DRUG PROFILE Kogenate® FS: antihemophilic factor rFVIII-FS
نویسندگان
چکیده
10.1586/14750708.3.6.699 © 2 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.
منابع مشابه
Production processes of licensed recombinant factor VIII preparations.
The state-of-the-art treatment for hemophilia A is replacement therapy with recombinant factor VIII (rFVIII) made possible by genetic engineering advances. Currently, there are four different products licensed and available for hemophilia A patients. All are produced by recombinant mammalian cells in large-scale fermenter cultures, purified to high purity, formulated in stable formulations and ...
متن کاملPatient preference for needleless factor VIII reconstitution device: the Italian experience
BACKGROUND Needlestick injuries, mostly due to unsafe needle devices, are a frequent adverse event among health care workers and patients on chronic treatment, such as hemophiliacs. To improve the safety of these procedures, a needleless reconstitution system, Bio-Set((R)) has been implemented for the sucrose-formulated recombinant factor VIII (rFVIII-FS) Kogenate((R)) Bayer (Bayer Healthcare, ...
متن کاملGenetic background and inhibitors in previously untreated or minimally treated young patients with severe haemophilia A treated with sucrose-formulated recombinant factor VIII.
Thromb Haemost 2006; 95: 903–5 Dear Sir, The conventional treatment of haemophilia A is the replacement of human factor VIII (FVIII) derived from plasma or recombinant sources. A major complication of therapy is the development of inhibitory antibodies against substituted factor VIII, affecting 20–30% of severely affected haemophilia A patients. Typically, these antibodies develop at therapy on...
متن کاملPhase I study of BAY 94-9027, a PEGylated B-domain-deleted recombinant factor VIII with an extended half-life, in subjects with hemophilia A
BACKGROUND BAY 94-9027 is a B-domain-deleted recombinant factor VIII (rFVIII) with site-specific attachment of poly(ethylene glycol) that has shown an extended half-life in animal models of hemophilia. OBJECTIVES To assess the pharmacokinetics and safety of BAY 94-9027 after single and repeated administration in subjects with severe hemophilia A. PATIENTS/METHODS This 8-week, prospective, m...
متن کامل