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 convert prothrombin to thrombin and fibrinogen to fibrin ultimately. NovoSeven has been FDA-approved to treat 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 (e.g., Jehovah’s Witnesses).
The literature cites NovoSeven used off-label to treat uncontrollable coagulopathy in trauma, liver transplantation, and cardiac surgery. As an anesthesiologist, I’ve used NovoSeven in these situations as a true “last resort” (especially after recent antiplatelet loading with Plavix, Brilinta, etc.), understanding the genuine risk of thrombotic events (myocardial infarction, stroke, pulmonary embolism, gut ischemia, etc.) I’m very mindful about weighing the pros/cons of administration, considering a single dose costs thousands of dollars!
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