ixinity



IXINITY

Product Specs IXINITY
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
  • Store refrigerated or at room temperature at 2°C to 25°C (36°F to 77°F).
  • Do not freeze.
  • Do not use IXINITY after the expiration date printed on the label. Throw away any unused IXINITY and diluents after it reaches this date.
  • Reconstituted product (after mixing dry product with Sterile Water for Injection) must be used within 3 hours and cannot be stored or refrigerated. Discard any IXINITY left in the vial at the end of your infusion.
    		•
    Shelf Life 36 months from manufactured date
    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.)


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