Afstyla



Afstyla

Product Specs Afstyla
Manufacturer Name CSL Behring
Description AFYSTYLA®, Antihemophilic Factor (Recombinant), Single Chain, is 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 AFYSTYLA or its excipients, or hamster proteins.
Stabilizer in Final Formulation Polysorbate 80, calcium chloride, sodium chloride, sucrose, L-Histidine
Viral Safety Process Purified by a controlled multi-step process including two virus reduction steps complementing each other in their mode of action. No human or animal derived proteins are used in the purification or formulation processes.
Product Half-Life ≥18yrs: 14.2 (26.0) hours
12 to < 18yrs: 14.3 (33.3) hours
6 to < 12yrs: 10.2 (19.4) hours
0 to < 6yrs: 10.4 (28.7) hours
Product Recovery Percentage Mean incremental recovery IR (IU/dL per IU/kg) ≥18 yrs: 2.00 (20.8)
12 to <18yrs: 1.69 (24.8)
6 to <12 yrs: 1.66 (19.7)
0 to <6yrs: 1.60 (21.1)
Storage Requirements
  • Refrigerated at 2°C to 8°C (36°F to 46°F), or room temperature room temperature not to exceed 25°C (77°F).
  • Do not freeze.
    		•
    Shelf Life Expiration date on label or 3 months at room temperature
    Nominal Vial Size & Diluent Volume 250, 500, 1000 IU/2.5 mL
    1500, 2500, 3000 IU/5 mL


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