Dedicated Support

GILENYA Go Program support for your child

Dedicated support tailored to you and your child

The GILENYA® Go Program Support Team is here to make sure you and your child have someone to lean on when you need it. A dedicated Support Specialist will be available to make sure you and your child's GILENYA journey is as smooth as possible.

Here are some of the things GILENYA Go Program Support Specialists can do for you:

Gilenya Go Program support benefits

$0 Co-pay* available for eligible children taking GILENYA

copay

Finances should not come between someone with relapsing MS and treatment. More than 95% of people with insurance have coverage for GILENYA and your dedicated Support Specialist is here to help you explore options when it comes to paying for your child's treatment.

After we receive your child's GILENYA Start Form, your Support Specialist will check your existing insurance coverage and call to explain your benefits. You and your child will also get a GILENYA Go Program Welcome Kit which can help you learn more about getting started on GILENYA.

STEPS TO STARTING

We want to make sure GILENYA is right for your child. That's why there are some tests your child will take before starting GILENYA, which your dedicated Support Specialist will schedule. The tests provide information that can help determine if GILENYA is right for your child. These include:

A blood test

A Blood Test

This checks liver function and how many white blood cells someone has in their body before starting GILENYA.

An Eye Exam

An Eye Exam

This checks for a visual problem called macular edema. You should schedule a follow-up eye exam for your child 3 to 4 months after starting GILENYA.

An Electrocardiogram (ECG)

An Electrocardiogram (ECG)

This checks your child's heart activity and sets a baseline heart rate prior to his or her first dose of GILENYA.

Scheduled Vaccinations

Scheduled Vaccinations

If you are the caregiver of a child between the ages of 10 and 17 who will be starting GILENYA, check with your child's doctor about your child's vaccine schedule, as it is recommended that it be completed before starting treatment with GILENYA.

YOUR CHILD'S FIRST DAY ON GILENYA

Your child will also be monitored for at least 6 hours during his or her first time taking GILENYA, because his or her heart rate is expected to temporarily slow down the first time taking GILENYA. This process can be done in a doctor's office, in a medical facility, or even in the comfort of your own home. For more information about this first-dose observation (FDO), see our FDO information page.

Your dedicated Support Specialist will check in with you after your child's first dose to make sure everything is going smoothly. If your child taking GILENYA weighs 88.2 lb or less, they will start with a 0.25 mg dosage and the GILENYA Go Program will supply his or her refills. After exceeding that weight, his or her health care professional may recommend your child move up to the 0.5 mg dosage, and at that time, your child will be monitored again during the first dose.

DEDICATED PARENT LINE

DEDICATED PARENT LINE

If you still have questions, feel free to call our dedicated parent line at 1-800-598-1410, 8 AM to 9 PM ET, Monday through Friday.§

§Excludes public holidays.

DEDICATED PARENT LINE

*Limitations apply. Valid only for those with private insurance. The Program includes the Co-pay Card, Payment Card (if applicable), and Rebate, with a combined annual limit up to $18,000. Patient is responsible for any costs once limit is reached in a calendar year. Program not valid (i) under Medicare, Medicaid, TRICARE, VA, DoD, or any other federal or state health care program, (ii) where patient is not using insurance coverage at all, (iii) where the patient's insurance plan reimburses for the entire cost of the drug, or (iv) where product is not covered by patient's insurance. The value of this program is exclusively for the benefit of patients and is intended to be credited towards patient out-of-pocket obligations and maximums, including applicable co-payments, coinsurance, and deductibles. Program is not valid where prohibited by law. Patient may not seek reimbursement for the value received from this program from other parties, including any health insurance program or plan, flexible spending account, or health care savings account. Patient is responsible for complying with any applicable limitations and requirements of their health plan related to the use of the Program. Valid only in the United States and Puerto Rico. This Program is not health insurance. Program may not be combined with any third-party rebate, coupon, or offer. Proof of purchase may be required. Novartis reserves the right to rescind, revoke, or amend the Program and discontinue support at any time without notice.

As of January 2019. Novartis Pharmaceuticals Corporation does not endorse any particular plan. Check with your individual health plans.

EFFICACY RESULTS IN CHILDREN

See how GILENYA has been shown to help children as young as 10 and their parents fight back against MS.

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SAFETY INFORMATION

Take a look at some important safety information to see if GILENYA may be right for your child.

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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 mini-stroke (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.
  • 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. Lymphoma has also occurred in patients receiving GILENYA.

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.

 
Novartis

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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