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Giapreza angiotensin II .5 mg/mL Injection, 1 vial — NDC 68547-0005-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Giapreza angiotensin II .5 mg/mL Injection, 1 vial — NDC 68547-005-01 (Billing 68547-0005-01)

by La Jolla Pharmaceutical Company · 1 VIAL, SINGLE-DOSE in 1 CARTON / 1 mL in 1 VIAL, SINGLE-DOSE

This is a package of 1 vial of Giapreza angiotensin II .5 mg/mL Injection from La Jolla Pharmaceutical Company, marketed since Sep 2022 and currently FDA-listed. It is this product's only package size.

NDC 68547-0005-01
🏷️ FDA NDC (as labeled) 68547-005-01 billing pads the product segment with a zero
Rx only Brand On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Aug 6, 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

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 68547-005-01
Product NDC 68547-005
11-digit billing NDC 68547000501
NCPDP billing unit ML — per mL (volume)
RxCUI 1999007, 1999012, 2611704, 2611707
UNII M089EFU921
UPC 0368547501023
Application # NDA209360
SPL Set ID c265d69a-3efe-4107-9a9e-e6fd3d531c48
Established class (EPC) Vasoconstrictor
Physiologic effect Vasoconstriction
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2022-09-15
Route INTRAVENOUS
Dosage form INJECTION
Substance ANGIOTENSIN II

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GCN Seq No 084039
GCN 53158
HICL code 044721
Ingredient (HICL) Angiotensin Ii Acetate, Human
HIC1 code P
Therapeutic class — broad (HIC1) Endocrine System
HIC2 code P7
Therapeutic class — intermediate (HIC2) Hepatic Hormones (Hormones Secreted By The Liver)
HIC3 code P7B
Therapeutic class — specific (HIC3) Renin-Angiotensin-Aldosterone Sys. (Raas) Hormones
AHFS code 68:44.00.00
AHFS class Renin-Angiotensin-Aldosterone Syst(Raas)
FDB label name GIAPREZA 0.5 MG/ML VIAL
FDB brand name Giapreza
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 084039
  • GCN: 53158
  • HICL (First Databank): 044721
  • AHFS class code: 68:44.00.00
  • RxCUI (RxNorm): 1999007
Why two NDCs? The FDA registers this code as 68547-005-01 — 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 → 68547-0005-01. 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 Vasoconstrictor class.

Pharmacologic class Vasoconstrictor
Drug family (ATC) Other cardiac stimulants
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.

Clinical

Label name GIAPREZA 0.5 MG/ML VIAL Ingredient Angiotensin Ii Acetate, Human

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
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.

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 eachPer 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.
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.
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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
68547-0005-01 You're viewing this Main listing 1 VIAL, SINGLE-DOSE in 1 CARTON / 1 mL in 1 VIAL, SINGLE-DOSE 2022-09-15 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Giapreza .5 mg/mLthis 68547-0005-01 La 1 vial — — FDA listed —
About this product: this is the brand-name version. Some generic versions are approved by the FDA, but we could not confirm current pharmacy availability from our pricing/market data.
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

🏛️
2021
First FDA approval
Dec 2021
📍
2026
Currently FDA-listed
5 years listed
🛡️
2037
Latest patent/protection listed
not a guaranteed launch date
🔒Generic approved by FDA, but pharmacy availability is not confirmed

The FDA lists approved generic versions of this medicine, but that does not always mean a pharmacy can get one today. Patent rules, launch agreements, supply and pricing can affect when generics actually arrive.

