Koāte®-DVI
Koāte®-DVI, Antihemophilic Factor (Human) is a plasma-derived product for the treatment of classic hemophilia (hemophilia A), in which there is a demonstrated deficiency of the plasma clotting factor, factor VIII. Koāte-DVI has been used to treat hemophilia A for more than 10 years, and over 1.5 billion units have been infused in patients worldwide.
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's disease, and hence is not approved for such usage.
Please refer to the Koate-DVI prescribing information for details.
Important Safety Information
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.
Allergic-type reactions may result from the administration of Antihemophilic Factor (Human) preparations. In clinical studies, adverse reactions included tingling in the arm, ear, and face, blurred vision, headache, nausea, stomach ache, and jittery feeling.
Koāte-DVI is made from human plasma. Products made from human plasma may contain infectious agents, such as viruses, and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent that can cause disease. There is also the possibility that unknown infectious agents may be present in such products.
Hepatitis B vaccination is essential for patients with hemophilia A; vaccination is recommended at birth or at the time of diagnosis. Hepatitis A vaccination is also recommended for hemophilia patients who are hepatitis A seronegative.
Please see Koate-DVI prescribing information for complete prescribing details.