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Multiple trials
Safety in MEC
Safety in HEC

Safety across multiple trials for MEC and HEC

Most frequently occurring adverse reactions ≥2% across 3 pivotal studies1

Chart showing that in clinical trials for the prevention of CINV following moderately or highly emetogenic chemotherapy, adverse reactions were similar in frequency and severity with ALOXI compared with ondansetron or dolasetron Chart showing that in clinical trials for the prevention of CINV following moderately or highly emetogenic chemotherapy, adverse reactions were similar in frequency and severity with ALOXI compared with ondansetron or dolasetron
  • In the pivotal study comparing ALOXI to ondansetron in adults receiving MEC, the most frequently occurring treatment-related adverse reactions for ALOXI were headache, constipation, and dizziness2
  • In clinical trials for the prevention of CINV following MEC or HEC, adverse reactions were similar in frequency and severity with ALOXI and ondansetron or dolasetron1

NO SIGNIFICANT EFFECT ON QTc INTERVALS

  • A thorough QT/QTc study demonstrated no significant effect on any ECG parameters with ALOXI (including QT/QTc intervals) at doses up to 2.25 mg, 9 times higher than the FDA-approved dose3
    • Double-blind, randomized, parallel, placebo- and positive- (moxifloxacin) controlled trial in 230 healthy adult patients3

Safety following moderately emetogenic chemotherapy (MEC)

Most frequently occurring treatment-related adverse reactions reported by >2% of patients following MEC in one pivotal study2

Chart showing safety of using ALOXI compared with ondansetron following moderately emetogenic chemotherapy (MEC) Chart showing safety of using ALOXI compared with ondansetron following moderately emetogenic chemotherapy (MEC)
  • In controlled clinical trials, ALOXI injection has been safely administered with corticosteroids, analgesics, antiemetics/antinauseants, antispasmodics, and anticholinergic agents1
  • No dose adjustments were required for the elderly* or those with renal or hepatic impairment1
    • Greater sensitivity in some older individuals cannot be ruled out1

NO SIGNIFICANT EFFECT ON QTc INTERVALS

  • A thorough QT/QTc study demonstrated no significant effect on any ECG parameters with ALOXI (including QT/QTc intervals) at doses up to 2.25 mg, 9 times higher than the FDA-approved dose3
    • Double-blind, randomized, parallel, placebo- and positive- (moxifloxacin) controlled trial in 230 healthy adult patients3

*No overall differences in safety or effectiveness were observed between cancer patients ≥65 years of age and younger subjects (18 to 64 years).1

Safety following highly emetogenic chemotherapy (HEC)

Treatment-related adverse reactions following HEC in one pivotal study4

Chart showing safety of using ALOXI compared with ondansetron following highly emetogenic chemotherapy (HEC) Chart showing safety of using ALOXI compared with ondansetron following highly emetogenic chemotherapy (HEC)
  • No dose adjustments were required for the elderly* or those with renal or hepatic impairment1
    • Greater sensitivity in some older individuals cannot be ruled out1

NO SIGNIFICANT EFFECT ON QTc INTERVALS

  • A thorough QT/QTc study demonstrated no significant effect on any ECG parameters with ALOXI (including QT/QTc intervals) at doses up to 2.25 mg, 9 times higher than the FDA-approved dose3
    • Double-blind, randomized, parallel, placebo- and positive- (moxifloxacin) controlled trial in 230 healthy adult patients3

*No overall differences in safety or effectiveness were observed between cancer patients ≥65 years of age and younger subjects (18 to 64 years).1

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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Chemotherapy-induced nausea and vomiting (CINV).

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. Morganroth J, Parisi S, Spinelli T, Moresino C, Thorn M, Cullen MT. High dose palonosetron does not alter ECG parameters including QTc interval in healthy subjects: results of a dose-response, double-blind, randomised, parallel E14 study of palonosetron vs. moxifloxacin or placebo. Presented at: 14th European Conference of Clinical Oncology (ECCO); September 23-27, 2007; Barcelona, Spain. 4. 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.
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