Generic Name and Formulations:
Antihemophilic Factor VIII (Recombinant), Fc fusion protein 250 IU, 500 IU, 750 IU , 1000 IU, 1500 IU, 2000 IU, 3000 IU; per vial; lyophilized pwd for IV inj after reconstitution; contains sucrose; preservative-free.
Indications for ELOCTATE:
In patients with Hemophilia A: to control and prevent hemorrhagic episodes, for perioperative management, and routine prophylaxis to prevent or reduce the frequency of hemorrhagic episodes.
Adults and Children:
Dosage Required (IU) = Body Weight (kg) × Desired % Factor VIII Increase × 0.5. Individualize. Give by IV bolus infusion at max rate 10mL/min. Children <6yrs: higher or more frequent dosing may be needed (see full labeling). Hemorrhage: Minor/moderate: obtain 40–60% FVIII increase; give 20–30 IU/kg every 24–48hrs until resolved. Major: obtain 80–100% FVIII increase; give 40–50 IU/kg every 12–24hrs until resolved ( approx. 7–10 days). Perioperative: Minor: obtain 50–80% FVIII increase; give 25–40 IU/kg every 24hrs for at least 1 day until healing achieved. Major: obtain 80–120% FVIII increase (pre- and post-op); give pre-op dose (40–60 IU/kg) followed by repeat dose (40–50 IU/kg) after 8–24hrs and then every 24hrs to maintain target range; give until adequate wound healing, then continue for at least 7 days to maintain target range. Routine prophylaxis: 50 IU/kg every 4 days; may adjust to range of 25–65 IU/kg at 3–5 day intervals based on response.
Not for von Willebrand's disease. Monitor for development of Factor VIII inhibitors; perform Bethesda inhibitor assay if expected Factor VIII plasma levels not attained or if bleeding not controlled with expected dose. Monitor plasma Factor VIII activity via validated test (eg, one stage clotting assay). Pregnancy (Cat.C). Nursing mothers.
Arthralgia, malaise; hypersensitivity reactions (discontinue if occur).
Kit—1 (vial w. diluent and vial adapter)