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Antihemophilic Factor (Human), Koatew-DVI, is a sterile, stable, purified, dried concentrate of human Antihemophilic Factor (AHF, factor VIII, AHG) 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. Koate (antihemophilic factor) -DVI is intended for use in therapy of classical hemophilia (hemophilia A).

Koate (antihemophilic factor) -DVI is purified from the cold insoluble fraction of pooled fresh-frozen plasma by modification and refinements of the methods first described by Hershgold, Pool, and Pappenhagen.¹ Koate (antihemophilic factor) -DVI contains purified and concentrated factor VIII. The factor VIII is 300–1000 times purified over whole plasma. Part of the fractionation may be performed by another licensed manufacturer. When reconstituted as directed, Koate (antihemophilic factor) -DVI contains approximately 50–150 times as much factor VIII as an equal volume of fresh plasma. The specific activity, after addition of Albumin (Human), is in the range of 9–22 IU/mg protein. Koate (antihemophilic factor) -DVI must be administered by the intravenous route.

Each bottle of Koate-DVI contains the labeled amount of antihemophilic factor activity in international units (IU). One IU, as defined by the World Health Organization standard for blood coagulation factor VIII, human, is approximately equal to the level of AHF found in 1.0 mL of fresh pooled human plasma. The final product when reconstituted as directed contains not more than (NMT) 1500 μg/mL polyethylene glycol (PEG), NMT 0.05 M glycine, NMT 25μg/mL polysorbate 80, NMT 5μg/g tri-n-butyl phosphate (TNBP), NMT 3 mM calcium, NMT 1μg/mL aluminum, NMT 0.06 M histidine, and NMT 10 mg/mL Albumin (Human).

REFERENCES

1. Hershgold EJ, Pool JG, Pappenhagen AR: The potent antihemophilic globulin concentrate derived from a cold insoluble fraction of human plasma: characterization and further data on preparation and clinical trial. J Lab Clin Med 67(1):23–32, 1966.

Last reviewed on RxList: 2/20/2009
This monograph has been modified to include the generic and brand name in many instances.