"April 20, 2012 -- Novartis, the maker of the drug Gilenya (fingolimod), a once-daily oral capsule taken for multiple sclerosis, has added stronger warnings to labels and prescription information about the drug's possible heart risks, according to"...
GILENYA can induce bradycardia as well as AV conduction blocks (including complete AV block). The decline in heart rate usually starts within 1 hour of the first dose and is maximal within 6 hours in most patients [see WARNINGS AND PRECAUTIONS]. In case of GILENYA overdosage, observe patients overnight with continuous ECG monitoring in a medical facility, and obtain regular measurements of blood pressure [see DOSAGE AND ADMINISTRATION].
Neither dialysis nor plasma exchange results in removal of fingolimod from the body.
Baseline QTc interval ≥ 500 msec
Treatment with Class Ia or Class III anti-arrhythmic drugs
Last reviewed on RxList: 5/20/2014
This monograph has been modified to include the generic and brand name in many instances.
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