Antihemophilic Factor VIII, Recombinant (Afstyla)

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 management 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