Home › NDC Lookup › Ingredients › Amisulpride › 71390-0125-20
Barhemsys Amisulpride 2.5 mg/mL Injection, Solution — NDC 71390-0125-20 package photo

Barhemsys Amisulpride 2.5 mg/mL Injection, Solution

by Acacia Pharma Ltd · 10 CARTON in 1 PACKAGE (71390-125-20) / 1 VIAL, SINGLE-DOSE in 1 CARTON (71390-125-21) / 2 mL in 1 VIAL, SINGLE-DOSE
NDC 71390-0125-20
🏷️ FDA NDC (as labeled) 71390-125-20 billing pads the product segment with a zero
This package
Contains2 mL in 1 vial, single-dose Pack sizes2 compare ↓
Also comes in: 4 mL 71390-0125-50
Rx only Brand On market Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

🆔 Identity & classification

FDA NDC (as labeled) 71390-125-20
Product NDC 71390-125
11-digit billing NDC 71390012520
NCPDP billing unit ML — per mL (volume)
RxCUI 2284232, 2284237, 2467148, 2467149
UNII 8110R61I4U
Application # NDA209510
SPL Set ID ab23bc6e-b6a8-165f-e053-2a95a90ab144
Established class (EPC) Dopamine-2 Receptor Antagonist
Mechanism of action Dopamine D2 Antagonists
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2020-02-27
Marketing end 2030-11-30
Route INTRAVENOUS
Dosage form INJECTION, SOLUTION
Substance AMISULPRIDE
GPI-14 50100010002020
GPI class Barhemsys
GCN Seq No 080792
GCN 47767
HICL code 010728
Ingredient (HICL) Amisulpride
HIC1 code H
Therapeutic class — broad (HIC1) Nervous System (Except Autonomic)
HIC2 code H6
Therapeutic class — intermediate (HIC2) Drugs Acting Principally On The Midbrain
HIC3 code H6J
Therapeutic class — specific (HIC3) Antiemetic/Antivertigo Agents
AHFS code 56:22.12.00
AHFS class Dopamine Receptor Antagonists
FDB label name BARHEMSYS 5 MG/2 ML VIAL
FDB brand name Barhemsys
Legend status F — Federal legend — prescription drug or device
Why two NDCs? The FDA registers this code as 71390-125-20 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 71390-0125-20. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏷️ RxNorm drug class

This medicine belongs to the Dopamine-2 Receptor Antagonist class.

Pharmacologic class Dopamine-2 Receptor Antagonist
Drug family (ATC) Benzamides
How it works Dopamine D2 Antagonists
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerAcacia Pharma Ltd
Application holderLXO IRELAND DESIGNATED ACTIVITY CO
FDA applicationNDA209510 (NDA)
Labeler code71390
First marketedFeb 2020
Product typeHuman Prescription Drug
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

Label name BARHEMSYS 5 MG/2 ML VIAL Ingredient Amisulpride
📗 Our plain-language guide HelloPharmacist
  • Barhemsys is used to prevent or treat nausea and vomiting that can happen after surgery — what doctors call postoperative nausea and vomiting, or PONV. If you're having surgery, yo...
  • Barhemsys blocks specific dopamine receptors in a part of the brain that acts like a 'nausea alarm.' When surgery and anesthesia trigger that alarm, the brain signals the body to v...
  • Most people tolerate this medicine well since it's a single, short infusion. The more commonly reported effects include chills, a temporary drop in blood pressure during the proced...
  • Yes — this is important. Barhemsys can affect the heart's electrical rhythm in a way called QT prolongation, which at higher levels can increase the risk of a serious irregular hea...
📖 Read our full Amisulpride Injection guide →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer mLPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
Medicare Part B allowsASP · J0184 No ASP payment limit on file for J0184 this quarter.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Try another pack size: 4 mL
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🧾 Billing & reimbursement

FDA NDC (as labeled)71390-125-20
11-digit billing NDC71390-0125-20
Format5-3-2 as registered → padded to 5-4-2 for billing (zero added to the product segment)
HCPCS J-codeJ0184
DescriptorINJECTION, AMISULPRIDE, 1 MG
Billing units / pkg2.5 units
Crosswalk sourcePDAC NDC-HCPCS crosswalk (DME MAC / DMEPOS)
Where does this data come from?
The HCPCS J-code crosswalk comes from the CMS ASP NDC-HCPCS crosswalk and the DMEPDAC (DME MAC) NDC-HCPCS crosswalk — free public CMS data. Billing units are derived from the code’s descriptor and the package amount.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Barhemsys 2.5 mg/mLthis 71390-0125-20 Acacia 1 vial — — FDA listed —
About this product: this is the brand-name version. We did not find an FDA-approved generic match for this exact strength, form and route.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

🏛️
2020
First FDA approval
Feb 2020
📍
2026
Currently FDA-listed
6 years listed
🛡️
2038
Latest patent/protection listed
not a guaranteed launch date
🔒No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route. Patent/protection dates below may affect future generic timing.

