Label: ADVATE (antihemophilic factor- recombinant kit

  • NDC Code(s): 0944-2941-01, 0944-2942-02, 0944-2943-02, 0944-2944-02, view more
  • Packager: Takeda Pharmaceuticals America, Inc.
  • Category: PLASMA DERIVATIVE
  • DEA Schedule: None
  • Marketing Status: Biologic Licensing Application

Drug Label Information

Updated April 3, 2025

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  • HIGHLIGHTS OF PRESCRIBING INFORMATION
    These highlights do not include all the information needed to use ADVATE® safely and effectively. See full prescribing information for ADVATE. ADVATE [antihemophilic factor (recombinant) ...
  • Table of Contents
    Table of Contents
  • 1 INDICATIONS AND USAGE
    ADVATE® [Antihemophilic Factor (Recombinant)] is a recombinant antihemophilic factor indicated for use in children and adults with hemophilia A (congenital factor VIII deficiency) for: Control ...
  • 2 DOSAGE AND ADMINISTRATION
    For intravenous injection after reconstitution only. 2.1 Dose - Dosage and duration of treatment depend on the severity of factor VIII deficiency, the location and extent of the bleeding, and ...
  • 3 DOSAGE FORMS AND STRENGTHS
    ADVATE is available as a lyophilized white to off-white powder in single-dose vials containing nominally 250, 500, 1000, 1500, 2000, 3000, or 4000 International Units (IU, unit). The 250 to 1500 ...
  • 4 CONTRAINDICATIONS
    ADVATE is contraindicated in patients who have life-threatening hypersensitivity reactions, including anaphylaxis, to mouse or hamster protein or other constituents of the product (mannitol ...
  • 5 WARNINGS AND PRECAUTIONS
    5.1 Hypersensitivity Reactions - Allergic-type hypersensitivity reactions, including anaphylaxis, have been reported with ADVATE. Symptoms include dizziness, paresthesia, rash, flushing, facial ...
  • 6 ADVERSE REACTIONS
    Serious adverse reactions seen with ADVATE are hypersensitivity reactions, including anaphylaxis, and the development of high-titer inhibitors necessitating alternative treatments to factor ...
  • 8 USE IN SPECIFIC POPULATIONS
    8.1 Pregnancy - Risk Summary - There are no data with ADVATE use in pregnant women to inform a drug-associated risk. Animal reproduction studies have not been conducted with ADVATE. It is not ...
  • 11 DESCRIPTION
    ADVATE [Antihemophilic Factor (Recombinant)] is a purified glycoprotein consisting of 2,332 amino acids that is synthesized by a genetically engineered Chinese hamster ovary (CHO) cell line but ...
  • 12 CLINICAL PHARMACOLOGY
    12.1 Mechanism of Action - ADVATE temporarily replaces the missing coagulation factor VIII that is needed for effective hemostasis. 12.2 Pharmacodynamics - The activated partial thromboplastin ...
  • 13 NONCLINICAL TOXICOLOGY
    13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility - No studies have been conducted with the active ingredient in ADVATE to assess its mutagenic or carcinogenic potential. RECOMBINATE was ...
  • 14 CLINICAL STUDIES
    Original Safety and Efficacy Study - A safety and efficacy trial evaluated the pharmacokinetics (double-blinded, randomized, crossover), safety, immunogenicity, and hemostatic efficacy ...
  • 15 REFERENCES
    Fischer K, Collins P, Björkman S, Blanchette V, Oh M, Fritsch S, Schroth P, Spotts G, Ewenstein B. Trends in bleeding patterns during prophylaxis for severe haemophilia: observations from a ...
  • 16 HOW SUPPLIED/STORAGE AND HANDLING
    How Supplied - ADVATE in a BAXJECT III system is packaged with 2 mL or 5 mL of Sterile Water for Injection, one Terumo Microbore Infusion set (2 mL only), one full prescribing physician insert ...
