Antihemophilic Factor (recombinant), Fc Fusion Protein
Class: Hemostatics
VA Class: BL500
CAS Number: 1270012-79-7
Brands: Eloctate
Introduction
Biosynthetic (recombinant DNA origin) preparation of blood coagulation factor VIII covalently linked to the Fc domain of human IgG1.
Uses for Antihemophilic Factor (recombinant), Fc Fusion Protein
Hemophilia A
On-demand treatment and control of bleeding episodes in patients with hemophilia A (congenital factor VIII deficiency; classic hemophilia).
Maintenance of hemostasis in patients with hemophilia A undergoing surgery (i.e., perioperative management of bleeding).
Routine prophylaxis (i.e., administration at regular intervals) to reduce frequency of bleeding events. Such prophylaxis considered the current standard of care for patients with hemophilia A. Decreases frequency of spontaneous musculoskeletal bleeding, preserves joint function, and improves quality of life.
Designated an orphan drug by FDA for treatment of hemophilia A.
Half-life of antihemophilic factor (recombinant), Fc fusion protein is longer than that of conventional preparations of recombinant antihemophilic factor; may allow for less frequent dosing and possibly improve patient compliance with prophylactic regimens.
Several antihemophilic factor concentrates are currently available in the US, including a variety of recombinant and plasma-derived preparations; the Medical and Scientific Advisory Council (MASAC) of the National Hemophilia Foundation recommends preferential use of recombinant antihemophilic factor preparations because of their potentially superior safety profile with respect to pathogen transmission. Other experts (e.g., World Federation of Hemophilia) state that choice of preparation should be determined by local criteria. When selecting an appropriate antihemophilic factor preparation, consider characteristics of each clotting factor concentrate, individual patient variables, patient/provider preference, and emerging data.
Not indicated for the treatment of von Willebrand disease.
Antihemophilic Factor (recombinant), Fc Fusion Protein Dosage and Administration
General
Monitor factor VIII activity to individualize dosage and assess response to therapy. (See Laboratory Monitoring under Cautions.) Ensure that adequate levels are attained and maintained. Careful control is especially important in cases of life-threatening bleeding or major surgery.
Administration
IV Administration
Administer by slow IV injection. (See Rate of Administration under Dosage and Administration.)
Reconstitution
Reconstitute with sterile water for injection (supplied by manufacturer). Allow drug vial and prefilled diluent syringe to warm to room temperature prior to reconstitution. Gently swirl vial until powder is completely dissolved; do not shake. Resultant solution should be clear to slightly opalescent and colorless; do not use if cloudy, discolored, or particulate matter observed.
Administer immediately or within 3 hours afte...
