Median time to trough levels of 1% FVIII has been estimated between 4 and 5 days, depending on dose and extrapolation method.
A phase I/III, open-label, multicenter, crossover study in patients ≥12 years, and a phase III, open-label, multicenter study in patients <12 years.
The pharmacokinetics (PK) of AFSTYLA was evaluated in 91 (81 adults and 10 adolescents) previously treated patients (PTPs) with severe hemophilia A (<1% endogenous Factor VIII activity) following an intravenous injection of a single dose of 50 IU/kg.
The PK of AFSTYLA was evaluated in 39 previously treated children (<12 years) with severe hemophilia A (<1% endogenous Factor VIII activity) following a 50 IU/kg intravenous injection of AFSTYLA.
Reference: 1. Data on file available from CSL Behring as DOF AFS-001.
The recommended starting regimen is
Adjust regimen based on patient response
The median doses used in AFSTYLA clinical trials were
*Annualized spontaneous bleeding rate in clinical trials (IQR=0–2.4 for patients ≥12 years; 0–2.2 for patients <12 years).
The dose to achieve a desired in vivo peak increase in Factor VIII level may be calculated using the following formula:
The amount of AFSTYLA to be administered and the frequency of administration should always be oriented to the clinical effectiveness in the individual case.