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

The site you are transferring to is not hosted by WHA. WHA's Terms of Use and internet Privacy Practices do not apply to your use of this linked site. Please review the policies on privacy and terms of use for the linked site. WHA does not control the accuracy, completeness, or timeliness of the content on the linked site.

Press Esc to cancel

El sitio Web al que está siendo transferido no es provisto por WHA. Las Condiciones de Uso y las Prácticas de Privacidad en Internet de WHA no se aplican a este sitio Web asociado que usted está usando. Revise las políticas sobre la privacidad y condiciones de uso de este sitio Web asociado. WHA no tiene control sobre la exactitud, la totalidad o la actualidad del contenido del sitio Web asociado. WHA no puede garantizar que los servicios de traducción de idiomas estarán disponibles en el sitio vinculado.

Presione «Esc» para cancelar