Pharmacology and clinical use of recombinant activated factor seven in neurosciences
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REVIEW PAPER
Pharmacology and clinical use of recombinant activated factor seven in neurosciences Matthias Hartmann Æ Christoph Sucker
Published online: 11 April 2007 Humana Press Inc. 2007
Abstract Recombinant activated factor VII (rFVIIa, NovoSeven, NovoNordisc, Danemark) has been approved for the treatment of patients with hemophilia with inhibitors, further indications, at least in some countries, include the treatment of factor VII deficiency and Glanzmann thrombasthenia refractory to conventional therapy. Apart from these indications, the agent is increasingly used for the treatment of severe and potentially life-threatening bleeding manifestations, irrespective of the underlying hemostatic abnormality. The agent has successfully been used for the treatment of both inherited and acquired coagulopathies as well as thrombocytopathia or thrombocytopenia, however, most information on off-label use derives from case reports and retrospective studies and therefore publication bias can-not be excluded. In this review, we focus on the use of rFVIIa for the treatment of spontaneous and perioperative intracranial hemorrhage as well as trauma patients. We review the current knowledge regarding the physiology of hemostasis, the pharmacology of rFVIIa, and its clinical use in neurosciences. Further studies are urgently needed to define the efficiacy and safety of recombinant activated factor VII in patients without hemophilia, factor VII deficiency, or Glanzmann thrombasthenia. At time, its use can be justified in lifethreatening bleeding situations refractory to conventional treatment. M. Hartmann (&) Klinik fu¨r Ana¨sthesiologie und Intensivmedizin, Universita¨tsklinikum Essen, Hufelandstrasse 55, 45122 Essen, Germany e-mail: [email protected] C. Sucker Institut fu¨r Ha¨mostaseologie und Transfusionsmedizin, Universita¨tsklinikum Du¨sseldorf, Duesseldorf, Germany
Keywords Recombinant activated factor VII Intracerebral hemorrhage Bleeding diathesis Neurosurgery Trauma
Introduction Unlike bleeding in most other regions, intracranial hemorrhage rapidly affects organ function and may be a life-threatening complication. Depending on the exact intracerebral localization, even a few milliliters of intracerebral blood can make the difference between recovery, disability, and death [1]. For this reason, the outcome of affected patients is critically dependent on the rapid control of bleeding. Apart from established basic principles in neurointensive care and acute surgical interventions, pharmacological measures and application of agents reversing hemostatic abnormalities have been recognized to be the mainstay of therapy in this setting [2]. Furthermore, induction of a supraphysiological state of hemostasis using rFVIIa has recently been demonstrated to improve the outcome of intracerebral hemorrhage, even in patients without pre-existing coagulopathy [3]. Recombinant activated factor VII (rFVIIa, NovoSeven, NovoNordisc, Danemark) has originally been introduced for the treatment of hemophiliacs with inhi
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