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*In Adults with Septic or Other Distributive Shock
GIAPREZA rapidly increased MAP with a median response time of approximately 5 minutes1a-d
At Hour 1*, 77% of GIAPREZA plus standard of care (SoC) treated patients vs 16% of placebo plus SoC treated patients achieved target MAPb-d
Three times as many patients treated with GIAPREZA plus SoC vs patients treated with placebo plus SoC achieved the primary endpoint of target MAP at Hour 3 (70% vs 23%)b-d
Only GIAPREZA activates the RAAS to increase MAP1
Watch the GIAPREZA mechanism of action video
Abbreviations: MAP, mean arterial pressure; RAAS, renin-angiotensin-aldosterone system; SoC, standard of care
*Hour 1 data using the same MAP target endpoint as defined for the primary analysis at Hour 3
aResponse was defined as achievement of target MAP ≥75 mmHg or increase of ≥10 mmHg from baseline without an increase in baseline vasopressor therapy.
bTarget MAP is defined as ≥75 mmHg or an increase from baseline of ≥10 mmHg without an increase in baseline vasopressor therapy.
cGIAPREZA and placebo were studied in conjunction with norepinephrine, epinephrine, dopamine, phenylephrine, and vasopressin.
dResults from the ATHOS-3 trial.
A Significant Number of Patients Remain Hypotensive Despite Standard of Care Fluid And Vasopressor Therapy2,4
Abbreviations: DS, distributive shock *GIAPREZA and placebo were studied in conjunction with SoC vasopressors, including norepinephrine, epinephrine, dopamine, phenylephrine, and vasopressin.
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.
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. Vincent JL, De Backer D. Circulatory Shock. New England Journal of Medicine. 2013;369(18):1726-1734. 4. Bassi E et al. Crit Care Res Pract. 2013;654-708.
