call your doctor right away if you have fever, tiredness, body aches, chills, nausea, or vomiting.
  • Macular edema, a vision problem, can cause some of the same vision symptoms as an MS attack (optic neuritis), or no symptoms. Macular edema usually starts in the first 3 to 4 months after starting GILENYA. Your doctor should test your vision before you start GILENYA; 3 to 4 months after you start GILENYA; and any time you notice vision changes. Vision problems may continue after macular edema has gone away. 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 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. Call 1-877-598-7237 for more information.

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.

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.

Please see Full Prescribing Information, including Patient Medication Guide.

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