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	250 IU strength only; store at 2 to 8°C (36 to 46°F). 500, 1000, 1500, 2000, and 3000 IU strengths: store at 2 to 25°C (36 to 77°F). Do not freeze. Keep the vial in the carton and protect from light. Infuse reconstituted solution immediately or within 3 hours of storage at room temperature after reconstitution. Do not refrigerate after reconstitution.
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.)