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International Journal of Hematology
Published in: International Journal of Hematology 4/2009

01-11-2009 | Review Article

Evolution of recombinant factor VIII safety: KOGENATE® and Kogenate® FS/Bayer

Authors: Jeanne M. Lusher, Inge Scharrer

Published in: International Journal of Hematology | Issue 4/2009

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Abstract

The use of factor VIII (FVIII) concentrates in the treatment of hemophilia A has raised important safety issues, historically of pathogen transmission and increasingly of inhibitor development to FVIII treatment. While manufacturing processes of current recombinant FVIII products have been shaped entirely around preventing pathogen transmission, the same modifications that afford a greater margin of safety could affect immunogenicity of the product, consequences of which could only be seen through long-term clinical experience. This review summarizes pathogen safety and inhibitor reports from clinical trials, post-marketing surveillance studies, and study reports on KOGENATE® and its successor, Kogenate® FS/Bayer. Although KOGENATE and Kogenate FS/Bayer are nearly identical products, subtle manufacturing improvements to address the need for greater margins of safety from a pathogen transmission perspective have also led to a potentially improved immunogenicity profile (15% in previously untreated/minimally treated patients with severe hemophilia A for Kogenate FS/Bayer). Notably, there has been no occurrence of pathogen contamination, and minimal de novo inhibitor formation in previously treated patients throughout the use of both products. Overall, KOGENATE and Kogenate FS/Bayer have a long history of safety in a variety of clinical settings, including treatment of bleeding, surgical management, and prophylaxis therapy.
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Metadata
Title
Evolution of recombinant factor VIII safety: KOGENATE® and Kogenate® FS/Bayer
Authors
Jeanne M. Lusher
Inge Scharrer
Publication date
01-11-2009
Publisher
Springer Japan
Published in
International Journal of Hematology / Issue 4/2009
Print ISSN: 0925-5710
Electronic ISSN: 1865-3774
DOI
https://doi.org/10.1007/s12185-009-0435-x

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