Off-Label Use of Recombinant Activated Factor VII (NovoSeven®)

NovoSeven® (Novo Nordisk, Denmark) is a recombinant DNA preparation of activated blood coagulation factor VII (rFVIIa). It is used to manage bleeding in hemophilia patients for whom standard therapy is inadequate because of the presence of inhibitors to either factor VIII (hemophilia A) or factor IX (hemophilia B). It poses no risk for the transmission of human pathogens, and it is infused in relatively low volumes. As a drug that has been approved by the Food and Drug Administration (FDA), NovoSeven® may be prescribed for offlabel purposes, including neonatal coagulopathies; severe hepatic disease; high-risk surgical procedures; traumatic blood loss; bone marrow transplantation; thrombocytopenias and platelet function disorders; urgent reversal of oral anticoagulation; congenital deficiencies of factors V, VII, X, and XI; and von Willebrand disease with inhibitors to von Willebrand factor. Most of these uses are constrained by cost and limited clinical evidence, and additional work is needed to extend the FDA-approved labeling for this product.