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Serotonin plays an important role in chemotherapy-induced nausea and vomiting (CINV)

Chemotherapy causes the release of serotonin, which triggers CINV when it binds to the 5-HT3 receptors in the brain1,2

Image showing that when ALOXI binds to the 5-HT3 receptor, it prevents the binding of serotonin. Chemotherapy causes the release of serotonin, which triggers CINV when it binds to the 5-HT3 receptors in the brain

When ALOXI® binds to the 5-HT3 receptor, it prevents the binding of serotonin.1,2*

ALOXI binds strong, stays long2,3

  • ALOXI has a 40-hour half-life, and has been shown to have a strong binding affinity to the 5-HT3 receptor2,3*
Image demonstrating thought that chemotherapeutic agents produce nausea and vomiting by releasing serotonin from the small intestine and that the released serotonin then activates the 5-HT3 receptors located in the brain to initiate the vomiting reflex. When ALOXI binds to the 5-HT3 receptor, it prevents the binding of serotonin

*The correlation between these pharmacological data and clinical efficacy has not been established. It is thought that chemotherapeutic agents produce nausea and vomiting by releasing serotonin from the small intestine and that the released serotonin then activates 5-HT3 receptors in the brain to initiate the vomiting reflex.1,2

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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References: 1. Gregory RE, Ettinger DS. 5-HT3 receptor antagonists for the prevention of chemotherapy-induced nausea and vomiting: a comparison of their pharmacology and clinical efficacy. Drugs. 1998;55:173-189. 2. ALOXI® (palonosetron HCl) injection. Full Prescribing Information. 3. Schwartzberg L, Szabo S, Gilmore J, et al. Likelihood of a subsequent chemotherapy-induced nausea and vomiting (CINV) event in patients receiving low, moderately or highly emetogenic chemotherapy (LEC/MEC/HEC). Curr Med Res Opin. 2011;27:837-845.

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.
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