HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to useGILENYA™safely and effectively.See full prescribing information forGILENYA.
GILENYA(fingolimod) capsules
Initial U.S. Approval:2010

INDICATIONS AND USAGE
GILENYA is a sphingosine1-phosphate receptor modulator indicated for the treatment of patients with relapsingforms 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 mgorally once daily,with or without food. (2)
 
DOSAGE FORMS AND STRENGTHS
0.5 mg hard capsules. (3)
 
CONTRAINDICATIONS
None. (4)
 
WARNINGS AND PRECAUTIONS
Decrease in heart rate and/or atrioventricular conduction after first dose of GILENYA: Observe all patients for signs and symptoms of bradycardia for 6 hours after first dose. Obtain baseline ECGbefore first dose if not recently available in those at higher risk of bradyarrhythmia. Patients receiving Class Ia or Class III antiarrhythmic drugs,beta blockers, calcium channel blockers, those witha low heart rate, history of syncope, sick sinus syndrome, 2nd degree or higher conduction block, ischemic heart disease, or congestive heart failure are at increased risk of developing bradycardia or heart blocks. (5.1)

Infections:GILENYA may increase the risk of infections.Arecent CBC should be available before initiating treatment with GILENYA. Monitor for signs and symptoms of infectionduring treatment and for two months after discontinuation. Do not start GILENYA treatment in patients with active acute or chronic infections.(5.2)

Macular edema: Can occur with or without visual symptoms. An ophthalmologic eva luation should be performedbefore starting GILENYA and at 3-4 months after treatment initiation. Monitor visual acuity at baseline and during routine eva luations of patients. Patients with diabetes mellitus or ahistory of uveitis are at increased risk and should have regular ophthalmologic eva luations.(5.3)

Decrease in pulmonary function tests with GILENYA: Obtain spirometry and diffusion lung capacity for carbon monoxide (DLCO) when clinically indicated. (5.4)

Hepatic effects: GILENYA may increase liver transaminases. Recent liver enzyme results should be available before initiating treatment with GILENYA. Assessliver enzymes if symptoms suggestive of hepatic injury develop.Discontinue GILENYA if significant liver injury is confirmed.(5.5)

Fetal risk: Women of childbearing potential should use effective contraception during and for two months after stopping GILENYA treatment. (5.6)
ADVERSE REACTIONS
Most common adverse reactions (incidence ≥10% and > placebo):Headache, influenza, diarrhea, back pain, liver transaminase elevations and cough.(6.1)

To report SUSPECTED ADVERSE REACTIONS, contact Novartis Pharmaceuticals Corporation at 1-888-669-6682 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
DRUG INTERACTIONS
Class Ia or Class III antiarrhythmic drugs:Because of a risk of serious rhythm disturbances, carefully monitor patients on Class Ia or Class III antiarrhythmic drugs during initiation of therapy. (5.1, 7)

Beta blockers: Because of a risk of additive effect on heart rate, carefully monitor patients on beta blockers during initiation of therapy. (5.1, 7)

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