FREQUENTLY ASKED
QUESTIONS ABOUT GILENYA®

Not an actual patient.

We're here to help you with any questions you might have about GILENYA or the generic versions of GILENYA. If you have any additional questions about GILENYA or what the generics may mean for you, reach out to your health care professional, insurance company, or pharmacy for more information.

GILENYA & generic fingolimod

Is GILENYA now available as a generic?

Yes, the GILENYA brand of fingolimod has reached the end of its patent exclusivity period. This means that generic fingolimod options are now available for the treatment of RMS.

Now is a great time to talk with your doctor about how you are doing and how your current treatment is effectively managing your RMS.

In addition to GILENYA, Novartis is proud to offer another treatment option for adults with RMS.

This option includes:

  • Proven safety and effectiveness
  • Quick onboarding and support to help you get started
  • Services you've come to expect
LEARN ABOUT ANOTHER RMS TREATMENT

I'm taking branded GILENYA. What does it mean for me now that generics are available?

Now that generic fingolimod is available, this could mean:

  • Your insurance company or pharmacy may switch you to a generic
  • The medication you receive may look different from branded GILENYA or come in different packaging
  • Generic fingolimod is not made by Novartis and won't come with the assistance and support from Novartis that you may currently receive
  • Your out-of-pocket costs may be affected, and financial support from the branded GILENYA Prescription Co-pay Support Program will no longer be available to you

What is the difference between branded GILENYA and generic fingolimod?

The FDA approval for generic fingolimod, the active ingredient in GILENYA, is based on comparability to GILENYA in quality and efficacy.

What does the introduction of generic fingolimod mean for my child?

Like branded GILENYA, generic fingolimod is also approved for treatment of children 10 to 17 years of age. If your child is taking GILENYA, please contact your health care professional to find out how this change may impact your child's treatment and what treatment option is most safe and effective for them.

What branded GILENYA Go Program® services are available to me?

GILENYA Go Program services available for patients prescribed GILENYA prior to December 31, 2022 include*:

  • GILENYA onboarding (pretest, first-dose observation [FDO])
  • Co-pay financial assistance (for patients with commercial insurance). Patients will need to achieve their deductible based on their commercial insurance program requirements

As of January 1, 2023, no new patient Start Forms will be accepted for the GILENYA Go Program. For co-pay assistance, contact 1-855-443-1759.*

*For eligible patients with commercial insurance who do not reside in Massachusetts or California.

Will co-pay assistance be available for me if I start branded GILENYA after December 31, 2022?

Yes, co-pay financial assistance will be available (for patients with commercial insurance) through the end of 2023.* Patients will need to achieve their deductible based on their commercial insurance program requirements. To access the program, patients and health care professionals can call the co-pay support line for GILENYA at 1-855-443-1759.

*For eligible patients with commercial insurance who do not reside in Massachusetts or California.

Taking GILENYA

What if I'm noticing changes while on GILENYA?

If you are noticing any changes while on GILENYA, it may be time to talk to your doctor. Novartis offers another treatment option that may work for you. Explore another treatment option.

Is there another Novartis treatment for RMS?

Novartis offers a portfolio of RMS treatments to provide people with the best possible care. Treatment options are available for adults with RMS. Wherever you are in your MS journey, talk to your doctor about the other RMS treatment options available. Explore one of our treatment options.

Should I keep GILENYA in the refrigerator?

Nope! No need—simply keep GILENYA in a dry, room-temperature (68 °F to 77 °F) place that's out of reach of children.

I'm going to be traveling, how should I pack my GILENYA?

First off, make sure you have enough to get you through your time away and call in a refill if you're short. If you're traveling by plane, keep GILENYA in your carry-on so it doesn't get lost along the way. For car journeys, just make sure GILENYA is kept in a spot that won't get too hot.

What if I forget to take a dose?

Call your health care professional for advice if you miss a dose, or if you're thinking about stopping treatment with GILENYA—it's important that you don't stop without talking to them first.

Starting GILENYA

I am ready to start GILENYA. How do I get started?

Tell your health care professional why you're interested in GILENYA and ask them all your questions. Need help getting that conversation started? Learn more about starting GILENYA. If you have any additional questions, speak with your health care professional.

What's a first-dose observation (FDO)?

An FDO is monitoring done during your first day on GILENYA. Your health care professional can explain more about why it's done and what to expect. It typically takes about 6 hours, and you can do stuff like read, work, or watch movies while the time passes. Learn more about starting GILENYA.

Where will my FDO happen?

At your health care professional's office or at another medical facility—you and your health care professional will decide where's best for you.

What's a specialty pharmacy?

Prescriptions for GILENYA are filled by specialty pharmacies. These pharmacies have a few perks:

  • They support you in ways like answering your questions, making sure you always have enough GILENYA, and finding ways to help you save
  • They deliver GILENYA right to your door, so you can skip those long lines at the local pharmacy
  • They work closely with your health care professional to help them manage your treatment plan

What should I know about GILENYA and family planning?