🛡️ Latest patent/protection date listed: FDA patent/protection data lists protections through Feb 2038. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved Feb 26, 2020 RLD RS ⏳ ~11.4 yr to latest listed protection

Why the date isn’t exact: Generic timing can change because patents may be challenged, settled, licensed, added, removed, or worked around with a narrower label — and FDA approval does not always mean a pharmacy can get the generic today.

Patents & exclusivity — FDA Orange Book
US 9545426 — method of use (U-1744)
US 9545426 — method of use (U-2754)
US 9084765 — method of use (U-1744)
US 9084765 — method of use (U-2754)
US 9889118 — method of use (U-2754)
US 9889118 — method of use (U-1744)
US 12005042 — method of use (U-1744)
US 12005042 — method of use (U-3467)
US 12005042 — method of use (U-3467)
US 12005042 — method of use (U-2754)
US 12005042 — method of use (U-2754)
US 12005042 — method of use (U-1744)
US 11357753 — method of use (U-2754)
US 11357753 — method of use (U-2754)
US 9084765 — method of use (U-1744)
US 9084765 — method of use (U-2754)
US 9889118 — method of use (U-2754)
US 9889118 — method of use (U-1744)
US 9545426 — method of use (U-2754)
US 9545426 — method of use (U-1744)
US 12329740 — method of use (U-2754)
US 12329740 — method of use (U-2754)
US 12329740 — method of use (U-3467)
US 12329740 — method of use (U-3467)
US 12194022 — method of use (U-1744)
US 12194022 — method of use (U-1744)
US 12194022 — method of use (U-3467)
US 12194022 — method of use (U-3467)
US 9084765 — method of use (U-3467)
US 9084765 — method of use (U-3467)
US 10525033 — drug product
US 10525033 — drug product
2020 2022 2024 2026 2028 2030 2032 2034 2036 2038
Today
LOE
Substance patent Formulation patent Method-of-use patent Exclusivity Pediatric +6mo
🏛️FDA exclusivity
FDA-granted marketing protection. It’s separate from patents and may be shorter than patent protection.
🧪Product / substance patents
Patents covering the active ingredient, product, formulation, or related drug features.
🎯Method-of-use patents
Patents covering specific approved uses. These can sometimes be carved out with a “skinny label,” but not always.
🛈 What do these terms mean?
Patent
Legal protection listed in the Orange Book that may delay generic approval or launch. Issued by the U.S. Patent & Trademark Office.
Substance patent
Covers the active drug molecule itself — the hardest to design around. A generic generally can’t launch until it expires.
Formulation (product) patent
Covers a specific formulation or dosage form. A generic can sometimes work around it with a different formulation.
Method-of-use patent
A patent covering one specific approved use of the drug — not necessarily the whole molecule. A generic can sometimes launch with a “skinny label” that carves out the protected use and keeps the others.
Skinny label
A generic label that omits a still-patented use when the FDA allows it — letting a generic reach the market for the unprotected uses.
Exclusivity
FDA-granted marketing protection, separate from patents — e.g. 5-yr new chemical entity, 7-yr orphan drug, or a +6-month pediatric extension.
Paragraph IV
A generic applicant’s formal challenge to a listed patent. It can potentially lead to earlier generic entry, but often involves litigation or a settlement.
RLD / RS
Reference Listed Drug — the brand product the FDA uses as the reference for generic applications. Reference Standard — the product the FDA expects generics to compare against in bioequivalence testing.
TE / AB rating
FDA therapeutic-equivalence rating. An AB rating generally means the FDA considers a generic therapeutically equivalent to — and substitutable for — the brand.
LOE (loss of exclusivity)
The latest patent or exclusivity currently listed — the loss-of-exclusivity / latest-listed-protection date shown on this page. Paragraph-IV challenges and settlements can move the real date earlier; FDA approval and a manufacturer’s decision to market can move it later.

Built from the FDA Orange Book. The bars above are scaled to each protection’s expiry; the red LOE marker is the last one to lapse.

