Rixubis



RIXUBIS

Product Specs RIXUBIS
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.
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    Nominal Vial Size & Diluent Volume 250, 500, 1000, 1500, 2000, or 3000 IU/5 mL SWI


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