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This program is a clinical measure program

Under the GIAPREZA Limited Warranty Program, La Jolla Pharmaceutical Company will replace eligible vials of GIAPREZATM (angiotensin II) free of charge in the event the GIAPREZA patient does not meet the following clinical measurement: increase in mean arterial pressure (MAP) by 10 mmHg, or reach a MAP of 65 mmHg, within the first three hours of initiation.

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Program Eligibility

  • This Limited Warranty Program shall only apply to vials purchased by an inpatient hospital facility (“Hospital”) from an authorized distributor for GIAPREZA (“Authorized Distributor”). For our current list of Authorized Distributors, please visit GIAPREZA.com/distribution.
  • To submit a claim seeking Replacement Product (defined below), an authorized representative of the hospital must submit the GIAPREZA Limited Warranty Program Return Form to La Jolla Pharmaceutical Company within thirty (30) days from the date on which GIAPREZA was administered.
  • In order to be eligible for Limited Warranty Program, Hospital must certify the following:

– GIAPREZA was administered in a United States inpatient hospital between May 1, 2019 and September 30, 2019 in adults being treated for septic or other distributive shock;

– GIAPREZA was administered for an FDA-approved indication, in accordance with the GIAPREZA prescribing information;

– At the time of initiation of GIAPREZA, the patient received no more than 0.46 mcg/kg/min of norepinephrine equivalent vasopressor(s);

– The patient did not meet the following clinical measurement: increase in mean arterial pressure (MAP) by 10 mmHg, or reach a MAP of 65mmHg, within the first three hours of GIAPREZA 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;

– Hospital will not bill the patient, insurer, or any third party for the free Replacement Product received under the GIAPREZA Limited Warranty Program

– Hospital has complied with all other Terms and Conditions of the GIAPREZA Limited Warranty Program.

  • Eligibility of the Limited Warranty Program is not contingent on the institution’s volume of purchases, formulary commitment, or any other requirement tied to the volume or value of referrals generated between La Jolla Pharmaceutical Company and Hospital.

Program Term

  • The Limited Warranty Program shall apply to vials of GIAPREZA administered to the patient between May 1, 2019 and September 30, 2019. La Jolla Pharmaceutical Company may extend, shorten, or modify the term of the Limited Warranty Program at its sole discretion.

Issuance of Replacement Product

  • Upon receipt of a completed GIAPREZA Limited Warranty Return Form and verification of eligibility for the GIAPREZA Limited Warranty Program, La Jolla Pharmaceutical Company shall issue a vial(s) of the same NDC of GIAPREZA that was originally purchased by Hospital (“Replacement Product”). Replacement Product shall be shipped to Hospital by La Jolla Pharmaceutical Company’s 3PL (Third-party logistics) at no cost. The replacement vial(s) will include an invoice of replacement product at zero cost. La Jolla Pharmaceutical Company reserves the right to review each request on a claim by claim basis and may deny provider any claim for Replacement Product in the event that any of the Terms and Conditions are not met or followed. In addition, La Jolla Pharmaceutical Company may audit the hospital to confirm compliance with these eligibility requirements.

Please see the full Terms and Conditions

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

Important Safety Information See more

Warnings and Precautions The safety of GIAPREZA was evaluated in 321 adults with septic or other distributive shock in the randomized, double-blind, placebo-controlled ATHOS-3 study. 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% (21/163 patients) vs. 5% (8/158 patients)]. The major imbalance was in deep venous thromboses. Use concurrent venous thromboembolism prophylaxis.

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

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 the randomized, double-blind, placebo-controlled ATHOS-3 study. 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% (21/163 patients) vs. 5% (8/158 patients)]. The major imbalance was in deep venous thromboses. Use concurrent venous thromboembolism 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 inhibitors may increase response to GIAPREZA.

Angiotensin II receptor blockers may reduce response to GIAPREZA.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

For additional Important Safety Information, please see the full Prescribing Information.

Reference: GIAPREZA™ (angiotensin II) [prescribing information]. San Diego, CA: La Jolla Pharmaceutical Company; 2017.