🛡️ Latest patent/protection date listed: FDA patent/protection data lists protections through Jan 2037. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved Dec 23, 2021 RLD RS ⏳ ~10.3 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 9220745 — method of use (U-2218)
US 9220745 — method of use (U-2217)
US 9220745 — method of use (U-2217)
US 9220745 — method of use (U-2218)
US 9867863 — method of use (U-2231)
US 10028995 — method of use (U-2338)
US 9572856 — method of use (U-2221)
US 10335451 — method of use (U-2581)
US 9867863 — method of use (U-2231)
US 10548943 — method of use (U-2740)
US 10548943 — method of use (U-2739)
US 10548943 — method of use (U-2740)
US 10548943 — method of use (U-2739)
US 10493124 — method of use (U-2679)
US 10500247 — method of use (U-2681)
US 10500247 — method of use (U-2680)
US 10493124 — method of use (U-2679)
US 10500247 — method of use (U-2681)
US 10500247 — method of use (U-2680)
US 10028995 — method of use (U-2338)
US 11559559 — method of use (U-3514)
US 11559559 — method of use (U-3514)
US 11559559 — method of use (U-3514)
US 11219662 — method of use (U-3262)
US 11219662 — method of use (U-3262)
US 11219662 — method of use (U-3262)
US 9572856 — method of use (U-2221)
US 10335451 — method of use (U-2581)
US 11096983 — method of use (U-3211)
US 11096983 — method of use (U-3211)
US 11096983 — method of use (U-3212)
US 11096983 — method of use (U-3212)
US 10500247 — method of use (U-2681)
US 10500247 — method of use (U-2680)
US 10493124 — method of use (U-2679)
US 10548943 — method of use (U-2740)
US 10548943 — method of use (U-2739)
US 11096983 — method of use (U-3212)
US 11096983 — method of use (U-3211)
US 10028995 — method of use (U-2338)
US 10335451 — method of use (U-2581)
US 9572856 — method of use (U-2221)
US 9867863 — method of use (U-2231)
US 9220745 — method of use (U-2217)
US 9220745 — method of use (U-2218)
2021 2023 2025 2027 2029 2031 2033 2035 2037
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 (45)
PatentTypeUse codeExpires
US 9220745 ↗ Method of use U-2218 Dec 18, 2034
US 9220745 ↗ Method of use U-2217 Dec 18, 2034
US 9220745 ↗ Method of use U-2217 Dec 18, 2034
US 9220745 ↗ Method of use U-2218 Dec 18, 2034
US 9867863 ↗ Method of use U-2231 Dec 16, 2029
US 10028995 ↗ Method of use U-2338 Dec 18, 2034
US 9572856 ↗ Method of use U-2221 Jul 18, 2031
US 10335451 ↗ Method of use U-2581 Dec 16, 2029
US 9867863 ↗ Method of use U-2231 Dec 16, 2029
US 10548943 ↗ Method of use U-2740 Dec 16, 2029
US 10548943 ↗ Method of use U-2739 Dec 16, 2029
US 10548943 ↗ Method of use U-2740 Dec 16, 2029
US 10548943 ↗ Method of use U-2739 Dec 16, 2029
US 10493124 ↗ Method of use U-2679 Dec 18, 2034
US 10500247 ↗ Method of use U-2681 Dec 16, 2029
US 10500247 ↗ Method of use U-2680 Dec 16, 2029
US 10493124 ↗ Method of use U-2679 Dec 18, 2034
US 10500247 ↗ Method of use U-2681 Dec 16, 2029
US 10500247 ↗ Method of use U-2680 Dec 16, 2029
US 10028995 ↗ Method of use U-2338 Dec 18, 2034
US 11559559 ↗ Method of use U-3514 Dec 18, 2034
US 11559559 ↗ Method of use U-3514 Dec 18, 2034
US 11559559 ↗ Method of use U-3514 Dec 18, 2034
US 11219662 ↗ Method of use U-3262 Jan 6, 2037
US 11219662 ↗ Method of use U-3262 Jan 6, 2037
US 11219662 ↗ Method of use U-3262 Jan 6, 2037
US 9572856 ↗ Method of use U-2221 Nov 20, 2030
US 10335451 ↗ Method of use U-2581 Dec 16, 2029
US 11096983 ↗ Method of use U-3211 Dec 18, 2034
US 11096983 ↗ Method of use U-3211 Dec 18, 2034
US 11096983 ↗ Method of use U-3212 Dec 18, 2034
US 11096983 ↗ Method of use U-3212 Dec 18, 2034
US 10500247 ↗ Method of use U-2681 Dec 16, 2029
US 10500247 ↗ Method of use U-2680 Dec 16, 2029
US 10493124 ↗ Method of use U-2679 Dec 18, 2034
US 10548943 ↗ Method of use U-2740 Dec 16, 2029
US 10548943 ↗ Method of use U-2739 Dec 16, 2029
US 11096983 ↗ Method of use U-3212 Dec 18, 2034
US 11096983 ↗ Method of use U-3211 Dec 18, 2034
US 10028995 ↗ Method of use U-2338 Dec 18, 2034
US 10335451 ↗ Method of use U-2581 Dec 16, 2029
US 9572856 ↗ Method of use U-2221 Jul 18, 2031
US 9867863 ↗ Method of use U-2231 Dec 16, 2029
US 9220745 ↗ Method of use U-2217 Dec 18, 2034
US 9220745 ↗ Method of use U-2218 Dec 18, 2034
Common questions
Is there a generic version of GIAPREZA 0.5 MG/ML VIAL?
Yes — an FDA-approved generic equivalent is listed in the FDA Orange Book for GIAPREZA 0.5 MG/ML VIAL. See the alternatives section for substitutable, lower-cost products.
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.