Listed patents (32)
PatentTypeUse codeExpires
US 9545426 ↗ Method of use U-1744 Mar 10, 2031
US 9545426 ↗ Method of use U-2754 Mar 10, 2031
US 9084765 ↗ Method of use U-1744 Feb 26, 2034
US 9084765 ↗ Method of use U-2754 Feb 26, 2034
US 9889118 ↗ Method of use U-2754 Mar 10, 2031
US 9889118 ↗ Method of use U-1744 Mar 10, 2031
US 12005042 ↗ Method of use U-1744 Feb 9, 2038
US 12005042 ↗ Method of use U-3467 Feb 9, 2038
US 12005042 ↗ Method of use U-3467 Feb 9, 2038
US 12005042 ↗ Method of use U-2754 Feb 9, 2038
US 12005042 ↗ Method of use U-2754 Feb 9, 2038
US 12005042 ↗ Method of use U-1744 Feb 9, 2038
US 11357753 ↗ Method of use U-2754 Feb 9, 2038
US 11357753 ↗ Method of use U-2754 Feb 9, 2038
US 9084765 ↗ Method of use U-1744 Feb 26, 2034
US 9084765 ↗ Method of use U-2754 Feb 26, 2034
US 9889118 ↗ Method of use U-2754 Mar 10, 2031
US 9889118 ↗ Method of use U-1744 Mar 10, 2031
US 9545426 ↗ Method of use U-2754 Mar 10, 2031
US 9545426 ↗ Method of use U-1744 Mar 10, 2031
US 12329740 ↗ Method of use U-2754 Feb 9, 2038
US 12329740 ↗ Method of use U-2754 Feb 9, 2038
US 12329740 ↗ Method of use U-3467 Feb 9, 2038
US 12329740 ↗ Method of use U-3467 Feb 9, 2038
US 12194022 ↗ Method of use U-1744 Mar 10, 2031
US 12194022 ↗ Method of use U-1744 Mar 10, 2031
US 12194022 ↗ Method of use U-3467 Mar 10, 2031
US 12194022 ↗ Method of use U-3467 Mar 10, 2031
US 9084765 ↗ Method of use U-3467 Feb 26, 2034
US 9084765 ↗ Method of use U-3467 Feb 26, 2034
US 10525033 ↗ Drug product — Mar 10, 2031
US 10525033 ↗ Drug product — Mar 10, 2031
Common questions
Is there a generic version of BARHEMSYS 5 MG/2 ML VIAL?
No FDA-approved generic equivalent is currently listed in the FDA Orange Book for BARHEMSYS 5 MG/2 ML VIAL. Based on the patents and exclusivity currently listed, the Orange Book estimate is that full-label generic entry may be delayed until Feb 2038 — an estimate, not a guaranteed launch date.
The FDA approved a generic — why can’t I get it at my pharmacy yet?
FDA approval and pharmacy availability are two different things. The FDA can approve a generic years before it actually reaches pharmacies, because the brand company may still hold patents or have a settlement that delays the launch. A manufacturer also has to choose to make and sell it, and have supply ready. So a drug can be “FDA-approved generic exists” and still be brand-only at the counter today.
Why do different websites show different generic release dates?
Generic availability is not based on one single date. Some sources use the first exclusivity expiration, some use the last product patent, and others use the latest method-of-use patent. Patent challenges, settlements, licenses, and label carve-outs can also change the real-world launch date. This page shows the underlying Orange Book dates so you can see why estimates may differ.
What does “FDA listed” mean?
It means the product appears in the FDA’s official NDC directory. That’s a good sign a product exists and is intended for the U.S. market, but on its own it does not confirm a pharmacy can fill it today. Where we have recent retail pricing data (NADAC) for a product, we label it “Availability likely” instead.
What does a patent or protection date mean here?
It’s the latest date currently listed in the FDA Orange Book for a patent or exclusivity on the brand product. It can affect when a full generic version becomes widely available — but it is not a guaranteed generic launch date. Generics sometimes arrive earlier (through a settlement or patent challenge) or later (a manufacturer still has to make and sell one).
What does “current Orange Book estimate” mean?
It means we are using the latest patent and exclusivity dates currently listed in the FDA Orange Book. It is not a guaranteed launch date.
Can a generic come out before the last patent expires?
Sometimes. A generic company may challenge a patent, settle with the brand manufacturer, receive a license, or obtain approval with a narrower label that avoids a patented use. In other cases, the last listed protection may delay full-label generic competition.
Can a generic come out after the listed dates?
Yes. Even after patents or exclusivity expire, a generic still needs FDA approval and a manufacturer must choose to market it. Supply, litigation, business decisions, or regulatory issues can delay actual availability.
What is the difference between patents and exclusivity?
Patents are legal protections usually issued by the U.S. Patent and Trademark Office. FDA exclusivity is marketing protection granted by the FDA. They are separate, and either one can affect generic timing.
Why are there multiple patent dates?
One drug can have several patents covering different things: the active ingredient, a formulation, a manufacturing process, or a specific approved use. That is why a page may show several expiration dates instead of one simple generic date.
Built from FDA Orange Book patent and exclusivity data. Dates are refreshed from public FDA data when available; the marker is max(latest patent expiry, latest exclusivity expiry). Paragraph-IV settlements and first-filer 180-day exclusivity can shift the real date; a method-of-use patent may allow an earlier skinny-label generic for non-protected indications. Generic launch timing is an estimate, not a guarantee.
Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

