How GILENYA Works

MS pill

To understand how GILENYA affects the body, we need to start at the beginning.

Multiple sclerosis (MS) is an autoimmune disease that attacks the healthy tissues in the central nervous system (CNS). When MS attacks myelin—the covering that surrounds and protects the body's nerve fibers—nerve impulses are interrupted, causing MS symptoms.

See how GILENYA is thought to work

Research is still being done on which immune cells are mounting the attack, the factors that cause the attack, and the sites that appear to be attracted to the myelin to begin the destructive process. There are plenty of websites that provide a more thorough scientific description of this process (check out nmss.org, for example), but here's a quick snapshot on how cells called lymphocytes affect the immune system.

The immune system contains a network of lymph nodes, which are tiny glands containing immune cells called lymphocytes. Lymphocytes are normally good guys, but sometimes they can go rogue. This can mean they go after your CNS and cause problems.

While it's not exactly clear how GILENYA works, it is thought to keep lymphocytes from attacking your CNS by lowering the number of lymphocytes circulating in your blood.

GILENYA may lead to a slow heart rate after you take your first dose—here's why

GILENYA works differently from other MS treatments. One difference—your heart rate is expected to slow down the first time you take GILENYA.

This slowdown is usually temporary. Not only that, in clinical trials, less than 1% of adults taking GILENYA experienced symptoms of slow heart rate. Whether you're part of this 1% or not, you will still be monitored during your first dose—so it's important for you to understand what's happening.

Why does GILENYA affect your heart?

By now, you know that MS happens when your lymphocytes, and other immune cells, mistakenly attack your central nervous system.

How can GILENYA help? GILENYA is thought to help by activating certain sensors on your lymph nodes, which keeps some white blood cells in your lymph nodes. That way, these white blood cells aren't released into your bloodstream, where they can attack your central nervous system.

GILENYA also activates certain sensors on your heart (similar to the ones on your lymph nodes), which cause your heart rate to slow down. Unlike the sensors on your lymph nodes, the effect on the sensors on your heart is temporary and only happens when you start GILENYA. This slowdown in heart rate is expected, and it's the reason you're monitored during your first dose.

If you're one of the few people who experiences symptoms of slow heart rate (such as dizziness, tiredness, feeling like your heart is beating slowly or skipping beats, or chest pain), the health care professional monitoring you can help you manage these symptoms.

Symptoms of slow heart rate usually happen within the first 6 hours of your first dose, and can happen up to 24 hours after your first dose. To help you start off safely and confidently, we'll make sure your heart rate is monitored by a health care professional for these first 6 hours when you take your first dose. If your ECG shows any heart problems or if your heart rate is still too low or continues to decrease, you will continue to be observed.

*This effect was only observed in animal models.

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INDICATION

GILENYA is a prescription medicine used to treat relapsing forms of multiple sclerosis (MS) in adults and children 10 years of age and older.

IMPORTANT SAFETY INFORMATION

You should not take GILENYA if in the last 6 months you experienced heart attack, unstable angina, stroke or ministroke (transient ischemic attack or TIA), or certain types of heart failure. Do not take GILENYA if you have an irregular or abnormal heartbeat (arrhythmia), including a heart finding called prolonged QT as seen on an ECG, or if you take medicines that change your heart rhythm. Do not take GILENYA if you are allergic to fingolimod or any of the other ingredients.

GILENYA may cause serious side effects such as:

