Treatment of classical hemophilia (hemophilia A) in which there is a demonstrated deficiency of activity of the plasma clotting factor, factor VIII. Koate-DVI provides a means of temporarily replacing the missing clotting factor in order to control or prevent bleeding episodes, or in order to perform emergency and elective surgery on individuals with hemophilia.
Koate-DVI contains naturally occurring von Willebrand's factor, which is co-purified as part of the manufacturing process. Koate-DVI has not been investigated for efficacy in the treatment of von Willebrand's disease, and hence, is not approved for such usage.