HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use PALONOSETRON HYDROCHLORIDE INJECTION safely and effectively. See full prescribing information for PALONOSETRON HYDROCHLORIDE INJECTION.
PALONOSETRON HYDROCHLORIDE injection, for intravenous use
Initial U.S. Approval: 2003
INDICATIONS AND USAGE
Palonosetron hydrochloride injection is a serotonin-3 (5-HT3) receptor antagonist indicated in:
Adults for prevention of:
Pediatric patients aged 1 month to less than 17 years for prevention of:
DOSAGE AND ADMINISTRATION
Chemotherapy-Induced Nausea and Vomiting (2.1)
Postoperative Nausea and Vomiting (2.1)
DOSAGE FORMS AND STRENGTHS
Hypersensitivity to palonosetron or any of its components. (4)
WARNINGS AND PRECAUTIONS
Most common adverse reactions in
To report SUSPECTED ADVERSE REACTIONS, contact Hospira, Inc. at 1-800-441-4100 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Serotonergic Drugs: Monitor for serotonin syndrome; if symptoms occur, discontinue palonosetron and initiate supportive treatment. (7.1)
See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.
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