ixinity
| Product Specs | Description |
|---|---|
| Manufacturer Name | Medexus |
| Description | IXINITY is a coagulation factor IX (recombinant) indicated in adults and children ≥12 years of age with hemophilia B. IXINITY is not indicated for induction of immune tolerance 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 | Contraindicated in patients who have known hypersensitivity to IXINITY or its excipients, including hamster protein. |
| Viral Safety Process | Chromatography, solvent/detergent treatment, nanofiltration and a validated step to reduce the presence of CHO proteins |
| Product Half-Life | Terminal* Half-Life: 24 ±7 hours |
| Product Recovery Percentage Mean incremental recovery IR (IU/dL per IU/kg) | 0.98 (± 0.21) |
| Manufacturing Method | Third generation recombinant factor IX |
| Storage Requirements/Shelf Life |
|
| Nominal Vial Size & Diluent Volume | 250, 500, 1000, 1500, 2000, or 3000 IU/5 mL SWI |
*Note: Terminal half-life is the time required to divide the plasma concentration by two after reaching pseudo-equilibrium, and not the time required to eliminate half the administered dose. (Toutain PL, et al. J Vet Pharmacoll Ther. 2004.)