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GILENYA SAFETY

GILENYA® has been studied in clinical trials and was approved by the FDA back in September 2010.

GILENYA has been prescribed to more than 40,000 people in the United States.

Facts about safety are sometimes mixed up with misconceptions. Don't be fooled — arm yourself with the facts before you and your health care team make a decision. And see what other people have to say about their experiences with GILENYA (check out a few of them right here).

This quick quiz may help you and your doctor know if GILENYA is right for you

Wondering if GILENYA might be right for you? To help you get started, we've created this quick quiz. You can bring these questions to your doctor, since only those conversations with your health care team can truly help you decide what's best for managing your relapsing multiple sclerosis (MS). You can simply download and print out these questions, then bring them with you when you visit your doctor.

  • Have you experienced:
    heart attack
    unstable angina
    stroke or warning stroke
    certain types of heart failure
  • Do you have:
    irregular or abnormal heartbeat
  • Do you:
    take medicines that change heart rhythm

If you answered "No" to these 3 questions, GILENYA may be right for you. It's worth doing a little more homework and talking to your doctor.

If you answered "Yes" to any of these 3 questions, GILENYA may not be right for you. Certain heart conditions may prevent you from making GILENYA your choice. Obviously, only you and your health care team can decide, so ask your doctor to explain more about this before you make any final decisions.

Common Side Effects

The most common side effects of GILENYA are:

  • Headache
  • Flu
  • Diarrhea
  • Back pain
  • Abnormal liver tests
  • Cough

Your safety matters to us. If you're considering taking GILENYA, there are some serious side effects we'd like you to know about:

Slow heart rate

It's fairly common for you to experience slow heart rate after you take your first dose. That's why your doctor and health care team will watch you in a medical facility for at least 6 hours when you take your first dose, and you will have a test to check the electrical activity of your heart (ECG). It's the best way to make sure you're starting off right.

After you take your first dose of GILENYA:

  • Your pulse and blood pressure will be checked every hour
  • You should be watched by a health care professional to see if you have any serious side effects. If your heart rate slows down too much, you may have symptoms such as:
    • Dizziness
    • Tiredness
    • Feeling like your heart is beating slowly or skipping beats
  • If you experience slow heart rate, it will usually happen during the first 6 hours after your first dose of GILENYA, but can happen up to 24 hours after your first dose
  • Six hours after you take your first dose of GILENYA, you will have another ECG. If your ECG does not show any issues, you will probably be ready to head home. If the test shows any heart problems, or if your heart rate is still too low or continues to decrease, you will continue to be watched
  • If you have any serious side effects after your first dose of GILENYA, 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 are taking certain types of medicines that can affect the 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, like dizziness, tiredness, or feeling like your heart is skipping beats.

Risk of serious 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

Problems with your vision

Some people may experience a problem with their vision called macular edema. This can cause some of the same vision symptoms as an MS attack (optic neuritis). You may not notice any symptoms, but if macular edema occurs, it usually begins in the first 3 to 4 months after starting GILENYA.

Your doctor should test your vision before you start taking GILENYA, as well as 3 to 4 months into treatment, or any time you notice vision changes. Your risk of macular edema may be higher if you have diabetes or have had an inflammation of the 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

Breathing problems

Some people who take GILENYA have shortness of breath. Call your doctor right away if you have trouble breathing.

Liver problems

GILENYA may cause liver problems. Your doctor should do blood tests to check your liver before you start taking GILENYA.

These are not the only side effects. For additional information, ask your doctor or pharmacist, and see Important Safety Information.

Call your doctor right away if you have any of the following symptoms of liver problems:

  • Nausea
  • Vomiting
  • Stomach pain
  • Loss of appetite
  • Tiredness
  • Your skin or the whites of your eyes turn yellow
  • Dark urine

Blood Pressure

Some people who take GILENYA may experience increases in blood pressure (BP). Your health care provider should monitor your BP during your treatment.

*GILENYA can result in a slow heart rate when first taken. You will be observed by a health care professional for at least 6 hours after you take your first dose. You may need to repeat this monitoring if you miss a dose.

Safety of GILENYA

 
 

For relapsing forms of multiple sclerosis (MS)

 
Join the "HEY MS" Conversation!
Novartis

Speak up and share your message. Tell MS how you really feel by posting your message on the GILENYA® map.

Please know we may not be able to post part or all of your message — but we're still listening! To help ensure your message gets posted, please read our Community Guidelines before proceeding:

  • Do not include medical advice or any non-approved use of GILENYA

  • No profane, indecent, or inappropriate language in your message or image, please (a no-no)

  • Avoid using your full name and/or e-mail address in your message, so this personal information remains private and protected

  • Do not include spam, such as links to, or URLs for, other Web sites or social networks in your message

  • Avoid mention of side effects from GILENYA. We take drug product safety seriously. If you are experiencing a side effect, we encourage you to report it to the FDA directly at www.fda.gov/medwatch or
    1-800-FDA-1088

Please note that in order to comply with our Community Guidelines as well as the FDA's Prescription Drug Advertising Guidelines, your statement may be subject to modification, while maintaining the spirit of your message. Your photo and statement may be used in other GILENYA marketing materials.