Factor IX (Recombinant), Fc fusion protein
Class: Hemostatics
VA Class: BL500
CAS Number: 1270012-74-2
Brands: Alprolix
Introduction
Biosynthetic (recombinant DNA origin) preparation of blood coagulation factor IX covalently linked to the Fc domain of human immunoglobulin G1 (IgG1).
Uses for Factor IX (Recombinant), Fc fusion protein
Hemophilia B
On-demand treatment and control of hemorrhagic episodes in patients with hemophilia B (congenital factor IX deficiency, or Christmas disease). Designated an orphan drug by FDA for such use.
Maintenance of hemostasis in patients with hemophilia B undergoing surgery (i.e., perioperative management of bleeding).
Routine prophylaxis (i.e., administration at regular intervals on an ongoing basis) to reduce frequency of hemorrhagic events. Such prophylactic therapy with factor IX concentrates considered the current standard of care for patients with hemophilia B. Decreases frequency of spontaneous musculoskeletal hemorrhage, preserves joint function, and improves quality of life.
Half-life of factor IX (recombinant), Fc fusion protein longer than that of conventional preparations of recombinant factor IX; may allow for less frequent dosing and possibly improve patient compliance with prophylactic regimens.
Several factor IX 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 factor IX 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 factor IX preparation, consider characteristics of each clotting factor concentrate, individual patient variables, patient/provider preference, and emerging data.
Not indicated for induction of immune tolerance in patients with hemophilia B.
Factor IX (Recombinant), Fc fusion protein Dosage and Administration
General
Initiate therapy under supervision of a clinician experienced in the treatment of hemophilia B.
Monitor factor IX activity (with one-stage clotting assay) to individualize dosage and assess response to therapy. Ensure that adequate levels are attained and maintained. (See Laboratory Monitoring under Cautions.)
Administration
IV Administration
Administer by slow IV injection. (See Rate of Administration under Dosage and Administration.)
Safety and efficacy of continuous IV infusions of the drug not established. Thromboembolic complications reported with use of other factor IX preparations administered as a continuous IV infusion. (See Thromboembolic Complications under Cautions.)
Reconstitution
Reconstitute with manufacturer-supplied prefilled diluent syringe. May require reconstitution of more than one vial depending on dose...
