Gilenya (fingolimod)

Gilenya® (fingolimod) is a sphingosine 1-phosphate receptor modulator. It is used to treat people with relapsing forms of multiple sclerosis (MS). This includes clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease in adults and children 10 years of age and older. Gilenya is the first FDA approved drug to treat pediatric MS.1,4 The active ingredient in Gilenya is fingolimod.1

How does Gilenya work?

While the mechanism by which fingolimod exerts therapeutic effects in multiple sclerosis is unknown, experts believe Gilenya works by blocking the capacity of lymphocytes (white blood cells in the lymphatic system) to escape from lymph nodes. This reduces the number of lymphocytes migrating to the central nervous system.1

Several tests are needed before you can begin taking Gileyna. This includes a cardiac evaluation, complete blood count, and tests for serum transaminase liver enzymes (ALT, AST) and bilirubin levels.1

What are the possible side effects?

Many clinical trials looked at the safety and efficacy of Gilenya. The most common side effects include:1,3

  • Headache
  • Increased liver enzymes
  • Diarrhea
  • Cough
  • Influenza
  • Sinus inflammation
  • Back pain
  • Abdominal pain
  • Pain in extremity

Less frequent side effects include:1,3

  • Slow heart rate
  • Hypotension
  • Dizziness
  • Fatigue
  • Palpitations and/or chest pain
  • Risk of infection
  • Rash or hives
  • Swelling of lips, tongue or face
  • Macular edema
  • Skin cancers including basal cell carcinoma and melanoma

This is not a complete list of all the possible side effects of Gilenya. For more information about what to expect, talk to your doctor.

If you notice any new side effects when taking Gilenya or if your symptoms get worse, call your doctor. If you have a history of hypersensitivity or allergic reaction to any of the ingredients of Gilenya or similar drugs, call your doctor immediately.

Things to know about Gilenya

Gilenya can cause a slower heart rate (bradycardia). You should be observed after taking the first dose for at least 6 hours to see if you have any changes in pulse and blood pressure. An electrocardiogram (ECG) should be performed before you begin taking Gilenya, and at the end of the observation period. Gilenya should be given in a medical setting that can respond quickly to changes in how the heart works.1

Effects of Gilenya on heart rate

The effects of Gilenya on heart rate are most significant after the first dose. However, milder effects on heart rate may continue for 2 to 4 weeks after the first dose. Heart rate generally returns to baseline after 1 month. Anyone taking this drug and their doctors should pay close attention for any changes in heart rhythm and signs that the heart may not be working properly.

If your doctor has you stop taking Gilenya and start again, the doctor should talk to you about how to do this safely.1

Infections and vaccinations

Gilenya may increase the risk of infection, including human papilloma virus (HPV). Your doctor may also want to check you for chickenpox (varicella zoster virus) antibodies. An HPV or VZV vaccination may be needed before you can begin treatment. You will be monitored for signs of infection as long as you take Gilenya and for 2 months after you stop taking it.1

Do not take Gilenya if you have a history of:1,2

  • Myocardial infarction or unstable angina in the last 6 months
  • Stroke or TIA
  • Class III/IV heart failure or heart failure requiring hospitalization
  • Mobitz Type II, 2nd or 3rd degree AV block, or sick sinus syndrome unless you have a pacemaker
  • Arrhythmias requiring treatment with Class Ia or Class III anti-arrhythmic drugs

Talk with your doctor if in the last 6 months you:1,2

  • Had or were planning to get certain vaccines
  • Had a fever or infection
  • Have had fainting, liver injury, macular edema, high blood pressure, cancer
  • Are pregnant or are planning to become pregnant

Gilenya and pregnancy

Women who are able to become pregnant should use effective birth control while taking Gilenya and for at least 2 months after their last dose.1 Live vaccines should not be given during treatment with Gilenya and for 2 months after treatment ends.3

Do not stop taking Gileyna without talking to your doctor. While taking Gilenya, report any new or worsening of MS symptoms, such as weakness, difficulty using arms or legs, or any changes to eyesight, balance, or thinking. Tumefactive MS can develop during or after treatment with Gilenya.1-2

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Written by Linda Saxl Minton | Last review date: July 2021.