Rixubis

Product Specs	Description
Manufacturer Name	Takeda
Description	RIXUBIS (Coagulation Factor IX [Recombinant]) is an antihemophilic factor indicated in adults and children with hemophilia B. RIXUBIS 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	Do not use in patients with known hypersensitivity to RIXUBIS or its excipients including hamster protein, disseminated intravascular coagulation (DIC), or signs of fibrinolysis.
Viral Safety Process	15 nm nanofiltration, solvent/detergent treatment
Product Half-Life	≥12 yrs: 25.7 ± 1.5 hours 6 to <12 yrs: 23.2 ± 1.6 hours <6 yrs: 27.7 ± 2.7 hours
Product Recovery Percentage Mean incremental recovery IR (IU/dL per IU/kg)	0.67 (± 0.16)
Manufacturing Method	Purified protein produced by recombinant DNA technology
Storage Requirements/Shelf Life	Store refrigerated, 2°C to 8°C (36°F to 46°F) for up to 24 months. Do not freeze. May store at room temperature not to exceed 30°C (86°F) for up to 12 months within the 24 month time period. After storage at room temperature, do not return the product to the refrigerator. Do not use beyond the expiration date printed on the carton or vial.
Nominal Vial Size & Diluent Volume	250, 500, 1000, 1500, 2000, or 3000 IU/5 mL SWI