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HIGHLIGHTS OF PRESCRIBING INFORMATION |
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These highlights do not include all the information needed to use ALOXIsafely and effectively. See full prescribing information for ALOXI. |
ALOXI(palonosetron hydrochloride) injection for intravenoususe
Initial U.S. Approval:2003 |
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RECENT MAJOR CHANGES
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Indications and Usage, Postoperative and Postdischarge Nausea and Vomiting (1.2)02/2008
Dosage and Administration, Recommended Dosing (2.1)02/2008
Warnings and Precautions, QTc Intervals (5.2) - Deletion02/2008
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INDICATIONS AND USAGE
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ALOXI is a serotonin subtype 3 (5-HT3) receptor antagonist indicated 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 (1.2)
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DOSAGE AND ADMINISTRATION
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Chemotherapy Induced Nausea and Vomiting (2.1)
• Adult Dosage: a single 0.25 mg I.V. dose administered over 30 seconds. Dosing should occur approximately 30 minutes before the start of chemotherapy.
Postoperative Nausea and Vomiting (2.1)
• Adult Dosage: a single 0.075 mg I.V. dose administered over 10 seconds immediately before the induction of anesthesia.
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DOSAGE FORMS AND STRENGTHS
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0.25 mg/5ml (free base) single-use vial (3)
0.075 mg/1.5ml (free base) single-use vial (3)
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CONTRAINDICATIONS
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ALOXI is contraindicated in patients known to have hypersensitivity to the drug or any of its components (4)
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WARNINGS AND PRECAUTIONS
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• Hypersensitivity reactions may occur in patients who have exhibited hypersensitivity to other selective 5-HT3 receptor antagonists (5.1)
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ADVERSE REACTIONS
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The most common adverse reactions in chemotherapy-induced nausea and vomiting (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.
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To report SUSPECTED ADVERSE REACTIONS, contact MGI PHARMA at1-800-562-5580or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
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DRUG INTERACTIONS
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The potential for clinically significant drug interactions with palonosetron appears to be low (7)
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USE IN SPECIFIC POPULATIONS
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Safety and effectiveness in patients below the age of 18 years have not been established (8.4)
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See 17 for PATIENT COUNSELING INFORMATION |
Revised: 09/2008 |
