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Explore the sustained power of prevention in one dose
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ALOXI® 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.
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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
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Please see below for additional Important Safety Information.
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Significantly greater complete response rates were achieved with ALOXI vs ondansetron following moderately emetogenic chemotherapy (MEC) in adults2
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Acute phase: 81.0% of ALOXI patients (n=189) achieved complete response rates vs 68.6% for ondansetron (n=185) (p=0.0085)2
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Delayed phase: 74.1% of ALOXI patients (n=189) achieved complete response rates vs 55.1% for ondansetron (n=185) (p<0.001)2
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Clinical superiority over other 5-HT3 receptor antagonists has not been adequately demonstrated in the acute phase1
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Double-blind, randomized, phase III noninferiority trial comparing single doses of ALOXI with ondansetron with a primary endpoint of complete response during the acute phase (Day 1) following MEC. P values represent adjusted post hoc, 2-sided, Fisher's exact test comparison of ALOXI with ondansetron. Significance level=0.025, 97.5% CI.2
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Received "preferred" status designation by the National Comprehensive Cancer Network® (NCCN®) and the American Society of Clinical Oncology (ASCO) for prevention of acute and delayed emesis following IV MEC3,4
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CI=confidence interval.
IV=intravenous.
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Warnings and Precautions
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Hypersensitivity reactions, including anaphylaxis, have been reported with or without known hypersensitivity to other 5-HT3 receptor antagonists
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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
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Adverse Reactions
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In adults, the most commonly reported adverse drug reactions include headache (9%) and constipation (5%)
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For more information about ALOXI, please see Full Prescribing Information.
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References: 1. ALOXI® (palonosetron HCI) injection. Full Prescribing Information. 2. 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. 3. 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 June 21, 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. 4. Hesketh PJ, Bohlke K, Lyman GH, et al. Antiemetics: American Society of Clinical Oncology Focused Guideline Update. J Clin Oncol. 2016;34:381-386.
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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.
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Eisai, Inc. 100 Tice Boulevard, Woodcliff Lake, NJ 07677 - (USA).
Helsinn Therapeutics (U.S.), Inc., 170 Wood Avenue South, 5th Floor, Iselin, NJ 08830 - (USA).
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© 2016 Eisai Inc. All rights reserved. ALOX-US0090 07/16
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