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The Adverse Impact of Postoperative Nausea and Vomiting (PONV)

PONV Is a Common Complication of Surgery and Anesthesia

In all surgical patients
can suffer from postoperative nausea1
can experience vomiting within 24 hours after surgery1
In high-risk patients
can experience PONV2,3
can experience PONV despite prophylaxis4,5

PONV may result in clinical complications of varying frequency and severity in patients after surgical procedures.

Clinical complications of persistent retching or vomiting include electrolyte abnormalities and dehydration, tension on suture lines, and development of hematomas beneath surgical flaps.2,6,7

These clinical complications and others may delay PACU discharge, result in unanticipated hospitalization, or prolong hospital stay.2,8,9

Patients Want to Avoid PONV

In a survey of patients (N=220) undergoing preoperative anesthetic examination, avoiding PONV was a major concern.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 Adults2

1

Risk Factors

Patient-Related

Patient-Related

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

Environmental

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

Consider

Cost-Effectiveness

Cost-Effectiveness

  • Cost of drugs
  • Cost of patient care
Reducing Baseline Risk

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

Risk Factors

Give 2 agents

>2 Risk Factors

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

PONV agents are associated with challenges and undesirable side effects.

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

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

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.

Renal Impairment
Avoid BARHEMSYS in patients with severe renal impairment (estimated glomerular filtration rate [eGFR] < 30 mL/min/1.73 m2). The pharmacokinetics of amisulpride in patients with severe renal impairment have not been adequately studied in clinical trials. Amisulpride is known to be substantially excreted by the kidneys, and patients with severe renal impairment may have increased systemic exposure and an increased risk of adverse reactions.

No dosage adjustment is necessary in patients with mild to moderate renal impairment (eGFR ≥ 30 mL/min/1.73 m2).

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.

Please click to access full Prescribing Information.

BAR HCP ISI 02/2020

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

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.

Renal Impairment
Avoid BARHEMSYS in patients with severe renal impairment (estimated glomerular filtration rate [eGFR] < 30 mL/min/1.73 m2). The pharmacokinetics of amisulpride in patients with severe renal impairment have not been adequately studied in clinical trials. Amisulpride is known to be substantially excreted by the kidneys, and patients with severe renal impairment may have increased systemic exposure and an increased risk of adverse reactions.

No dosage adjustment is necessary in patients with mild to moderate renal impairment (eGFR ≥ 30 mL/min/1.73 m2).

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.

Please click to access full Prescribing Information.

BAR HCP ISI 02/2020

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

References: 1. Gan TJ, Diemunsch P, Habib AS, et al. Consensus guidelines for the management of postoperative nausea and vomiting. Anesth Analg. 2014;118(1):85-113. 2. 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. 3. 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. 4. 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. 5. 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. 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. Watcha MF, White PF. Postoperative nausea and vomiting: its etiology, treatment, and prevention. Anesthesiology. 1992;77:162-184. 8. Chung F, Mezei G. Factors contributing to a prolonged stay after ambulatory surgery. Anesth Analg. 1999;89(6):1352-1359. 9. 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. 10. Eberhart LH, Morin AM, Wulf H. Patient preferences for immediate postoperative recovery. Br J Anaesth. 2002;89(5):760-761.