IMPORTANT SAFETY INFORMATION | FULL PRESCRIBING INFORMATION | PATIENT WEBSITE | HEALTHCARE PROFESSIONALS OUTSIDE THE US

ALOXI®: prevention of acute CINV in HEC

Complete response rates during the acute phase (0-24 hours)1,2*

Complete response rates comparing ALOXI to ondansetron following highly emetogenic chemotherapy (HEC). Chart showing percentage of complete response rates in the first 24 hours after HEC treatment Complete response rates comparing ALOXI to ondansetron following highly emetogenic chemotherapy (HEC). Chart showing percentage of complete response rates in the first 24 hours after HEC treatment

Phase III, multinational, randomized, double-blind, double-dummy, stratified, parallel-group, active-comparator noninferiority trial comparing single doses of ALOXI with ondansetron, with a primary endpoint of complete response during the acute phase (Day 1) following HEC. P values represent adjusted post hoc, 2-sided Fisher’s exact test comparisons of ALOXI with ondansetron. Significance level=0.025, 97.5% CI.2

  • In this study, 83% of ALOXI patients received cisplatin2
  • The most common chemotherapy regimens were cisplatin, cyclophosphamide, and dacarbazine (≥10% of patients in any group)2
  • Concomitant dexamethasone 20 mg IV on Day 1 was administered prophylactically to 67% of the ITT population1,2
    • Efficacy was greater when prophylactic steroids were administered concomitantly2
  • NK1 RAs were not used in this study1
  • Clinical superiority over other 5-HT3 receptor antagonists has not been adequately demonstrated in the acute phase1

*In adults receiving HEC.

CR=no emetic episode and no use of rescue medication.

Intent-to-treat (ITT) cohort.

Important Safety Information Expand  Collapse 

Important Safety Information

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%)
  • 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.

back to top

Chemotherapy-induced nausea and vomiting (CINV). Highly emetogenic chemotherapy (HEC).

References: 1. ALOXI® (palonosetron HCl) injection. Full Prescribing Information. 2. Aapro MS, Grunberg SM, Manikhas GM, et al. A phase III, double-blind, randomized trial of palonosetron compared with ondansetron in preventing chemotherapy-induced nausea and vomiting following highly emetogenic chemotherapy. Ann Oncol. 2006;17:1441-1449.

Important Safety Information Expand  Collapse 

Important Safety Information

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%)
  • 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.

Eisai Helsinn

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 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.
© 2017 Eisai Inc.    All rights reserved.    ALOX-US0241    01/17    us.eisai.com