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Ordering Info

Using Giapreza

Dosing and administration

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DOSING

Flexible and easily titratable for rapid MAP control

1

INITIATE

  • The recommended starting dose of GIAPREZA is 20 ng/kg/min (0.02 mcg/kg/min)

2

access

  • The median time to reach target MAP was 5 minutes
  • The median dose of GIAPREZA was 10 ng/kg/min at 30 minutes

3

optimize

  • 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
  • The half-life of GIAPREZA is less than 1 minute
  • Once the underlying shock has sufficiently improved, down-titrate every 5 to 15 minutes in increments of up to 15 ng/kg/min, based on blood pressure

Doses as low as 1.25 ng/kg/min
may be used

During the first 3 hours, the maximum dose should not exceed 80 ng/kg/min

Maintenance dose should not exceed 40 ng/kg/min

To learn more about dosing, download a Dosing and Administration Guide

PREPARATION

Available in 0.5 mg and 2.5 mg vial options

GIAPREZA® (angiotensin II) injection bottle 0.5 mg vial
GIAPREZA® (angiotensin II) injection bottle 2.5 mg vial

GIAPREZA injection is a clear, aqueous solution supplied in a carton with a 1 mL single-dose vial containing 0.5 or 2.5 mg angiotensin II as a sterile liquid

  • Inspect for particulate matter and discoloration prior to administration
  • Dilute 1 mL of GIAPREZA in a normal saline (NS) (0.9% sodium chloride) infusion bag to achieve a final concentration as follows1:

Fluid Restricted?

No

Yes

NS Infusion Bag Size

500 mL

250 mL

Final Concentration

5,000 ng/mL

10,000 ng/mL

ADMINISTRATION & STORAGE

How to administer and store

Administration

Administer GIAPREZA
via continuous intravenous infusion

Administration through a central venous line is recommended

Monitor blood pressure closely after GIAPREZA initiation

Storage

  • GIAPREZA vials should be stored in the refrigerator between 2°C to 8°C (36°F to 46°F)
  • Diluted solution may be stored at room temperature or under refrigeration for up to 24 hours, after which it should be discarded
  • Discard vial and any unused portion of the drug product after use

WASTAGE PRODUCT REPLACEMENT PROGRAM

Innoviva Specialty Therapeutics will replace eligible vials of GIAPREZA free of charge in the event that GIAPREZA vials are spoiled, or are otherwise unable to be administered.

For eligibility criteria and instructions on initiating replacement requests, please fill out this form and refer to the Terms and Conditions below.

If you have any questions, please contact fieldops@ljpc.com.

Giapreza wastage product replacement program terms and conditions

Innoviva Specialty Therapeutics, Inc. (an affiliate of La Jolla Pharmaceutical Company) will replace eligible vials of GIAPREZA® free of charge in the event that GIAPREZA vials are spoiled, or are otherwise unable to be administered.

Eligibility

This program applies to GIAPREZA vials purchased from an authorized distributor of GIAPREZA (full list of authorized distributors available at https://www.giapreza.com/resources).

Each replacement requires completion of the GIAPREZA (angiotensin II) Wastage Product Replacement Program Form. In order to receive GIAPREZA replacement vials, the hospital must certify that the GIAPREZA vials to be replaced:

  • Were purchased to be used in accordance with the GIAPREZA FDA prescribing information;
  • Spoiled, or were unable to be administered due to one of the following Wastage Events:
    • GIAPREZA was mishandled, dropped or broken;
    • GIAPREZA was inappropriately stored or frozen;
    • GIAPREZA was diluted but not administered due to unforeseen patient condition; or
    • A dosage preparation error occurred;
  • Were not administered (including bolus) and are not intended to be administered to another patient; and
  • Were not billed to the patient or a payor.

To submit a claim seeking GIAPREZA replacement vials, an authorized representative of the hospital must submit the GIAPREZA (angiotensin II) Wastage Product Replacement Program Form within 30 days from the date on which the GIAPREZA Wastage Event occurred.

