These highlights do not include all the information needed to use ALOXI Capsules safely and effectively. See full prescribing information for ALOXI.
ALOXI (palonosetron HCl) Capsules
Initial U.S. Approval: 2003
RECENT MAJOR CHANGES
Warnings and Precautions (5.2) 09/2014
INDICATIONS AND USAGE
ALOXI Capsules, a serotonin subtype 3 (5-HT3) receptor antagonist, are indicated for:
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Moderately emetogenic cancer chemotherapy -- prevention of acute nausea and vomiting associated with initial and repeat courses (1.1)
DOSAGE AND ADMINISTRATION
Adult Dosage: one 0.5 mg capsule administered approximately one hour prior to the start of chemotherapy (2.1)
ALOXI can be taken with or without food (12.3)
DOSAGE FORMS AND STRENGTHS
CONTRAINDICATIONS
ALOXI is contraindicated in patients known to have hypersensitivity to the drug or any of its components (4)
WARNINGS AND PRECAUTIONS
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Hypersensitivity reactions may occur in patients who have exhibited hypersensitivity to other 5-HT3 receptor antagonists (5.1)
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Serotonin syndrome has been reported with 5-HT3 receptor antagonists alone but particularly with concomitant use of serotonergic drugs (5.2)
ADVERSE REACTIONS
No adverse reactions have been reported at an incidence of ≥5 % for the 0.5 mg dose. Headache and constipation are the most common adverse reactions but occur less frequently (6)
To report SUSPECTED ADVERSE REACTIONS, contact EISAI at 1- 888-422-4743 or FDA at 1-800-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
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
