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.2,4,5
2020 Guideline Recommendations4
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 agents4
- 5-HT3 antagonists
- Anticholinergics
- Antihistamines
- Corticosteroids
- Dopamine antagonists
- NK-1 receptor antagonists
What is the only antiemetic proven to be an effective rescue treatment for PONV in patients failing prophylaxis?
Barhemsys 10 mg, the first and only FDA-approved antiemetic for PONV rescue treatment despite prophylaxis with an agent of a different class
At 24 hours
29%
Placebo
(n=235)
42%
Barhemsys 10 mg
(n=230)
In patients who failed prophylaxis
42% (96/230) of Barhemsys 10 mg-treated patients met the criteria for complete response at 24 hours compared with 29% (67/235) of placebo-treated patients2,5,*
Difference (95% CI): 13% (5%, 22%); P=0.003
Complete Response Rates at 2 Hours
Secondary endpoint
In patients who failed prophylaxis
70% (160/230) of patients met the criteria for complete response at 2 hours after receiving a 10 mg dose of Barhemsys compared with 49% (116/235) of placebo-treated patients2,†
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
(N=416)
(N=418)
(N=741)
(N=748)
*Reported in ≥2% of patients treated with Barhemsys and at a higher rate than placebo.
Barhemsys Is Nonsedating5,6,§
§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.
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. CI=confidence interval. D2/D3=dopamine 2/dopamine 3. 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. Eberhart LH, Morin AM, Wulf H. Patient preferences for immediate postoperative recovery. Br J Anaesth. 2002;89(5):760-761. 4. 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. 5. Barhemsys [package insert]. Indianapolis, IN: Acacia Pharma Inc; 2022. 6. Acacia Pharma. Data on File.