Dosing factor VIIa (recombinant) in nonhemophiliac patients with bleeding after cardiac surgery.
OBJECTIVE
The dosing of factor VIIa (recombinant) in nonhemophiliac patients with cardiac-surgery-associated bleeding (CSAB) is discussed.


CONCLUSIONS
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.


CONCLUSIONS
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.
Johnson
Sarah J
SJ
Medication Use Evaluation, Department of Pharmaceutical Care, University of Iowa Hospitals and Clinics (UIHC), Iowa City, IA, USA.
Ross
Mary B
MB
Moores
Kevin G
KG
D002986:Clinical Trials as Topic; D015942:Factor VIIa / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D006467:Hemophilia A; D006488:Hemostasis, Surgical / Q000379:methods; D006801:Humans; D019106:Postoperative Hemorrhage / Q000188:drug therapy*; D011994:Recombinant Proteins / Q000009:adverse effects / Q000627:therapeutic use*; D013903:Thoracic Surgery; D013923:Thromboembolism / Q000139:chemically induced
D011994:Recombinant Proteins; D015942:Factor VIIa