What is recombinant factor VIIa (rFVIIa) and when is it used as an alternative to transfusion?

Updated: Apr 16, 2019
  • Author: Linda L Maerz, MD, FACS, FCCM; Chief Editor: Emmanuel C Besa, MD  more...
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rFVIIa was introduced above in the setting of massive transfusion, principally as related to the trauma patient. Further details with respect to its evolution and indications will be provided or reiterated here.

Factor VII is key in the extrinsic pathway of the coagulation cascade. When activated, factor VII complexes with tissue factor, leading to activation of factor X, which ultimately leads to thrombin generation. At high doses, factor VIIa can directly bind to platelets, activating factor X, and converting prothrombin to thrombin by a tissue factor-independent mechanism. The ultimate result is amplified thrombin production.

rFVIIa is a thrombotic drug licensed for use in patients with hemophilia A or B with inhibitors. Approved use also includes patients with acquired inhibitors to factor VIII or IX.

As mentioned previously, numerous off-label uses have been identified in the literature. Such uses include neurosurgical operative procedures, postoperative bleeding in patients with cirrhosis, and in children with hepatic failure. Efficacy in patients with other severe hemorrhagic disorders, in surgical procedures, and in severe trauma has been documented.

rFVIIa is costly. Adverse events occur in 1-2% of patients and include disseminated intravascular coagulation, myocardial infarction, stroke, and deep vein thrombosis. Since some of these events are known complications in these specific patient populations, the precise role of factor VIIa in their genesis remains unclear.

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