The Adverse Impact of
Postoperative Nausea
and Vomiting (PONV)

PONV Is A Common Complication of Surgery and Anesthesia Despite Prophylaxis

Nausea and vomiting in the PACU may result in1,5-8

  • Clinical complications of varying frequency and severity
  • Poor patient satisfaction
  • More nursing efforts
  • Delayed PACU discharge
    • Patients with PONV had 14 minutes longer direct nursing time and 1 hour longer PACU length of stay than patients without PONV8
    • Each minute in the PACU can cost approximately $13.339,*
*Data was derived from Phase I PACU of a single facility.

Patients Perceive That PONV Is Worse Than Pain

In a survey of patients (N=220) undergoing preoperative anesthetic examination, more patients ranked PONV as their top postoperative concern than pain (49% vs 27%).10

49% of the surveyed patients ranked PONV as more concerning than pain when asked about postsurgical complications.

Learn More About PONV and Its Complex Pathophysiology

2020 Consensus Guidelines Address Management of PONV Using Antiemetics

Management of PONV for Adults1
1

Risk Factors

Patient-Related

  • Female sex
  • Younger age
  • Nonsmoker status
  • History of PONV or motion sickness

Treatment-Related

  • Postoperative opioids
  • Emetogenic surgery (type and duration)
2

Consider

Cost-Effectiveness

  • Cost of drugs
  • Cost of patient care

Reducing Baseline Risk

  • Avoidance/minimization of
    • Nitrous oxide
    • Volatile anesthetic
    • Intraoperative and postoperative opioids
  • Adequate hydration
3

Risk Stratification

Quantify the number of risk factors to determine risk and guide prophylactic antiemetic therapy

1-2 Risk Factors

Give 2 agents

>2 Risk Factors

Give 3-4 agents

4

Prophylactic Treatment Options

  • 5-HT3 antagonist
  • Corticosteroids
  • Antihistamines
  • Anticholinergics
  • Dopamine antagonists
  • NK-1 receptor antagonist
  • Nonpharmacologic: acupuncture
  • Propofol anesthesia
5

Rescue Treatment

  • Use an antiemetic from a different pharmacological class than prophylactic agents
  • Treatment of established PONV should be prompt and aggressive

For patients needing rescue treatment, options may be limited as PONV agents are associated with challenges and undesirable side effects.

  • Antiemetics have a variety of adverse effects, which may include sedation, extrapyramidal symptoms, QT prolongation, and dry mouth.1

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

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

5-HT3=serotonin. NK=neurokinin. PACU=postanesthesia care unit.

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. Apfel CC, Laara E, Koivuranta M, Greim CA, Roewer N. A simplified risk score for predicting postoperative nausea and vomiting: conclusions from cross-validations between two centers. Anesthesiology. 1999;91(3):693-700. 3. White PF, O’Hara JF, Roberson CR, et al. The impact of current antiemetic practices on patient outcomes: a prospective study on high-risk patients. Anesth Analg. 2008;107:452-458. 4. Habib AS, Kranke P, Bergese SD, et al. Amisulpride for the rescue treatment of postoperative nausea or vomiting in patients failing prophylaxis: a randomized, placebo-controlled phase III trial. Anesthesiology. 2019;130(2):203-212. 5. Habib AS, Chen YT, Taguchi A, Hu XH, Gan TJ. Postoperative nausea and vomiting following inpatient surgeries in a teaching hospital: a retrospective database analysis. Curr Med Res Opin. 2006;22(6):1093-1099. 6. Golembiewski J, Chernin E, Chopra T. Prevention and treatment of postoperative nausea and vomiting. Am J Health-Sys Pharm. 2005;62:1247-1260. 7. Hill RP, Lubarsky DA, Phillips-Bute B, et al. Cost-effectiveness of prophylactic antiemetic therapy with ondansetron, droperidol, or placebo. Anesthesiology. 2000;92(4):958-967. 8. Parra-Sanchez I, Abdallah R, You J, et al. A time-motion economic analysis of postoperative nausea and vomiting in ambulatory surgery. Can J Anaesth. 2012;59(4):366-375. 9. Viellette EL, Gonzalez B, Irwin JS, Peters I. Nurse discharge by criteria decreases post anesthesia care unit (PACU) length stay. J Perianesth Nurs. 2021;36:e13. 10. Eberhart LH, Morin AM, Wulf H. Patient preferences for immediate postoperative recovery. Br J Anaesth. 2002;89(5):760-761.