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Example Patient

55-year-old male with history of hypertension, obesity, type 2 diabetes mellitus, and hypercholesterolemia was admitted with a non-ST-segment elevation myocardial infarction:

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Cardiac magnetic resonance imaging revealed a left ventricular ejection fraction (LVEF) of 18%, and a left heart catheterization demonstrated triple-vessel disease. He was subsequently referred for a 3-vessel coronary artery bypass graft.

  • After transitioning off cardiopulmonary bypass (CPB), patient developed distributive shock characterized by severe hypotension and vasoplegia with a MAP of 56 mmHg
  • The immediate post-CPB hemoglobin and LVEF were 8.5 g/dL and 28%, respectively
  • The patient was receiving norepinephrine at 0.23 mcg/kg/min and vasopressin at 0.06 units/min. Methylene blue (MB) was also added to combat the vasoplegia
  • Post-operatively, his cardiac index (CI) was 2.4 L/min/m2
  • Patient remained severely hypotensive despite requiring a norepinephrine-equivalent dose of 0.41 mcg/kg/min
  • Patient is a good candidate for GIAPREZA

*This is not based on an actual patient. Patient profile is for illustrative purposes only and does not constitute treatment advice.

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.