Label: GAZYVA- obinutuzumab injection, solution, concentrate

  • NDC Code(s): 50242-070-01, 50242-070-86
  • Packager: Genentech, Inc.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Biologic Licensing Application

Drug Label Information

Updated August 23, 2023

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  • HIGHLIGHTS OF PRESCRIBING INFORMATION
    These highlights do not include all the information needed to use GAZYVA safely and effectively. See full prescribing information for GAZYVA. GAZYVA® (obinutuzumab) injection, for intravenous use ...
  • Table of Contents
    Table of Contents
  • BOXED WARNING (What is this?)

    WARNING: HEPATITIS B VIRUS REACTIVATION and PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY

    • Hepatitis B Virus (HBV) reactivation, in some cases resulting in fulminant hepatitis, hepatic failure, and death, can occur in patients receiving CD20-directed cytolytic antibodies, including GAZYVA. Screen all patients for HBV infection before treatment initiation. Monitor HBV-positive patients during and after treatment with GAZYVA. Discontinue GAZYVA and concomitant medications in the event of HBV reactivation [see Warnings and Precautions (5.1)].
    • Progressive Multifocal Leukoencephalopathy (PML) including fatal PML, can occur in patients receiving GAZYVA [see Warnings and Precautions (5.2)].
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  • 1 INDICATIONS AND USAGE
    1.1 Chronic Lymphocytic Leukemia (CLL) GAZYVA, in combination with chlorambucil, is indicated for the treatment of patients with previously untreated chronic lymphocytic leukemia. 1.2 ...
  • 2 DOSAGE AND ADMINISTRATION
    2.1 Important Dosing Information - Premedicate before each infusion [see Dosage and Administration (2.4)]. Provide prophylactic hydration and anti-hyperuricemics to patients at high risk of ...
  • 3 DOSAGE FORMS AND STRENGTHS
    Injection: 1,000 mg/40 mL (25 mg/mL) clear, colorless to slightly brown solution in single-dose vial.
  • 4 CONTRAINDICATIONS
    GAZYVA is contraindicated in patients with known hypersensitivity reactions (e.g., anaphylaxis) to obinutuzumab or to any of the excipients, or serum sickness with prior obinutuzumab use [see ...
  • 5 WARNINGS AND PRECAUTIONS
    5.1 Hepatitis B Virus Reactivation - Hepatitis B virus (HBV) reactivation, in some cases resulting in fulminant hepatitis, hepatic failure, and death, can occur in patients treated with anti-CD20 ...
  • 6 ADVERSE REACTIONS
    The following clinically significant adverse reactions are described elsewhere in the labeling: Hepatitis B virus reactivation [see Warnings and Precautions (5.1)] Progressive multifocal ...
  • 8 USE IN SPECIFIC POPULATIONS
    8.1 Pregnancy - Risk Summary - Based on findings from animal studies and its mechanism of action, GAZYVA can cause fetal B-cell depletion [see Clinical Pharmacology (12.1)]. There are no data ...
  • 10 OVERDOSAGE
    There has been no experience with overdose in human clinical trials. For patients who experience overdose, treatment should consist of immediate interruption or reduction of GAZYVA and supportive ...
  • 11 DESCRIPTION
    Obinutuzumab is a humanized anti-CD20 monoclonal antibody of the IgG1 subclass. It recognizes a specific epitope of the CD20 molecule found on B cells. The molecular mass of the antibody is ...
  • 12 CLINICAL PHARMACOLOGY
    12.1 Mechanism of Action - Obinutuzumab is a monoclonal antibody that targets the CD20 antigen expressed on the surface of pre-B and mature B lymphocytes. Upon binding to CD20, obinutuzumab ...
  • 13 NONCLINICAL TOXICOLOGY
    13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility - No carcinogenicity or genotoxicity studies have been conducted with obinutuzumab. No specific studies have been conducted to evaluate ...
  • 14 CLINICAL STUDIES
    14.1 Chronic Lymphocytic Leukemia - The efficacy of GAZYVA was evaluated in a three-arm, open-label, active-controlled, randomized, multicenter trial (CLL11; NCT01010061) in 781 patients with ...
  • 16 HOW SUPPLIED/STORAGE AND HANDLING
    GAZYVA is a clear, colorless to slightly brown, preservative-free solution for intravenous use supplied as 1,000 mg/40 mL (25 mg/mL) in single-dose vials (NDC 50242-070-01). Store at 2°C to 8°C ...
  • 17 PATIENT COUNSELING INFORMATION
    Advise patients to seek immediate medical attention for any of the following: Signs and symptoms of infusion-related reactions including dizziness, nausea, chills, fever, vomiting, diarrhea ...
  • SPL UNCLASSIFIED SECTION
    GAZYVA® (obinutuzumab) Manufactured by: Genentech, Inc. A Member of the Roche Group - South San Francisco, CA 94080-4990 - U.S. License No. 1048 - GAZYVA is a registered trademark of Genentech ...
  • SPL UNCLASSIFIED SECTION
    Representative sample of labeling (see the HOW SUPPLIED section for complete listing):
  • PRINCIPAL DISPLAY PANEL - 40 mL Vial Carton
    NDC 50242-070-01 - Gazyva® (obinutuzumab) Injection - 1000 mg/40 mL - (25 mg/mL) For Intravenous Infusion After Dilution. Single-Dose Vial. Discard Unused Portion. No preservative. 1 vial - Rx ...
  • INGREDIENTS AND APPEARANCE
    Product Information