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Read Important Information on Helixate® FS, Antihemophilic Factor (Recombinant)

Read Important Information on Helixate® FS, Antihemophilic Factor (Recombinant)

Designed for Increased Stability and Extended Time in Circulation

pkParameterChart 50 IU/kg

Median time to trough levels of 1% FVIII activity has been estimated between 4 and 5 days, depending on dose and extrapolation method.

Reference: 1. Data on file available from CSL Behring as DOF AFS-001.

AFSTYLA demonstrated enhanced half-life and increased bioavailability

  • 14.2-hour half-life allows 2x- or 3x-weekly dosing depending on your patients' needs
    • The half-life of AFSTYLA in patients <12 years was approximately 10 hours
14.2 hour half-life

PK parameters by age

pkParameterChart

AUC and clearance rate parameters illustrate the enhanced bioavailability of AFSTYLA in circulation.

Study design

Information based on overall data from two AFSTYLA studies

Phase I/III, open-label, multicenter, crossover study in patients ≥12 years, and a phase III open label, multicenter study in patients <12 years.

Adult/adolescent study

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.

Pediatric study

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.

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