KOATE

Antihemophilic Factor (Human)

Kedrion

Koāte-DVI is indicated for the treatment of classical hemophilia (hemophilia A) in which there is a demonstrated deficiency of activity of the plasma clotting factor, Factor VIII. Koāte-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.

Koāte-DVI contains naturally occurring von Willebrand factor, which is co-purified as part of the manufacturing process. Koāte-DVI has not been investigated for efficacy in the treatment of von Willebrand disease, and hence is not approved for such usage.

Koāte-DVI should be stored under refrigeration (2–8°C; 36–46°F). Storage of lyophilized powder at room temperature (up to 25°C or 77°F) for 6 months, such as in home treatment situations, may be done without loss of Factor VIII activity. Freezing should be avoided as breakage of the diluent bottle might occur.