Hematology 2006
© 2006 The American Society of Hematology
Challenges in the Therapeutic Use of a "So-Called" Universal Hemostatic Agent: Recombinant Factor VIIa
W. Keith Hoots
Correspondence: W. Keith Hoots, MD, M.D. Anderson Cancer Center & University of Texas Health Science Center, Gulf States Hemophilia & Thrombophilia Center, 6655 Travis St., Suite 400, Houston TX 77030; Phone 713-500-8360; Fax 713-500-8464; Email keith.hoots{at}uth.tmc.edu
Abstract
Recombinant factor VIIa (rFVIIa) was developed in the early 1990s to provide "bypassing" hemostatic therapy for hemophilia A and B patients with inhibitors. More recently, it has been licensed for use in patients with inherited deficiency of factor VII. Since it was licensed for use in hemophilia with inhibitors in the US, Europe, and other countries for these specific indications, it has been used selectively but in a wide array of clinical settings for uncontrolled hemorrhage in individuals without an inherited bleeding disorder. Many of these uses have been described in the medical literature as case reports or small, uncontrolled series. Several randomized clinical trials (RCT) for these "off-label" medical uses have been published in recent months and will serve as the focus of this review. In particular, a review of an RCT for spontaneous intracranial hemorrhage that has demonstrated clinical efficacy in reducing both mortality and volume of central nervous system hemorrhage will be offered. A brief discussion of hypothesized physiologic mechanisms of supraphysiologic doses of rFVIIa will introduce the clinical discussion of these broad off-label uses. Since rFVIIa is a very expensive therapy, possible strategies for optimizing its use in the these settings will be presented.
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Copyright © 2006 by the American Society of Hematology.
