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).