menu

Treating Breakthrough PONV: A Review of Therapeutic Approaches, Considerations, and Guidelines

Be part of the knowledge.
Register

We’re glad to see you’re enjoying ReachMD…
but how about a more personalized experience?

Register for free

Treating Breakthrough PONV: A Review of Therapeutic Approaches, Considerations, and Guidelines

4 chapters
Play All
Details
Chapters
Recommended

Overview

Chapter 1
ReachMD Healthcare Image
RestartResume

Review key information on ERAS protocols, management guidelines, clinical considerations for a rescue treatment for PONV, and more.

  • Overview

    When it comes to postoperative nausea and vomiting (PONV) management, multimodal, antiemetic therapy based on patients’ risk factors is routinely provided to minimize the incidence, but unfortunately, patients may still develop breakthrough PONV, in which an antiemetic should be administered from a different class from what's given for prevention.1 Barhemsys® (amisulpride) is an FDA-approved antiemetic for the treatment of PONV in patients who have or have not received prophylaxis.2 Learn more about this treatment option along with current management guidelines, key clinical considerations, and a real-world case study with TJ Gan, MD, MBA, MHS, and Dru Riddle, PhD, DNP. Dr. Gan is the Head of the Division of Anesthesiology and Perioperative Medicine, Critical Care, and Pain Medicine at the University of Texas MD Anderson Cancer Center in Houston, and Dr. Riddle is a certified nurse anesthetist at Texas Christian University in Ft. Worth, TX.

  • Indications and Important Safety Information

    Indications
    Barhemsys is a selective dopamine-2 (D2) and dopamine-3 (D3) receptor antagonist indicated in adults for:

    • prevention of postoperative nausea and vomiting (PONV), either alone or in combination with an antiemetic of a different class
    • treatment of PONV in patients who have received antiemetic prophylaxis with an agent of a different class or have not received prophylaxis

    Important Safety Information
    Contraindication
    Barhemsys is contraindicated in patients with known hypersensitivity to amisulpride.

    QT Prolongation
    Barhemsys causes dose- and concentration-dependent prolongation of the QT interval. The recommended dosage is 5 mg or 10 mg as a single intravenous (IV) dose infused over 1 to 2 minutes.

    Avoid Barhemsys in patients with congenital long QT syndrome and in patients taking droperidol.

    Electrocardiogram (ECG) monitoring is recommended in patients with pre-existing arrhythmias/cardiac conduction disorders, electrolyte abnormalities (e.g., hypokalemia or hypomagnesemia), congestive heart failure, and in patients taking other medicinal products (e.g., ondansetron) or with other medical conditions known to prolong the QT interval.

    Adverse Reactions
    Common adverse reactions reported in ≥ 2% of adult patients who received Barhemsys 5 mg (N=748) and at a higher rate than placebo (N=741) in clinical trials for the prevention of PONV were: chills (4% vs. 3%), hypokalemia (4% vs. 2%), procedural hypotension (3% vs. 2%), and abdominal distention (2% vs. 1%).

    Serum prolactin concentrations were measured in one prophylaxis study where 5% (9/176) of Barhemsys-treated patients had increased blood prolactin reported as an adverse reaction compared with 1% (1/166) of placebo-treated patients.

    The most common adverse reaction, reported in ≥ 2% of adult patients who received Barhemsys 10 mg (N=418) and at a higher rate than placebo (N=416), in clinical trials for the treatment of PONV was infusion site pain (6% vs. 4%).

    Use in Specific Populations
    Pregnancy
    Available data with amisulpride use in pregnant women are insufficient to establish a drug associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes.

    Lactation
    Amisulpride is present in human milk. There are no reports of adverse effects on the breastfed child and no information on the effects of amisulpride on milk production.

    Barhemsys may result in an increase in serum prolactin levels, which may lead to a reversible increase in maternal milk production. In a clinical trial, serum prolactin concentrations in females (n=112) increased from a mean of 10 ng/mL at baseline to 32 ng/mL after Barhemsys treatment and from 10 ng/mL to 19 ng/mL in males (n=61). No clinical consequences due to elevated prolactin levels were reported.

    To minimize exposure to a breastfed infant, lactating women may consider interrupting breastfeeding and pumping and discarding breast milk for 48 hours after receiving a dose of Barhemsys.

    Pediatric Use
    Safety and effectiveness in pediatric patients have not been established.

    Geriatric Use
    No overall differences in safety or effectiveness were observed between these patients and younger patients, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

    Drug Interactions

    • Barhemsys causes dose- and concentration-dependent QT prolongation. To avoid potential additive effects, avoid use of Barhemsys in patients taking droperidol.
    • ECG monitoring is recommended in patients taking other drugs known to prolong the QT interval (e.g., ondansetron).
    • Reciprocal antagonism of effects occurs between dopamine agonists (e.g., levodopa) and Barhemsys. Avoid using levodopa with Barhemsys.

    To report SUSPECTED ADVERSE REACTIONS, contact Acacia Pharma at 1-877-357-9237 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

    Please click to access full Prescribing Information.

    BAR HCP ISI 09/2022

    ERAS=enhanced recovery after surgery.

    References:

    1. Gan TJ, Belani KG, Bergese S, et al. Fourth consensus guidelines for the management of postoperative nausea and vomiting. Anesth Analg. 2020;131(2):411-448.
    2. Barhemsys [Prescribing Information], Indianapolis, IN. Acacia Pharma; 2022.

    Barhemsys® is a registered trademark of Acacia Pharma Limited.
    © 2024 Acacia Pharma Inc. All rights reserved. MLR-BAR-US-0110 06/2024
    Acacia Pharma Limited and Acacia Pharma Inc. are wholly owned subsidiaries of Eagle Pharmaceuticals, Inc.

Schedule20 Jul 2024