NovoSeven (recombinant factor VIIa) in centeral nervous systems bleeds

Data is presented from two compassionate-use clinical trials using recombinant factor VIIa (rFVIIa) to treat central nervous system haemorrhage in 18 haemophilia A and B patients with inhibitors, and in 3 patients with FVII deficiency. Prior to rFVIIa treatment 78% of the haemophilia patients had inhibitor titres greater than 10 Bethesda units/ml. Sixty-two percent of the bleeding episodes were treated with a mean dose of 80-100 mu g/kg of rFVIIa administered repeatedly until cessation of bleeding. The overall efficacy was 84% with only one fatality and there were no major adverse events or laboratory indicators of disseminated intravascular coagulation.