GILENYA (fingolimod hcl) capsule
[Novartis Pharmaceuticals Corporation]
Permanent Link: http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=cc9e1c8c-0e2b-44e2-878b-27057f786be9 Category DEA Schedule Marketing Status
HUMAN PRESCRIPTION DRUG LABEL  New Drug Application
Drug Label Sections
Description Clinical Pharmacology Indications & Usage Contraindications Warnings Precautions Adverse Reactions Overdosage Dosage & Administration How Supplied Patient Counseling Information Supplemental Patient Material Boxed Warning Patient Package Insert Highlights Full Table of Contents Medication Guide
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use GILENYA™ safely and effectively. See full prescribing information for GILENYA.
GILENYA (fingolimod) capsules
Initial U.S. Approval: 2010
RECENT MAJOR CHANGES
Dosage and Administration (2)              04/2012
Contraindications (4)                               04/2012
Warnings and Precautions (5.1, 5.7)     04/2012
INDICATIONS AND USAGE
GILENYA is a sphingosine 1-phosphate receptor modulator indicated for the treatment of patients with relapsing forms of multiple sclerosis to reduce the frequency of clinical exacerbations and to delay the accumulation of physical disability. (1)
DOSAGE AND ADMINISTRATION
•Recommended dose: 0.5 mg orally once daily, with or without food (2)
•First Dose Monitoring:
◦Observe all patients for signs and symptoms of bradycardia for at least 6 hours after first dose with hourly pulse and blood pressure measurement. Obtain ECG prior to dosing and at the end of the observation period.
◦Patients who develop a heart rate <45 bpm, or a new onset 2nd degree or higher atrioventricular block should be monitored until resolution of the finding. Patients at lowest post-dose heart rate at the end of the observation period should be monitored until heart rate increases.
◦In patients experiencing symptomatic bradycardia, begin continuous ECG monitoring until the symptoms have resolved; if pharmacological intervention is required to treat bradycardia, continuous ECG monitoring should continue overnight in a medical facility, and first-dose monitoring procedures should be repeated for the second dose.
◦Patients at higher risk of symptomatic bradycardia or heart block because of a coexisting medical condition or certain concomitant medications should be observed overnight with continuous ECG monitoring (2).
◦Patients with prolonged QTc interval at baseline or during the observation period, or taking drugs with known risk of torsades de pointes should be observed overnight with continuous ECG monitoring (2).
DOSAGE FORMS AND STRENGTHS
0.5 mg hard capsules. (3)
CONTRAINDICATIONS
•Recent (within the last 6 months) occurrence of: myocardial infarction, unstable angina, stroke, transient ischemic attack, decompensated heart failure requiring hospitalization, or Class III/IV heart failure (4)
•History or presence of Mobitz Type II 2nd degree or 3rd degree AV b