Gilenya (Fingolimod) for Multiple Sclerosis

Overview
Gilenya is a prescription medication approved by the Food and Drug Administration (FDA) for treating relapsing forms of multiple sclerosis (MS) in adults. Gilenya is also known by its drug name, Fingolimod. Gilenya is not a cure for MS, but it can decrease the number of flare-ups and help delay or prevent disability. It is not suitable for people with many types of heart problems or for pregnant women or nursing mothers.

It is believed that Gilenya works by suppressing the immune system. It traps lymphocytes (white blood cells) in the lymph nodes. The lymphocytes are prevented from circulating in the bloodstream and contributing to the autoimmune attack on the nervous system.

How do I take it?
Gilenya comes in capsules and is taken orally once a day, with or without food.

Before the first time you take Gilenya, your doctor will perform several tests to establish your body’s normal functions and make it easier to monitor for side effects. These tests might include a complete blood count (CBC), a blood pressure check, and possibly an EKG. The first time you take Gilenya, it will be in a medical facility. Your doctor will monitor your heart for at least six hours after taking your first dose in order to make sure your heart rate does not become too slow.

If you stop taking Gilenya for two weeks or more later on, you will have to be monitored when you begin taking it once again.

Always follow your doctor’s instructions exactly when taking Gilenya.

Results
The FDA approved Fingolimod (Gilenya) based on two clinical trials. The first study spanned two years and involved 1,272 people. Of the people given a .5 mg dose of Fingolimod, 70 percent did not experience a relapse by the end of the study, compared to 46 percent of those receiving the placebo.

In the second study, which last for one year, 1,292 people were given either .5 mg of Fingolimod or weekly intramuscular injections of interferon beta-1a. Of those taking Fingolimod, 83 percent did not experience a relapse compared to 70 percent of those receiving interferon beta-1a.

More than 37,000 people have taken Fingolimod since it was approved in 2010.

Side effects
The three most serious potential side effects of Gilenya are slow heart rate (bradycardia), infections and eye problems.

Before prescribing Gilenya, your doctor will carefully go over your medical history for any sign of heart problems and evaluate your current medications for any that may affect your heart in combination with Gilenya. While taking Gilenya, it is important to call your doctor if you have signs of slow heart rate such as dizziness, fatigue or the sensation that your heart is beating more slowly than usual or skipping beats. After taking Gilenya for one month, your heart rate should return to normal.

Since Gilenya is an immunosuppressant, it can make it easier for you to contract a serious infection while you are taking it. You should call your doctor if you have signs of infection such as fever, fatigue, aches, chills or vomiting.

Gilenya can cause an eye problem called macular edema. Symptoms of this condition include sensitivity to light, strangely colored vision, or a blind spot, blurriness or shadows in the center of your vision. It is important to call your doctor if you experience any of these. It can seem similar to vision symptoms of an MS flare-up.

Gilenya can also cause liver problems and breathing problems such as shortness of breath. The most commonly experienced side effects of Gilenya are headache, flu-like symptoms, diarrhea, back pain, cough, and abnormal results on liver tests.

Gilenya can also cause allergic reactions. Get medical help immediately if you experience difficulty breathing or swelling in the face, throat, eyes, lips or tongue.