重组凝血因子Ⅸ Alprolix.pdf

HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all of the information needed to use _____________ DOSAGE FORMS AND STRENGTHS______________ ALPROLIX™ safely and effectively. See full prescribing information for ALPROLIX™ is available as a lyophilized powder in single use vials ALPROLIX™ containing nominally 500, 1000, 2000, or 3000 international units (IU). (3) ALPROLIX™ [Coagulation Factor IX (Recombinant), Fc Fusion ___________________ CONTRAINDICATIONS ___________________ Protein], Lyophilized Powder for Solution For Intravenous Injection. Do not use in individuals who have a known history of hypersensitivity Initial U.S. Approval: [2014] reactions, including anaphylaxis, to the product or its excipients. (4) __________________ INDICATIONS AND USAGE _________________ _______________WARNINGS AND PRECAUTIONS _______________ ALPROLIX™, Coagulation Factor IX (Recombinant), Fc Fusion Protein, is a • Hypersensitivity reactions, including anaphylaxis, may occur. recombinant DNA derived, coagulation Factor IX concentrate indicated in Should symptoms occur, discontinue ALPROLIX™ and adults and children with hemophilia B for: administer appropriate treatment. (5.1) • Control and prevention of bleeding episodes, • Development of neutralizing antibodies (inhibitors) to • Perioperative management, ALPROLIX™ may occur. Perform an assay that measures Factor • Routine prophylaxis to prevent or reduce the frequency of bleedin