Limitations and Conditions

GIAPREZA replacement vials will only be shipped to facilities that provide a copy of their state license. Hospitals may not receive more than 15 GIAPREZA replacement vials during any 12-month period.

Issuance of Replacement Vials

Upon receipt of a completed GIAPREZA (angiotensin II) Wastage Product Replacement Program Form and verification of eligibility for the GIAPREZA (angiotensin II) Wastage Product Replacement Program, the hospital will receive a confirmation email with a link to a GIAPREZA (angiotensin II) Certificate of Destruction Form. Following the destruction of GIAPREZA vials and submission of the GIAPREZA (angiotensin II) Certificate of Destruction Form, La Jolla shall issue a replacement vial of GIAPREZA to the hospital bearing the same NDC code as the originally purchased vial of GIAPREZA. The GIAPREZA replacement vials shall be shipped to the hospital by La Jolla’s third-party logistics provider at no cost to the hospital.

Term

La Jolla may extend, shorten, discontinue or otherwise modify the GIAPREZA (angiotensin II) Wastage Product Replacement Program at any time, for any reason or no reason, in its sole discretion.

Adverse Reactions

You are encouraged to report negative side effects of prescription drugs to the FDA. To report SUSPECTED ADVERSE REACTIONS, please contact:

La Jolla Pharmaceutical Company

1-800-651-3861

medicalinformation@ljpc.com

U.S. Food and Drug Administration

1-800-FDA-1088

www.fda.gov/medwatch

Compliance with Law

The hospital shall comply with all applicable federal, state and local laws and regulations governing its activities related to the GIAPREZA (angiotensin II) Wastage Product Replacement Program, including without limitation: (i) HIPAA, and state and local privacy and data protection laws; (ii) the Federal Anti-Kickback Statute (42 U.S.C. § 1320a-7b(b)), and analogous state laws; (iii) the Food Drug & Cosmetic Act and regulations promulgated thereunder; and (iv) all Federal healthcare program reporting obligations, including without limitation, the Medicare requirements prohibiting billing for no cost items (42 U.S.C. 1395y(a)(2)). The hospital shall not provide Protected Health Information (PHI), as that term is defined under HIPAA, or information that is considered patient-identifiable under any applicable state laws, to La Jolla.

Questions

For questions about the GIAPREZA Wastage Product Replacement Program, please email fieldops@ljpc.com.

LIMITED WARRANTY PROGRAM

Innoviva Specialty Therapeutics will replace eligible vials of GIAPREZA free of charge in the event that a patient receiving GIAPREZA does not reach an increase in mean arterial pressure (MAP) of 10 mmHg, or reach a MAP of 65 mmHg, within the first three hours of initiation.

For eligibility criteria and instructions on initiating warranty claims, please fill out this form and refer to the Terms and Conditions below.

If you have any questions, please contact warranty@ljpc.com.

GIAPREZA LIMITED WARRANTY PROGRAM TERMS AND CONDITIONS

Innoviva Specialty Therapeutics, Inc. (an affiliate of La Jolla Pharmaceutical Company) will replace eligible vials of GIAPREZA® free of charge in the event that a patient receiving GIAPREZA does not reach an increase in mean arterial pressure (MAP) of 10 mmHg, or reach a MAP of 65 mmHg, within the first three hours of initiation.

Eligibility

This program applies to GIAPREZA vials purchased from an authorized distributor of GIAPREZA (full list of authorized distributors available at https://www.giapreza.com/resources).

Each replacement requires completion of the GIAPREZA (angiotensin II) Limited Warranty Program Return Form. In order to receive GIAPREZA replacement vials, the hospital must certify the following:

  • GIAPREZA was administered for a Food and Drug Administration (FDA)-approved indication, in accordance with the GIAPREZA FDA prescribing information;
  • The patient receiving GIAPREZA did not reach an increase in MAP of 10 mmHg, or reach a MAP of 65 mmHg, within the first three hours of initiation;
  • The healthcare provider overseeing treatment was, at all times, responsible for determining whether a specific treatment, including the administration of GIAPREZA, was medically necessary and clinically appropriate for a particular patient;
  • The hospital will not bill the patient, insurer, or any third party for vials of GIAPREZA that are replaced under the GIAPREZA (angiotensin II) Limited Warranty Program; and
  • The hospital has complied with all other Terms and Conditions of the GIAPREZA (angiotensin II) Limited Warranty Program.

