Recombinant activated factor VII (rFVIIa, NovoSeven).

ABSTRACT

Recombinant activated factor VII (rFVIIa, NovoSeven) enhances haemostasis in individuals, with its predominant action limited to areas of injury, apparently without systemic activation of the coagulation cascade. rFVIIa is currently licensed in most countries worldwide, for its use in the treatment of bleeding episodes in patients with hemophilia and the presence of inhibitors. Recently in the European Union, rFVIIa, has been approved for use in congenital Factor VII deficiency and Glanzmann's thrombasthenia. Furthermore, a large number of case series studies and anecdotal evidences, from patients with different bleeding conditions, have now shown that rFVIIa is actually a very valuable general haemostatic agent. It has been reported to reduce bleeding in patients with liver disease, thrombocytopenia/thrombocytopathia, trauma, spontaneous intracerebral hemorrhage and in the reversal of anticoagulant overdosage or toxicity. A number of trials have been carried out, which have shown that it is a relatively safe and well tolerated drug with a few episodes of unwanted thrombosis.