Recombinant Factor VIIa: clinical applications for an intravenous hemostatic agent with broad-spectrum potential.

Recombinant Factor VIIa (NovoSeven, Novo Nordisk) is a unique hemostatic agent with potential for broad-spectrum applications in bleeding patients with congenital and acquired bleeding abnormalities. At present, recombinant Factor VIIa is only approved for the treatment of hemophilia A and B patients who have acquired antibodies to Factors VIII and IX. However, the literature is rapidly expanding indicating that rFVIIa could benefit patients with bleeding due to a variety of etiologies. Unfortunately, the vast majority of these reports are case studies or small-series summaries, and are neither prospective nor controlled. Controlled trials are currently underway in several potential areas of application. While the possibility of thrombotic complications has been a clinical concern, safety data on patients treated to date have not revealed a significant problem. Expansion of the clinical applications for this interesting and important hemostatic agent are hampered by its expense, the limited scope of the US Food and Drug Administration approval for its use, and the absence of an appropriate laboratory monitoring assay.