Important Safety Information Expand  Collapse 

Important Safety Information

Important Safety Information


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


  • 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


  • In adults, the most commonly reported adverse drug reactions include headache (9%) and constipation (5%)
  • In pediatric patients, while they require a higher dose of palonosetron, the safety profile is consistent with the established profile in adults; however, adverse reactions were reported in < 0.1% of pediatric patients

Indication in Adults

ALOXI injection 0.25 mg/5 mL 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.

Indication in Pediatrics

ALOXI injection 20 mcg/kg (max 1.5 mg) is indicated in patients ≥ 1 month up to 17 years of age, for the prevention of acute nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including highly emetogenic chemotherapy.

For more information about ALOXI, see Full Prescribing Information.

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The health information contained herein is provided for educational purposes only and is not intended to replace discussions with a healthcare professional. All decisions regarding patient care must be made with a healthcare professional, considering the unique characteristics of the patient.

This site is intended for residents of the United States only. Any products discussed herein may have different product labeling in different countries.

To report suspected adverse reactions contact Helsinn Medical Information at 1- 84HELSINN-U (1-844-357- 4688) and select option 1 or FDA at

ALOXI® is a registered trademark of Helsinn Healthcare SA, Switzerland, used under license.
Distributed and Marketed by Helsinn Therapeutics (U.S.), Inc. under license of Helsinn Healthcare SA, Switzerland.
© 2019 Helsinn Therapeutics (U.S.), Inc.    All rights reserved.    V-ALOXI-US-0012    04/2019