Development of inhibitors to Factor VIII can occur following administration of Factor VIII products.
The most common adverse reactions in clinical trials (>0.5%) were dizziness and hypersensitivity.
One patient withdrew due to an adverse reaction (hypersensitivity).
The one-stage clotting assay result underestimates the Factor VIII activity level compared to the chromogenic assay result by approximately one-half.
If the one-stage clotting assay is used, multiply the result by a conversion factor of 2 to determine the patient’s Factor VIII activity level.
Data from three AFSTYLA studies: Safety of AFSTYLA was assessed in patients enrolled in the phase I/III, open-label, multicenter, crossover study, the phase III, open-label study, and the ongoing phase III, open-label, multicenter extension study. Adverse reactions were reported for 14 of 258 (5.4%) patients in all studies. In the clinical studies, there have been a total of 28,418 exposure days, with at least 28,492 injections of AFSTYLA administered.