💊 Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
1 vial71390-0125-50 49 Rx · $8,263
1 vial this page71390-0125-20 No Medicaid data
Drug total (last 4 qtrs): 49 Rx · 182 units · $8,263 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
71390-0125-20 You're viewing this 10 CARTON in 1 PACKAGE (71390-125-20) / 1 VIAL, SINGLE-DOSE in 1 CARTON (71390-125-21) / 2 mL in 1 VIAL, SINGLE-DOSE 2020-02-27 Active
71390-0125-50 10 CARTON in 1 PACKAGE (71390-125-50) / 1 VIAL, SINGLE-DOSE in 1 CARTON (71390-125-51) / 4 mL in 1 VIAL, SINGLE-DOSE 2020-02-27 Active

Pack size FAQ

What quantity is in NDC 71390-0125-20?
NDC 71390-0125-20 is listed by the FDA — 10 carton in 1 package / 1 vial, single-dose in 1 carton / 2 ml in 1 vial, single-dose.
What NDC number is used to bill for this package of Barhemsys Amisulpride 2.5 mg/mL Injection, Solution?
Bill NDC 71390-0125-20 — the 11-digit billing format is 71390012520. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available.
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk ✓ Available
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 71390-125-20, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 71390-0125-20, written without dashes as 71390012520. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 71390-0125-20, the first segment (71390) is the labeler code FDA assigned to Acacia Pharma Ltd; the middle segment (0125) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (20) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page it is currently marketed — but Acacia Pharma Ltd has reported a marketing end date of 2030-11-30, after which this package is expected to stop being marketed. The directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 1 vial (71390-0125-50). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Acacia Pharma Ltd is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
Does this product have a billing J-code?
Yes — this NDC cross-references HCPCS code J0184 for medical-claim billing (typically used when a product is administered in a clinical setting rather than dispensed at a retail pharmacy). See the Billing section on this page.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description 💬 Information for Patients
🎯 Indications and Usage 111 words ▾

1 INDICATIONS AND USAGE BARHEMSYS ® is 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. BARHEMSYS is a dopamine-2 (D 2 ) antagonist indicated in adults for: Prevention of postoperative nausea and vomiting (PONV), either alone or in combination with an antiemetic of a different class.

( 1 ) Treatment of PONV in patients who have received antiemetic prophylaxis with an agent of a different class or have not received prophylaxis. ( 1 )

⏱️ Dosage and Administration ~1 min read ▾

2 DOSAGE AND ADMINISTRATION The recommended dosage of BARHEMSYS: Prevention of PONV, either alone or in combination with another antiemetic : 5 mg as a single intravenous dose infused over 1 to 2 minutes at the time of induction of anesthesia. ( 2.1 ) Treatment of PONV : 10 mg as a single intravenous dose infused over 1 to 2 minutes in the event of nausea and/or vomiting after a surgical procedure. ( 2.1 ) See full prescribing information for preparation and administration instructions .

( 2.2 )

2.1Recommended Dosage The recommended adult dosage of BARHEMSYS and infusion rate by indication is shown in the table below: Indication Adult Dosage Regimen Prevention of PONV 5 mg as a single intravenous injection infused over 1 to 2 minutes at the time of induction of anesthesia [see Dosage and Administration (2.2) ] . Treatment of PONV 10 mg as a single intravenous injection infused over 1 to 2 minutes in the event of nausea and/or vomiting after a surgical procedure [see Dosage and Administration (2.2) ] .

2.2Preparation and Administration Dilution of BARHEMSYS is not required before administration. BARHEMSYS is chemically and physically compatible with Water for Injection, 5% Dextrose Injection, 0.9% Sodium Chloride Injection, and Lactated Ringer's Solution (also known as Ringer's Lactate Solution, Compound Sodium Lactate Solution, and Hartmann's Solution), any of which may be used to flush an intravenous line before or after administration of BARHEMSYS. Protect from light.

BARHEMSYS is subject to photodegradation. Administer BARHEMSYS within 12 hours of removal of the vial from the protective carton. Prior to administration, inspect the BARHEMSYS solution visually for particulate matter and discoloration.

Discard if particulate matter or discoloration is observed.

