"The European Medicines Agency (EMA) today issued updated recommendations on ways to minimize the risk for progressive multifocal leukoencephalopathy with dimethyl fumarate (Tecfidera, Biogen).
To date, three cases of PML have"...
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.
- Patients who in the last 6 months experienced myocardial infarction, unstable angina, stroke, TIA, decompensated heart failure requiring hospitalization or Class III/IV heart failure
- History or presence of Mobitz Type II second-degree or third-degree atrioventricular (AV) block or sick sinus syndrome, unless patient has a functioning pacemaker
- Baseline QTc interval ≥ 500 msec
- Treatment with Class Ia or Class III anti-arrhythmic drugs
Last reviewed on RxList: 8/13/2015
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