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.

  • No subjects experienced serious or severe adverse drug reactions (ADRs) to NUWIQ7
  • No subjects experienced anaphylaxis7
  • No subjects withdrew from the study due to ADRs7

 

 

*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.