GILENYA may harm your unborn baby. Effective birth control should be used by people who may become pregnant while taking GILENYA and for at least 2 months after stopping. If you become pregnant or are thinking about trying to become pregnant, tell your health care professional right away.

A pregnancy registry is available for those who become pregnant during GILENYA treatment. Learn more by visiting www.gilenyapregnancyregistry.com.

I'm a new mom on GILENYA—anything I should know?

It's not known if GILENYA passes through breast milk, so ask your health care professional about the best way to feed your baby.

GILENYA & COVID-19

Can I get the COVID-19 vaccine or vaccine boosters before starting GILENYA?

It's understandable to have questions about getting a COVID-19 vaccine or vaccine booster. Vaccines, like the COVID-19 vaccines and vaccine boosters, are an important part of public health. So, you should talk to your doctor to better understand the types of vaccines and vaccine boosters available to you and how to manage getting a vaccine or vaccine booster before starting GILENYA.

The GILENYA Medication Guide does not advise against taking non-live vaccines or boosters; however, they may not work as well when given during treatment with GILENYA.

The National Multiple Sclerosis Society (NMSS) offers more information and guidance on COVID-19 and RMS. Visit their website at nationalmssociety.org.

For more information about COVID-19, visit the Centers for Disease Control and Prevention (CDC) website at CDC.gov and search: COVID-19 vaccines or COVID-19 vaccine boosters.

Can I get the COVID-19 vaccine and vaccine boosters while taking GILENYA?

It's understandable to have questions about getting a COVID-19 vaccine or vaccine booster. Vaccines, like the COVID-19 vaccines and vaccine boosters, are an important part of public health. So, you should talk to your doctor to better understand the types of vaccines and vaccine boosters available to you and how to manage getting a vaccine or vaccine booster while taking GILENYA.

The GILENYA Medication Guide does not advise against taking non-live vaccines or boosters; however, they may not work as well when given during treatment with GILENYA.

The National Multiple Sclerosis Society (NMSS) offers more information and guidance on COVID-19 and RMS. Visit their website at nationalmssociety.org.

For more information about COVID-19, visit the Centers for Disease Control and Prevention (CDC) website at CDC.gov and search: COVID-19 vaccines or COVID-19 vaccine boosters.

Are the available COVID-19 vaccines live or non-live?

Just like some other vaccines you may have received in the past, the COVID-19 vaccines available in the United States as of September 2022 are non-live vaccines. That means the vaccines do not contain live virus and will not cause COVID-19 disease.

Are there any known risks of getting the COVID-19 vaccine while being treated with GILENYA?

The GILENYA Medication Guide does not advise against taking non-live vaccines; however, they may not work as well when given during treatment with GILENYA. COVID-19 vaccines haven't been specifically studied in people taking GILENYA. When we have more clinical information, we'll reach out to both you and the health care community.

As always, your doctor will be the best person to talk to about your overall health concerns and to help make decisions about your treatment.

Where can I get more information about COVID-19 and vaccines for people with RMS?

The National Multiple Sclerosis Society (NMSS) offers information and guidance on COVID-19 for people living with RMS. Your doctor is also a trusted source for guidance on this topic.

Still have questions?

We're ready to answer them at 1-888-NOW-NOVA (1-888-669-6682), 8:30 AM to 5:00 PM ET, Mon-Fri.*

MS=multiple sclerosis; RMS=relapsing MS.

GO PROGRAM is a registered trademark of Novartis AG.

*Excludes public holidays.

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.

Indication

GILENYA is a prescription medicine used to treat relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, 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.

Indication

GILENYA is a prescription medicine used to treat relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults and children 10 years of age and older.

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.

  • During pregnancy. Consult your doctor before getting pregnant. You should avoid becoming pregnant while taking GILENYA or in the 2 months after you stop taking it because of the risk of harm to the baby.

  • 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. Because GILENYA has an increased risk of human papilloma virus (HPV), women should consult their doctor about a routine pap-smear. 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.

  • Liver damage. Your doctor should do blood tests to check your liver before you start GILENYA and periodically during treatment. Call your doctor right away if you have nausea, vomiting, stomach pain, tiredness, loss of appetite, dark urine, or if your skin or the whites of your eyes turn yellow.

  • Breathing problems. Some patients have shortness of breath. Call your doctor right away if you have trouble breathing.

  • 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, squamous, and Merkel cell carcinomas 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 should stop taking GILENYA 2 months before trying 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-1088.1-800-FDA-1088.

Indication

GILENYA is a prescription medicine used to treat relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults and children 10 years of age and older.

Please see full Prescribing Information, including Medication Guide.