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Gilenya is contraindicated in patients who have: in the last 6 months experienced myocardial infarction, unstable angina, stroke, TIA, decompensated heart failure requiring hospitalization or Class III/IV heart failure;
a history or presence of Mobitz Type II second-degree or third-degree AV block or sick sinus syndrome, unless patient has a functioning pacemaker (see PRECAUTIONS);
a baseline QTc interval ≥ 500 msec;
cardiac arrhythmias requiring anti-arrhythmic treatment with Class Ia or Class III anti-arrhythmic drugs;
during pregnancy and in women of childbearing potential not using effective contraception (see PRECAUTIONS and USE IN PREGNANCY & LACTATION);
had a hypersensitivity reaction to fingolimod or any of the excipients in Gilenya. Observed reactions include rash, urticaria and angioedema upon treatment initiation (see PRECAUTIONS).
