Dosing and monitoring NovoSeven treatment

The concept of using factor VIIa (FVIIa) to induce hemostasis in hemophilia is new and takes advantage of the normal tissue factor/FVII-dependent coagulation pathway which is enhanced by the administration of extra exogenous recombinant FVIIa. Since this is a pharmacological treatment and not a simple substitution therapy the current dosis recommendations are based on preclinical data (in vitro and in animals) as well as on clinical experience. It is concluded that the initial dose should be high enough to maintain a plasma level of FVII-coagulant activity (FVII:C) at > 6 U/ml for several hours corresponding roughly to a dose of 90-120 mu g/kg.