GIAPREZA WASTAGE PRODUCT REPLACEMENT PROGRAM TERMS AND CONDITIONS

La Jolla Pharmaceutical Company (La Jolla) will replace eligible vials of GIAPREZA free of charge in the event that GIAPREZA vials are spoiled and 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/).

 

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 and were unable to be administered due to one of the following events:

    • GIAPREZA was mishandled, dropped or broken;

    • GIAPREZA was inappropriately stored or frozen;

    • GIAPREZA was reconstituted 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 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 7 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 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) Wastage Product Replacement Program shall apply to eligible vials of GIAPREZA that were both: (i) purchased; and (ii) determined to be spoiled and unable to be administered, between April 1, 2020 and September 30, 2021. 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.

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.

 Privacy Notice                    Terms of Use

LJPC logo (1).png

This site is intended for healthcare professionals in the United States

Giapreza-white.png

IMPORTANT SAFETY INFORMATION

SEE MORE

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