Eloctate



Eloctate

Product Specs Eloctate
Manufacturer Name Sanofi
Description ELOCTATE, Antihemophilic Factor (Recombinant), Fc Fusion Protein, is a recombinant DNA derived, antihemophilic factor indicated 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 lifethreatening hypersensitivity reactions, including anaphylaxis, to ELOCTATE or excipients of ELOCTATE.
Stabilizer in Final Formulation Sucrose, sodium chloride, L-histidine, calcium chloride, and polysorbate 20
Viral Safety Process Chromatography, detergent treatment, 15 nm filtration
Product Half-Life Terminal* Half-life (95%CI)
>18yrs: 19.7 (17.4,22.0) hours
12-17yrs: 16.4 (14.1, 18.6) hours
6-11yrs: 14.9 (12.0, 17.8) hours
1-5yrs: 12.7 (11.2, 14.1) hours
Product Recovery Percentage Mean incremental recovery IR (IU/dL per IU/kg) IR (95%CI)
>18 yrs: 2.26
(2.13, 2.40)
2.53 ± 0.43
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 pre-filled 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 ELOCTATE is removed from refrigeration on the carton in the area provided. After storage at room temperature, do not return the product to the refrigerator.
  • Do not use beyond the expiration date printed on the vial or 6 months after the date that was written on the carton, whichever is earlier.

    • After Reconstitution:

  • The reconstituted product 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 or has particulate matter.
    		•
    Shelf Life 36 months, or 6 months at room temperature from manufactured date
    Nominal Vial Size & Diluent Volume 250, 500, 750, 1000, 1500, 2000, 3000, 4000, 5000, or 6000 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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