Document Detail


Evolution of recombinant factor VIII safety: KOGENATE and Kogenate FS/Bayer.
MedLine Citation:
PMID:  19882376     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
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.
Authors:
Jeanne M Lusher; Inge Scharrer
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Publication Detail:
Type:  Comparative Study; Journal Article; Review     Date:  2009-11-03
Journal Detail:
Title:  International journal of hematology     Volume:  90     ISSN:  1865-3774     ISO Abbreviation:  Int. J. Hematol.     Publication Date:  2009 Nov 
Date Detail:
Created Date:  2010-01-21     Completed Date:  2010-04-08     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  9111627     Medline TA:  Int J Hematol     Country:  United States    
Other Details:
Languages:  eng     Pagination:  446-54     Citation Subset:  IM    
Affiliation:
Hemophilia and Hemostasis Program, Children's Hospital of Michigan, Detroit, MI, USA.
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MeSH Terms
Descriptor/Qualifier:
Clinical Trials as Topic
Disease Transmission, Infectious / prevention & control
Factor VIII / adverse effects*,  antagonists & inhibitors,  immunology,  therapeutic use
Hemophilia A / drug therapy
Humans
Recombinant Proteins / adverse effects*,  antagonists & inhibitors,  immunology,  therapeutic use
Technology, Pharmaceutical / methods
Chemical
Reg. No./Substance:
0/F8 protein, human; 0/Recombinant Proteins; 9001-27-8/Factor VIII

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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