  • 17 PATIENT COUNSELING INFORMATION
    Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use). Advise patients to report any adverse reactions or problems following ADVATE ...
  • SPL UNCLASSIFIED SECTION
    Takeda Pharmaceuticals U.S.A., Inc. Cambridge, MA 02142 - U.S. License No. 1898 - ADVATE, BAXJECT and RECOMBINATE are registered trademarks of Baxalta Incorporated. Takeda and are registered ...
  • Patient Information
    ADVATE® (ad-vate) [Antihemophilic Factor (Recombinant)] This leaflet summarizes important information about ADVATE. Please read it carefully before using this medicine. This information does not ...
  • Instructions For Use
    ADVATE® [Antihemophilic Factor (Recombinant)] (For intravenous use only) Do not attempt to do an infusion to yourself unless you have been taught how by your healthcare provider or hemophilia ...
  • PRINCIPAL DISPLAY PANEL - 250 IU 2 mL Kit Carton
    ADVATE® [Antihemophilic Factor (Recombinant)] NDC 0944-3051-02 - Single-dose only - For Intravenous Administration Only - Rx Only - Lyophilized powder for reconstitution - ADVATE and diluent ...
  • PRINCIPAL DISPLAY PANEL - 250 IU 2 mL Blister Pack Label
    ADVATE® [Antihemophilic Factor (Recombinant)] NDC 0944-3051-03 - For Intravenous Administration Only - ADVATE and diluent preassembled in - BAXJECT® III system - Do not open until time of use - Do not ...
  • PRINCIPAL DISPLAY PANEL - 250 IU 2 mL Container Label
    ADVATE® [Antihemophilic Factor (Recombinant)] For Intravenous Administration Only - Rx Only - ADVATE and diluent preassembled in BAXJECT® III system - Directions for use: see package ...
  • PRINCIPAL DISPLAY PANEL - 500 IU 2 mL Kit Carton
    ADVATE® [Antihemophilic Factor (Recombinant)] NDC 0944-3052-02 - Single-dose only - For Intravenous Administration Only - Rx Only - Lyophilized powder for reconstitution - ADVATE and diluent ...
  • PRINCIPAL DISPLAY PANEL - 500 IU 2 mL Blister Pack Label
    ADVATE® [Antihemophilic Factor (Recombinant)] NDC 0944-3052-03 - For Intravenous Administration Only - ADVATE and diluent preassembled in - BAXJECT® III system - Do not open until time of use - Do not ...
  • PRINCIPAL DISPLAY PANEL - 500 IU 2 mL Container Label
    ADVATE® [Antihemophilic Factor (Recombinant)] For Intravenous Administration Only - Rx Only - ADVATE and diluent preassembled in BAXJECT® III system - Directions for use: see package ...
  • PRINCIPAL DISPLAY PANEL - 1000 IU 2 mL Kit Carton
    ADVATE® [Antihemophilic Factor (Recombinant)] NDC 0944-3053-02 - Single-dose only - For Intravenous Administration Only - Rx Only - Lyophilized powder for reconstitution - ADVATE and diluent ...
  • PRINCIPAL DISPLAY PANEL - 1000 IU 2 mL Blister Pack Label
    ADVATE® [Antihemophilic Factor (Recombinant)] NDC 0944-3053-03 - For Intravenous Administration Only - ADVATE and diluent preassembled in - BAXJECT® III system - Do not open until time of use - Do not ...
  • PRINCIPAL DISPLAY PANEL - 1000 IU 2 mL Container Label
    ADVATE® [Antihemophilic Factor (Recombinant)] For Intravenous Administration Only - Rx Only - ADVATE and diluent preassembled in BAXJECT® III system - Directions for use: see package ...
  • PRINCIPAL DISPLAY PANEL - 1500 IU 2 mL Kit Carton
    ADVATE® [Antihemophilic Factor (Recombinant)] NDC 0944-3054-02 - Single-dose only - For Intravenous Administration Only - Rx Only - Lyophilized powder for reconstitution - ADVATE and diluent ...
