Recombinant Factor VIIa (Eptacog Alfa)
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Drugs 2005; 65 (8): 1161-1177 0012-6667/05/0008-1161/$39.95/0 © 2005 Adis Data Information BV. All rights reserved.
Recombinant Factor VIIa (Eptacog Alfa) A Review of its Use in Congenital or Acquired Haemophilia and Other Congenital Bleeding Disorders M. Asif A. Siddiqui and Lesley J. Scott Adis International Limited, Auckland, New Zealand Various sections of the manuscript reviewed by: F. Baudo, Department of Haematology and Thrombosis Haemostasis Unit, Niguarda Hospital, Milan, Italy; P.H. Bolton-Maggs, Department of Clinical Haematology, Manchester Royal Infirmary, Manchester, United Kingdom; P.L.F. Giangrande, Oxford Haemophilia Centre and Thrombosis Unit, Churchill Hospital, Oxford, United Kingdom; J. Ingerslev, Center for Haemophilia and Thrombosis, University Hospital Skejby, Aarhus, Denmark; M. Makris, Sheffield Haemophilia and Thrombosis Centre, Royal Hallamshire Hospital, Sheffield, United Kingdom; M.-C. Poon, Departments of Medicine and Paediatrics/Oncology, Faculty of Medicine, University of Calgary, Calgary, Alberta, Canada. Data Selection Sources: Medical literature published in any language since 1980 on recombinant factor VIIa, identified using MEDLINE and EMBASE, supplemented by AdisBase (a proprietary database of Adis International). Additional references were identified from the reference lists of published articles. Bibliographical information, including contributory unpublished data, was also requested from the company developing the drug. Search strategy: MEDLINE and EMBASE search terms were ‘recombinant FVIIa’ or ‘recombinant factor VIIa’ or ‘eptacog alfa’. AdisBase search terms were ‘recombinant factor VIIa’ or ‘eptacog alfa’. Searches were last updated 7 April 2005. Selection: Studies in patients with haemophilia, Glanzmann’s thrombasthenia or congenital factor VII deficiency who received recombinant factor VIIa as an intravenous bolus. Inclusion of studies was based mainly on the methods section of the trials. When available, large, well controlled trials with appropriate statistical methodology were preferred. Relevant pharmacodynamic and pharmacokinetic data are also included. Index terms: Recombinant activated factor VII, recombinant factor VIIa, eptacog alfa, haemophilia, bleeding disorders, coagulation disorders, pharmacodynamics, pharmacokinetics, therapeutic use, tolerability.
Contents Summary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1162 1. Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1164 2. Overview of Pharmacological Properties . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1164 2.1 Pharmacodynamics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1164 2.1.1 Mechanism of Action . . . . . . . . . . . . . . .
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