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.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call
1-800-FDA-1088.