Idelvion



IDELVION

Product Specs IDELVION
Manufacturer Name CSL Behring
Description IDELVION, Coagulation Factor IX (Recombinant), Albumin Fusion Protein (rIX-FP), a recombinant human blood coagulation factor, is indicated in children and adults with hemophilia B (congenital Factor IX deficiency).
IDELVION is not indicated for immune tolerance induction in patients with hemophilia B.
Indications for Adults:

Control and Prevention of Bleeding Episodes

 Yes

Perioperative Management

 Yes

Routine Prophylaxis to Prevent or Reduce the Frequency of Bleeding Episodes

 Yes
Indications for Children:

Control and Prevention of Bleeding Episodes

 Yes

Perioperative Management

 Yes

Routine Prophylaxis to Prevent or Reduce the Frequency of Bleeding Episodes

 Yes
Contraindications Nutrient in Cell Culture Do not use in patients who have had life-threatening hypersensitivity reactions to IDELVION or its components, including hamster proteins.
Viral Safety Process Solvent/detergent treatment and virus removal by filtration.
Product Half-Life Adults ≥18 years:
rIX-FP 25 (IU/kg) N=7: 118 (38) hours
rIX-FP 50 (IU/kg) N=47: 104 (25)hours
rIX-FP 75 (IU/kg) N=8: 104 (18) hours
Product Recovery Percentage Mean incremental recovery IR (IU/dL per IU/kg) Adults ≥18 years:
rIX-FP 25 (IU/kg) N=7: 1.65 (11)
rIX-FP 50 (IU/kg) N=47: 1.30 (24)
rIX-FP 75 (IU/kg) N=8: 1.08 (20)
Manufacturing Method Genetic fusion of recombinant albumin to recombinant coagulation Factor IX.
Storage Requirements/Shelf Life
  • Store in original package to protect from light.
  • Store refrigerated or at room temperature 2°C to 25°C (36°F to 77°F).
  • Do not freeze.
  • Do not use beyond the expiration date printed on the labels.
  • Do not use beyond the expiration date printed on the label.
    		•
    Nominal Vial Size & Diluent Volume 2.5 mL SWI for reconstitution of 250, 500 or 1000 IU vials
    5 mL SWI for reconstitution of 2000 or 3500 IU vials


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