Antihemophilic Factor VIII, Recombinant (Afstyla)

OFFICE ADMINISTRATION

FDA Approved Indications:
  • Indicated in adults and children with hemophilia A (congenital Factor VIII deficiency) for:
    • On-demand treatment and control of bleeding episodes
    • Routine prophylaxis to reduce the frequency of bleeding episodes
    • Perioperative managment of bleeding
Patients must meet the following criteria for the indications above:
  • On-demand treatment, perioperative management or routine prophlaxis for patients with hemophilia A
  • Patient does not have known hypersensitivity to hamster proteins
Dosing:
  • One unit per kilogram body weight will raise the Factor VIII level by 2 IU/dL
  • Dose (IU) = Body Weight (kg) x desired Factor VIII rise (IU/dL or % of normal) x 0.5 (IU/kg per IU/dL)
  • Routine Prophylaxis:
    • Adults and adolescents (12 years of age or older): The recommended starting regimen is 20-50 IU/kg administered 2 to 3 times weekly
    • Children (<12 years): The recommended starting regimen is 30-50 IU/kg administered 2 to 3 times weekly.  More frequent or higher doses may be required in children <12 years of age to account for the higher clearance in this age group.
    • The regimen may be adjusted based on patient response
  • Perioperative Management:
    • Ensure the appropriate Factor VIII activity level is achieved and maintained
Approval:
  • One year