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
What are the ingredients in Gilenya?
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. It also includes testing for antibodies to varicella zoster virus to ensure vaccinations are not needed before starting treatment.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
These are not all the possible side effects of Gilenya. Talk to your doctor about what to expect when taking Gilenya. You also should call your doctor if you have any changes that concern you when taking Gilenya.
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.
Other 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
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
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 a time after you stop taking it.1,3
Talk with your doctor if in the last 6 months you:1-3
- Had a fever or infection
- Had or were planning to get certain vaccines. Live vaccines should not be given during treatment with Gilenya and for a time after the last dose.
- Have had fainting, liver injury, macular edema, high blood pressure, cancer
- Are pregnant or are planning to become pregnant. People who are able to become pregnant should use effective birth control while taking Gilenya and for a time after their last dose.
Do not stop taking Gilenya 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.1,2
Before beginning treatment for MS, tell your doctor about all your health conditions and any other drugs, vitamins, or supplements you are taking. This includes over-the-counter drugs.