fingolimod (Gilenya)

What is fingolimod? What is fingolimod used for?

Fingolimod is an oral medication used for treating multiple sclerosis (MS). Its mechanism of action is unknown, although it may work by reducing the number of circulating lymphocytes (a type of white blood cell), leading to reduced migration of white blood cells into the central nervous system. White blood cells cause inflammation and destruction of nerves in patients with MS. Fingolimod does not cure MS. It decreases the number of MS flares and slows down the development of physical disability caused by MS. The FDA approved fingolimod in September 2010.

What brand names are available for fingolimod?


Is fingolimod available as a generic drug?


Do I need a prescription for fingolimod?


What are the side effects of fingolimod?

The most common side effects are:

Fingolimod may decrease heart rate, especially after the first dose. Patients should be observed for signs and symptoms of low heart rate for 6 hours after the first dose. Fingolimod may increase the risk of infections. Signs and symptoms of infection should be monitored during treatment and for two months after discontinuation of treatment. Fingolimod should not be administered to patients who have an infection. Fingolimod may cause inflammation of the eye (uveitis) and other eye problems. Therefore, visual acuity should be checked prior to starting therapy, 3 to 4 months after initiation of therapy, and during routine patient evaluation. Fingolimod has also been associated with difficulty breathing. Fingolimod reduces the white blood cell count, and this effect may last for 2 months after treatment is discontinued.

What is the dosage for fingolimod?

The recommended dose is 0.5 mg orally once daily, with or without food. Doses higher than 0.5 mg cause more adverse reactions without providing additional benefit.


What Is Multiple Sclerosis? MS Symptoms, Causes, Diagnosis See Slideshow

Which drugs or supplements interact with fingolimod?

The blood levels of fingolimod are increased when combined with ketoconazole (Nizoral, Extina, Xolegel, Kuric). This may increase the incidence of side effects.

Vaccines may be less effective during and up to 2 months after discontinuation of fingolimod treatment. Live attenuated vaccines should not be administered during and for 2 months after fingolimod treatment because of the risk of infection.

When combined with drugs that decrease heart rate (for example, atenolol [Tenormin]) there is an additional 15% reduction of heart rate.

Is fingolimod safe to take if I'm pregnant or breastfeeding?

Fingolimod has not been adequately studied in pregnant women.

It is not known whether fingolimod is secreted in breast milk.

What else should I know about fingolimod?

What preparations of fingolimod are available?

Capsules: 0.5 mg.

How should I keep fingolimod stored?

Fingolimod should be stored at room temperature, 15 C - 30 C (59 F - 86 F).


Fingolimod (Gilenya) is a drug prescribed for reducing the frequency of relapses and delaying the physical disability in individuals with relapsing forms of MS (multiple sclerosis). Side effects, drug interactions, warnings and precautions, and pregnancy information should be reviewed prior to taking any medication.

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You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

See more info: fingolimod on RxList
FDA Prescribing Information for Gilenya (fingolimod)