Gilenya® (Fingolimod) Multiple Sclerosis (MS) Oral Pill Disease Modifying Therapy

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Gilenya® (Fingolimod)


Gilenya® (fingolimod) is an oral treatment which is thought to work by retaining certain white blood cells (lymphocytes) in the lymph nodes and thus suppressing those cells from crossing the blood brain barrier. However, Gilenya’s exact mechanisms of disease progression reduction are still unknown.  Prescribed for patients with Relapsing Remitting Multiple Sclerosis Gilenya was approved by the Federal Drug Administration in 2010.  Gilenya reduces the frequency of MS relapses by preventing certain immune cells from reaching the central nervous system, where they could potentially attack myelin, the fatty substance that insulates nerves and helps them transmit impulses between the brain and the body.


Gilenya is administrated as a 0.5 mg capsule oral taken once daily, with or without food.

Gilenya can result in a slowed heart rate when first taken. You will be observed by a health care professional for at least 6 hours after you take your first dose. You may need to repeat this monitoring if you miss a dose.

Efficacy Results:

Study One
This 2-year randomized, double-blind, placebo-controlled study in 1,272 patients with Relapsing Remitting Multiple Sclerosis who had not received any interferon-beta or glatiramer acetate for at least the previous 3 months and had not received any natalizumab for at least the previous 6 months. The subjects received Gilenya 0.25mg, 1.25mg or placebo for up to 24 months. The primary endpoint was the annual relapse rate. The 1.25 mg dose resulted in no additional benefit over the 0.5 mg dose. Results are as follows: Annualized relapse rate 0.18 for Gilenya 0.5mg vs. 0.40 for placebo. Percentage of patients without relapse: 70% for Gilenya 0.5mg vs. 46% for placebo. The mean (median) number of new or newly enlarging T2 lesions over 24 months was 2.5 for Gilenya 0.5mg vs. 9.8 for placebo.

Study Two
This 1-year randomized, double-blind, double-dummy, active-controlled study enrolled 1,292 subjects with Relapsing Remitting Multiple Sclerosis who had not received any natalizumab in the previous 6 months. The subjects were randomized to receive Gilenya 0.5 mg, 1.25 mg or interferon beta-1a, 30 micrograms via the intramuscular route (IM) once weekly for up to 12 months. The annualized relapse rate was significantly lower in patients treated with Gilenya 0.5 mg than in patients who received interferon beta-1a IM. The 1.25 mg dose resulted in no additional benefit over the Gilenya 0.5 mg dose. The results are as follows: Annualized relapse rate 0.16 for Gilenya 0.5mg vs. 0.33 for Interferon beta-1a (p<0.001). Percentage of patients without relapse: 83% for Gilenya 0.5mg vs. 70% for Interferon beta-1a (p<0.001). The mean (median) number of new or newly enlarging T2 lesions over 24 months was 1.6 for Gilenya 0.5mg vs. 2.6 for IFN beta.

Side Effects:

The most common side effects of Gilenya:

  • Headache
  • Abnormal liver tests
  • Diarrhea
  • Cough
  • Flu
  • Sinusitis
  • Back pain
  • Abdominal pain
  • Pain in arms or legs

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

  • Slow heart rate, dizziness, feeling very weak or tired;
  • Chest pain, pounding heartbeats or fluttering in your chest;
  • Sudden numbness or weakness, severe headache, problems with speech or walking;
  • Wheezing, chest tightness, trouble breathing, cough with yellow or green mucus;
  • Fever, chills, body aches, flu symptoms, nausea and vomiting, sores in your mouth and throat;
  • Swelling, warmth, redness, oozing, itchy rash, or other signs of skin infection;
  • Nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or
  • Vision problems, blurred vision, eye pain, increased sensitivity to light, or having a blind spot or shadows in the center of your vision (vision problems may occur 3 to 4 months after you start taking fingolimod).
  • PML, a rare brain infection that usually leads to death or severe disability
    • There have been 3 confirmed cases of PML with Gilenya.

Women taking Gilenya should not get pregnant. Based on animal studies, Gilenya may harm the fetus. Patients should tell their doctor right away if they become pregnant while taking Gilenya or within two months after stopping the drug. It is not known if Gilenya passes into breast milk, so women should not take Gilenya while breast feeding.

Novartis logoNovartis AG was founded in 1996 with the merger of Ciba-Geigy Ltd. and Sandoz Ltd. Based in Basel, Switzerland, Novartis is an international leader in the development and marketing of pharmaceuticals and nutrition products, in addition to operating a number of research institutes dedicated to the study of gene therapy. Novartis provides innovative healthcare solutions that address the evolving needs of patients and societies. Headquartered in Basel, Switzerland, Novartis offers a diversified portfolio to best meet these needs: innovative medicines, eye care and cost-saving generic pharmaceuticals. Novartis is the only global company with leading positions in these areas.

Gilenya Patient Guide:

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