Afystyla



Afystyla

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/Shelf Life
  • Store in the original package to protect from light.
  • Store in powder form at 2°C to 8°C (36°F to 46°F). Do not freeze.
  • Can be stored at room temperature, not to exceed 25°C (77°F), for a single period of up to 3 months, within the expiration date printed on the labels.
  • Once stored at room temperature, do not return the product to the refrigerator. The shelf-life then expires after storage at room temperature for 3 months, or after the expiration date, whichever is earlier.
  • Do not use after the expiration date indicated on the vial.
  • The reconstituted product can be stored at 2°C to 8°C (36°F to 46°F), or at room temperature, not to exceed 25°C (77°F), for up to 4 hours.
  • After reconstitution, if the product is not used within 4 hours, it must be discarded.
  • Do not use if the reconstituted solution is cloudy or has particulate matter.
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    Nominal Vial Size & Diluent Volume 250, 500, 1000 IU/2.5 mL
    1500, 2500, 3000 IU/5 mL


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