RECOMBINATE SUMMARY
RECOMBINATE, Antihemophilic Factor (Recombinant) (rAHF) is a glycoprotein synthesized by a genetically engineered Chinese Hamster Ovary (CHO) cell line. In culture, the CHO cell line secretes recombinant antihemophilic factor (rAHF) into the cell culture medium. The rAHF is purified from the culture medium utilizing a series of chromatography columns. A key step in the purification process is an immunoaffinity chromatography methodology in which a purification matrix, prepared by immobilization of a monoclonal antibody directed to factor VIII, is utilized to selectively isolate the rAHF in the medium. The synthesized rAHF produced by the CHO cells has the same biological effects as Antihemophilic Factor (Human) [AHF (Human)]. Structurally the protein has a similar combination of heterogenous heavy and light chains as found in AHF (Human).
The use of RECOMBINATE rAHF is indicated in hemophilia A (classical hemophilia) for the prevention and control of hemorrhagic episodes.1 RECOMBINATE rAHF is also indicated in the perioperative management of patients with hemophilia A (classical hemophilia).
RECOMBINATE rAHF can be of therapeutic value in patients with acquired AHF inhibitors not exceeding 10 Bethesda Units per mL2. In clinical studies with RECOMBINATE rAHF, patients with inhibitors who were entered into the previously treated patient trial and those previously untreated children who have developed inhibitor activity on study, showed clinical hemostatic response when the titer of inhibitor was less than 10 Bethesda Units per mL. However, in such uses, the dosage of RECOMBINATE rAHF should be controlled by frequent laboratory determinations of circulating AHF levels.
RECOMBINATE rAHF is not indicated in von Willebrand's disease.
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