Adynovate
| Product Specs | Description |
|---|---|
| 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 |
|
| 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.)