  • PRINCIPAL DISPLAY PANEL - 1500 IU 2 mL Blister Pack Label
    ADVATE® [Antihemophilic Factor (Recombinant)] NDC 0944-3054-03 - For Intravenous Administration Only - ADVATE and diluent preassembled in - BAXJECT® III system - Do not open until time of use - Do not ...
  • PRINCIPAL DISPLAY PANEL - 1500 IU 2 mL Container Label
    ADVATE® [Antihemophilic Factor (Recombinant)] For Intravenous Administration Only - Rx Only - ADVATE and diluent preassembled in BAXJECT® III system - Directions for use: see package ...
  • PRINCIPAL DISPLAY PANEL - 2000 IU 5 mL Kit Carton
    ADVATE® [Antihemophilic Factor (Recombinant)] NDC 0944-3045-10 - Single-dose only - For Intravenous Administration Only - Rx Only - Lyophilized powder for reconstitution - ADVATE and diluent ...
  • PRINCIPAL DISPLAY PANEL - 2000 IU 5 mL Blister Pack Label
    ADVATE® [Antihemophilic Factor (Recombinant)] NDC 0944-3045-11 - For Intravenous Administration Only - ADVATE and diluent preassembled in - BAXJECT® III system - Do not open until time of use - Do not ...
  • PRINCIPAL DISPLAY PANEL - 2000 IU 5 mL Container Label
    ADVATE® [Antihemophilic Factor (Recombinant)] For Intravenous Administration Only - Rx Only - ADVATE and diluent preassembled in BAXJECT® III system - Directions for use: see package ...
  • PRINCIPAL DISPLAY PANEL - 3000 IU 5 mL Kit Carton
    ADVATE® [Antihemophilic Factor (Recombinant)] NDC 0944-3046-10 - Single-dose only - For Intravenous Administration Only - Rx Only - Lyophilized powder for reconstitution - ADVATE and diluent ...
  • PRINCIPAL DISPLAY PANEL - 3000 IU 5 mL Blister Pack Label
    ADVATE® [Antihemophilic Factor (Recombinant)] NDC 0944-3046-11 - For Intravenous Administration Only - ADVATE and diluent preassembled in - BAXJECT® III system - Do not open until time of use - Do not ...
  • PRINCIPAL DISPLAY PANEL - 3000 IU 5 mL Container Label
    ADVATE® [Antihemophilic Factor (Recombinant)] For Intravenous Administration Only - Rx Only - ADVATE and diluent preassembled in BAXJECT® III system - Directions for use: see package ...
  • PRINCIPAL DISPLAY PANEL - 4000 IU 5 mL Kit Carton
    ADVATE® [Antihemophilic Factor (Recombinant)] NDC 0944-3047-10 - Single-dose only - For Intravenous Administration Only - Rx Only - Lyophilized powder for reconstitution - ADVATE and diluent ...
  • PRINCIPAL DISPLAY PANEL - 4000 IU 5 mL Blister Pack Label
    ADVATE® [Antihemophilic Factor (Recombinant)] NDC 0944-3047-11 - For Intravenous Administration Only - ADVATE and diluent preassembled in - BAXJECT® III system - Do not open until time of use - Do not ...
  • PRINCIPAL DISPLAY PANEL - 4000 IU 5 mL Container Label
    ADVATE® [Antihemophilic Factor (Recombinant)] For Intravenous Administration Only - Rx Only - ADVATE and diluent preassembled in BAXJECT® III system - Directions for use: see package ...
  • PRINCIPAL DISPLAY PANEL - Advate Vial Label
    Antihemophilic Factor (Recombinant) Takeda - 0754067 - Lot No.:
  • PRINCIPAL DISPLAY PANEL - Sterile Water for Injection Vial Label
    Sterile Water for Injection - Lot No.: Siegfried Hameln GmbH - 0742211
  • INGREDIENTS AND APPEARANCE
    Product Information