Use in adults and children with hemophilia A for: 1.On-demand treatment and control of bleeding episodes
2.Perioperative management of bleeding
3.Routine prophylaxis to reduce the frequency of bleeding episodes

glycopegylated form of recombinant anti-hemophilic factor, temporarily replaces the missing coagulation Factor VIII needed for effective hemostasis in congenital hemophilia A patients. The Factor VIII in ESPEROCT is conjugated to a 40-kDa polyethylene glycol molecule which increases the half-life and decreases the clearance compared to the non-pegylated molecule.

Distribution: Vss : Children <6 years of age: 44.2 mL/kg; Children 6 to <12 years of age: 47.3 mL/kg; Children and Adolescents 12 to <18 years of age: 36.4 mL/kg; Adults 18 years of age: 37.3 mL/kg.
Half-life elimination : Children <6 years of age: 14.7 hours; Children 6 to <12 years of age: 13.8 hours; Children and Adolescents 12 to <18 years of age: 17.4 hours; Adults 18 years of age: 21.7 hours.

Do not use in patients who have known hypersensitivity to ESPEROCT or its components, including hamster proteins.

There are no data use in pregnant women to determine whether there is a drug-associated risk.

There is no information regarding the presence of ESPEROCT in human milk, the effect on the breastfed infant, and the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need and any potential adverse effects.

rash, redness, itching (pruritus), and injection site reactions.

Dosing to Control Bleeding Episodes

Type of bleeding	Adolescents/Adults	Children <12 years Dose (IU/kg)
Minor	40	65
Moderate	40	65
Major	50	65

Dosing for Perioperative Management

Type of bleeding	Adolescents/Adults	Children <12 years Dose (IU/kg)
Minor	50	65
Major	50	65

Routine Prophylaxis
1.Adults and adolescents (( 12 years): The recommended starting dose is 50 IU per kg body weight every 4 days.
2.Children (< 12 years): A dose of 65 IU per kg body weight twice weekly.