Esperoct

Product Specs	Description
Manufacturer Name	Novo Nordisk
Description	Esperoct® [antihemophilic factor (recombinant), glycopegylated-exei] is a recombinant analogue of human coagulation FVIII conjugated with a 40-kDa polyethylene glycol (PEG) molecule.
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	You should not use Esperoct® if you are allergic to factor VIII or any of the other ingredients of Esperoct® or if you are allergic to hamster proteins
Stabilizer in Final Formulation	Sodium chloride, L-histidine, sucrose, polysorbate 80, L-methionine, and calcium chloride
Viral Safety Process	20 nm filtration, detergent treatment
Product Half-Life	Children (1-<6 years): 14.7 (27) hours Children (6-<12 years): 13.8 (32) hours Adolescents (12-<18 years): 17.4 (39) hours Adults (>18 years): 21.7 (33) hours
Product Recovery Percentage Mean incremental recovery IR (IU/dL per IU/kg)	Children (1-<6 years): 1.82 (32) Children (6-<12 years): 1.67 (22) Adolescents (12-<18 years): 2.45 (16) Adults (>18 years): 2.53 (24)
Storage Requirements/Shelf Life	Store in the original package to protect from light. Store in a powder form under refrigeration at 36°F to 46°F (2°C to 8°C) for up to 30 months from the date of manufacture until the expiration date stated on the label. May be stored at room temperature [not to exceed 86°F(30°C)] for up to 12 months within the 30-month time period. The total time of storage at room temperature should not exceed 12 months. Do not return the product to the refrigerator after room temperature storage. Do not use beyond the expiration date printed on the vial or 12 months after the date it was removed from refrigeration (whichever is earlier). Do not freeze. Use within 4 hours after reconstitution when stored at room temperature, or within 24 hours when stored in the refrigerator.
Nominal Vial Size & Diluent Volume	500, 1000, 1500, 2000, 3000 IU/4mL of saline diluent