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FDA Approves Giapreza for Treatment of Low BP

FDA news release; ePub 2017 Dec 21

The FDA has approved Giapreza (angiotensin II) injection for intravenous infusion to increase blood pressure in adults with septic or other distributive shock. The approval was granted to La Jolla Pharmaceutical Co., San Diego, CA.

Indications: Giapreza is a vasoconstrictor to increase blood pressure in adults with septic or other distributive shock.

Dosage and administration: Dilute Giapreza in 0.9% sodium chloride prior to use. Must be administered as an intravenous infusion. Start intravenously at 20 ng/kg/min. Titrate as frequently as every 5 minutes by increments 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.

Safety/efficacy: In a clinical trial of 321 patients with shock and a critically low blood pressure, significantly more patients responded to treatment with Giapreza to those treated with placebo. Giapreza effectively increased blood pressure when added to conventional treatments used to raise blood pressure.

Adverse reactions: The most common adverse reactions reported in >10% in patients treated with Giapreza were thromboembolic events.

Citation:

US Food and Drug Administration. FDA approves drug to treat dangerously low blood pressure. [news release]. FDA Web site. December 21, 2017. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm590249.htm. Accessed December 22, 2017.