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.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII QTT17582CB
    A strong acid used to adjust and maintain the proper pH level in liquid medicines, ensuring stability and preventing breakdown of active ingredients.
  • 25 mg / 1 mL UNII 3OWL53L36A
    A natural sugar alcohol derived from seaweed or synthesized in the lab. It's used as a filler to add bulk, a sweetener in sugar-free formulas, and a disintegrant to help tablets break apart in the stomach.
  • UNII 55X04QC32I
    A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

4 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

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.

Manufacturer & labeler

LabelerLa Jolla Pharmaceutical Company
Application holderLA JOLLA PHARMA LLC
FDA applicationNDA209360 (NDA)
Labeler code68547
First marketedSep 2022
Product typeHuman Prescription Drug
Portfolio5 products on file
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.

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 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Recent Major Changes 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 40 words ▾

1. INDICATIONS AND USAGE GIAPREZA increases blood pressure in adults with septic or other distributive shock [see Clinical Studies (14)] . GIAPREZA is a vasoconstrictor to increase blood pressure in adults with septic or other distributive shock. ( 1 )

⏱️ Dosage and Administration ~1 min read ▾

2. DOSAGE AND ADMINISTRATION Dilute GIAPREZA in 0.9% sodium chloride prior to use. See Full Prescribing Information for instructions on preparation and administration of injection.

Diluted solution may be stored at room temperature or under refrigeration and should be discarded after 24 hours. GIAPREZA must be administered as an intravenous infusion. ( 2.1 ) Start GIAPREZA intravenously at 20 nanograms (ng)/kg/min.

Titrate as frequently as every 5 minutes by increments of up to 15 ng/kg/min as needed. During the first 3 hours, the maximum dose should not exceed 80 ng/kg/min. Maintenance dose should not exceed 40 ng/kg/min.

Doses as low as 1.25 ng/kg/min may be used.( 2.2 ) 2.1. Preparation Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. GIAPREZA must be administered as an intravenous infusion.

GIAPREZA must be diluted in 0.9% sodium chloride prior to use. Dilute the appropriate amount of GIAPREZA in a normal saline (0.9% sodium chloride) infusion bag to achieve the desired final concentration of 5,000 ng/mL or 10,000 ng/mL. Discard vial and any unused portion of the drug product after use.

Diluted solution may be stored at room temperature (20°C to 25°C [68°F to 77°F]) or under refrigeration (2°C to 8°C [36°F to 46°F]). Discard prepared solution after 24 hours at room temperature or under refrigeration. 2.2.

