Long-term follow-up with regard to potential immunogenicity: clinical experience with NovoSeven(recombinant factor VIIa).
Twenty-eight patients were followed up for potential specific antibody formation after repeated use of recombinant factor VIIa (rFVIIa). The population included 27 patients with congenital bleeding disorders and 1 nonhemophiliac with an FVIII inhibitor. From 5 to 77 bleeding episodes were treated during a follow-up period of at least 5 months. None of these repeatedly treated patients showed signs of antibody formation against FVII or foreign protein that could be related to the treatment.
Nicolaisen
E M
EM
NovoNordisk, Gentofte, Denmark.
D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000917:Antibody Formation; D002648:Child; D002675:Child, Preschool; D015942:Factor VIIa / Q000009:adverse effects* / Q000276:immunology; D005500:Follow-Up Studies; D006801:Humans; D007223:Infant; D008875:Middle Aged; D011994:Recombinant Proteins / Q000009:adverse effects / Q000276:immunology
D011994:Recombinant Proteins; D015942:Factor VIIa