Indication

ALOXI^® (palonosetron HCl) injection is indicated in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic chemotherapy, and the prevention of acute nausea and vomiting associated with initial and repeat courses of highly emetogenic chemotherapy.

Important Safety Information

CONTRAINDICATIONS

• ALOXI is contraindicated in patients known to have hypersensitivity to the drug or any of its components

WARNINGS AND PRECAUTIONS

• Hypersensitivity reactions, including anaphylaxis, have been reported with or without known hypersensitivity to other 5-HT₃ receptor antagonists
• Serotonin syndrome has been reported with 5-HT₃ receptor antagonists alone, but particularly with the use of serotonergic drugs. Serotonin syndrome can be life threatening. Symptoms may include the following combination of signs and symptoms: mental status changes, autonomic instability, neuromuscular symptoms, seizures, and gastrointestinal symptoms. Patients should be monitored for the emergence of serotonin syndrome, and if symptoms occur, discontinue ALOXI and initiate supportive treatment. Patients should be informed of the increased risk of serotonin syndrome, especially if ALOXI is used concomitantly with other serotonergic drugs

ADVERSE REACTIONS

• In adults, the most commonly reported adverse drug reactions include headache (9%) and constipation (5%)

For more information about ALOXI, please see Full Prescribing Information.

Moderately emetogenic chemotherapy (MEC).

*Palonosetron received “preferred” status designation for prevention of acute and delayed emesis following IV moderately emetogenic chemotherapy.

^§Double-blind, randomized, phase III noninferiority trial comparing single doses of ALOXI (n=189) with ondansetron (n=185) with a primary endpoint of complete response during the acute phase (Day 1) following MEC. ALOXI demonstrated significantly greater complete response in the acute phase (81.0% vs 68.6%, p=0.0085) and in the delayed phase (74.1% vs 55.1%, p<0.001). Clinical superiority over other 5-HT₃ receptor antagonists has not been adequately demonstrated in the acute phase.^3,4

References: 1. Hesketh PJ, Bohlke K, Lyman GH, et al. Antiemetics: American Society of Clinical Oncology Focused Guideline Update. J Clin Oncol. 2016;34:381-386. 2. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines^®) for Antiemesis V2.2016. © National Comprehensive Cancer Network, Inc. 2016. All rights reserved. Accessed November 2, 2016. To view the most recent and complete version of the guideline, go online to NCCN.org. NATIONAL COMPREHENSIVE CANCER NETWORK^®, NCCN^®, NCCN GUIDELINES^®, and all other NCCN Content are trademarks owned by the National Comprehensive Cancer Network, Inc. 3. ALOXI^® (palonosetron HCl) injection. Full Prescribing Information. 4. Gralla R, Lichinitser M, Van der Vegt S, et al. Palonosetron improves prevention of chemotherapy-induced nausea and vomiting following moderately emetogenic chemotherapy: results of a double-blind randomized phase III trial comparing single doses of palonosetron with ondansetron. Ann Oncol. 2003;14:1570-1577.

ALOXI^® is a registered trademark of Helsinn Healthcare SA, Switzerland, used under license. Distributed by Eisai Inc. under license of Helsinn Healthcare SA, Switzerland. Marketed by Eisai Inc. and Helsinn Therapeutics (U.S.), Inc. © 2017 Eisai Inc. All rights reserved. ALOX-US0217 01/17