Bleeding disorders:

Indications for: ESPEROCT

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.

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:

Hamster protein sensitivity.

ESPEROCT 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 Classification:

Clotting factor.

Adverse Reactions:

Rash, redness, pruritus, inj site reactions; antibody formation.

Drug Elimination:

Half-life: (1–<6yrs): 14.7hrs; (6–<12yrs): 13.8hrs; (12–<18yrs): 17.4hrs; (≥18yrs): 21.7hrs.

Generic Drug Availability:

NO

How Supplied:

Single-dose vial─1 (w. diluent + vial adapter)