ater than 65 years of age.
Co-primary efficacy measures were Complete Response (CR) defined as no emetic episode and no use of rescue medication in the 0-24 and in the 24-72 hours postoperatively.
Secondary efficacy endpoints included:
Complete Response (CR) 0-48 and 0-72 hours
Complete Control (CC) defined as CR and no more than mild nausea
Severity of nausea (none, mild, moderate, severe)
The primary hypothesis in Study 1 was that at least one of the three palonosetron doses were superior to placebo.
Results for Complete Response in Study 1 for 0.075 mg palonosetron versus placebo are described in the following table.
Table 8: Prevention of Postoperative Nausea and Vomiting: Complete Response (CR), Study 1, Palonosetron 0.075 mg Vs Placebo * To reach statistical significance for each co-primary endpoint, the required significance limit for the lowest p-value was p<0.017.
Δ Difference (%): palonosetron 0.075mg minus placebo
Treatment n/N (%) Palonosetron Vs Placebo
Δ p-value*
Co-primary Endpoints
CR 0-24hours
Palonosetron 59/138 (42.8%) 16.8% 0.004
Placebo 35/135 (25.9%)
CR 24-72hours
Palonosetron 67/138 (48.6%) 7.8% 0.188
Placebo 55/135 (40.7%)
Palonosetron 0.075 mg reduced the severity of nausea compared to placebo. Analyses of other secondary endpoints indicate that palonosetron 0.075 mg was numerically better than placebo, however, statistical significance was not formally demonstrated.
A phase 2 randomized, double-blind, multicenter, placebo-controlled, dose ranging study was performed to eva luate I.V. palonosetron for the prevention of post-operative nausea and vomiting following abdominal or vaginal hysterectomy. Five I.V. palonosetron doses (0.1, 0.3, 1.0, 3.0, and 30 µg/kg) were eva luated in a total of 381 intent-to-treat patients. The primary efficacy measure was the proportion of patients with CR in the first 24 hours after recovery from surgery. The lowest effective dose was palonosetron 1 µg/kg (approximately 0.075 mg) which had a CR rate of 44% versus 19% for placebo, p=0.004. Palonosetron 1 µg/kg also significantly reduced the severity of nausea versus placebo, p=0.009.
16 HOW SUPPLIED/STORAGE AND HANDLING
NDC # 62856-797-01, ALOXI Injection 0.25 mg/5 mL (free base) single-use vial individually packaged in a carton.
NDC # 62856-798-01, ALOXI Injection 0.075 mg/1.5 mL (free base) single-use vial packaged in a carton containing 5 vials.
Storage
Store at controlled temperature of 20-25°C (68°F-77°F).
Excursions permitted to 15-30°C (59-86°F).
Protect from freezing.
Protect from light.
17 PATIENT COUNSELING INFORMATION
See FDA-approved patient labelling (Patient Information).
Instructions for PatientsPatients should be advised to report to their physician all of their medical conditions, including any pain, redness, or swelling in and around the infusion site [see Adverse Reactions (6.3)].
Advise patients of the possibility of serotonin syndrome, especially with concomitant use of ALOXI and another serotonergic agent such as medications to treat depression and migraines. Advise patients to seek immediate medical attention if the following |
