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.
