All analyses of clinical endpoints were intent-to–treat. MRI analysis used eva luable dataset.

‡ Hazard ratio is an estimate of the relative risk of having the event of disability progression on GILENYA as compared to control.

Pooled results of study 1 and study 2 showed a consistent and statistically significant reduction of annualized relapse rate compared to comparator in subgroups defined by gender, age, prior MS therapy, and disease activity.

16 HOW SUPPLIED/STORAGE AND HANDLING
0.5 mg GILENYA capsules are hard gelatin capsules with a white opaque body and bright yellow cap imprinted with “FTY 0.5 mg” on the cap and two radial bands imprinted on the capsule body with yellow ink.

GILENYA capsules are supplied in blister packs.

Carton of 28 capsules containing 2 folded blister cards of 14 capsules per blister cardNDC 0078-0607-51

Carton of 7 capsules containing 1 blister card of 7 capsules per blister cardNDC 0078-0607-89

GILENYA capsules should be stored at 25ºC (77ºF); excursions permitted to 15-30ºC (59-86ºF). Protect from moisture.

17 PATIENT COUNSELING INFORMATIONSee Medication Guide.

A Medication Guide is required for distribution with GILENYA. Encourage patients to read the GILENYA Medication Guide. The complete text of the Medication Guide is reprinted at the end of this document.

17.1 Benefits and Risks
Summarize for patients the benefits and potential risks of treatment with GILENYA. Tell patients to take GILENYA once daily as prescribed. Tell patients not to discontinue GILENYA without first discussing this with the prescribing physician.

17.2 Cardiac Effects
Advise patients that initiation of GILENYA treatment results in a transient decrease in heart rate. Inform patients that they will need to be observed in the doctor's office or other facility for 6 hours after the first dose. Advise patients that if GILENYA is discontinued for more than two weeks, effects similar to those observed on treatment initiation may be seen and observation for 6 hours will be needed on treatment re-initiation.

17.3 Risk of Infections
Inform patients that they may be more likely to get infections when taking GILENYA, and that they should contact their physician if they develop symptoms of infection. Advise patients that the use of some vaccines should be avoided during treatment with GILENYA and for 2 months after discontinuation. Advise patients who have not had chickenpox or vaccination to consider VZV vaccination prior to commencing treatment with GILENYA.

17.4 Macular Edema
Advise patients that GILENYA may cause macular edema, and that they should contact their physician if they experience any changes in their vision. Inform patients with diabetes mellitus or a history of uveitis that their risk of macular edema is increased.

17.5 Respiratory Effects
Advise patients that they should contact their physician if they experience new onset or worsening of dyspnea.

17.6 Hepatic Effects
Inform patients that GILENYA may increase liver enzymes. Advise patients that they should contact their physician if they have any unexplained nausea, vomiting, abdominal pain, fatigue, anorexia, or jaundice and/or dark urine.

17.7 Fetal Risk
Inform patients that, bas