HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use ALOXI safely and effectively. See full prescribing information for ALOXI.
ALOXI® (palonosetron HCl) Injection for Intravenous Use
Initial U.S. Approval: 2003
RECENT MAJOR CHANGES
Indication (1.2) 05/2014
Dosage and Administration, Pediatric Cancer Patients (2.1) 05/2014
Warnings and Precautions, Serotonin Syndrome (5.2) 09/2014
INDICATIONS AND USAGE
ALOXI is a serotonin-3 (5-HT3) receptor antagonist indicated in adults for:
Moderately emetogenic cancer chemotherapy --prevention of acute and delayed nausea and vomiting associated with initial and repeat courses (1.1)
Highly emetogenic cancer chemotherapy -- prevention of acute nausea and vomiting associated with initial and repeat courses (1.1)
Prevention of postoperative nausea and vomiting (PONV) for up to 24 hours following surgery. Efficacy beyond 24 hours has not been demonstrated (1.3)
ALOXI is indicated in pediatric patients aged 1 month to less than 17 years for:
Prevention of acute nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including highly emetogenic cancer chemotherapy (1.2)
DOSAGE AND ADMINISTRATION
Chemotherapy-Induced Nausea and Vomiting (2.1)
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 17 years)
20 micrograms per
kilogram (max 1.5 mg) x 1
Infuse over 15 minutes beginning approx.
30 min before the start of chemo
*Note different dosing units in pediatrics
Postoperative Nausea and Vomiting (2.1)
Adult Dosage: a single 0.075 mg intravenous dose administered over 10 seconds immediately before the induction of anesthesia.
DOSAGE FORMS AND STRENGTHS
0.25 mg/5mL (free base) single-use vial (3)
0.075 mg/1.5mL (free base) single-use vial (3)
CONTRAINDICATIONS
ALOXI is contraindicated in patients known to have hypersensitivity to the drug or any of its components (4)
WARNINGS AND PRECAUTIONS
Hypersensitivity reactions, including anaphylaxis, have been reported with or without known hypersensitivity to other selective 5-HT3 receptor antagonists (5.1)
Serotonin syndrome has been reported with 5-HT3 receptor antagonists alone but particularly with concomitant use of serotonergic drugs (5.2)
ADVERSE REACTIONS
The most common adverse reactions in chemotherapy-induced nausea and vomiting in adults (incidence ≥5%) are headache and constipation (6.1).
The most common adverse reactions in postoperative nausea and vomiting (incidence ≥ 2%) are QT prolongation, bradycardia, headache, and constipation (6.2).
To report SUSPECTED ADVERSE REACTIONS, contact EISAI at 1-888-422-4743 or FDA at 1-8 |
