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Giapreza

Generic Name: Angiotensin II Acetate
Class: Renin-Angiotensin-Aldosterone System (RAAS)

Introduction

Angiotensin II acetate is a hormone or synthetic substitute that affects the renin-angiotensin-aldosterone system (RAAS).

Uses for Giapreza

Angiotensin II acetate has the following uses:

Angiotensin II acetate is a vasoconstrictor to increase blood pressure in adults with septic or other distributive shock. 1

Giapreza Dosage and Administration

General

Angiotensin II acetate is available in the following dosage form(s) and strength(s):

Injection: 2.5 mg/mL and 5 mg/2 mL (2.5 mg/mL) in a vial.1

Dosage

It is essential that the manufacturer's labeling be consulted for more detailed information on dosage and administration of this drug. Dosage summary:

Adults

Dosage and Administration

Dilute angiotensin II acetate 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. Angiotensin II acetate must be administered as an intravenous infusion.1

  • Start angiotensin II acetate 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.1

Cautions for Giapreza

Contraindications

None.1

Warnings/Precautions

Risk for Thrombosis

The safety of angiotensin II acetate 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 angiotensin II acetate 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.1

Specific Populations

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 angiotensin II acetate.1

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.1

Disease-associated Maternal and/or Embryofetal 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.1

Lactation

It is not known whether angiotensin II acetate is present in human milk. No data are available on the effects of angiotensin II on the breast-fed child or the effects on milk production.1

Pediatric Use

The safety and efficacy of angiotensin II acetate in pediatric patients have not been established.1

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 angiotensin II acetate.1

Common Adverse Effects

The most common adverse reactions reported in greater than 10% in angiotensin II acetate-treated patients were thromboembolic events.1

Drug Interactions

Specific Drugs

It is essential that the manufacturer's labeling be consulted for more detailed information on interactions with this drug, including possible dosage adjustments. Interaction highlights:

  • Angiotensin-converting Enzyme (ACE) Inhibitors: ACE inhibitors may increase response to angiotensin II acetate.1

  • Angiotensin II Receptor Blockers (ARBs): ARBs may reduce response to angiotensin II acetate.1

Actions

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 Ca2+/calmodulin-dependent phosphorylation of myosin and causes smooth muscle contraction.1

Additional Information

AHFSfirstRelease. For additional information until a more detailed monograph is developed and published, the manufacturer's labeling should be consulted. It is essential that the manufacturer's labeling be consulted for more detailed information on usual uses, dosage and administration, cautions, precautions, contraindications, potential drug interactions, laboratory test interferences, and acute toxicity.

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

Angiotensin II Acetate

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Parenteral

Injection

2.5 mg/1 mL

Giapreza

La Jolla Pharmaceutical Company

AHFS Drug Information. © Copyright 2018, Selected Revisions February 12, 2018. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, Maryland 20814.

References

1. La Jolla Pharmaceutical Company. Giapreza (angiotensin II) INTRAVENOUS prescribing information. 2018 Jan.

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