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palonosetron HCl injection Highlights

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use PALONOSETRON HYDROCHLORIDE INJECTION safely and effectively. See full prescribing information for PALONOSETRON HYDROCHLORIDE INJECTION.

PALONOSETRON HYDROCHLORIDE injection, for intravenous use

Initial U.S. Approval: 2003

INDICATIONS AND USAGE

Palonosetron hydrochloride injection is a serotonin-3 (5-HT3) receptor antagonist indicated in:

Adults for prevention of:

  • acute and delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC). (1)
  • acute nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC). (1)
  • postoperative nausea and vomiting (PONV) for up to 24 hours following surgery. Efficacy beyond 24 hours has not been demonstrated. (1)

Pediatric patients aged 1 month to less than 17 years for prevention of:

  • acute nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including highly emetogenic cancer chemotherapy (HEC). (1)

DOSAGE AND ADMINISTRATION

Chemotherapy-Induced Nausea and Vomiting (2.1)

AgeDose*Infusion Time
*
Note different dosing units in pediatrics
Adults0.25 mg as a single doseInfuse over 30 seconds beginning approximately 30 minutes before the start of chemotherapy
Pediatrics
(1 month to less than 17 years)		20 micrograms per kilogram (maximum 1.5 mg) as a single doseInfuse over 15 minutes beginning approximately 30 minutes before the start of chemotherapy

Postoperative Nausea and Vomiting (2.1)

  • The recommended adult dosage is 0.075 mg as a single intravenous dose administered over 10 seconds immediately before the induction of anesthesia.

DOSAGE FORMS AND STRENGTHS

Injection:

  • 0.25 mg palonosetron in 5 mL (0.05 mg/mL) in a single-dose vial (3)
  • 0.075 mg palonosetron in 1.5 mL (0.05 mg/mL) in a single-dose vial (3)

CONTRAINDICATIONS

Hypersensitivity to palonosetron or any of its components. (4)

WARNINGS AND PRECAUTIONS

  • Hypersensitivity reactions, including anaphylaxis and anaphylactic shock: reported in patients with or without known hypersensitivity to other selective 5-HT3 receptor antagonists. If symptoms occur, discontinue palonosetron and initiate appropriate medical treatment. (5.1)
  • Serotonin syndrome: reported with 5-HT3 receptor antagonists alone, but particularly with concomitant use of serotonergic drugs. (5.2, 7.1)

ADVERSE REACTIONS

Most common adverse reactions in

  • chemotherapy-induced nausea and vomiting in adults (≥5%) are: headache and constipation. (6.1)
  • postoperative nausea and vomiting (≥ 2%) are: QT prolongation, bradycardia, headache, and constipation. (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact Hospira, Inc. at 1-800-441-4100 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DRUG INTERACTIONS

Serotonergic Drugs: Monitor for serotonin syndrome; if symptoms occur, discontinue palonosetron and initiate supportive treatment. (7.1)

See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.

Revised: 4/2021

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