Gilenya (Fingolimod) for Multiple Sclerosis

What Members SayTop TipsSide EffectsCopay HelpFAQs

Gilenya (fingolimod) is a prescription medication approved by the U.S. Food and Drug Administration (FDA) to treat relapsing forms of multiple sclerosis (MS) in adults and children 10 years and older.

What Members Say

MHT logo These insights are based on 7,373 comments about Gilenya from MyMSTeam members. These are the experiences of a small number of people and are not meant to be medical advice.

Benefits:

Once-daily capsules feel easier than injections or infusions.
Some people have fewer relapses or longer periods without flare-ups.
Oral dosing can make travel and day-to-day treatment feel simpler.

Considerations:

You need to be monitored for at least six hours after your first dose because the medicine can slow your heart rate.
Infection risk is an important concern because white blood cell counts can drop.
Stopping treatment can be followed by severe worsening of multiple sclerosis.

How Gilenya Works and How It’s Taken

Gilenya is a type of medication called a sphingosine 1-phosphate receptor modulator. It works by keeping certain white blood cells, called lymphocytes, inside the lymph nodes. This lowers the number of these cells in the blood.

This may help reduce damage to the brain and spinal cord in people with multiple sclerosis. The exact way it works is not fully known.

Doctors prescribe Gilenya for people 10 years and older who have relapsing forms of multiple sclerosis. This includes clinically isolated syndrome, relapsing-remitting MS, and active secondary progressive MS. By targeting this pathway, the medication may help manage symptoms and slow disease activity.

Gilenya comes as a capsule that you take by mouth once each day. It can be taken with or without food.

Typical Dosing for Multiple Sclerosis

The recommended dose of Gilenya for multiple sclerosis depends on body weight, which is a standard way healthcare providers choose the right amount for some medicines.

People who weigh more than 40 kilograms take 0.5 milligrams once daily.
Children who weigh 40 kilograms or less take 0.25 milligrams once daily.

If Gilenya is stopped for a period of time, the first-dose monitoring may need to be repeated. This depends on how long the medicine was stopped and when the interruption happened.

This information is based on prescribing information, but your healthcare provider may tailor your treatment plan. Always follow their guidance.

Top Advice From Members on Gilenya

These insights are based on 7,373 comments about Gilenya from MyMSTeam members.

Members who use Gilenya often say the most helpful tips are about keeping up with monitoring, building a simple daily routine, and staying in close touch with a neurologist about side effects or changes. Many also mention planning ahead for first-dose monitoring and being careful about stopping or restarting treatment without medical guidance.

1

Get blood work when your doctor orders it.
“You have to have your liver checked every so often.”
2

Plan ahead for first-dose monitoring and missed doses.
“It’s not a drug you can just stop and pick back up. You need to be monitored for six hours after your first dose to make sure your heart rate doesn’t drop too low.”
3

Talk to your doctor before stopping or switching Gilenya.
“I stopped the medication and I just had the most scary flare-up. I was unable to walk.”

Connect with others who understand life with multiple sclerosis. Join MyMSTeam for free.

Gilenya Side Effects

In clinical studies of Gilenya for relapsing forms of multiple sclerosis in people ages 10 years and older, the most common side effects occurred in about 10 percent to 25 percent of people. These were:

Headache
Higher liver enzyme tests (abnormal liver tests)
Diarrhea
Cough
Influenza (flu)
Sinusitis (sinus infection)
Back pain
Abdominal pain (stomach-area pain)
Pain in an arm or leg

Serious Side Effects and Warnings

Gilenya can cause serious side effects that require immediate medical attention. These include:

Reduction in heart rate and atrioventricular blocks — Slow heart rate and heart rhythm problems can arise, especially after the first dose.
Serious infections — These include opportunistic infections such as cryptococcal and herpes viral infections.
Progressive multifocal leukoencephalopathy (PML) — This rare brain infection can lead to severe disability or death.
Macular edema — Swelling in the back of the eye can affect vision.
Liver injury — Liver damage can be serious.
Posterior reversible encephalopathy syndrome (PRES) — This rare brain condition can cause severe headache, confusion, vision changes, or seizures.
Respiratory effects — Breathing problems can include new or worsening shortness of breath.
Fetal harm — This medication may harm your baby if used during pregnancy.
Severe worsening of multiple sclerosis after stopping Gilenya — A sudden increase in disability has been reported.
Increased blood pressure — Blood pressure may rise during treatment.
Immune system effects — Decreased lymphocyte counts increase the risk of infection.
Skin cancer and lymphoma — These include basal cell carcinoma, melanoma, and other cancers of the skin or lymph system.
Serious allergic reactions — This includes hypersensitivity, rash, hives, or swelling under the skin, such as angioedema.

