IMPORTANT SAFETY INFORMATION | FULL PRESCRIBING INFORMATION | PATIENT WEBSITE | HEALTHCARE PROFESSIONALS OUTSIDE THE US
For prevention of chemotherapy-induced nausea and vomiting*

HELP YOUR PATIENTS WEATHER CHEMOTHERAPY BETTER1†

*ALOXI® was studied in MEC, including AC-based chemotherapy.

5 days strong defense against CINV following moderately emetogenic chemotherapy (MEC)

Indications

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. 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.

Anthracycline-cyclophosphamide (AC).

In a trial versus ondansetron in adults receiving 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).2

ALOXI: Over 13 years of FDA-approved CINV prevention1

Powerful

A single IV dose is clinically proven to prevent CINV for up to 5 days following MEC1,2

Proven

Efficacy and safety studied across a variety of patients, chemotherapy regimens, and concomitant agents in multiple clinical trials1-3

Preferred

Palonosetron (ALOXI) is the preferred 5-HT3 receptor antagonist prior to MEC listed in both the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) and ASCO guidelines4,5

Moderately emetogenic chemotherapy (MEC). Chemotherapy-induced nausea and vomiting (CINV).

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.

References: 1. ALOXI® (palonosetron HCl) 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. 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. 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. 5. 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 October 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.

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.
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