💊 Dosage Forms and Strengths 46 words ▾

3 DOSAGE FORMS AND STRENGTHS Injection: 5 mg/2 mL (2.5 mg/mL) or 10 mg/4 mL (2.5 mg/mL) as a clear, colorless sterile solution in a single-dose vial. Injection: 5 mg/2 mL (2.5 mg/mL) or 10 mg/4 mL (2.5 mg/mL) in a single-dose vial. ( 3 )

⛔ Contraindications 25 words ▾

4 CONTRAINDICATIONS BARHEMSYS is contraindicated in patients with known hypersensitivity to amisulpride [see Adverse Reactions (6.2) ] . Known hypersensitivity to amisulpride. ( 4 )

⚠️ Warnings and Cautions 179 words ▾

5 WARNINGS AND PRECAUTIONS QT Prolongation : Occurs in a dose- and concentration-dependent manner. Avoid use in patients with congenital long QT syndrome and in patients taking droperidol. 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.

( 5.1 , 7.2 )

5.1QT Prolongation BARHEMSYS causes dose- and concentration-dependent prolongation of the QT interval [see Clinical Pharmacology (12.2) ] . The recommended dosage is 5 or 10 mg as a single intravenous dose infused over 1 to 2 minutes [see Dosage and Administration (2.1) ] . Avoid use 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 [see Drug Interactions (7.2) ] .

🤒 Adverse Reactions ~2 min read ▾

6 ADVERSE REACTIONS Most common adverse reactions (≥ 2%) are: Prevention of PONV : increased blood prolactin concentrations, chills, hypokalemia, procedural hypotension, and abdominal distension. ( 6.1 ) Treatment of PONV : infusion site pain. ( 6.1 ) 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.

6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The data described below reflect exposure to BARHEMSYS in 1,166 patients treated in placebo-controlled trials. 748 of these patients received a dose of 5 mg for prevention of PONV (of whom 572 received another antiemetic concomitantly) and 418 patients received 10 mg for treatment of PONV [see Clinical Studies (14.1 , 14.2) ] .

The mean age of the population was 49 years (range 18 to 91 years), 87% female, 80% White/Caucasian, 9% Black, and 1% Asian. Prevention of PONV Common adverse reactions reported in at least 2% of adult patients who received BARHEMSYS 5 mg and at a higher rate than placebo in Studies 1 and 2 for the prevention of PONV are shown in Table 1. Table 1.

Common Adverse Reactions Reported in at least 2% of patients treated with BARHEMSYS and at a higher rate than placebo in Adult Patients in Studies 1 and 2 of BARHEMSYS for Prevention of PONV BARHEMSYS 5 mg Placebo N=748 N=741 Chills 4% 3% Hypokalemia 4% 2% Procedural hypotension 3% 2% Abdominal distension 2% 1% Serum prolactin concentrations were measured in Study 1 where 5% (9/176) of BARHEMSYS-treated patients vs 1% (1/166) of placebo-treated patients had increased blood prolactin reported as an adverse reaction. Serum prolactin concentrations increased from a mean of 10 ng/mL at baseline to 32 ng/mL after BARHEMSYS treatment in 112 females (upper limit of normal 29 ng/mL) and from 10 ng/mL to 19 ng/mL in 61 males (upper limit of normal 18 ng/mL).

No clinical consequences due to elevated prolactin levels were reported. Treatment of PONV The most common adverse reaction, reported in at least 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 (Studies 3 and 4) was infusion site pain (BARHEMSYS 6%; placebo 4%).

6.2Postmarketing Experience The following adverse reactions have been identified during post-approval chronic oral use of amisulpride outside of the United States (BARHEMSYS is not approved for oral dosing or chronic use). Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Blood and lymphatic system disorders : agranulocytosis Cardiac disorders : bradycardia, torsades de pointes, ventricular tachycardia, prolonged QT by electrocardiogram General disorders : neuroleptic malignant syndrome Immune system disorders : angioedema, hypersensitivity, urticaria Hepatic disorders : increased hepatic enzymes Nervous system disorders : agitation, anxiety, dystonia, extrapyramidal disorder, seizure Psychiatric disorders : confusional state, insomnia, somnolence Vascular disorders : hypotension

🔄 Drug Interactions 79 words ▾

7 DRUG INTERACTIONS

7.1Dopamine Agonists Reciprocal antagonism of effects occurs between dopamine agonists (e.g., levodopa) and BARHEMSYS. Avoid using levodopa with BARHEMSYS.

7.2Drugs Prolonging the QT Interval BARHEMSYS causes dose- and concentration-dependent QT prolongation [see Clinical Pharmacology (12.2) ] . 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) [see Warnings and Precautions (5.1) ] .

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS Lactation : A lactating woman may pump and discard breast milk for 48 hours after BARHEMSYS administration. ( 8.2 )

8.1Pregnancy Risk Summary 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. In animal reproduction studies, there were no adverse developmental effects observed with oral administration of amisulpride in rats and rabbits during the period of organogenesis at exposures about 43 and 645 times, respectively, the exposure delivered by the highest recommended human dose (see Data ) . The estimated background risk of major birth defects and miscarriage for the indicated population is unknown.

