Immunological Aspects of Recombinant Factor Vila (rFVIIa) in Clinical Use

Else Marie Nicolaisen; Lisbeth Lyng Hansen; Fritz Poulsen; Steven Glazer; Ulla Hedner

doi:10.1055/s-0038-1650554

Thrombosis and Haemostasis, Table of Contents

Thromb Haemost 1996; 76(02): 200-204
DOI: 10.1055/s-0038-1650554

Original Article

Schattauer GmbH Stuttgart

Immunological Aspects of Recombinant Factor Vila (rFVIIa) in Clinical Use

Else Marie Nicolaisen

Novo Nordisk A/S, Gentofte, Denmark

,

Lisbeth Lyng Hansen

Novo Nordisk A/S, Gentofte, Denmark

,

Fritz Poulsen

Novo Nordisk A/S, Gentofte, Denmark

,

Steven Glazer

Novo Nordisk A/S, Gentofte, Denmark

,

Ulla Hedner

Novo Nordisk A/S, Gentofte, Denmark

› Author Affiliations

Abstract

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Summary

Patients, receiving rFVIIa for treatment of bleeding disorders, have been followed for specific antibody formation. No antibodies against FVII were demonstrated in 170 patients, with hemophilia, or with acquired inhibitors to clotting factors. Of 6 FVII-deficient patients, one overdosed patient developed antibodies to human FVII. There was no indication of de novo formation of antibodies to potential contaminating foreign protein, which could be correlated to the rFVIIa treatment. Except for the FVII-deficient population, which may represent a risk group, rFVIIa appears to be immunologically safe for use in patient groups with bleeding disorders, including hemophilia A and B patients.

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References

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