Antihemophilic Factor [recombinant] pegylated-aucl (Jivi®)

OFFICE ADMINISTRATION - IV

Indications for Prior Authorization:
  • Indicated for use in previously treated adults and adolescents (12 years of age and older) with hemophila A (congenital Factor VIII deficiency) for:
    • On-demand treatment and control of bleeding episodes
    • Perioperative management of bleeding
    • Routine prophylaxis to reduce the frequency of bleeding episodes
  • Limitations of use:
    • Not indicated for use in children <12 years of age due to a greater risk for hypersensitivity reactions
    • Not indicated for use in previously untreated patients
    • Not indicated for the treatment of Von Willebrand disease
Patients must meet the following criteria for the indication(s) above:
  • Patient is at least 12 years of age, AND
  • Patient has a documented diagnosis hemophilia A confirmed by chart note documentation, AND
  • Patient has been previously treated, AND
  • Patient does not have Von Willebrand disease, AND
  • Patient is not allergic to rodents (mice, hamsters)
Dosing:
  • Routine prophylaxis:
    • Initially 30-40 IU/kg IV twice weekly
    • The regimen may be adjusted to 45-60 IU/kg IV once every 5 days
    • A regimen may be further individually adjusted to less or more frequent dosing
  • Control of bleeding episodes and perioperative managment:
    • Expected recovery: one unit per kilogram body weight of Jivi will increase the Factor VIII level by international units per deciliter (IU/dL)
    • Required dose (IU) = body weight (kg) x desired Factor VIII rise (% of normal or IU/dL) x reciprocal of expected recovery (or observed recovery, if available)
    • Estimated increment of Factor VIII (IU/dL or % of normal) = [total dose (IU)/body weight (kg)] x 2 (IU/dL per IU/kg).
Approval:
  • One year

Last review date: June 26, 2019