Administration The recommended starting dosage of GIAPREZA is 20 nanograms (ng)/kg/min via continuous intravenous infusion. Administration through a central venous line is recommended. Monitor blood pressure response and titrate GIAPREZA as frequently as every 5 minutes by increments of up to 15 ng/kg/min as needed to achieve or maintain target blood pressure.

Do not exceed 80 ng/kg/min during the first 3 hours of treatment. Maintenance dose should not exceed 40 ng/kg/min. Doses as low as 1.25 ng/kg/min may be used.

Once the underlying shock has sufficiently improved, down-titrate every 5 to 15 minutes by increments of up to 15 ng/kg/min based on blood pressure.

💊 Dosage Forms and Strengths 33 words ▾

3. DOSAGE FORMS AND STRENGTHS Injection: 0.5 mg/mL angiotensin II and 2.5 mg/mL angiotensin II in a vial. GIAPREZA is a clear, aqueous solution. Injection: 0.5 mg/mL and 2.5 mg/mL in a vial.

⛔ Contraindications 5 words ▾

4. CONTRAINDICATIONS None. None (4.1)

⚠️ Warnings and Cautions 101 words ▾

5. WARNINGS AND PRECAUTIONS There is a potential for venous and arterial thrombotic and thromboembolic events in patients who receive GIAPREZA. Use concurrent venous thromboembolism (VTE) prophylaxis. ( 5.1 , 6.1 )

5.1Risk for Thrombosis The safety of GIAPREZA was evaluated in 321 adults with septic or other distributive shock in a randomized, double-blind, placebo-controlled study, ATHOS-3. There was a higher incidence of arterial and venous thrombotic and thromboembolic events in patients who received GIAPREZA compared to placebo-treated patients in the ATHOS-3 study (13% vs. 5%).

The major imbalance was in deep venous thromboses. Use concurrent venous thromboembolism (VTE) prophylaxis.

🤒 Adverse Reactions ~1 min read ▾

6. ADVERSE REACTIONS The most common adverse reactions reported in greater than 10% of GIAPREZA treated patients were thromboembolic events. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact La Jolla Pharmaceutical Company at 1-800-651-3861 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

6.1. Clinical 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. ATHOS-3 The safety of GIAPREZA was evaluated in ATHOS-3 [see Warnings and Precautions(5.1) ] .

Patients in ATHOS-3 were receiving other vasopressors in addition to GIAPREZA or placebo, which were titrated to effect on mean arterial pressure (MAP). Table 1 summarizes adverse reactions with an incidence of at least 4% among patients treated with GIAPREZA and with a rate of at least 1.5% higher with GIAPREZA than with placebo. Table 1: Adverse Reactions Occurring in ≥ 4% of Patients Treated with GIAPREZA and ≥ 1.5% More Often than in Placebo-treated Patients in ATHOS-3 Adverse Event GIAPREZA N=163 Placebo N=158 Thromboembolic events Including arterial and venous thrombotic events 21 (12.9%) 8 (5.1%) Deep vein thrombosis 7 (4.3%) 0 (0.0%) Thrombocytopenia 16 (9.8%) 11 (7.0%) Tachycardia 14 (8.6%) 9 (5.7%) Fungal infection 10 (6.1%) 2 (1.3%) Delirium 9 (5.5%) 1 (0.6%) Acidosis 9 (5.5%) 1 (0.6%) Hyperglycemia 7 (4.3%) 4 (2.5%) Peripheral ischemia 7 (4.3%) 4 (2.5%)

🔄 Drug Interactions 72 words ▾

7. DRUG INTERACTIONS Angiotensin converting enzyme (ACE) inhibitors ACE inhibitors may increase response to GIAPREZA. ( 7.1 ) Angiotensin II Receptor Blockers (ARB) ARBs may reduce response to GIAPREZA.

( 7.2 ) 7.1. Angiotensin Converting Enzyme (ACE) Inhibitors Concomitant use of angiotensin converting enzyme (ACE) inhibitors may increase the response to GIAPREZA. 7.2.

