IDELVION®

• IDELVION®, Coagulation Factor IX (Recombinant), Albumin Fusion Protein (rIX-FP), a recombinant DNA-derived coagulation Factor IX concentrate, is 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 and routine prophylaxis to reduce the frequency of bleeding episodes.

Limitations of Use:
IDELVION is not indicated for immune tolerance induction in patients with Hemophilia B

 Do not use in patients who have had life-threatening hypersensitivity reactions to IDELVION or its components, including hamster proteins.

On-demand treatment and control of bleeding episodes and perioperative management: 

• Dosage and duration of treatment with IDELVION depends on the severity of the Factor IX deficiency, the location and extent of bleeding, and the patient’s clinical condition, age and recovery of Factor IX.  
• Determine the initial dose using the following formula: Required 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 ≥12 years of age: 25-40 IU/kg body weight every 7 days. Patients who are 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.

• Attach the syringe containing the reconstituted IDELVION solution to a sterile infusion set and administer by intravenous injection. Adapt the infusion rate to the comfort level of each patient, not exceeding 10 mL per minute
• Each single-dose vial of IDELVION is labeled with the actual Factor IX potency in international units (IU). 
• 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
• Administer IDELVION at room temperature and within 4 hours of reconstitution. Discard any unused product.