NovoSeven (recombinant factor VIIa or rFVIIa) is an intravenous, structurally similar molecule to human factor VII – a protein involved in the extrinsic pathway of the coagulation cascade. This protein then activates factors IX and X to ultimately convert prothrombin to thrombin and fibrinogen to fibrin. NovoSeven has been FDA approved for the treatment of bleeding in patients with acquired hemophilia, hemophilia A/B with inhibitors, congenital FVII deficiency, and most recently Glanzmann thrombasthenia (a qualitative platelet dysfunction).
The gene for human FVII is expressed in baby hamster kidney (BHK) cell lines and undergoes a purification process to activate it into rFVIIa. Consequently, no human serum is used in the formulation of NovoSeven making it an important option for certain patients (ie, Jehovah’s Witnesses).
The literature cites instances of NovoSeven being used off-label to treat uncontrollable coagulopathy in trauma, liver transplantation, and cardiac surgery. As an anesthesiologist, I’ve used NovoSeven in all of these situations as a true “last resort” understanding the very real risk of thrombotic events (myocardial infarction, stroke, pulmonary embolism, etc.) I’m very mindful about weighing the pros/cons of administration considering a single dose can easily cost more than $10,000.
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