Angiotensin II Receptor Blockers (ARB) Concomitant use of angiotensin II receptor blockers (ARBs) may decrease the response to GIAPREZA.

👥 Use in Specific Populations ~1 min read ▾

8. USE IN SPECIFIC POPULATIONS 8.1. Pregnancy Risk Summary The published data on angiotensin II use in pregnant women are not sufficient to determine a drug-associated risk of adverse developmental outcomes.

Animal reproduction studies have not been conducted with GIAPREZA. All pregnancies have a background risk of birth defects, loss, or other adverse outcomes. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown.

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. Clinical Considerations Disease-associated maternal and/or embryo/fetal risk Septic or other distributive shock is a medical emergency that can be fatal if left untreated. Delaying treatment in pregnant women with hypotension associated with septic or other distributive shock is likely to increase the risk of maternal and fetal morbidity and mortality.

8.2. Lactation Risk Summary It is not known whether GIAPREZA is present in human milk. No data are available on the effects of angiotensin II on the breastfed child or the effects on milk production.

8.4. Pediatric Use The safety and efficacy of GIAPREZA in pediatric patients have not been established. 8.5.

Geriatric Use In ATHOS-3, 48% of the total patient population was aged 65 years and older. There was no significant difference in safety or efficacy between patients less than 65 and those 65 years or older when treated with GIAPREZA .

🤰 Pregnancy 143 words ▾

8.1. Pregnancy Risk Summary The published data on angiotensin II use in pregnant women are not sufficient to determine a drug-associated risk of adverse developmental outcomes. Animal reproduction studies have not been conducted with GIAPREZA.

All pregnancies have a background risk of birth defects, loss, or other adverse outcomes. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. 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.

Clinical Considerations Disease-associated maternal and/or embryo/fetal risk Septic or other distributive shock is a medical emergency that can be fatal if left untreated. Delaying treatment in pregnant women with hypotension associated with septic or other distributive shock is likely to increase the risk of maternal and fetal morbidity and mortality.

🧒 Pediatric Use 16 words ▾

8.4. Pediatric Use The safety and efficacy of GIAPREZA in pediatric patients have not been established.

🧓 Geriatric Use 42 words ▾

8.5. Geriatric Use In ATHOS-3, 48% of the total patient population was aged 65 years and older. There was no significant difference in safety or efficacy between patients less than 65 and those 65 years or older when treated with GIAPREZA .

🆘 Overdosage 35 words ▾

10. OVERDOSAGE Overdose of GIAPREZA would be expected to result in hypertension, necessitating close monitoring and supportive care. Effects are expected to be brief because the half-life of angiotensin II is less than one minute.

🧬 Clinical Pharmacology ~2 min read ▾

12. CLINICAL PHARMACOLOGY 12.1. Mechanism of Action Angiotensin II raises blood pressure by vasoconstriction and increased aldosterone release.

Direct action of angiotensin II on the vessel wall is mediated by binding to the G-protein-coupled angiotensin II receptor type 1 on vascular smooth muscle cells, which stimulates Ca 2+ /calmodulin-dependent phosphorylation of myosin and causes smooth muscle contraction. 12.2. Pharmacodynamics For the 114 (70%) patients in the GIAPREZA arm who reached the target MAP at Hour 3, the median time to reach the target MAP endpoint was approximately 5 minutes.

GIAPREZA is titrated to effect for each individual patient. 12.3. Pharmacokinetics Following intravenous infusion of angiotensin II in adults with septic or other distributive shock, serum levels of angiotensin II are similar at Baseline and Hour 3 after intravenous infusion.

After 3 hours of treatment, however, the serum level of angiotensin I (the angiotensin II precursor peptide) is reduced by approximately 40%. Distribution: No specific studies were conducted that examined the distribution of GIAPREZA. Metabolism and Excretion: No specific studies were conducted that examined the metabolism and excretion of GIAPREZA.

