ABSTRACT
The product is indicated for treatment and prophylaxis of bleeding in patients with hemophilia A. (The preparation does not contain von Willebrand’s factor and therefore is not indicated in von Willebrand’s disease.)
Manufacturer: Bayer AG, 51368 Leverkusen, Germany, https://www.pharma.bayer.com/ (manufacturer is responsible for import and batch release in the European Economic Area) Bayer Corporation, 800 Dwight Way, P.O. Box 1986, Berkeley, CA 947011986, https://www.pharma.bayer.com/ (U.S.)
Marketing: Bayer AG, 51368 Leverkusen, Germany, https://www.pharma.bayer.com/ (E.U.) Bayer Corporation, 800 Dwight Way, P.O. Box 1986, Berkeley, CA 947011986, https://www.pharma.bayer.com/ (for marketing in U.S. with the trade name Kogenate FS) Aventis Behring, 1020 First Avenue, King of Prussia, PA19406, https://www.aventisbehring.com/ (for marketing in U.S. with the trade name Helixate FS)
Manufacturing
The recombinant coagulation factor VIII is produced by recombinant DNA technology. The human coagulation factor VIII gene is expressed in BHK cells, with posttranslational modifications largely similar to the plasma-derived factor VIII being observed. Helixate NexGen differs from the previously approved Helixate in the purification process and in the use of sucrose instead of human albumin as a stabilizer. The purification process involves several chromatographic steps, including immunoaffinity chromatography using a murine IgG, as well as ultrafiltration. A
Overview of Therapeutic Properties
of, coagulation factor VIII, which is involved in the cascade for the formation of a fibrin clot. Lack of coagulation factor VIII results in profused bleeding, occurring spontaneously or after trauma or surgery.
