Страна: Соединенные Штаты
Язык: английский
Источник: NLM (National Library of Medicine)
SUSOCTOCOG ALFA (UNII: 6892UQT2GK) (SUSOCTOCOG ALFA - UNII:6892UQT2GK)
Takeda Pharmaceuticals America, Inc.
SUSOCTOCOG ALFA
SUSOCTOCOG ALFA 500 [USP'U] in 1 mL
OBIZUR, Antihemophilic Factor (Recombinant), Porcine Sequence, is a recombinant DNA derived, antihemophilic factor indicated for the on-demand treatment and control of bleeding episodes in adults with acquired hemophilia A. Limitations of Use: - Safety and efficacy of OBIZUR has not been established in patients with baseline anti-porcine factor VIII inhibitor titer greater than 20 BU. - OBIZUR is not indicated for the treatment of von Willebrand disease. OBIZUR is contraindicated in patients: - Who have had life-threatening hypersensitivity reactions to OBIZUR or its components (including traces of hamster proteins). - With congenital hemophilia A with inhibitors (CHAWI) due to the high incidence of anamnestic reactions to human factor VIII (hFVIII) and porcine factor VIII (pFVIII) [see Adverse Reactions (6.1)] . Risk Summary There are no data with OBIZUR use in pregnant women to inform a drug-associated risk. There are no adequate and well-controlled studies in pregnant women. Animal reproduction studies ha
How Supplied OBIZUR is supplied as a white lyophilized powder in single-dose vials in the following package size: Each package contains one package insert and one of each of the components listed below: The actual amount of OBIZUR in units is stated on the label of each vial. Not made with natural rubber latex. Storage and Handling
Biologic Licensing Application
OBIZUR- ANTIHEMOPHILIC FACTOR (RECOMBINANT), PORCINE SEQUENCE TAKEDA PHARMACEUTICALS AMERICA, INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE OBIZUR SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR OBIZUR. OBIZUR [ANTIHEMOPHILIC FACTOR (RECOMBINANT), PORCINE SEQUENCE] LYOPHILIZED POWDER FOR SOLUTION FOR INTRAVENOUS INJECTION INITIAL U.S. APPROVAL: 2014 RECENT MAJOR CHANGES Contraindications (4) 2/2023 INDICATIONS AND USAGE OBIZUR, Antihemophilic Factor (Recombinant), Porcine Sequence, is an antihemophilic factor indicated for the on-demand treatment and control of bleeding episodes in adults with acquired hemophilia A. (1) Limitations of Use: Safety and efficacy of OBIZUR has not been established in patients with a baseline anti-porcine factor VIII inhibitor titer of greater than 20 BU. (1) OBIZUR is not indicated for the treatment of von Willebrand disease. (1) DOSAGE AND ADMINISTRATION FOR INTRAVENOUS USE AFTER RECONSTITUTION ONLY. Initial dose of OBIZUR is 200 units per kg. (2.1) Titrate dose and frequency of administration based on factor VIII recovery levels and individual clinical response. (2.1) Initial dosing below the recommended 200 U/kg has been associated with lack of efficacy. (2.1) DOSAGE FORMS AND STRENGTHS OBIZUR is available as lyophilized powder for solution in single-dose vials containing nominally 500 units per vial. (3) CONTRAINDICATIONS Patients who have had life-threatening hypersensitivity reactions to OBIZUR or its components, including hamster protein. (4) Patients with congenital hemophilia A with inhibitors (4) WARNINGS AND PRECAUTIONS Hypersensitivity reactions, including anaphylaxis, may occur. Should symptoms occur, discontinue OBIZUR and administer appropriate treatment. (5.1) Development of inhibitory antibodies to OBIZUR has occurred and may result in a lack of efficacy. (5.2) Anamnestic reactions with rise in human factor VIII and/or recombinant factor VIII, porcine sequence inhibitors have occur Прочитать полный документ