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Sepsis

is the most common cause of AKI in critical care patients2

Septic Shock Patients May Develop Septic AKI1:

A large retrospective cohort study (n=4532) of adult patients with septic shock found that more than 60% developed AKI. The authors concluded that AKI is commonly encountered in critically ill patients and independently predicts poor outcomes.1

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Patients on RRT at Baseline in the ATHOS-3 Trial Experienced Improved Outcomes3*:

  • Significantly greater MAP response at Hour 33
  • More likely to be ventilator free at Day 73
  • More Likely to be RRT free at Day 73
  • Vasopressor utilization was also evaluated3

*This was a post-hoc analysis of data from the ATHOS-3 pivotal trial for GIAPREZA. Because these analyses were not pre-specified and multiplicity adjustments were not applied, these data require cautious interpretation.

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. Bagshaw SM, et al. Intensive Care Med. 2009; 35:871–81. 2. Zarbock A, Gomez H, Kellum JA. Curr Opin Crit Care. 2014;20(6):588–595. 3. Tumlin JA et al. Crit Care Med.2018; 46(6): 949-9572.

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