Koate-DVI Warnings

Koate-DVI is made from human plasma. Products made from human plasma may contain infectious agents eg, viruses, that can cause disease. The risk that such products will transmit an infectious agent has been reduced by screening plasma donors for prior exposure to certain viruses, by testing for the presence of certain current virus infections, and by inactivating and/or removing certain viruses. Despite these measures, such products can still potentially transmit disease. There is also the possibility that unknown infectious agents may be present in such products.
The physician should discuss the risks and benefits of Koate-DVI with the patient before prescribing or administering it to the patient. 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 upon diagnosis. Hepatitis A vaccination is also recommended for hemophilic patients who are hepatitis A seronegative.