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Neville Gibbs
Department of Anaesthesia, Sir Charles Gairdner Hospital, Perth, WA

Recombinant activated factor VII (rFVIIa, NovoSeven, NovoNordisk, Denmark) was introduced for the treatment of bleeding episodes in haemophilia patients who have developed antibodies to factor VIII. It received TGA approval for this indication in 1998. Several case reports and case series have indicated that it is very effective in improving coagulation in many other situations, including coagulopathies associated with trauma, major surgery, and organ transplantation. However, its use for these indications remains 'off-label'. So far, few serious adverse effects have been reported. This has led to increased requests for its use peri-operatively, despite its high cost (AU$6000 per dose).

Recombinant FVIIa is identical to human FVIIa. It carries no risk of virus transmission, and contains no human protein. It acts in a similar manner to human FVIIa, by binding to tissue factor (TF) and activating both factors IX and X. In addition, in high doses it activates factor X on the surface of activated platelets. In this way it has both TF dependent and TF-independent effects. The recommended dose for the treatment of a severe coagulopathy is 100mcg/kg. It acts within a few minutes and has a half-life of about 2.5 hours.

Most hospitals currently limit the 'off-label' use of rFVIIa to those patients who have severe coagulopathies associated with ongoing life-threatening bleeding refractory to maximal conventional therapy. This limitation is due the high cost of rFVIIa and the absence of current TGA approval for this indication. Further studies are required to confirm both the safety and the cost-efficacy of rFVIIa in comparison to conventional therapy for major coagulopathic bleeding. Nevertheless, the use of rFVIIa is already a major advance in the management of severe coagulopathies. It is likely that its indications will expand in the future, possibly to prevention as well as treatment of major coagulopathies and bleeding.

Time of Presentation
Saturday 1 May 2004 - 1030-1200