Esperoct Generic Name & Formulations
Legal Class
Rx
General Description
Antihemophilic Factor VIII (recombinant), glycopegylated-exei 500 IU, 1000 IU, 1500 IU, 2000 IU, 3000 IU; per vial; lyophilized pwd for IV inj after reconstitution; preservative-free.
Pharmacological Class
Clotting factor.
How Supplied
Single-dose vial─1 (w. diluent + vial adapter)
Manufacturer
Generic Availability
NO
Esperoct Indications
Indications
In patients with hemophilia A: for on-demand treatment and control of bleeding episodes, perioperative management of bleeding, and routine prophylaxis to reduce the frequency of bleeding episodes.
Limitations of Use
Not for treatment of von Willebrand disease.
Esperoct Dosage and Administration
Adults and Children
Individualize. Infuse slowly over 2mins. <12yrs: Bleeding: 65 IU/kg once; (Minor): one dose is sufficient; (Moderate): an additional dose may be given after 24hrs; (Major): additional dose(s) may be given every 24hrs. Perioperative: 65 IU/kg once; (Minor): additional dose(s) can be given after 24hrs; (Major): additional dose(s) can be given approx. every 24hrs for the first week, then approx. every 48hrs until wound has healed. Routine prophylaxis: 65 IU/kg twice weekly; then may adjust individually based on bleeding episodes. ≥12yrs: Bleeding (Minor): 40 IU/kg once; (Moderate): 40 IU/kg once; an additional dose may be given after 24hrs; (Major): 50 IU/kg once; additional dose(s) may be given every 24hrs. Perioperative: 50 IU/kg once; (Minor): additional dose(s) can be given after 24hrs; (Major): additional dose(s) can be given approx. every 24hrs for the first week, then approx. every 48hrs until wound has healed. Routine prophylaxis: initially 50 IU/kg every 4 days; then may adjust individually based on bleeding episodes. Also to achieve a specific target Factor VIII activity level, calculate dose using: Dosage Required (IU) = Body Weight (kg) × Desired Factor VIII Increase (IU/dL or % of Normal) × 0.5.
Esperoct Contraindications
Contraindications
Hamster protein sensitivity.
Esperoct Boxed Warnings
Not Applicable
Esperoct Warnings/Precautions
Warnings/Precautions
Discontinue if hypersensitivity reactions occur. Monitor for development of Factor VIII inhibitors. Perform a Bethesda assay if expected plasma FVIII levels not attained or if bleeding uncontrolled with recommended dose. Elderly. Pregnancy. Nursing mothers.
Esperoct Pharmacokinetics
See Literature
Esperoct Interactions
Not Applicable
Esperoct Adverse Reactions
Adverse Reactions
Rash, redness, pruritus, inj site reactions; antibody formation.
Esperoct Clinical Trials
See Literature
Esperoct Note
Not Applicable
Esperoct Patient Counseling
See Literature