Esperoct

— THERAPEUTIC CATEGORIES —
  • Bleeding disorders

Esperoct Generic Name & Formulations

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