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International Journal of Hematology

, Volume 90, Issue 4, pp 446–454 | Cite as

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

  • Jeanne M. Lusher
  • Inge Scharrer
Review Article

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.

Keywords

Hemophilia FVIII Recombinant FVIII Inhibitors Pathogen safety 

Notes

Acknowledgments

The authors thank Bayer HealthCare for editorial support in the development of this manuscript.

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Copyright information

© The Japanese Society of Hematology 2009

Authors and Affiliations

  1. 1.Hemophilia and Hemostasis ProgramChildren’s Hospital of MichiganDetroitUSA
  2. 2.University HospitalMainzGermany
  3. 3.Department of Hematology/OncologyJohannes Gutenberg-University MainzMainzGermany

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