Get medical help right away if you think you are having a serious reaction.

How To Save on Gilenya

Novartis Pharmaceuticals, the manufacturer of Gilenya, offers the Gilenya Co-Pay Program. Eligible people with commercial insurance may pay as little as $0 per prescription.

The Gilenya Co-Pay Program also provides financial support and insurance navigation, including help with benefits investigation, prior authorizations, and the appeals process to help secure drug coverage. It also offers coordination support for the required first-dose observation and medical testing, along with educational materials and 24/7 access to specialized support staff.

To learn more, visit the Gilenya Co-Pay Program or call 800-445-3692.

What To Know Before Taking Gilenya

Before starting Gilenya, your doctor will test or check for:

Complete blood count (CBC)
Liver blood tests
An eye exam of the back of the eye, including the macula
A skin exam
Whether you have antibodies to varicella zoster virus (VZV)

Before your first dose, you will have an electrocardiogram (ECG) to check your heart. Your doctor will review any medications you take that can slow your heart rate or affect heart rhythm. Some people with certain heart conditions may need a heart evaluation.

If you are not immune to varicella zoster virus, your doctor may recommend a vaccine before starting treatment. Children should be up to date on vaccines if possible. Do not get live vaccines during treatment or for two months after stopping Gilenya.

Tell your doctor if you have any allergies to fingolimod or any ingredients in Gilenya. Do not take Gilenya if you have had a serious allergic reaction to fingolimod or any of its ingredients.

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

Tell your doctor if you have an infection, eye problems, diabetes, breathing problems, liver problems, high blood pressure, or any type of skin cancer.

Do not take Gilenya if you have certain heart problems, a recent heart attack, unstable angina, stroke, transient ischemic attack (TIA), or certain types of heart failure in the last six months. Do not take it if you have certain heart rhythm problems or a QTc of 500 milliseconds or more.

If you miss one or more doses, call your doctor. You may need to be watched by a healthcare professional when you take your next dose.

If you are pregnant, planning to become pregnant, or breastfeeding while taking Gilenya, talk with your doctor about the risks and benefits. Gilenya may harm your baby if you are pregnant. Females who can become pregnant should use effective birth control during treatment and for two months after stopping.

Community FAQs

These answers are fact-checked by our editorial staff.

How effective is Gilenya?

In two studies of adults with relapsing-remitting multiple sclerosis, people who took Gilenya had fewer relapses.

In a two-year study, the yearly relapse rate was 0.18 with Gilenya and 0.40 with placebo (an inactive treatment). Also, 70 percent of people taking Gilenya had no relapse, compared with 46 percent taking placebo.

In a one-year study, the yearly relapse rate was 0.16 with Gilenya and 0.33 with interferon beta-1a. Also, 83 percent of people taking Gilenya had no relapse, compared with 70 percent taking interferon beta-1a.

Gilenya also reduced new or growing spots seen on MRI scans in both studies.

How long does Gilenya take to work for multiple sclerosis?

Studies of Gilenya looked at results over one year and two years. These studies showed fewer relapses and fewer new or growing lesions on MRI scans.

Gilenya reaches steady levels in the blood in about one to two months. However, there is no exact timeline for when someone may start to notice symptom improvement.

What should I do if I miss a dose of Gilenya for multiple sclerosis?

If you miss one or more doses of Gilenya, call your healthcare provider. You may need to be monitored when you take your next dose because the medicine can slow your heart rate again.

After the first month of treatment, if Gilenya has been stopped for more than 14 days, first-dose monitoring is needed again. Your doctor will decide what is needed based on how long you stopped the medicine and when it happened.