Hemophilia is a genetic disorder characterized by the deficiency or absence of one of the proteins (or factors) in blood plasma that is responsible for clotting. Low levels of one of these plasma proteins result in bleeding and difficulty clotting in the affected individual. There are more than a dozen clotting factors in our bodies. The most common deficiency of a clotting protein is factor VIII.
Talecris Biotherapeutics' 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.
Individuals who receive infusions of blood or plasma products may develop signs and/or symptoms of some viral infections, particularly hepatitis C. It is emphasized that hepatitis B vaccination is essential for patients with hemophilia and it is recommended that this be done at birth or diagnosis. Hepatitis A vaccination is also recommended for hemophilic patients who are hepatitis A seronegative. As with all plasma-derived therapeutics, the potential to transmit infectious agents cannot be totally eliminated.