Altuviiio



Altuviiio

Product Specs Altuviiio
Manufacturer Name Sanofi
Description ALTUVIIIO [antihemophilic factor (recombinant), Fc-VWF-XTEN fusion protein-ehtl] is a recombinant DNAderived, Factor VIII concentrate indicated for use in adults and children with hemophilia A (congenital factor VIII deficiency)
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 who have had severe hypersensitivity reactions, including anaphylaxis, to ALTUVIIIO or excipients of ALTUVIIIO.
Stabilizer in Final Formulation
Viral Safety Process ALTUVIIIO is manufactured without addition of human- or animal-derived components and purified by a combination of multiple chromatography steps, a detergent viral inactivation step, a nano filtration step for viral clearance, and ultra-filtration steps.
Product Half-Life Terminal* Half-life
≥18yrs: 48.2 (9.31) hours
12 to < 18yrs: 44.6 (4.99) hours
6 to < 12yrs: 42.4 (3.70) hours
0 to < 6yrs: 39.9 (5.71) hours
Product Recovery Percentage Mean incremental recovery IR (IU/dL per IU/kg) ≥18 yrs: 2.64 (.61)
12 to <18yrs: 2.25 (.61)
6 to <12 yrs: 2.17 (.46)
0 to <6yrs: 2.10 (.53)
Storage Requirements Prior to reconstitution:

  • Store in the original package to protect the vials from light.
  • Store in powder form at 2°C to 8°C (36°F to 46°F). Do not freeze to avoid damage to the prefilled diluent syringe.
  • May 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 label.
  • If stored at room temperature, record the date that ALTUVIIIO is removed from refrigeration on the carton in the area provided. After storage at room temperature, do not return the product to the refrigerator.

    • After Reconstitution:

  • May be stored at room temperature, not to exceed 30°C (86°F), for up to 3 hours. Protect from direct sunlight. After reconstitution, if the product is not used within 3 hours, it must be discarded.
  • Do not use if the reconstituted solution is cloudy
    		•
    Shelf Life Expiration date on label or 6 months at room temperature
    Nominal Vial Size & Diluent Volume 250, 500, 750, 1000, 2000, 3000, or 4000 IU/3 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.)


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