title: Immunological aspects of recombinant factor VIIa (rFVIIa) in clinical use.
abstract: 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.
authors.affiliation: Novo Nordisk A/S, Gentofte, Denmark.
authors.forename: E M
authors.initials: EM
authors.lastname: Nicolaisen
authors.forename: L L
authors.initials: LL
authors.lastname: Hansen
authors.forename: F
authors.initials: F
authors.lastname: Poulsen
authors.forename: S
authors.initials: S
authors.lastname: Glazer
authors.forename: U
authors.initials: U
authors.lastname: Hedner
mesh_terms: D000818:Animals; D016022:Case-Control Studies; D002417:Cattle; D015942:Factor VIIa / Q000276:immunology / Q000627:therapeutic use*; D005500:Follow-Up Studies; D006467:Hemophilia A / Q000188:drug therapy* / Q000276:immunology; D006470:Hemorrhage / Q000188:drug therapy* / Q000276:immunology; D006801:Humans; D051379:Mice; D011506:Proteins / Q000276:immunology; D011994:Recombinant Proteins / Q000276:immunology / Q000627:therapeutic use; D015203:Reproducibility of Results
chemical_list: D011506:Proteins; D011994:Recombinant Proteins; D015942:Factor VIIa