Hematology
Hemophilia is an inherited bleeding disorder in which a person’s blood does not clot properly. Hemophilia is a genetic or acquired disorder characterized by the deficiency or absence of one of the blood proteins responsible for clotting.
People with hemophilia are missing or have low levels of certain clotting factors. Clotting factors are proteins that help blood clot. An effective clot is needed to seal wounds and stop bleeding. Lack of clotting factors puts a person at risk for longer bleeding episodes and other complications.
Hemophilia A affects 1 in 5000 males in the US. People with Hemophilia A are missing a clotting factor called Factor VIII.
Depending on how much factor VIII is missing, hemophilia A may be classified as mild, moderate, or severe. About 6 out of 10 people with hemophilia A have the severe form. The goal of treatment is to replace the missing factor VIII in order to stop and prevent bleeding.
Koate-DVI contains naturally occurring von Willebrand 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 disease, and hence is not approved for such usage.
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.