The plasma half-life of IV administered angiotensin II is less than one minute. It is metabolized by aminopeptidase A and angiotensin converting enzyme 2 to angiotensin-(2-8) [angiotensin III] and angiotensin-(1-7), respectively in plasma, erythrocytes and many of the major organs (i.e., intestine, kidney, liver and lung). Angiotensin II type 1 receptor (AT1) mediated activity of angiotensin III is approximately 40% of angiotensin II; however, aldosterone synthesis activity is similar to angiotensin II.

Angiotensin-(1-7) exerts the opposite effects of angiotensin II on AT1 receptors and causes vasodilation. Specific Populations No formal pharmacokinetic studies were conducted with GIAPREZA in the following specific populations. Renal Impairment The clearance of angiotensin II is not dependent on renal function.

Therefore, the pharmacokinetics of GIAPREZA are not expected to be influenced by renal impairment. Hepatic Impairment The clearance of angiotensin II is not dependent on hepatic function. Therefore, the pharmacokinetics of GIAPREZA are not expected to be influenced by hepatic impairment.

Age The effect of age was analyzed in the 163 patients receiving GIAPREZA in ATHOS-3. There were no significant differences in pharmacokinetics between age groups (< 65 years / ≥ 65 years). Male and Female Patients The effect of sex was analyzed in the 163 patients receiving GIAPREZA in ATHOS-3.

There were no significant differences in pharmacokinetics between male and female patients.

🧬 Mechanism of Action 54 words ▾

12.1. Mechanism of Action Angiotensin II raises blood pressure by vasoconstriction and increased aldosterone release. Direct action of angiotensin II on the vessel wall is mediated by binding to the G-protein-coupled angiotensin II receptor type 1 on vascular smooth muscle cells, which stimulates Ca 2+ /calmodulin-dependent phosphorylation of myosin and causes smooth muscle contraction.

📦 How Supplied / Storage and Handling 127 words ▾

16. HOW SUPPLIED/STORAGE AND HANDLING 16.1. How Supplied GIAPREZA (angiotensin II) Injection is a clear, aqueous solution for administration by intravenous infusion supplied as a single-dose vial: 2.5 mg/mL vial: NDC 68547-501-02: A carton of one 1 mL single-dose vial containing 2.5 mg angiotensin II (as a sterile liquid).

0.5mg/mL vial: NDC 68547-005-05: A carton of five 1 mL single-dose vials (NDC 68547-005-01) containing 0.5 mg angiotensin II (as a sterile liquid). 0.5 mg/mL vial: NDC 68547-005-01: A carton of one 1 mL single-dose vial containing 0.5 mg angiotensin II (as a sterile liquid). 16.2.

Storage and Handling GIAPREZA vials should be stored in the refrigerator between 2°C to 8°C (36°F to 46°F). Discard prepared diluted solution after 24 hours at room temperature or under refrigeration.

📦 Storage and Handling 32 words ▾

16.2. Storage and Handling GIAPREZA vials should be stored in the refrigerator between 2°C to 8°C (36°F to 46°F). Discard prepared diluted solution after 24 hours at room temperature or under refrigeration.

📋 Description 197 words ▾

11. DESCRIPTION Angiotensin II is a naturally occurring peptide hormone of the renin-angiotensin-aldosterone system (RAAS) that causes vasoconstriction and an increase in blood pressure. GIAPREZA is a sterile, aqueous solution of synthetic human angiotensin II for intravenous administration by infusion.

Each 2.5 mg/mL vial of GIAPREZA contains 2.5 mg angiotensin II equivalent to an average of 2.9 mg angiotensin II acetate, 25 mg mannitol, and Water for Injection adjusted with sodium hydroxide and/or hydrochloric acid to pH of 5.5. Each 0.5 mg/mL vial of GIAPREZA contains 0.5 mg angiotensin II equivalent to an average of 0.6 mg angiotensin II acetate, 25 mg mannitol, and Water for Injection adjusted with sodium hydroxide and/or hydrochloric acid to pH of 5.5. The chemical name of the synthetic angiotensin II acetate is L-Aspartyl-L-arginyl-L-valyl-Ltyrosyl-L-isoleucyl-L-histidyl-L-prolyl-L-phenylalanine, acetate salt.

