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

Authors

  • 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
Further Information

Publication History

Received 01 February 1996

Accepted after revision 26 April 1996

Publication Date:
10 July 2018 (online)

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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.