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Home > Drug Category > Immunosuppressive Agents > Gilenya and Equivalent

Gilenya (Fingolimod) Information

Gilenya, which contains the active ingredient fingolimod, is a prescription disease-modifying therapy used to treat adults and children (10 years and older) with relapsing forms of multiple sclerosis (MS). It is designed to reduce the frequency of clinical flare-ups and help delay the progression of physical disability associated with the disease. Because the first dose can significantly affect heart rate, the initial administration must be performed in a clinical setting where the patient can be monitored for at least 6 hours, with hourly pulse and blood pressure checks.

The mechanism of action involves binding to sphingosine 1-phosphate (S1P) receptors on lymphocytes (a type of white blood cell), effectively locking them inside the lymph nodes. By preventing these inflammatory cells from reaching the brain and spinal cord, Gilenya limits damage to the nervous system.

Gilenya Side Effects

Gilenya is generally well-tolerated, but common side effects may occur as your body adjusts to the medication. Commonly reported effects include headaches, diarrhea, back pain, and nausea. Many patients also experience respiratory issues, such as coughs, sinusitis, or flu-like symptoms, as well as arm or leg pain. It is very common for liver enzyme levels to increase during treatment, which usually requires regular blood monitoring to ensure the liver remains healthy. Liver enzyme and white blood cell levels are monitored via blood tests before starting and periodically during treatment.

More serious side effects can occur and require immediate medical attention. Seek emergency medical attention if you experience:
• Breathing Problems: New or worsening shortness of breath.
• Cardiac Issues: Signs of a dangerously slow heart rate (bradycardia), such as dizziness, chest pain, or feeling like your heart skipped a beat.
• Severe Infections: Gilenya weakens the immune system, increasing the risk of serious infections like PML (a rare brain infection) or shingles. Watch for fever, stiff neck, confusion, or personality changes.
• Skin Changes: New or changing moles, as the medication may increase the risk of certain skin cancers.
• Vision Changes: Blurriness or a blind spot in the center of your vision, which may indicate macular edema (swelling in the back of the eye).

Gilenya Precautions

Do not use Gilenya if you have a known allergy to fingolimod or any of its inactive ingredients. Before starting treatment, inform your doctor of your complete medical history, especially if you have a history of heart problems, including a heart attack, stroke, or chest pain within the last six months. It is also essential to mention conditions like diabetes, uveitis (eye inflammation), liver disease, or high blood pressure. Because Gilenya affects your immune system, tell your doctor about any recent infections or if you have never had chickenpox or the varicella vaccine. Doctors will almost always check for VZV antibodies with a blood test before starting Gilenya; if the patient isn't immune, they must be vaccinated and wait a month before starting Gilenya. Tell your doctor about all medications you are taking, including prescription drugs, over-the-counter medicines, vitamins, and herbal supplements. Gilenya may interact with drugs that affect heart rate or the immune system, such as beta-blockers, digoxin, or other MS treatments. You should avoid receiving live vaccines during treatment and for 2 months after stopping Gilenya, as they may cause infection.

Inform your doctor if you are pregnant, planning to become pregnant, or breastfeeding. Gilenya can cause serious congenital disabilities. You must have a negative pregnancy test before starting and use effective contraception during treatment and for two months after your last dose. If you plan to become pregnant, you must stop the medication two months in advance. It is unknown whether Gilenya is excreted into human milk. Because animal studies show the drug in milk at high concentrations, you should consult your doctor to determine if the benefits of breastfeeding outweigh the potential risks to the infant.

Use Gilenya exactly as your doctor tells you. Do not stop taking Gilenya without talking to your doctor, as your MS symptoms can return and become significantly worse (rebound) after stopping the treatment. Gilenya capsules should be swallowed whole and taken at the same time each day. If you miss a dose, do not take a double dose. Contact your doctor immediately, as missing even one dose at the start of treatment may require you to undergo the six-hour heart-monitoring process again. Because Gilenya stays in your system for a long time, the risk of infection persists for 2 months after the final dose. The medication should be stored at room temperature (20°C to 25°C) in a dry place. Always keep this and all other medications strictly out of the reach of children.

Do I need a prescription to order Gilenya?

Yes, a prescription is required from your physician to order Gilenya.