Overall experience with NovoSeven.

Recombinant activated factor VII (rFVIIa, NovoSeven) was first developed for treating those haemophilia patients with inhibitors who cannot benefit from conventional therapies. Several clinical trials have clearly demonstrated that rFVIIa is a safe and effective therapy for home treatment of mild-to-moderate bleeding episodes. Its theoretical inability to abnormally activate the coagulation system has also prompted many clinicians to use it in elective surgical procedures. Recommended dose ranges for rFVIIa usually vary from 60 to 120 microg/kg, although 90 microg/kg is generally accepted as an initial treatment dose. If necessary, further rFVIIa can be administered as bolus injections every 2 to 6 h or, alternatively, as a continuous infusion. In patients with congenital haemophilia, this treatment is effective in up to 92% of cases. Recombinant FVIIa has also been successfully used in patients with acquired haemophilia where results have shown a wide safety margin, suggesting that rFVIIa should be considered as first-line therapy. The prospect of extending the indication of rFVIIa exists, and preliminary reports suggest that rFVIIa could be useful in patients with congenital or acquired platelet disorders, thrombocytopenia or liver failure. This drug represents a major advance in the treatment and prevention of bleeding in predisposed patients.