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.
US residents, refer to the WARNINGS section of the Koāte®-DVI, Antihemophilic Factor (Human) package insert (PDF).
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 the Koāte-DVI Prescribing Information (PDF) 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.
You need the Adobe® Reader® installed on your computer to view PDFs. You can download a copy of the Adobe Reader by clicking the link below.
|
|
| Adobe and Adobe Reader are registered trademarks of Adobe Systems Incorporated. |
|
