Giapreza (angiotensin II)

The following drug information is obtained from various newswires, published medical journal articles, and medical conference presentations.

Approval Status:

Approved December 2017

Specific Treatments:

septic shock

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General Information

Giapreza (angiotensin II)  is a vasoconstrictor to increase blood pressure in adults with septic or other distributive shock.

Giaprezza is specifically indicated to increase blood pressure in adults with septic or other distributive shock. 

Giapreza is supplied as a solution for intravenous administration. Dilute Giapreza in 0.9% sodium chloride prior to use.  See Full Prescribing Information for instructions on preparation and administration of injection. Giapreza must be administered as an intravenous infusion. Start Giapreza intravenously at 20 nanograms (ng)/kg/min. Titrate as frequently as every 5 minutes by increments of up to 15 ng/kg/min as needed. During the first 3 hours, the maximum dose should not exceed 80 ng/kg/min. Maintenance dose should not exceed 40 ng/kg/min.

Clinical Results

FDA Approval

The FDA approval of Giapreza was based on The Angiotensin II for the Treatment of High-Output Shock (ATHOS-3) trial. The double-blind study enrolled 321 adults with septic or other distributive shock who remained hypotensive despite fluid and vasopressor therapy were randomized 1:1 to Giapreza or placebo.  Doses of Giapreza or placebo were titrated to a target mean arterial pressure (MAP) of ≥ 75 mmHg during the first 3 hours of treatment while doses of other vasopressors were maintained. From Hour 3 to Hour 48, Giapreza or placebo were titrated to maintain MAP between 65 and 70 mmHg while reducing doses of other vasopressors.The primary endpoint was the percentage of subjects who achieved either a MAP ≥ 75 mmHg or a ≥ 10 mmHg increase in MAP without an increase in baseline vasopressor therapy at 3 hours. The primary endpoint was achieved by 70% of patients randomized to Giapreza compared to 23% of placebo subjects; p < 0.0001 (a treatment effect of 47%). 

Side Effects

Adverse events associated with the use of Giapreza may include, but are not limited to, the following:

  •  thromboembolic events

Mechanism of Action

Giapreza (angiotensin II)  is a vasoconstrictor to increase blood pressure in adults with septic or other distributive shock. Angiotensin II raises blood pressure by vasoconstriction and increased aldosterone release.  Direct action of angiotensin II on the vessel wall is mediated by binding to the G-protein-coupled angiotensin II receptor type 1 on vascular smooth muscle cells, which stimulates Ca2+/calmodulin-dependent phosphorylation of myosin and causes smooth muscle contraction.

Additional Information

For additional information regarding Giapreza or septic shock, please visit http://giapreza.com/