Recombinant factor VIIa

Recombinant factor VIIa is a preparation of activated coagulation factor VI I (factor VIIa) that is produced by recombinant DNA technology. The drug ex pedites blood coagulation without the need for factors VIII and IX in patie nts with haemophilia. Indicators of activation of systemic coagulation of blood were unchanged an d mean prothrombin times and activated partial thromboplastin times were de creased substantially after administration of recombinant factor VIIa at do ses of up to 90 I-L,mu g/kg in pharmacodynamic studies. Recombinant factor VIIa has been shown to be effective at doses ranging fro m 17.5 to 120 mu g/kg in the control of joint, muscle and mucocutaneous ble eding in patients with haemophilia A or B with inhibitors of factor VIII or IX. Satisfactory postoperative haemostasis was achieved in all patients with ha emophilia and inhibitors of factors VIII and IX who received multiple doses of recombinant factor Wa 90 mu g/kg during and after surgery The drug has also demonstrated some efficacy in the control of internal or CNS bleeding in small numbers of patients. Self-administration of recombinant factor VIIa or administration by caregiv ers has been used successfully to control bleeding episodes in patients wit h haemophilia without the need for hospital or clinic admission in home tre atment programmes In 3 countries. Recombinant factor VIIa is well tolerated. No thrombotic complications have been reported, and there is no evidence to date of the formation of antibo dies to the drug in patients with haemophilia A or B or acquired inhibitors of factor VIII or IX.