title: Antidotes to haemorrhage: recombinant factor VIIa.
abstract: Recombinant Factor VIIa (rFVIIa) concentrates were originally developed to treat the refractory bleeding complications associated with allo-antibody inhibitors in hemophilias A and B. As experience was gained in the hemophilias, the physiology of rFVIIa and its successes in controlling bleeds stimulated rFVIIa use in other challenging medical conditions complicated by bleeding. Thus, rFVIIa has assumed the role of a 'universal pancoagulant' without sufficient evidence-based data from well-designed, adequately powered clinical trials. This chapter discusses the anecdotal experience with rFVIIa based upon the few controlled trials that do exist, and emphasizes that these empirical dosing strategies have not yielded the best approach to achieve effective control of bleeding. Evidence-based data are necessary to establish the cost-benefit and risk-benefit profiles of rFVIIa, and to establish it as a standard treatment for bleeding.
authors.affiliation: Lombardi Comprehensive Cancer Center, Georgetown University Medical Center, 3800 Reservoir Road, NW, Washington, DC 20007, USA. kesslerc@gunet.georgetown.edu
authors.forename: Craig M
authors.initials: CM
authors.lastname: Kessler
mesh_terms: D000925:Anticoagulants / Q000009:adverse effects / Q000037:antagonists & inhibitors; D003029:Coagulants / Q000627:therapeutic use; D020147:Coagulation Protein Disorders / Q000188:drug therapy / Q000209:etiology; D005167:Factor VII / Q000627:therapeutic use*; D015942:Factor VIIa; D006470:Hemorrhage / Q000188:drug therapy* / Q000209:etiology / Q000517:prevention & control; D006801:Humans; D011994:Recombinant Proteins / Q000627:therapeutic use*
chemical_list: D000925:Anticoagulants; D003029:Coagulants; D011994:Recombinant Proteins; D005167:Factor VII; C103587:recombinant FVIIa; D015942:Factor VIIa