Coagulation Factor IX, (recombinant), Albumin Fusion Protein (Idelvion)

OFFICE ADMINISTRATION

Indications for Prior Authorization:
  • Indicated in children and adults with Hemophilia B (congenital Factor IX deficiency) for:
    • On-demand treatment and control of bleeding episodes
    • Perioperative management of bleeding
    • Routine prophylaxis to reduce the frequency of bleeding episodes
Patients must meet the following criteria for the indications above:
  • On-demand treatment, perioperative management or routine prophylaxis for patients with Hemophilia B
  • Patient does not have a known hypersensitivity to hamster protein
Dosing:
  • One IU of Idelvion per kg body weight is expected to increase the circulating activity of Factor IX as follows:
    • Adolescents and adults: 1.3 IU/dL per IU/kg
    • Pediatrics (<12 years): 1 IU/dL per IU/kg
  • On-demand treatment and control of bleeding episdoes and perioperative management:
    • Initial dose: require dose (IU) = Body weight (kg) x desired Factor IX rise (% of normal or IU/dL) x (reciprocal of recovery (IU/kg per IU/dL))
    • Adjust dose based on the patient's clinical condition and response
  • Routine prophylaxis:
    • Patients at least 12 years of age: 25-40 IU/kg body weight every 7 days.  Patients well-controlled on this regimen may be switched to a 14-day interval at 50-75 IU/kg body weight.
    • Patients <12 years of age: 40-55 IU/kg body weight every 7 days.
Approval:
  • 1 year
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