Demonstrated safety profile in previously treated patients (PTPs)
- In clinical studies with 135 PTPs:
- No subjects developed neutralizing antibodies to NUWIQ7*
Confidence in switching to NUWIQ8
pdFVIII = plasma-derived Factor VIII.
*In clinical studies with 135 PTPs (74 adults, 3 adolescents, and 58 children), non-neutralizing antibodies without any inhibitor activity were reported in 4 patients (3%). The most frequently occurring adverse reactions (>0.5%) in clinical trials were paresthesia, headache, injection site inflammation, injection site pain, non-neutralizing anti-Factor VIII antibody formation, back pain, vertigo and dry mouth. Development of FVIII neutralizing antibodies (inhibitors) may occur.