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
BARHEMSYS is contraindicated in patients with known hypersensitivity to amisulpride.
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.
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
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.
Safety and effectiveness in pediatric patients have not been established.
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.
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).
- 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
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full Prescribing Information.
BAR HCP ISI 02/2020