"Oct. 5, 2011 -- People with multiple sclerosis (MS) may soon have a second needle-free option to control their disease.
Last year, the FDA approved the first disease-modifying pill, a drug called Gilenya, to treat MS.
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
- Patients who have had a hypersensitivity reaction to fingolimod or any of the excipients in GILENYA. Observed reactions include rash, urticaria and angioedema upon treatment initiation [see WARNINGS AND PRECAUTIONS].
Last reviewed on RxList: 3/3/2016
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