To submit a claim seeking GIAPREZA replacement vials, an authorized representative of the hospital must submit the GIAPREZA (angiotensin II) Limited Warranty Program Return Form within 30 days from the date on which GIAPREZA was administered.

Issuance of Replacement Vials

Upon receipt of a completed GIAPREZA (angiotensin II) Limited Warranty Return Form and verification of eligibility for the GIAPREZA (angiotensin II) Limited Warranty Program, La Jolla shall issue a replacement vial of GIAPREZA to the hospital bearing the same NDC code as the originally purchased vial of GIAPREZA. The GIAPREZA replacement vials shall be shipped to the hospital by La Jolla’s third-party logistics provider at no cost to the hospital.

Term

La Jolla may extend, shorten, or modify the term of the GIAPREZA Limited Warranty Program any time, for any reason or no reason, at its sole discretion.

Adverse Reactions

You are encouraged to report negative side effects of prescription drugs to the FDA. To report SUSPECTED ADVERSE REACTIONS, please contact:

La Jolla Pharmaceutical Company

1-800-651-3861

medicalinformation@ljpc.com

U.S. Food and Drug Administration

1-800-FDA-1088

www.fda.gov/medwatch

Compliance with Law

The hospital shall comply with all applicable federal, state, and local laws and regulations governing its activities related to the GIAPREZA (angiotensin II) Limited Warranty Program, including without limitation, (i) HIPAA, and state and local privacy and data protection laws; (ii) the Federal Anti-Kickback Statute (42 U.S.C. § 1320a-7b(b)), and analogous state laws; (iii) the Food Drug & Cosmetic Act and regulations promulgated thereunder; and (iv) all Federal healthcare program reporting obligations, including without limitation, the Medicare requirements prohibiting billing for no cost items (42 U.S.C. 1395y(a)(2)). The hospital shall not provide Protected Health Information (PHI), as that term is defined under HIPAA, or information that is considered patient-identifiable under any applicable state laws, to La Jolla.

Questions

For questions about the GIAPREZA Limited Warranty Program, please email warranty@ljpc.com.

Connect with a GIAPREZA sales
representative for information and support.

References:

  1. Baker DE, Levien TL. Angiotensin II. Hosp Pharm. 2018;53(4):230-233. doi: 10.1177/0018578718778224

Important Safety Information

Indication

GIAPREZA® (angiotensin II) increases blood pressure in adults with septic or other distributive shock.

Contraindications

None.

Warnings and Precautions

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

The most common adverse reactions reported in greater than 10% of GIAPREZA-treated patients were thromboembolic events. Adverse reactions occurring in ≥4% of patients treated with GIAPREZA and ≥1.5% more often than placebo‑treated patients in the ATHOS-3 study were thromboembolic events (including deep vein thrombosis), thrombocytopenia, tachycardia, fungal infection, delirium, acidosis, hyperglycemia, and peripheral ischemia.

Drug Interactions

Angiotensin converting enzyme (ACE) inhibitors may increase response to GIAPREZA. Angiotensin II receptor blockers (ARBs) may reduce response to GIAPREZA.

You are encouraged to report negative side effects of prescription drugs to the FDA.
To report SUSPECTED ADVERSE REACTIONS, please contact:

La Jolla Pharmaceutical Company

1-800-651-3861

medicalinformation@ljpc.com

U.S. Food and Drug Administration

1-800-FDA-1088

www.fda.gov/medwatch

Before administering, please see the Full Prescribing Information for GIAPREZA.

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GIAPREZA® is marketed by Innoviva Specialty Therapeutics, Inc. in partnership with La Jolla Pharmaceutical Company.

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