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