The efficacy of recombinant activated factor VII (rFVIIa, NovoSeven) in five Haemophiliacs (four Haemophilia A, one Haemophilia B), with high inhibitors ranging from 70 to 1900 Bethesda units, was evaluated. The treatment regimen was divided into two groups: group I, continuous infusion of 16.5 microg h-1 kg-1 body weight (bw) after the initial bolus of 90 microg kg-1 bw in three episodes of severe bleeding and group II, bolus injection 80-150 microg kg-1 bw every 3 hours for a maximum of four doses in six haemarthroses. The bleeding was effectively controlled within 1 to 48 h in five of nine bleeding episodes. One patient in group I, who had active arterial bleeding requiring sutures, had an ineffective response and three patients in group II had partially effective responses because the rFVIIa was given after the onset of bleeding at 36, 44 and 72 h, respectively. The prothrombin time was shortened and the FVII:C levels were successfully achieved at approximately 10 U mL-1. The continuous infusion reduced the total dose of rFVIIa by 50%. Recurrent bleeding episodes were found in three patients; two occurred at the same site after ceasing rFVIIa for 51 h and while receiving rFVIIa at 144 h and one occurred at a new site after ceasing rFVIIa for 12 h. Our experience would suggest that rFVIIa is effective in controlling acute bleeding episodes in Haemophiliacs with high inhibitors either by continuous infusion or bolus injection.