Koate^®-DVI is a high-purity FVIII concentrate prepared from human plasma from healthy donors in the United States. A sample of every unit of donated plasma is sent to an FDA-licensed testing facility for screening for viral markers including:

			Human immunodeficiency virus (HIV-1 and HIV-2) antibodies
			Hepatitis C antibodies (anti-HCV)
			Hepatitis B virus surface antigen (HBsAg)

Koate^®-DVI undergoes two viral inactivation procedures — solvent/detergent and heat treatment — during the manufacturing process to inactivate both enveloped and non-enveloped viruses respectively. These processes are only two aspects of a comprehensive product safety program.

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. Reactions include tingling in the arm, ear, and face, blurred vision, headache, nausea, stomach ache, and jittery feeling.

Koāte-DVI is made from human plasma.  As with all plasma-derived therapeutics, the potential to transmit infectious agents, such as viruses and theoretically, the Creutzfeldt-Jakob (CJD) agent that can cause disease, cannot be totally eliminated.  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 who are hepatitis A seronegative. 

Please speak to your doctor and refer to Koāte-DVI Prescribing Information for full details.

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.