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Indication and Important Safety Information

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.

ASCO=American Society of Clinical Oncology.
CINV=chemotherapy-induced nausea and vomiting.
MEC=moderately emetogenic chemotherapy.

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

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 V.2.2016. © National Comprehensive Cancer Network, Inc. 2016. All rights reserved. Accessed March 15, 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.

To report SUSPECTED ADVERSE REACTIONS, contact EISAI at 1‑888‑422‑4743 or FDA at 1‑800‑FDA‑1088 or www.fda.gov/medwatch.

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.