GIAPREZA LIMITED WARRANTY PROGRAM TERMS AND CONDITIONS

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 mm Hg, or reach a MAP

of 65 mm Hg, 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/).

 

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 in a United States hospital between May 1, 2019 and September 30, 2020 in adults being treated for septic or other distributive shock;

  • 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 mm Hg, or reach a MAP of 65 mm Hg, 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.

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 vial of the same NDC of GIAPREZA that was originally purchased by the hospital. 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

The GIAPREZA (angiotensin II) Limited Warranty Program shall apply to vials of GIAPREZA administered between May 1, 2019 and September 30, 2020. 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.

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

For additional information, please see GIAPREZA FDA prescribing information.

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IMPORTANT SAFETY INFORMATION

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There is a potential for venous and arterial thrombotic and thromboembolic events in patients who receive GIAPREZA. Use concurrent venous thromboembolism (VTE) prophylaxis.