Afystyla

Product Specs	Description
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.
Nominal Vial Size & Diluent Volume	250, 500, 1000 IU/2.5 mL 1500, 2500, 3000 IU/5 mL