All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Animal Data Reproduction studies of amisulpride were conducted in pregnant rats administered oral doses up to 160 mg/kg/day (43 times the exposure based on area under the curve (AUC) at the highest recommended dose of 10 mg) throughout the period of organogenesis.

No adverse embryo-fetal developmental effects were observed at any dose level. Maternal animals exhibited a dose-related decrease in overall mean body weight gain. In rabbits administered amisulpride throughout the period of organogenesis, oral doses up to 210 mg/kg/day (645 times the exposure based on AUC at the highest recommended dose of 10 mg) had no adverse developmental effects on the fetus.

Maternal animals exhibited reduced mean body weight gain at doses of 100 and 210 mg/kg/day and reduced food intake was observed at 210 mg/kg/day. The pre- and post-natal developmental effects of amisulpride were assessed in rats administered oral doses of 60, 100 or 160 mg/kg/day during the periods of organogenesis and lactation. At 160 mg/kg/day (43 times the exposure based on AUC at the highest recommended dose of 10 mg), maternal animals exhibited a reduction in mean body weight gain and decrease in food intake during lactation.

Amisulpride had no effect on maternal pregnancy parameters, litter survival or pup growth, development or maturation at any dose tested.

8.2Lactation Risk Summary Based on case reports in published literature, amisulpride is present in human milk at concentrations that are 11- to 20-fold higher than human plasma in patients taking multiple oral doses of amisulpride (200 to 400 mg/day). The estimated infant daily dose ranged from 5% to 11% of the maternal dose. There are ways to minimize drug exposure to a breastfed infant (see Clinical Considerations ).

There are no reports of adverse effects on the breastfed child and no information on the effects of amisulpride on milk production. The pharmacological action of amisulpride, a dopamine-2 (D 2 ) receptor antagonist, may result in an increase in serum prolactin levels, which may lead to a reversible increase in maternal milk production [see Adverse Reactions (6.1) ]. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for BARHEMSYS and any potential adverse effects on the breastfed child from BARHEMSYS or from the underlying maternal condition.

Clinical Considerations A lactating woman may consider interrupting breastfeeding and pumping and discarding breast milk for 48 hours after BARHEMSYS administration to minimize drug exposure to a breastfed infant.

8.3Females and Males of Reproductive Potential Infertility In animal fertility studies, administration of repeated doses of amisulpride over a 10-day period to female rats resulted in infertility that was reversible [see Nonclinical Toxicology (13.1) ].

8.4Pediatric Use Safety and effectiveness in pediatric patients have not been established.

8.5 Geriatric Use…

🤰 Pregnancy ~2 min read ▾

8.1Pregnancy Risk Summary 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. In animal reproduction studies, there were no adverse developmental effects observed with oral administration of amisulpride in rats and rabbits during the period of organogenesis at exposures about 43 and 645 times, respectively, the exposure delivered by the highest recommended human dose (see Data ) . The estimated background risk of major birth defects and miscarriage for the indicated population is unknown.

All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Animal Data Reproduction studies of amisulpride were conducted in pregnant rats administered oral doses up to 160 mg/kg/day (43 times the exposure based on area under the curve (AUC) at the highest recommended dose of 10 mg) throughout the period of organogenesis.

No adverse embryo-fetal developmental effects were observed at any dose level. Maternal animals exhibited a dose-related decrease in overall mean body weight gain. In rabbits administered amisulpride throughout the period of organogenesis, oral doses up to 210 mg/kg/day (645 times the exposure based on AUC at the highest recommended dose of 10 mg) had no adverse developmental effects on the fetus.

Maternal animals exhibited reduced mean body weight gain at doses of 100 and 210 mg/kg/day and reduced food intake was observed at 210 mg/kg/day. The pre- and post-natal developmental effects of amisulpride were assessed in rats administered oral doses of 60, 100 or 160 mg/kg/day during the periods of organogenesis and lactation. At 160 mg/kg/day (43 times the exposure based on AUC at the highest recommended dose of 10 mg), maternal animals exhibited a reduction in mean body weight gain and decrease in food intake during lactation.

Amisulpride had no effect on maternal pregnancy parameters, litter survival or pup growth, development or maturation at any dose tested.

🧒 Pediatric Use 13 words ▾

8.4Pediatric Use Safety and effectiveness in pediatric patients have not been established.

🧓 Geriatric Use 92 words ▾

8.5Geriatric Use Of the total number of patients enrolled in controlled clinical trials who received BARHEMSYS 5 mg for prevention of PONV or 10 mg for treatment of PONV, 235 (17%) were 65 years of age and older, while 59 (4%) were 75 years of age and older. 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.

