Adynovate



Adynovate

Product Specs Adynovate
Manufacturer Name Takeda
Description ADYNOVATE, Antihemophilic Factor (Recombinant), PEGylated, is a human antihemophilic factor indicated in children and adults 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 prior anaphylactic reaction to ADYNOVATE, the parent molecule (ADVATE), mouse or hamster protein, or excipients of ADYNOVATE.
Stabilizer in Final Formulation Tris (hydroxymethyl) aminomethane, Calcium Chloride, Mannitol, Sodium Chloride, Trehalose Dihydrate, Glutathione, Histidine, Polysorbate
Viral Safety Process Covalent conjugation with polyethylene glycol; solvent/detergent
Product Half-Life Terminal* Half-life
>18yrs: 14.69 ± 3.79 hours
12-18yrs: 13.43 ± 4.05 hours
Product Recovery Percentage Mean incremental recovery IR (IU/dL per IU/kg) >18 yrs: 2.66 ± 0.68
12-18yrs: 2.12 ± 0.60
2.66 ± 0.68
Storage Requirements/Shelf Life
  • Store in powder form at 2°C to 8°C (36°F to 46°F).
  • Do not freeze.
  • May be stored at room temperature not to exceed 30°C (86°F) for a period of up to 3 months not to exceed the expiration date.
  • After storage at room temperature, do not return the product to the refrigerator.
  • Do not use beyond expiration date printed on the label.
  • Store in the original box and protect from extreme exposure to light.
    		•
    Nominal Vial Size & Diluent Volume 250, 500, 750, 1000, or 1500 IU/2 mL
    2000 or 3000 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