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Fingolimod (Gilenya): The Newest Medication For Multiple Sclerosis

Updated on May 1, 2012
In multiple sclerosis, immune cells like this T-lymphocyte attack nerve cells and damage their myelin sheath.
In multiple sclerosis, immune cells like this T-lymphocyte attack nerve cells and damage their myelin sheath. | Source

Disease-Modifying Drugs

Multiple sclerosis (MS) is an autoimmune disease in which cells of your immune system attack nerve cells of the brain and spinal cord. This attack by your immune system damages a fatty substance called myelin that coats the nerve cells and acts as insulation to insure efficient transmission of nerve signals from one cell to another. Medications used for multiple sclerosis, including Gilenya, are called disease-modifying drugs because they alter the course of MS and slow its progression by suppressing or altering the activity of your immune system. Although they do not cure MS, these drugs can improve the quality of your life.

Information on Fingolimod (Gilenya)

Gilenya was approved as a treatment for the relapsing form of multiple sclerosis by the U.S. Food and Drug Administration in September 2010. People with relapsing MS suffer clearly defined attacks (called relapses) of degrading neurological function followed by periods of partial or complete recovery. People with MS were excited to hear of Gilenya's approval because it is a once-a-day oral medication. Previous MS drugs were administered intravenously. According to, Gilenya traps immune cells inside the lymph nodes. The trapped cells are not able to attack the nerve cells of the brain and spinal cord, and so the patient suffers relapses less frequently.

In clinical trials before it came to market, Gilenya demonstated efficacy over both placebo and interferon beta-1a, an older MS drug. In the trial versus placebo, 70% of patients receiving Gilenya experienced no relapse compared to 46% of patients on placebo. In the trial versus interferon beta-1a, 83% of patients on Gilenya did not have a relapse whereas only 70% on interferon beta-1a had no relapse.

When the FDA approved Gilenya for marketing, it also recommended that patients taking their first dose should do so under medical supervision. This is because the first dose of Gilenya may cause bradycardia, a condition in which your heart rate slows down to a level that is below normal. Typically, you will get your first dose in a hospital where your heart rate can be monitored for around six hours after you take the drug. Symptoms of a slow heart rate include dizziness, fatigue and heart palpitations. According to an FDA Drug Safety Communication, your heart rate should return to normal within one month after you start taking Gilenya.

Besides bradycardia, Gilenya may cause other side effects. The most frequently occurring of these are headache, influenza, diarrhea, back pain, elevation of liver enzymes and cough. Other side effects may include hypertension, blurred vision, eye pain and macular edema, a swelling in the center of the retina.

Disclaimer: This hub has been written for the sole purpose of providing information to the reader. It is not intended to be a source of any kind of medical advice or instruction, and it should not be used in the diagnosis of any illness, disease or condition. You should consult your doctor if you have questions about a specific medical problem.

Gilenya, First Dose Experience


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    • healthwriterbob profile image

      healthwriterbob 6 years ago from United States

      Hi Jen's Solitude,

      Thanks for your comments. I hope Gilenya has made your life better. The post-market adverse effects reports that the FDA compiles are really valuable for people taking a new drug. Best of luck to you and take care.


    • Jen's Solitude profile image

      Jen's Solitude 6 years ago from Delaware

      Great info! I am 4 months in and am about to update how I am doing on Gilenya. Thanks for reminding me of a couple of side effects I need to report. :)

    • healthwriterbob profile image

      healthwriterbob 6 years ago from United States

      Thanks RealHousewife,

      I think that many MS patients are excited to have a drug that works and doesn't require a needle to administer it. Take care, and by the way I have enjoyed reading your hubs.


    • RealHousewife profile image

      Kelly Umphenour 6 years ago from St. Louis, MO

      Very interesting read! Great job explaining this!