Idelvion
| Product Specs | Description |
|---|---|
| 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 |
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| 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 |