How do you address PONV
after failed prophylaxis?

How many of your surgical patients experience PONV despite prophylactic treatment?
How many of your surgical patients experience PONV despite prophylactic treatment?

PONV is a common complication of surgery and anesthesia

In high-risk patients

can experience PONV3,4

can experience PONV despite prophylaxis1,2

In patients who failed prophylaxis

can experience nausea2,5

can experience vomiting2

How does Barhemsys enable guideline-driven care?

Barhemsys, as a selective D2/D3 receptor antagonist, offers a pharmacological treatment option from a different class than commonly used prophylaxis agents, enabling guideline-driven care.2,3,6

The 2020 guideline recommendations3

Administer PONV prophylaxis using ≥2 interventions in adults at risk (≥1 risk factor).

When PONV prophylaxis fails, use an antiemetic treatment from a different pharmacological class than the prophylactic drug.

—Fourth Consensus Guidelines for the Management of Postoperative Nausea and Vomiting from the Society for Ambulatory Anesthesia (SAMBA) and American Society of Enhanced Recovery (ASER)

Most commonly used classes of antiemetic agents3

5-HT3 antagonists

Anticholinergics

Antihistamines

Corticosteroids

Dopamine antagonists

NK-1 antagonists

Barhemsys was studied in 4 pivotal trials encompassing ~2000 patients6

Prophylaxis for PONV

The efficacy of Barhemsys 5 mg for the prevention of PONV was evaluated in 2 randomized, double-blind, placebo-controlled, multicenter trials in patients
undergoing general anesthesia and elective surgery. In both trials, patients were administered Barhemsys at the induction of anesthesia.6

5 mg
Monotherapy prophylaxis

Study 1 (N=342) patients received monotherapy with Barhemsys6,7

5 mg
Combination prophylaxis

Study 2 (N=1147) patients received Barhemsys in combination with 1 other intravenously administered, nondopaminergic antiemetic6,8

Treatment for PONV

The efficacy of Barhemsys 10 mg as a single dose was evaluated in 2 randomized, double-blind, placebo-controlled, multicenter trials in patients experiencing PONV after general anesthesia and elective surgery6

10 mg
Treatment

Study 3 (N=369) enrolled patients who had not received PONV prophylaxis6,9


10 mg
Rescue treatment

Study 4 (N=465) enrolled patients with moderate to high risk of PONV after they failed antiemetic prophylaxis with an antiemetic of another class2,6

Learn more about the Barhemsys clinical program

Learn More

Explore the established safety profile of Barhemsys

Understanding safety is important when considering new therapies.

Common Adverse Reactions*

The data below reflect exposures to Barhemsys in 1166 patients treated in placebo-controlled trials.6

Treatment and Rescue Treatment of PONV Clinical Trials Placebo
(N=416)		 Barhemsys 10 mg
(N=418)
Infusion site pain 4% 6%
Prevention of PONV Clinical Trials Placebo
(N=741)		 Barhemsys 5 mg
(N=748)
Chills 3% 4%
Hypokalemia 2% 4%
Procedural hypotension 2% 3%
Abdominal distension 1% 2%

*Reported in ≥2% of patients treated with Barhemsys and at a higher rate than placebo.

Barhemsys is nonsedating6,10

Based on a post-hoc analysis of safety data from the clinical development program, 922 subjects could be evaluated for treatment-related sedation and none of them experienced sedation or sedation-like events.

Guideline Recommendations
and P&T Considerations

Learn more about the impact and management guidelines for PONV, as well as considerations for P&T.

Watch Video

Barhemsys HCP Leave Behind

Everything you need to know about treating breakthrough PONV in the PACU with Barhemsys.

Download Resource

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. D2/D3=dopamine 2/dopamine 3. NK=neurokinin. P&T=Pharmacy & Therapeutics. PACU=postanesthesia care unit. PONV=postoperative nausea and vomiting.

References: 1. 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. 2. 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. 3. Gan TJ, Belani KG, Bergese SD, et al. Fourth Consensus Guidelines for the Management of Postoperative Nausea and Vomiting. Anesth Analg. 2020;131(2):411-448. 4. 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. 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. Barhemsys [package insert]. Indianapolis, IN: Acacia Pharma Inc; 2022. 7. Gan TJ, Kranke P, Minkowitz HS, et al. Intravenous amisulpride for the prevention of postoperative nausea and vomiting: two concurrent, randomized, double-blind, placebo-controlled trials. Anesthesiology. 2017;126(2):268-275. 8. Kranke P, Bergese SD, Minkowitz HS, et al. Amisulpride prevents postoperative nausea and vomiting in patients at high risk: a randomized, double-blind, placebo-controlled trial. Anesthesiology. 2018;128(6):1099-1106. 9. Candiotti KA, Kranke P, Bergese SD, et al. Randomized, double-blind, placebo-controlled study of intravenous amisulpride as treatment of established postoperative nausea and vomiting in patients who have had no prior prophylaxis. Anesth Analg. 2019;128(6):1098-1105. 10. Acacia Pharma. Data on File.