Formula & Concentration

Antihemophilic Factor (Human), Koāte-DVI, is a sterile, stable, purified, dried concentrate of human Antihemophilic Factor (AHF, Factor VIII) which has been treated with tri-n-butyl phosphate (TNBP) and polysorbate 80 and heated in lyophilized form in the final container at 80°C for 72 hours. Koa ̄te-DVI is intended for use in therapy of classical hemophilia (hemophilia A).

Manufacturer

Grifols

Indications

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.
Koāte-DVI, a plasma-derived factor VIII concentrate, contains naturally occurring von Willebrand factor, which is co-purified as part of the manufacturing process.
Koāte-DVI has not been investigated for efficacy in the treatment of von Willebrand disease, and is not approved for such usage.

Product Options

Approximate Factor VIII Activity

NDC #

Diluent

250 IU

13533-665-20

5 mL

500 IU

13533-675-30

5 mL

1000 IU

13533-675-50

10 mL

Storage

Koāte-DVI should be stored under refrigeration (2–8°C; 36–46°F). Storage of lyophilized powder at room temperature (up to 25°C or 77°F) for 6 months, such as in home treatment situations, may be done without loss of Factor VIII activity. Freezing should be avoided as breakage of the diluent bottle might occur.

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.