Kogenate R FS: antihemophilic factor rFVIII-FS

Jeanne Lusher and Meera Chitlur

Characterization of the factor VIII (FVIII) gene and expression of factor VIII through recombinant technology paved the way for the availability of recombinant factor VIII (rFVIII) for intravenous infusion, a significant breakthrough in the treatment of hemophilia A. Kogenate® FS (rFVIII-FS) is a native, full-length factor VIII molecule, produced from a baby hamster kidney cell line, purified and formulated without the addition of albumin, and stabilized with sucrose. Licensed in the USA and the EU in 2000, the hemostatic efficacy and safety (low rate of adverse events, viral safety and low incidence of inhibitors) have been consistently demonstrated through clinical trials and postmarketing studies. Accumulated evidence supports the use of rFVIII-FS for on-demand and prophylaxis treatment regimens, continuous infusion for surgeries or severe bleeding episodes, and immune tolerance induction for treatment of persistent inhibitors.