Alprolix



Alprolix

Product Specs Alprolix
Manufacturer Name Sanofi
Description ALPROLIX, Coagulation Factor IX (Recombinant), Fc Fusion Protein, is a recombinant DNA derived coagulation Factor IX concentrate indicated in adults and children with hemophilia B (congenital Factor IX deficiency).
ALPROLIX 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 individuals who have a known history of hypersensitivity reactions, including anaphylaxis, to the product or its excipients.
Viral Safety Process Detergent treatment, 15 nm filtration
Product Half-Life Terminal* Half-Life:
Adults: 86 to 97 hours
Adolescents 12-17 years: 80 hours
Product Recovery Percentage Mean incremental recovery IR (IU/dL per IU/kg) Adults: 1.02 (59)
Adolescents 12-17 years: 0.87 (44)
Manufacturing Method ALPROLIX is a recombinant factor IX
Storage Requirements
  • Store in the original package in order to protect it from light.
  • Store at 2°C to 8°C (36°F to 46°F). Do not freeze. Freezing will damage the prefilled diluent syringe.
  • Can be stored at room temperature, not to exceed 30°C (86°F), for a single period of up to 6 months within the expiration date printed on the carton and vial label. If stored at room temperature, record the date on the carton when the product was removed from refrigeration. Use the product before the end of this 6-month period or discard it. Do not place the product back into refrigeration after warming to room temperature.
  • Do not use product or diluent after the expiration date printed on the carton, vial, or syringe.
  • Reconstituted product may be stored at room temperature, not to exceed 30°C (86°F) for no longer than 3 hours. Protect from direct sunlight. Discard any product not used within 3 hours after reconstitution.
    		•
    Shelf Life Expires after storage at room temperature for 6 months, or after the expiration date on the product vial, whichever is earlier
    Nominal Vial Size & Diluent Volume 250, 500, 1000, 2000, 3000, or 4000 IU/5 mL

    *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.)


    Return to Manufacturer Name listing Return to Factor Type listing