Clinical use of recombinant FVIIa (rFVIIa)

Haemostasis is initiated by the complex formed by TF and FVIIa present in the blood (1% of the FVII protein). Recombinant FVIIa, which is active only after having formed complex with TF exposed following tissue damage, has been demonstrated to induce haemostasis in haemophilia patients with life- and limb-threatening bleedings with an efficacy rate of 76-84% in patients having failed on other treatment. Several had proven septicaemia but only one patient developed consumption coagulaopathy during extensive surgical manipulation and removal of myonecrotic tissue. No antibody formation against FVII has been seen in haemophilia patients. In 13 major surgical episodes complete intra- and post-operative haemostasis was achieved. rFVIIa has been used successfully in FVII-deficient patients and has been found to normalise the PT in patients with liver disease and in warfarin treated individuals. Single patients with platelet defects and with vWillebrand's disease type 3 achieved haemostasis with rFVIIa.