Is Fingolimod approved by the FDA?

Yes, fingolimod is FDA approved. The FDA first approved Gilenya (fingolimod) on September 21, 2010, for the treatment of relapsing forms of multiple sclerosis, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease.

Uses

Fingolimod is used for the following:

• Relapsing-Remitting MS: Reduces the frequency of relapses and delays the progression of physical disability.
• Clinically Isolated Syndrome: A first episode of neurological symptoms caused by inflammation and demyelination in the central nervous system.
• Active Secondary Progressive MS: For patients who continue to experience relapses.

Fingolimod is not intended for use as a fast-acting rescue medication during acute MS attacks.

Dosage and Administration

• Adults and Children Over 10 Years Weighing More Than 40 kg: 0.5 mg orally once a day.
• Children Over 10 Years Weighing 40 kg or Less: 0.25 mg orally once a day.

Fingolimod can be taken with or without food. The first dose is administered in a medical setting where heart rate and rhythm are monitored for at least six hours due to the risk of bradycardia (slow heart rate).

Side Effects

Common side effects include:

• Headache
• Back pain
• Stomach pain, diarrhea
• Pain in arms or legs
• Cough, stuffy nose, flu symptoms
• Abnormal liver function tests

Serious side effects that require immediate medical attention include:

• Signs of allergic reactions such as hives, difficulty breathing, and swelling of the face, lips, tongue, or throat.
• Brain infection symptoms including speech, thought, vision, or muscle movement problems.
• Increased susceptibility to infections even after stopping the medication.
• Vision problems, such as increased sensitivity to light, blurred vision, or unusual color vision.

Warnings and Precautions

• Heart Conditions: Fingolimod should not be used by individuals with certain heart rhythm disorders or those who have had a serious heart condition in the past six months.
• Immune System: Fingolimod can weaken the immune system, increasing the risk of infections.
• Vision: Monitor for vision problems that may develop three to four months after starting the medication.
• Skin Cancer: Increased risk of skin cancer; avoid sunlight and use protective measures.
• Vaccinations: Avoid live vaccines during and for two months after treatment.

Drug Interactions

Fingolimod may interact with various medications, including:

• Heart rhythm medications such as amiodarone, disopyramide, and others.
• Drugs that weaken the immune system, like cancer medications, steroids, and organ transplant rejection drugs.
• Ketoconazole and other medications that affect heart function.

Conclusion

Fingolimod (Gilenya, Tascenso ODT) is an FDA-approved medication used to treat relapsing forms of multiple sclerosis in adults and children aged 10 years and older. It helps reduce the frequency of relapses and slows the progression of disability. Patients should be aware of potential side effects and interactions with other medications. Regular monitoring by healthcare providers is essential to ensure the safe and effective use of fingolimod. Always consult a healthcare provider for personalized medical advice and treatment plans.

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