Warnings and Precautions (5.1, 5.2, 5.3, 5.5, 5.6)          5/2015

GILENYA is a sphingosine 1-phosphate receptor modulator indicated for the treatment of patients with relapsing forms of multiple sclerosis (MS) to reduce the frequency of clinical exacerbations and to delay the accumulation of physical disability. (1)

• Recommended dose: 0.5 mg orally once-daily, with or without food (2)
• First Dose Monitoring:
  • Observe all patients for bradycardia for at least 6 hours after first dose with hourly pulse and blood pressure measurement. Obtain electrocardiogram (ECG) prior to dosing and at end of observation period.
  • Patients who develop heart rate <45 bpm, 2nd degree or higher atrioventricular (AV) block, or in whom lowest postdose heart rate is at the end of the observation period should be monitored until resolution.
  • If symptomatic bradycardia occurs, begin continuous ECG monitoring until resolved. If pharmacological intervention is required, continue this monitoring overnight, and repeat first-dose monitoring for the second dose.
  • Patients at higher risk of symptomatic bradycardia or heart block, or prolonged QTc interval, or taking drugs with known risk of torsades de pointes should be observed overnight. (2, 7)

0.5 mg hard capsules (3)

• Recent (within the last 6 months) myocardial infarction, unstable angina, stroke, transient ischemic attack, decompensated heart failure requiring hospitalization, or Class III/IV heart failure (4)
• History of Mobitz Type II 2nd degree or 3rd degree AV block or sick sinus syndrome, unless patient has a pacemaker (