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

Find palonosetron HCl injection medical information:

Find palonosetron HCl injection medical information:

Our scientific content is evidence-based, scientifically balanced and non-promotional. It undergoes rigorous internal medical review and is updated regularly to reflect new information.

palonosetron HCl injection Quick Finder

Prescribing Information
Download Prescribing Information

Health Professional Information

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
Medication Guide

Health Professional Information

{{section_name_patient}}

{{section_body_html_patient}}

Resources

Didn’t find what you were looking for? Contact us.

MI Digital Assistant

Chat online with Pfizer Medical Information regarding your inquiry on a Pfizer medicine.

Call 800-438-1985*

*Speak with a Pfizer Medical Information Professional regarding your medical inquiry. Available 9AM-5Pm ET Monday to Friday; excluding holidays.

Medical Inquiry

Submit a medical question for Pfizer prescription products.

Report Adverse Event

Pfizer Safety

To report an adverse event related to the Pfizer-BioNTech COVID-19 Vaccine, and you are not part of a clinical trial* for this product, click the link below to submit your information:

Pfizer Safety Reporting Site

*If you are involved in a clinical trial for this product, adverse events should be reported to your coordinating study site.

If you cannot use the above website, or would like to report an adverse event related to a different Pfizer product, please call Pfizer Safety at (800) 438-1985.

FDA Medwatch

You may also contact the U.S. Food and Drug Administration (FDA) directly to report adverse events or product quality concerns either online at www.fda.gov/medwatch or call (800) 822-7967.