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ALOXI® studied in MEC
Complete response
Nausea-free patients

ALOXI: Studied in MEC, including AC-based chemotherapy

A comprehensive analysis of foundational protection comparing ALOXI to ondansetron1*

OVERVIEW

Double-blind, randomized, phase III noninferiority trial comparing single doses of ALOXI with 32 mg ondansetron IV.1

PRIMARY ENDPOINT

Complete response (including no emesis and no use of rescue medication) during the acute phase (Day 1). P values represent adjusted post hoc, 2-sided Fisher’s exact test comparison of ALOXI with ondansetron. Significance level=0.025, 97.5% CI.1

SELECT SECONDARY ENDPOINTS

Complete response (including no emesis and no use of rescue medication) in the delayed phase (Days 2-5), as well as the severity of nausea measured by the Likert Scale.1

ALOXI was studied in patients at elevated risk for CINV1

  • Mean patient age was 56.1 years1
  • 86.8% of patients rarely or never consumed alcohol1
 
52.4% of patients received AC-based chemotherapies, which was considered MEC at the time of the study2,3
 

*The most common types of cancer were breast, lung, colon/rectal, and bladder (≥5% of patients in any group).1

The most common chemotherapy regimens were cyclophosphamide, doxorubicin, cisplatin, methotrexate, and carboplatin (>10% of patients in any group).1

Continuous power in a single dose

Significantly greater complete response rates compared to ondansetron following MEC1*

Continuous complete response rates1

Complete control rates through 5 days of treatment comparing ALOXI to ondansetron following moderately emetogenic chemotherapy (MEC). Chart showing sustained control of nausea over 5 days after one dose of ALOXI Complete control rates through 5 days of treatment comparing ALOXI to ondansetron following moderately emetogenic chemotherapy (MEC). Chart showing sustained control of nausea over 5 days after one dose of ALOXI

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.1

  • At the time of this study, AC-based chemotherapies were considered MEC3
  • A single IV dose of ALOXI provided significantly higher CR rates vs ondansetron in both the acute and delayed phases (p=0.0085 and p<0.001)1
    • Clinical superiority over other 5-HT3 receptor antagonists has not been adequately demonstrated in the acute phase4

*In adults receiving MEC.

Intent-to-treat (ITT) cohort.

Continuous prevention of nausea

Rates of nausea-free patients compared to ondansetron following MEC2*

Nausea-free patients

Rates of nausea-free patients comparing ALOXI to ondansetron following moderately emetogenic chemotherapy (MEC). Chart showing sustained prevention of nausea over 5 days after one dose of ALOXI Rates of nausea-free patients comparing ALOXI to ondansetron following moderately emetogenic chemotherapy (MEC). Chart showing sustained prevention of nausea over 5 days after one dose of ALOXI

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.1

  • At the time of this study, AC-based chemotherapies were considered MEC3
  • Significantly fewer patients who received ALOXI experienced nausea (secondary endpoint) on Days 2-4 following MEC than those who received ondansetron2

*In adults receiving MEC.

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.

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

References: 1. 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. 2. Data on file. Eisai, Inc. 3. Hesketh PJ. Defining the emetogenicity of cancer chemotherapy regimens: relevance to clinical practice. The Oncologist. 1999;4:191-196. 4. ALOXI® (palonosetron HCl) injection. Full Prescribing Information.

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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