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Typical Treatment Cascade for Distributive Shock Patients

Role of GIAPREZA

A Significant Number of Patients Remain Hypotensive Despite Standard of Care Fluid and Vasopressor Therapy2,3

Abbreviations: DS, distributive shock
*GIAPREZA and placebo were studied in conjunction with SoC vasopressors, including norepinephrine, epinephrine, dopamine, phenylephrine, and vasopressin. Not intended to constitute treatment advice. Timing of administration of GIAPREZA is dependent on the patient’s clinical status and the institution’s standard of care protocols.

An overview of GIAPREZA discussing the unmet need and a role for GIAPREZA, mechanism of action, clinical trial evidence, and safety data.

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GIAPREZA Clinical Support Tools

Timing of administration of GIAPREZA is dependent on the patient’s clinical status and the institution’s protocols.

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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.

References: 1. GIAPREZA™ (angiotensin II) [prescribing information]. San Diego, CA: La Jolla Pharmaceutical Company; 2017. 2. Data on File. 3. Bassi E et al. Crit Care Res Pract. 2013;654-708.

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