The counter ion acetate is present in a non-stoichiometric ratio. It is a white to off-white powder, soluble in water. The structure of angiotensin II acetate is shown below.

Molecular formula: C 50 H 71 N 13 O 12 ∙ (C 2 H 4 O 2 ) n ; (n= number of acetate molecules; theoretical n = 3) Average molecular weight: 1046.2 (as free base). giapreza-structure

🧬 Pharmacokinetics ~1 min read ▾

12.3. Pharmacokinetics Following intravenous infusion of angiotensin II in adults with septic or other distributive shock, serum levels of angiotensin II are similar at Baseline and Hour 3 after intravenous infusion. After 3 hours of treatment, however, the serum level of angiotensin I (the angiotensin II precursor peptide) is reduced by approximately 40%.

Distribution: No specific studies were conducted that examined the distribution of GIAPREZA. Metabolism and Excretion: No specific studies were conducted that examined the metabolism and excretion of GIAPREZA. The plasma half-life of IV administered angiotensin II is less than one minute.

It is metabolized by aminopeptidase A and angiotensin converting enzyme 2 to angiotensin-(2-8) [angiotensin III] and angiotensin-(1-7), respectively in plasma, erythrocytes and many of the major organs (i.e., intestine, kidney, liver and lung). Angiotensin II type 1 receptor (AT1) mediated activity of angiotensin III is approximately 40% of angiotensin II; however, aldosterone synthesis activity is similar to angiotensin II. Angiotensin-(1-7) exerts the opposite effects of angiotensin II on AT1 receptors and causes vasodilation.

Specific Populations No formal pharmacokinetic studies were conducted with GIAPREZA in the following specific populations. Renal Impairment The clearance of angiotensin II is not dependent on renal function. Therefore, the pharmacokinetics of GIAPREZA are not expected to be influenced by renal impairment.

Hepatic Impairment The clearance of angiotensin II is not dependent on hepatic function. Therefore, the pharmacokinetics of GIAPREZA are not expected to be influenced by hepatic impairment. Age The effect of age was analyzed in the 163 patients receiving GIAPREZA in ATHOS-3.

There were no significant differences in pharmacokinetics between age groups (< 65 years / ≥ 65 years). Male and Female Patients The effect of sex was analyzed in the 163 patients receiving GIAPREZA in ATHOS-3. There were no significant differences in pharmacokinetics between male and female patients.

🧬 Pharmacodynamics 41 words ▾

12.2. Pharmacodynamics For the 114 (70%) patients in the GIAPREZA arm who reached the target MAP at Hour 3, the median time to reach the target MAP endpoint was approximately 5 minutes. GIAPREZA is titrated to effect for each individual patient.

🔬 Clinical Studies ~2 min read ▾

14. CLINICAL STUDIES 14.1. ATHOS-3 The Angiotensin II for the Treatment of High-Output Shock (ATHOS-3) trial was a double-blind study in which 321 adults with septic or other distributive shock who remained hypotensive despite fluid and vasopressor therapy were randomized 1:1 and treated with either GIAPREZA or placebo, both in addition to background vasopressor therapy.

Doses of GIAPREZA or placebo were titrated to a target MAP of ≥ 75 mmHg during the first 3 hours of treatment while doses of other vasopressors were maintained. From Hour 3 to Hour 48, GIAPREZA or placebo were titrated to maintain MAP between 65 and 70 mmHg while reducing doses of other vasopressors. The primary endpoint was the percentage of subjects who achieved either a MAP ≥ 75 mmHg or a ≥ 10 mmHg increase in MAP without an increase in baseline vasopressor therapy at 3 hours.

