Barhemsys FDA Approval History
Last updated by Judith Stewart, BPharm on Sep 8, 2020.
FDA Approved: Yes (First approved February 26, 2020)
Brand name: Barhemsys
Generic name: amisulpride
Dosage form: Injection
Company: Acacia Pharma
Treatment for: Nausea/Vomiting, Postoperative
Barhemsys (amisulpride) is a dopamine-2 (D2) antagonist for the management of post-operative nausea and vomiting (PONV).
- Barhemsys is used:
- for the prevention of PONV either alone or in combination with an antiemetic of a different class
- for the treatment of PONV in patients who have received antiemetic prophylaxis with an agent of a different class or have not received prophylaxis.
- Barhemsys is administered as an intravenous infusion over 1 to 2 minutes.
- Barhemsys causes dose- and concentration-dependent prolongation of the QT interval.
- Patients should contact their healthcare provider immediately if they perceive a change in their heart rate, if they feel lightheaded, or if they have a syncopal (fainting) episode.
- Barhemsys should be avoided in patients taking droperidol. ECG monitoring is recommended in patients taking other drugs known to prolong the QT interval such as ondansetron.
- Common side effects:
- Prevention of PONV: increased blood prolactin concentrations, chills, hypokalemia, procedural hypotension, and abdominal distension.
- Treatment of PONV: infusion site pain.
Development Timeline for Barhemsys
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