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Gilenya (fingolimod)

Gilenya® is a sphingosine 1-phosphate receptor modulator indicated for treatment of patients with relapsing forms of multiple sclerosis (MS), to reduce the frequency of clinical exacerbations and delay the increase in physical disability. It is administered once daily in a 0.5mg capsule.1

In May 2018, the U.S. Food and Drug Administration (FDA) expanded the use of Gilenya to include children ten years of age and older who have relapsing forms of MS. This marks the first FDA approval for a drug to treat pediatric MS.1

What are the ingredients in Gilenya?

The active ingredient in Gilenya is fingolimod.1

How does Gilenya work?

Gilenya works by blocking the capacity of lymphocytes (white blood cells in the lymphatic system) to escape from lymph nodes, reducing the number of lymphocytes migrating to the central nervous system.1

What are the possible side effects of Gilenya?

Many clinical trials evaluated the safety and efficacy of Gilenya. The most common side effects experienced by those taking Gilenya include:1

  • Slow heart rate
  • Hypotension
  • Dizziness
  • Fatigue
  • Palpitations and/or chest pain
  • Risk of infection
  • Rash or hives
  • Swelling of lips, tongue or face
  • Diarrheal/abdominal pain
  • Increased liver enzymes
  • Headache
  • Backache
  • Macular edema
  • Cough

This is not an exhaustive list of all potential side effects of Gilenya. For more information, consult your doctor or healthcare provider. If you notice any new or worsening side effects when taking Gilenya or if you have a history of hypersensitivity or allergic reaction to fingolimod or any of the excipients contact your doctor or healthcare provider immediately.

Things to note about Gilenya

Gilenya can cause a decrease in heart rate (bradycardia). Patients should be observed after taking the first dose for at least 6 hours for changes in pulse and blood pressure. An electrocardiogram (ECG) should be administered prior to dosing, and at end of the observation period. Gilenya should be given in a medical setting that can respond to treatment needs related to cardiac changes.1

The effects of Gilenya on heart rate are most significant after the first dose although milder effects on heart rate may continue for 2 to 4 weeks after initiation of therapy. Heart rate generally returns to baseline after 1 month. Patients and physicians should be alert to changes in and reports of cardiac symptoms. If Gilenya is stopped and restarted, consult your physician about reverting to the steps used in first dose monitoring.1

Before starting Gilenya talk with your doctor if in the last 6 months you:1

  • Have had myocardial infarction or unstable angina
  • Have had a stroke or TIA
  • Have Class III/IV heart failure or heart failure requiring hospitalization
  • Have Mobitz Type II, AV block or sick sinus syndrome
  • Are pregnant or are planning to become pregnant
  • Received or planning to get certain vaccines

Gilenya may increase the risk of infections, so patients should have a complete blood count before starting treatment and be monitored for infection symptoms during treatment and for two months after stopping treatment.

Women who are able to become pregnant should use effective birth control while taking Gilenya and for at least three months after their last dose.

Stopping treatment with Gilenya may cause a worsening of MS symptoms. While this is rare, this worsening of symptoms may lead to permanent disability. Patients should not stop taking this medication without talking to their doctor. After treatment with Gilenya, patients should report any new or worsening of MS symptoms, such as weakness, difficulty using arms or legs, or any changes to eyesight, balance, or thinking.2

Dosing information

Gilenya is taken as a 0.25mg dose for those under 40kg and as a 0.5mg for those over 40kg. It is taken by mouth in the form of a hard gelatin capsule once daily with or without food.

If you miss a dose or restart treatment consult your physician as you may need to follow the steps of first dose monitoring.1

For more information, read the full prescribing information of Gilenya.

Written by Linda Saxl Minton | Last review date: July 2019.
  1. GILENYA prescribing information available at: Accessed 4/15/18.
  2. Gilenya (fingolimod): Drug Safety Communication - Severe Worsening of Multiple Sclerosis After Stopping the Medicine. U.S. Food and Drug Administration. Available at Accessed 12/3/18.