🆘 Overdosage 97 words ▾

10 OVERDOSAGE Doses of oral amisulpride (BARHEMSYS is not approved for oral dosing) above 1200 mg/day have been associated with adverse reactions related to dopamine-2 (D 2 ) antagonism, in particular: cardiovascular adverse reactions (e.g., prolongation of the QT interval, torsades de pointes, bradycardia and hypotension) [see Warnings and Precautions (5.1) ] . neuropsychiatric adverse reactions (e.g., sedation, coma, seizures, and dystonic and extrapyramidal reactions). There is no specific antidote for amisulpride overdose.

Management includes cardiac monitoring and treatment of severe extrapyramidal symptoms. Since amisulpride is weakly dialyzed, hemodialysis should not be used to eliminate the drug.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Amisulpride is a selective dopamine-2 (D 2 ) and dopamine-3 (D 3 ) receptor antagonist. D 2 receptors are located in the chemoreceptor trigger zone (CTZ) and respond to the dopamine released from the nerve endings. Activation of CTZ relays stimuli to the vomiting center which is involved in emesis.

Studies in multiple species indicate that D 3 receptors in the area postrema also play a role in emesis. Studies conducted in ferrets have shown that amisulpride inhibits emesis caused by apomorphine, with an estimated ED 50 of less than 1 mcg/kg, subcutaneously; and inhibits cisplatin-induced emesis at 2 mg/kg and morphine-induced emesis at 3 to 6 mg/kg, when given intravenously. Amisulpride has no appreciable affinity for any other receptor types apart from low affinities for 5-HT 2B and 5-HT 7 receptors.

12.2Pharmacodynamics Cardiac Electrophysiology A significant exposure-response relationship was identified between amisulpride concentration and ΔΔQTcF. In 40 healthy Caucasian and Japanese subjects, the maximum mean difference (95% upper confidence bound) in QTcF from placebo after baseline-correction (ΔΔQTcF) was 5.0 (7.1) milliseconds after a 2-minute intravenous infusion of 5 mg BARHEMSYS and 23.4 (25.5) milliseconds after an 8-minute intravenous infusion of 40 mg BARHEMSYS [see Warnings and Precautions (5.1) ] .

The recommended infusion rate is 1 to 2 minutes for 5 mg or 10 mg of BARHEMSYS [see Dosage and Administration (2.1) ].

12.3Pharmacokinetics After an intravenous infusion, the peak plasma concentration of amisulpride is achieved at the end of the infusion period and the plasma concentration decreases to about 50% of the peak value within approximately 15 minutes. The AUC (0-∞) increases dose-proportionally in the dose range from 5 mg to 40 mg (4-times the maximum recommended dose). The following mean pharmacokinetic parameters of amisulpride were observed following a single 5 or 10 mg intravenous dose in adult healthy subjects and surgical patients.

Table 2. Summary of Key Pharmacokinetic Parameters of Amisulpride from Clinical Studies Single Dose Infusion Duration (minutes) Number of Subjects Mean (SD) Peak Plasma Concentration (ng/mL) AUC (0-∞) (ng∙h/mL) Healthy Subjects 5 mg 2 39 200 (139) 154 (30) Healthy Subjects 10 mg 1 29 451 (230) 136 (28) AUC (0-2 hr) Patients 5 mg 1 to 2 26 Patients in a clinical trial for prophylaxis of PONV 161 (58) 260 (65) 27 Patients in clinical trials for treatment of PONV 127 (64) 204 (94) Patients 10 mg 1 to 2 31 285 (446) 401 (149) Distribution Following intravenous infusion, the mean volume of distribution of amisulpride is estimated to be 127 to 144 L in surgical patients and 171 L in healthy subjects.

Amisulpride distributes into erythrocytes. Plasma protein binding is 25% to 30% in the concentration range from 37 to 1850 ng/mL. Elimination The mean elimination half-life is approximately 4 to 5 hours and similar between healthy subjects and surgical patients.

Population pharmacokinetic analysis estimated that the plasma clearance of amisulpride is

20.6 L/h in surgical patients and

24.1L/h in healthy subjects. Metabolism In a mass balance study, no metabolites were detectable in plasma while four metabolites were identified in urine and feces. Each metabolite accounts for less than 7% of the dose.

In vitro amisulpride is not metabolized by major cytochrome P450 enzymes. Excretion After intravenous administration of amisulpride, 74% and 23% of the administered dose was recovered in urine and feces, respectively. 58% and 20% of the dose was excreted as unchanged amisulpride in urine and feces, respectively.

