fingolimod, Gilenya

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Pharmacy Author:

Omudhome Ogbru, PharmD

Omudhome Ogbru, PharmD

Dr. Ogbru received his Doctorate in Pharmacy from the University of the Pacific School of Pharmacy in 1995. He completed a Pharmacy Practice Residency at the University of Arizona/University Medical Center in 1996. He was a Professor of Pharmacy Practice and a Regional Clerkship Coordinator for the University of the Pacific School of Pharmacy from 1996-99.

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Medical and Pharmacy Editor:

Jay W. Marks, MD

Jay W. Marks, MD

Jay W. Marks, MD, is a board-certified internist and gastroenterologist. He graduated from Yale University School of Medicine and trained in internal medicine and gastroenterology at UCLA/Cedars-Sinai Medical Center in Los Angeles.

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GENERIC NAME: fingolimod

BRAND NAME: Gilenya

DRUG CLASS AND MECHANISM: 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.

PRESCRIPTION: Yes

GENERIC AVAILABLE: No

PREPARATIONS: Capsules: 0.5 mg.

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

PRESCRIBED FOR: Fingolimod is used for reducing the frequency of relapses and for delaying the occurrence of physical disability in patients with relapsing forms of multiple sclerosis.

DOSING: 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.

DRUG INTERACTIONS: 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.

PREGNANCY: Fingolimod has not been adequately studied in pregnant women.

NURSING MOTHERS: It is not known whether fingolimod is secreted in breast milk.

SIDE EFFECTS: The most common side effects are headache, flu, diarrhea, back pain, elevations of liver enzymes and cough. 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.

Reference: FDA Prescribing Information for Gilenya (fingolimod)

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