Recombinant FVIIa

Some hemophilia A and B patients develop antibodies against FVIII and FIX, respectively. This complicates the direct administration of these proteins. An alternative in these cases is treatment with active factor VII (FVIIa), which complexes with factor III in the presence of phospholipids and Ca2+, activating factor X, which, in normal patients, is activated by active factors VIII and IX. The commercial name of recombinant FVIIa expressed in BHK cells and produced by Novo-Nordisk is NovoSeven (Table 16.1). 

Berntorp E. Recombinant FVIIa in the treatment of warfarin bleeding. Semin Thromb Hemost 2000 26(4) 433-5. 

Kenet G. Recombinant FVIIa for profuse bleeding in trauma and surgery. J Anasth Intensivbehandl 2001 3 S112-13. 

Haematologic In a study of rapid warfarin reversal for intracerebral haemorrhage using 3-factor prothrombin complex concentrate (PCC) and recombinant FVIIa, authors report that 2 of the 46 patients experienced thrombotic complications [124 J. Both patients experienced non-ST-elevated myocardial infarction. Notably, one of these occurred with a 2.4-mg dose of recombinant FVIIa and the study protocol was changed to all subsequent patients getting l.Omg of recombinant FVIIa. 

The Canadian National Advisory Committee on Blood and Blood Products reviewed recombinant FVIIa in massive bleeding and concluded that off-label treatment of bleeding is not recommended [125 ]. 

Autacoids The first case report that potentially implicates recombinant FVIIa involved a thoracic aorta surgery patient [126 ]. 

NovoSeven is an unusual product in that it is (a recombinant form of) human coagulation factor VII (FVII). The product is converted in an autocatalytic fashion into the active two-chain form (FVIIa) during its chromatographic purification. NovoSe-... 

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