sion between GILENYA and interferon beta-1a-treated patients at 1 year. The 1.25 mg dose resulted in no additional benefit over the GILENYA 0.5 mg dose. The results for this study are shown in Table 3.
Table 3 Clinical and MRI Results of Study 2 GILENYA 0.5 mg N=429 Interferon beta-1a IM 30 μg N=431 p-value
Clinical Endpoints
Annualized relapse rate (primary endpoint) 0.16 0.33 <0.001
Percentage of patients without relapse 83% 70% <0.001
Hazard ratio‡ of disability progression
(95% CI) 0.71
(0.42, 1.21) 0.21
MRI Endpoint
Mean (median) number of new or newly enlarging T2 lesions over 12 months 1.6 (0) 2.6 (1.0) 0.002
Mean (median) number of T1 Gd-enhancing lesions at Month 12 0.2 (0) 0.5 (0) <0.001
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 card NDC 0078-0607-51
Carton of 7 capsules containing 1 blister card of 7 capsules per blister card NDC 0078-0607-89
GILENYA capsules should be stored at 25ºC (77ºF); excursions permitted to 15-30ºC (59-86ºF). Protect from moisture.
17 PATIENT COUNSELING INFORMATION
See 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 at least 6 hours after the first dose. Advise patients that if GILENYA is discontinued for more than 14 days, effects similar to those observed on treatment initiation may be seen and observation for at least 6 hours will be needed on treatment re-initiation, and that the same precautions will be taken if treatment is interrupted for more than one day within the first 2 weeks of treatment, or for more than 7 days during week 3 and 4 of treatment.
17.3 Risk of Infections
Inform patients that they may be more likely to get infections when taking GI |
