Authors

  1. Aschenbrenner, Diane S. MS, RN

Abstract

* Giapreza, an exogenous form of angiotensin II, has been approved to treat hypotension in adults with septic or other distributive shock. It should be added to the vasopressors used in the standard treatment of hypotension and shock.

 

* Giapreza use can cause thrombotic and thromboembolic events. Patients receiving the drug require prophylaxis with anticoagulants.

 

 

Article Content

The Food and Drug Administration (FDA) has approved Giapreza, an exogenous form of angiotensin II, to increase blood pressure in adults with septic or other distributive shock. The drug should be added to the vasopressors used in the standard treatment of hypotension and shock. Angiotensin II is a potent endogenous vasoconstrictor; it also increases aldosterone release.

 

Giapreza was approved under a priority review, which the FDA gives to drugs it considers likely to "significantly improve the safety or effectiveness of treating, diagnosing or preventing a serious condition." A priority review guarantees that the FDA will make a decision on a drug application within six months. In a double-blind clinical trial of 321 patients with critical hypotension, significantly more patients responded positively to Giapreza added to conventional treatments than to placebo. The median time it took for patients to achieve the mean target arterial pressure of >=75 mmHg was five minutes.

 

The most common serious adverse effects of Giapreza use, occurring in more than 10% of those receiving the drug, are thrombotic and thromboembolic events, which can occur in both veins and arteries. Patients who take Giapreza also require standard prophylaxis with anticoagulants. There are two main drug interactions noted in the drug's labeling: angiotensin-converting enzyme inhibitors may increase, and angiotensin II receptor blockers may decrease, the response to Giapreza.

 

Giapreza must be diluted with normal saline and administered as an iv infusion. Nurses should confirm with the prescriber that the patient has been placed on anticoagulant prophylaxis before administering the drug. Giapreza should be added to other, traditional vasopressor treatments, not used as monotherapy. It is not necessary to wait until other drugs are at maximum dosage to begin Giapreza. Careful assessment of the patient for thrombotic and thromboembolic events is needed. For complete Giapreza prescribing information, see http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209360s000lbl.pdf.