Antihemophilic Factor [recombinant] pegylated-aucl (Jivi)

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 management:
  • 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