Renal clearance was estimated to be

20.5L/hr (342 mL/min) in healthy subjects suggesting that amisulpride undergoes active renal secretion. Specific Populations Age, Sex, and Racial Groups No clinically significant effect on the pharmacokinetics of amisulpride was observed based on age (18 to 90 years), sex, or race. Patients…

🧬 Mechanism of Action 136 words ▾

12.1Mechanism of Action Amisulpride is a selective dopamine-2 (D 2 ) and dopamine-3 (D 3 ) receptor antagonist. D 2 receptors are located in the chemoreceptor trigger zone (CTZ) and respond to the dopamine released from the nerve endings. Activation of CTZ relays stimuli to the vomiting center which is involved in emesis.

Studies in multiple species indicate that D 3 receptors in the area postrema also play a role in emesis. Studies conducted in ferrets have shown that amisulpride inhibits emesis caused by apomorphine, with an estimated ED 50 of less than 1 mcg/kg, subcutaneously; and inhibits cisplatin-induced emesis at 2 mg/kg and morphine-induced emesis at 3 to 6 mg/kg, when given intravenously. Amisulpride has no appreciable affinity for any other receptor types apart from low affinities for 5-HT 2B and 5-HT 7 receptors.

📦 How Supplied / Storage and Handling 110 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING BARHEMSYS (amisulpride) injection is supplied as follows: NDC 71390-125-20: Package of 10 cartons. Each carton (NDC 71390-125-21) contains one single-dose vial of clear, colorless, sterile solution of BARHEMSYS (amisulpride) injection, 5 mg in 2 mL (2.5 mg/mL). NDC 71390-125-50: Package of 10 cartons.

Each carton (NDC 71390-125-51) contains one single-dose vial of clear, colorless, sterile solution of BARHEMSYS (amisulpride) injection, 10 mg in 4 mL (2.5 mg/mL). Store vials at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature]. Protect from light.

Administer BARHEMSYS within 12 hours after the vial is removed from the protective carton [see Dosage and Administration (2.2) ] .

📦 Storage and Handling 38 words ▾

Store vials at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature]. Protect from light. Administer BARHEMSYS within 12 hours after the vial is removed from the protective carton [see Dosage and Administration (2.2) ] .

📋 Description ~1 min read ▾

11 DESCRIPTION The active ingredient of BARHEMSYS is amisulpride, a dopamine-2 (D 2 ) receptor antagonist. Its chemical name is 4-Amino- N -[(1-ethyl-2-pyrrolidinyl)methyl]-5-(ethylsulfonyl)- o -anisamide. It has the following chemical structure: (racemic) The empirical formula is C 17 H 27 N 3 O 4 S representing a molecular weight of 369.48.

Amisulpride is a white or almost white crystalline powder. It is practically insoluble in water, sparingly soluble in ethanol and freely soluble in methylene chloride, and has a melting point of around 126°C. The compound is racemic and shows no optical rotation and is not hygroscopic.

No other polymorphs of amisulpride have been reported. BARHEMSYS (amisulpride) injection is a clear, colorless, nonpyrogenic, sterile solution formulation of amisulpride 5 mg/2 mL (2.5 mg/mL) or 10 mg/4 mL (2.5 mg/mL) for intravenous infusion presented in a single-dose vial. It has a pH of approximately 5.0 and the osmolality of the product is between 250 and 330 mOsmol/kg.

Each 2 mL vial of BARHEMSYS contains 5 mg of amisulpride; 18.7 mg of citric acid monohydrate USP; 3.6 mg of sodium chloride USP; 32.64 mg of trisodium citrate dihydrate; hydrochloric acid NF and sodium hydroxide NF as needed to adjust the pH (4.75 to 5.25); and Water for Injection USP to make up to volume. Each 4 mL vial of BARHEMSYS contains 10 mg of amisulpride; 37.4 mg of citric acid monohydrate USP; 7.2 mg of sodium chloride USP; 65.3 mg of trisodium citrate dihydrate; hydrochloric acid NF and sodium hydroxide NF as needed to adjust the pH (4.75 to 5.25); and Water for Injection USP to make up to volume.

Chemical Structure

💬 Information for Patients 93 words ▾

17 PATIENT COUNSELING INFORMATION QT Prolongation Instruct patients to contact their healthcare provider immediately if they perceive a change in their heart rate, if they feel lightheaded, or if they have a syncopal episode [see Warnings and Precautions (5.1) ] . Drug Interactions Advise patients to report to their healthcare provider if they are taking drugs which prolong the QT interval [see Warnings and Precautions (5.1) ]. Lactation Women may consider reducing infant exposure through pumping and discarding breastmilk for 48 hours after BARHEMSYS administration [see Use in Specific Populations (8.2) ] .

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 71390-0011-11 · Acacia 71390-0250-02 · Acacia →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.