20:28.16 Hemostatics
Generic Name
Synonym
Coagulation factor IX (recombinant) is available as a lyophilized powder in preservative-free single-dose vials.3889; 3890; 3891 The drug should be reconstituted with the manufacturer-provided diluent according to the product labeling.3889; 3890; 3891 Prior to reconstitution, the drug and provided diluent should be allowed to come to room temperature.3889; 3890; 3891
Coagulation factor IX (recombinant) products are prepared from recombinant coagulation factor IX genes in cell lines derived from Chinese hamster ovary (CHO) cells; trace amounts of CHO proteins may be present.3889; 3890; 3891
BeneFIX: Coagulation factor IX (recombinant) (BeneFIX, Wyeth) is available in single-dose vials containing nominally 250, 500, 1000, 2000, or 3000 international units to be reconstituted with the manufacturer-provided sodium chloride diluent.3889 Each vial is packaged in a kit with a prefilled syringe containing 5 mL of sodium chloride 0.234% for reconstitution.3889 Following reconstitution, each vial contains the amount of coagulation factor IX (recombinant) stated on the vial label along with sodium chloride 0.234%, L-histidine 8 mM, sucrose 0.8%, glycine 208 mM, and polysorbate 80 0.004%.3889
Rixubis: Coagulation factor IX (recombinant) (Rixubis, Baxalta) is available in single-dose vials containing nominally 250, 500, 1000, 2000 or 3000 international units to be reconstituted with the manufacturer-provided sterile water for injection diluent.3890 Each vial is packaged in a kit with a vial containing 5 mL of sterile water for injection for reconstitution.3890 Following reconstitution, each vial contains the amount of coagulation factor IX (recombinant) stated on the vial label along with L-histidine 20 mM, sodium chloride 60 mM, calcium chloride 4 mM, mannitol 110 mM, sucrose 35 mM, and polysorbate 80 0.005%.3890
Ixinity: Coagulation factor IX (recombinant) (Ixinity, Medexus) is available in single-dose vials containing nominally 250, 500, 1000, 1500, 2000, or 3000 international units to be reconstituted with the manufacturer-provided sterile water for injection diluent.3891 Each vial is packaged in a kit with a prefilled syringe containing 5 mL of sterile water for injection for reconstitution.3891 Following reconstitution, each vial contains the amount of coagulation factor IX (recombinant) stated on the vial label along with histidine 10 mM, mannitol 3%, trehalose dihydrate 1%, sodium chloride 66 mM, and polysorbate 80 0.0075%.3891
Specific Activity
BeneFIX, Rixubis: At least 200 international units/mg of protein.3889; 3890
Trade Name(s)
BeneFIX, Rixubis, Ixinity
Coagulation factor IX (recombinant) is administered by intravenous bolus infusion following reconstitution.3889; 3890 Consult specific product labeling for details on infusion rates; some products are stated to have a maximum infusion rate of 10 mL/min.3890; 3891 Coagulation factor IX (recombinant) should not be mixed or administered in the same tubing or container with other drugs.3889; 3891
BeneFIX, Rixubis: The manufacturers state that safety and efficacy of administration by continuous infusion have not been established.3889; 3890
BeneFIX, Rixubis: White (BeneFIX) or white to almost white (Rixubis) lyophilized powder that forms a clear, colorless solution upon reconstitution with the provided diluent.3889; 3890 Intact containers of drug and diluent should be stored at 2 to 30°C.3889; 3890 Reconstituted solutions may be stored at room temperature and should be used within 3 hours.3889; 3890 Any unused solution should be discarded.3889; 3890
Solutions should be visually inspected for particulate matter and discoloration prior to administration; the solution should be discarded if discoloration or particulate matter is present.3889; 3890
Ixinity: White or almost white lyophilized powder that forms a clear, colorless solution upon reconstitution.3891 The 250-international unit vial should be stored at 2 to 8°C; the other strengths may be stored store at 2 to 25°C.3891 Reconstituted solutions should be stored at room temperature, not refrigerated, and should be used within 3 hours.3891 Any unused solution should be discarded.3891
Solutions should be visually inspected for particulate matter and discoloration prior to administration; the solution should be discarded if discoloration or particulate matter is present.3891
For a list of references cited in the text of this monograph, search the monograph titled References.