"The European Medicines Agency (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) has started a review of factor VIII-containing products to evaluate the risk of neutralizing antifactor VIII alloantibodies (inhibitors) developing in patients"...
[Coagulation Factor IX (Recombinant), Fc Fusion Protein], Lyophilized Powder for Solution For Intravenous Injection
Coagulation Factor IX (Recombinant), Fc Fusion Protein [rFIXFc], the active ingredient in ALPROLIX™, is a fully recombinant coagulation Factor IX protein consisting of the human coagulation Factor IX sequence covalently linked to the Fc domain of human immunoglobulin G1 (IgG1). The Factor IX portion of rFIXFc has a primary amino acid sequence that is identical to the Thr148 allelic form of plasma derived Factor IX and has structural and functional properties similar to endogenous Factor IX. The Fc domain of rFIXFc contains the hinge, CH2, and CH3 regions of IgG1. rFIXFc contains 867 amino acids with a molecular weight of approximately 98 kilodaltons.
ALPROLIX™ is not derived from human blood and contains no preservatives. The recombinant Factor IX Fc fusion protein is expressed in a human embryonic kidney (HEK) cell line, which produces rFIXFc into a defined cell culture medium that does not contain proteins derived from animal or human sources. The purification process for rFIXFc does not include use of a monoclonal antibody reagent. To enhance viral safety, the purification process incorporates a nanofiltration step and a column chromatography purification step that have been validated for viral clearance. The content of activated Factor IX Fc fusion protein (FIXaFc) is limited to ≤ 0.035 mole percent FIXaFc/FIXFc.
ALPROLIX™ is a sterile, non-pyrogenic, preservative-free, white to off-white, lyophilized powder to cake for reconstitution with the provided diluent, for intravenous injection. After reconstitution, the solution has a clear to slightly opalescent appearance and contains the excipients: sucrose, mannitol, sodium chloride, L-histidine and polysorbate 20. ALPROLIX™ is available in single-use vials containing the labeled amount of Factor IX activity, expressed in international units. Each vial contains nominally 500 IU, 1000 IU, 2000 IU or 3000 IU.
Last reviewed on RxList: 1/11/2017
This monograph has been modified to include the generic and brand name in many instances.
Additional Alprolix Information
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