  • Slow heart rate, especially after first dose. Adults and children will be monitored by a health care professional for at least 6 hours after the first dose or after a child takes the first dose of 0.5mg of GILENYA when switching from 0.25mg daily dose. Your pulse and blood pressure will be checked hourly. You'll get an ECG before and 6 hours after your first dose. If any heart problems arise or your heart rate is still low, you'll continue to be monitored. If you have any serious side effects, especially those that require treatment with other medicines, or if you have certain types of heart problems, or if you're taking medicines that can affect your heart, you'll be watched overnight. If you experience slow heart rate, it will usually return to normal within 1 month. Call your doctor, or seek immediate medical attention if you have any symptoms of slow heart rate, such as dizziness, tiredness, feeling like your heart is beating slowly or skipping beats, or chest pain. Symptoms can happen up to 24 hours after the first dose. Call your doctor if you miss 1 or more doses of GILENYA—you may need to repeat the 6-hour monitoring.
  • Increased risk of serious infections, some of which could be life threatening and cause death. You should not receive live vaccines during treatment with GILENYA and for 2 months after you stop taking GILENYA. Vaccines may not work as well when given during treatment with GILENYA. 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 to check your white blood cells before you start GILENYA. Call your doctor right away if, while taking GILENYA or for 2 months after your last dose, you have fever, tiredness, body aches, chills, nausea, vomiting, or headache accompanied by fever, neck stiffness, sensitivity to light, nausea, and/or confusion. These may be symptoms of meningitis.
  • Progressive multifocal leukoencephalopathy (PML). PML is a rare brain infection that usually leads to death or severe disability. If PML happens, it usually happens in people with weakened immune systems but has happened in people who do not have weakened immune systems. Call your doctor right away if you have any new or worsening symptoms of PML that have lasted several days, including changes in your thinking or memory, changes in your vision, decreased strength, problems with balance, weakness on 1 side of your body, loss of coordination in your arms and legs, confusion or changes in your personality.
  • Macular edema, a vision problem that can cause some of the same vision symptoms as an MS attack (optic neuritis), or no symptoms. If it happens, 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 is 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.
  • Swelling and narrowing of the blood vessels in your brain. A condition called PRES (posterior reversible encephalopathy syndrome) has happened rarely in adults taking GILENYA. Symptoms of PRES usually get better when you stop taking GILENYA. However, if left untreated, it may lead to a stroke. Call your doctor right away if you experience any symptoms, such as sudden severe headache, sudden confusion, seizures, or sudden loss of 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.
  • Severe worsening of MS after stopping GILENYA. Many people who have worsening of MS symptoms after stopping GILENYA do not return to the level of function that they had before or during treatment with GILENYA. This can also occur in women stopping due to pregnancy or planning a pregnancy. This worsening happens most often within 12 weeks after stopping GILENYA, but can happen later. Do not stop taking GILENYA without talking with your doctor. Tell your doctor if you have worsening symptoms of MS after stopping GILENYA.
  • Increases in blood pressure (BP). BP should be monitored during treatment.
  • Skin cancers including basal and Merkel cell carcinoma and melanoma. Tell your doctor if you have any changes in the appearance of your skin, including changes in a mole, new darkened area in your skin, a sore that does not heal, or growths on your skin such as a bump that may be shiny, pearly white, skin colored, or pink. While taking GILENYA, limit the amount of time you spend in sunlight and ultraviolet (UV) light as well as use sunscreen with a high sun protection factor and wear protective clothing.

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. It is not known if GILENYA passes into breast milk. Talk to your doctor about the best way to feed your baby if you take GILENYA. A pregnancy registry is available for women who become pregnant during GILENYA treatment. For more information, contact the GILENYA Pregnancy Registry by calling Quintiles at 1-877-598-7237, by e-mailing gpr@quintiles.com, or by going to www.gilenyapregnancyregistry.com.

Tell your doctor about all your medical conditions, including if you had or now have an irregular or abnormal heartbeat; stroke or mini-stroke; heart problems; a history of repeated fainting; a fever or infection, or if you are unable to fight infections due to a disease or are taking medicines that lower your immune system, including corticosteroids, or have taken them in the past; eye problems; diabetes; breathing or liver problems; or uncontrolled high blood pressure. Also tell your doctor if you have had chicken pox or have received the chicken pox vaccine. Your doctor may test for the chicken pox virus, and you may need to get the full course of the chicken pox vaccine and wait 1 month before starting GILENYA. Children 10 years and older should complete their vaccination schedule before starting GILENYA.

If you take too much GILENYA, call your doctor or go to the nearest hospital emergency room right away.

Tell your doctor about all the medicines you take or have recently taken, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

The most common side effects with GILENYA were headache, abnormal liver tests, diarrhea, cough, flu, sinusitis, back pain, abdominal pain, and pain in arms or legs.

In the pediatric study:

  • The safety in children 10 years and older receiving GILENYA was similar to that seen in adults.
  • The rate of seizures was higher in GILENYA-treated patients compared to that of a leading injectable.

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.

 
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Speak up and share your message. Tell multiple sclerosis (MS) how you really feel by posting your message on our "HEY MS" message board.

Make sure your voice is heard. We love that you want to say "Take This!" to relapsing MS, but there are still some words even we can't use—words that might not be appropriate. They're defined in the Community Guidelines below. But have no fear; we'll give you a heads up if you use any problematic words by highlighting them after you hit submit. So, go for it, and tell relapsing MS how you really feel!

  • 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 websites or social networks in your message

  • Refrain from sharing any treatment and/or dosage information, as well as names of specific medicines (brand name or generic) and product manufacturers

  • Avoid mention of side effects from GILENYA. We take drug product safety seriously. 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 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

 
 

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