91% of subjects had septic shock; the remaining subjects had other forms of distributive shock such as neurogenic shock. At the time of study drug administration, 97% of subjects were receiving norepinephrine, 67% vasopressin, 15% phenylephrine, 13% epinephrine, and 2% dopamine. 83% of subjects had received two or more vasopressors and 47% three or more vasopressors prior to study drug administration.

61% of subjects were male, 80% were White, 10% were Black, and 10% were other races. The median age of subjects was 64 years (range: 22-89 years). Patients requiring high doses of steroids, patients with a history of asthma or bronchospasm, and patients with Raynaud's syndrome were not included.

The primary endpoint was achieved by 70% of patients randomized to GIAPREZA compared to 23% of placebo patients; p < 0.0001 (a treatment effect of 47%). Figure 1 shows the results in all patients and in selected subgroups. Figure 1: ATHOS-3: Primary Endpoint – Overall Result and Results in Selected Subgroups NE Equiv = norepinephrine equivalent dose: the sum of all vasopressor doses with each vasopressor dose converted to the clinically equivalent norepinephrine dose.

Note: The figure above presents effects in various subgroups, all of which are baseline characteristics. The 95% confidence limits that are shown do not take into account the number of comparisons made and may not reflect the effect of a particular factor after adjustment for all other factors. Apparent homogeneity or heterogeneity among groups should not be over-interpreted.

In the GIAPREZA-treated group, the median time to reach the target MAP endpoint was 5 minutes. The effect on MAP was sustained for at least the first three hours of treatment. The median dose of GIAPREZA was 10 ng/kg/min at 30 minutes.

Of the 114 responders at Hour 3, only 2 (1.8%) received more than 80 ng/kg/min. Patients were not necessarily on maximum doses of other vasopressors at the time of randomization. The effect of GIAPREZA when added to maximum doses of other vasopressors is unknown.

Mortality through Day 28 was 46% on GIAPREZA and 54% on placebo (hazard ratio 0.78; 95% confidence interval 0.57 – 1.07). giapreza-forest-plot

🧪 Nonclinical Toxicology 130 words ▾

13. NONCLINICAL TOXICOLOGY 13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility No genetic toxicity studies have been conducted with GIAPREZA.

No carcinogenicity or fertility studies with GIAPREZA have been conducted in animals. 13.2. Animal Toxicology and/or Pharmacology No animal toxicology studies were conducted with GIAPREZA.

13.3. Safety Pharmacology In a cardiovascular safety pharmacology study in normotensive dogs, GIAPREZA doses of 150, 450, and 1,800 ng/kg (5, 15, and 60 ng/kg/min) were infused intravenously for 30 minutes each. At ≥ 450 ng/kg, GIAPREZA caused significantly elevated MAP and systemic vascular resistance, as expected.

The 1,800 ng/kg dose also caused increased heart rate, increased systemic vascular resistance, increased left ventricular systolic and end-diastolic pressures, and PR interval prolongation. GIAPREZA did not significantly alter respiratory rate or cause electrocardiographic changes in QRS duration or QTc.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 27 words ▾

13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility No genetic toxicity studies have been conducted with GIAPREZA. No carcinogenicity or fertility studies with GIAPREZA have been conducted in animals.

📄 Recent Major Changes 11 words ▾

RECENT MAJOR CHANGES Dosage and Administration, Preparation ( 2.1 ) 12/2021

📄 Package Label / Principal Display Panel 38 words ▾

Package Label – 2.5 mg/mL Single-Dose Vial Label 2.5-vial-label

Package Label – 2.5 mg/mL Single Vial Carton Label 2.5-carton-label

Package Label - 0.5 mg/mL Single-Dose Vial Label 0.5-vial-label

Package Label - 0.5 mg/mL Single Vial Carton Label 0.5-vial-carton-label

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

About this NDC listing & data coverage

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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.
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Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by La Jolla Pharmaceutical Company. Listing status can change — the directory data on this page refreshes weekly.
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La Jolla Pharmaceutical Company 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.
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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.
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← 68546-0479-56 · Teva 68547-0111-10 · La →
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