00-FDA-1088 or www.fda.gov/medwatch.
DRUG INTERACTIONS
The potential for clinically significant drug interactions with palonosetron appears to be low (7)
USE IN SPECIFIC POPULATIONS
Chemotherapy-Induced Nausea and Vomiting
Pediatric use: Safety and effectiveness in neonates (less than 1 month of age) have not been established (8.4)
Postoperative Nausea and Vomiting
Safety and Effectiveness in patients below the age of 18 years have not been established (8.4)
See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.
Revised: 9/2014
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
1.1 Chemotherapy-Induced Nausea and Vomiting in Adults 1.2 Chemotherapy-Induced Nausea and Vomiting in Pediatric Patients Aged 1 Month to Less than 17 Years 1.3 Postoperative Nausea and Vomiting in Adults 2 DOSAGE AND ADMINSTRATION
2.1 Recommended Dosing 2.2 Instructions for Intravenous Administration 3 DOSAGE FORM AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Hypersensitivity 5.2 Serotonin Syndrome 6 ADVERSE REACTIONS
6.1 Chemotherapy-Induced Nausea and Vomiting 6.2 Postoperative Nausea and Vomiting 6.3 Postmarketing Experience 7 DRUG INTERACTIONS
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy 8.3 Nursing Mothers 8.4 Pediatric Use 8.5 Geriatric Use 8.6 Renal Impairment 8.7 Hepatic Impairment 8.8 Race 10 OVERDOSAGE
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action 12.2 Pharmacodynamics 12.3 Pharmacokinetics 13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility 14 CLINICAL STUDIES
14.1 Chemotherapy-Induced Nausea and Vomiting in Adults 14.2 Chemotherapy-Induced Nausea and Vomiting in Pediatrics 14.3 Postoperative Nausea and Vomiting 16 HOW SUPPLIED/STORAGE AND HANDLING
17 PATIENT COUNSELING INFORMATION
Instructions for Patients * Sections or subsections omitted from the full prescribing information are not listed. Close
1 INDICATIONS AND USAGE
1.1 Chemotherapy-Induced Nausea and Vomiting in AdultsALOXI is indicated for:
Moderately emetogenic cancer chemotherapy --prevention of acute and delayed nausea and vomiting associated with initial and repeat courses
Highly emetogenic cancer chemotherapy -- prevention of acute nausea and vomiting associated with initial and repeat courses
1.2 Chemotherapy-Induced Nausea and Vomiting in Pediatric Patients Aged 1 Month to Less than 17 YearsALOXI is indicated for prevention of acute nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including highly emetogenic cancer chemotherapy.
1.3 Postoperative Nausea and Vomiting in AdultsALOXI is indicated for prevention of postoperative nausea and vomiting (PONV) for up to 24 hours following surgery. Efficacy beyond 24 hours has not been demonstrated.
As with other antiemetics, routine prophylaxis is not recommended in patients in whom there is little expectation that nausea and/or vomiting will occur postoperatively. In patients where nausea and vomiting must be avoided during the postoperative period, ALOXI is recommended even where the incidence of postoperative nausea and/or vomiting is low.
2 DOSAGE AND ADMINSTRATION
2.1 Recommended DosingChemotherapy-Induced Nausea and Vomiting
Age Dose* Infusion Time
Adults 0.25 mg x 1 Infuse over 30 seconds beginning approx.
30 min before the start of chemo
Pediatrics
(1 month to less than |
