Factor IX (Recombinant)
Class: Hemostatics
VA Class: BL500
Chemical Name: Blood-coagulation factor IX (synthetic human)
CAS Number: 181054-95-5
Brands: BeneFIX, Rixubis
Introduction
Biosynthetic (recombinant DNA origin) preparation of blood coagulation factor IX.
Uses for Factor IX (Recombinant)
Hemophilia B
Prevention and control of bleeding episodes in patients with hemophilia B (congenital factor IX deficiency or Christmas disease).
Maintenance of hemostasis in patients with hemophilia B undergoing surgery.
Designated an orphan drug by FDA for treatment of hemophilia B.
Also used for routine prophylaxis (i.e., administration at regular intervals) to prevent or reduce frequency of bleeding events. Such prophylactic therapy currently considered the standard of care for patients with hemophilia B. Decreases frequency of spontaneous musculoskeletal hemorrhage, preserves joint function, and improves quality of life.
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 the treatment of other coagulation factor deficiencies (e.g., factors II, VII, VIII, X) or for management of hemophilia A in patients with inhibitors to factor VIII.
Not indicated for reversal of coumarin-induced anticoagulation or for treatment of bleeding associated with low levels of liver-dependent coagulation factors.
Safety and efficacy of factor IX (recombinant) for induction of immune tolerance in patients with hemophilia B not established.
Factor IX (Recombinant) Dosage and Administration
General
Initiate therapy under supervision of a clinician experienced in the treatment of hemophilia B.
Individualize dosage and duration of therapy based on patient's age, severity and location of bleeding, degree of factor IX deficiency, desired factor IX levels, presence of factor IX inhibitors, and clinical and pharmacokinetic (e.g., half-life, incremental recovery) response. (See Laboratory Monitoring under Cautions.)
Monitor factor IX activity (by one-stage clotting assay) to individualize dosage and assess response to therapy. (See Laboratory Monitoring under Cautions.)
Administration
IV Administration
Administer by slow (over several minutes) IV injection.
Has been given by continuous infusion†; however, manufacturers state that safety and efficacy of ...
