fingolimod, Gilenya (cont.)

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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)

Last Editorial Review: 10/26/2010 1:38:23 PM

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