Home - GIAPREZA (angiotensin II) injection for intravenous infusion

GIAPREZA is the first and only FDA-approved synthetic human angiotensin II that increases blood pressure in adults with septic or other distributive shock.

Abbreviations: MAP, mean arterial pressure; RAAS, renin-angiotensin-aldosterone system.

^aTarget MAP defined as ≥75 mmHg or an increase from baseline of ≥10 mmHg without an increase in baseline vasopressor therapy.

^bGIAPREZA and placebo were studied in conjunction with norepinephrine, epinephrine, dopamine, phenylephrine, and vasopressin.

^cResults from the ATHOS-3 trial.

^dResponse was defined as achievement of target MAP ≥75 mmHg or increase of ≥10 mmHg from baseline without an increase in baseline vasopressor therapy.

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% in 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.

GIAPREZA is the first and only FDA-approved synthetic human angiotensin II that increases blood pressure in adults with septic or other distributive shock.

WHY GIAPREZA?

INCREASED MAP

RAPID RESPONSE

GIAPREZA is the first and only FDA-approved synthetic human angiotensin II that increases blood pressure in adults with septic or other distributive shock.

WHY GIAPREZA?

INCREASED MAP

RAPID RESPONSE

GIAPREZA is the first and only FDA-approved synthetic human angiotensin II that increases blood pressure in adults with septic or other distributive shock.

WHY GIAPREZA?

INCREASED MAP

RAPID RESPONSE

GIAPREZA is the first and only FDA-approved synthetic human angiotensin II that increases blood pressure in adults with septic or other distributive shock.

WHY GIAPREZA?

INCREASED MAP

RAPID RESPONSE

Important Safety Information

GIAPREZA is the first and only FDA-approved synthetic human angiotensin II that increases blood pressure in adults with septic or other distributive shock.

GIAPREZA is the first and only FDA-approved synthetic human angiotensin II that increases blood pressure in adults with septic or other distributive shock.

GIAPREZA is the first and only FDA-approved synthetic human angiotensin II that increases blood pressure in adults with septic or other distributive shock.

GIAPREZA is the first and only FDA-approved synthetic human angiotensin II that increases blood pressure in adults with septic or other distributive shock.

Important Safety Information

Important Safety Information

Warnings and Precautions

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