Recombinant
activated factor VII (
rFVIIa, '
NovoSeven') is indicated for the treatment of
bleeding in patients with
haemophilia and inhibitors to factors VIII or IX. However, by virtue of its ability to promote
thrombin generation on the platelet surface
rFVIIa may also be effective in non-haemophilic
bleeding, for example, in patients with thrombocytopenic or oral
anticoagulant-induced haemorrhage. Studies in
thrombocytopenia indicate that
rFVIIa increases the generation of
thrombin at the site of injury, leading to the control of
bleeding episodes in these conditions. Additionally, preclinical and early clinical evidence has demonstrated the ability of
rFVIIa to normalise prothrombin times and international normalised ratios in situations of over-anticoagulation. Although initial observations indicate that
rFVIIa may be fast, efficacious, and safe in reversing oral
anticoagulant-induced bleeds and those associated with
thrombocytopenia, randomised, double-blind, placebo-controlled trials must be conducted to confirm its utility in these and other investigational uses.