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SARAH J. JOHNSON, PHARM.D., is Clinical Pharmacy Specialist, Medication Use Evaluation, Department of Pharmaceutical Care, University of Iowa Hospitals and Clinics (UIHC), Iowa City, and Assistant Professor (Clinical), University of Iowa College of Pharmacy (UICP), Iowa City. MARY B. ROSS, B.S.PHARM., M.B.A., is Assistant Director, Department of Pharmaceutical Care, UIHC, and Adjunct Associate Professor, UICP. KEVIN G. MOORES, PHARM.D., is Associate Professor (Clinical) and Director, Division of Drug Information Service, UICP.

Address correspondence to Dr. Moores at the University of Iowa College of Pharmacy, 100 Oakdale Campus, N330OH, Iowa City, IA 52242-5000 (kevin-moores{at}uiowa.edu).

Purpose. The dosing of factor VIIa (recombinant) in nonhemophiliac patients with cardiac-surgery-associated bleeding (CSAB) is discussed. Summary. 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. Conclusion. 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 µg/kg should be considered. Index terms: Dosage; Factor VIIa; Hemorrhage; Hemostatics; Surgery; Toxicity

 

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