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
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.

Allergic-type reactions may result from the administration of Antihemophilic Factor (Human) preparations. In the clinical study of Koate^®-DVI, all adverse reactions were mild and included tingling in the arm, ear, and face, blurred vision, headache, nausea, stomach ache, and jittery feeling.