Dosing factor VIIa (recombinant) in nonhemophiliac patients with bleeding after cardiac surgery

Abstract

The dosing of factor VIIa (recombinant) in nonhemophiliac patients with cardiac-surgery-associated bleeding (CSAB) is discussed. Factor VIIa (recombinant) is a vitamin K-dependent glycoprotein that is FDA-approved for use in patients with hemophilia A or B with inhibitors to factor VIII or IX and for patients with factor VII deficiency. Case reports and observational studies indicate that factor VIIa (recombinant) may be efficacious for the treatment of acute bleeding episodes related to trauma, surgery, and coagulopathies. The use of factor VIIa (recombinant) for CSAB is increasing. No controlled clinical trials have been conducted to determine the safety and efficacy of factor VIIa (recombinant) in the treatment of CSAB; therefore, the appropriate dosing scheme remains unclear. In addition, thromboembolic events associated with factor VIIa (recombinant) have been reported, so the safety of factor VIIa (recombinant) in patients with normal coagulation systems is unclear. Data from one randomized, controlled, clinical trial of the use of factor VIIa (recombinant) in intracerebral hemorrhage showed a dose-related trend toward adverse events when factor VIIa (recombinant) was compared with placebo. No particular dose of factor VIIa (recombinant) is strongly supported in the literature for off-label use, and thromboembolic events may be dose dependent. Use of the smallest possible dose is warranted because of the high cost of factor VIIa (recombinant) and the potential for thromboembolic events. A single dose of 2.4 or 4.8 mg or 45 microg/kg should be considered.