Label: TRUXIMA- rituximab-abbs injection, solution

  • NDC Code(s): 63459-103-10, 63459-104-50
  • Packager: Cephalon, Inc.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Biologic Licensing Application

Drug Label Information

Updated December 20, 2024

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  • HIGHLIGHTS OF PRESCRIBING INFORMATION
    These highlights do not include all the information needed to use TRUXIMA safely and effectively. See full prescribing information for TRUXIMA. TRUXIMA® (rituximab-abbs) injection, for intravenous ...
  • Table of Contents
    Table of Contents
  • BOXED WARNING (What is this?)
    Infusion-Related Reactions - Administration of rituximab products, including TRUXIMA, can result in serious, including fatal, infusion-related reactions. Deaths within 24 hours of rituximab ...

    WARNING: FATAL INFUSION-RELATED REACTIONS, SEVERE MUCOCUTANEOUS REACTIONS, HEPATITIS B VIRUS REACTIVATION and PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY (PML)

    Infusion-Related Reactions

    Administration of rituximab products, including TRUXIMA, can result in serious, including fatal, infusion-related reactions. Deaths within 24 hours of rituximab infusion have occurred. Approximately 80% of fatal infusion-related reactions occurred in association with the first infusion. Monitor patients closely. Discontinue TRUXIMA infusion for severe reactions and provide medical treatment for Grade 3 or 4 infusion-related reactions [see Warnings and Precautions (5.1), Adverse Reactions (6.1)].

    Severe Mucocutaneous Reactions

    Severe, including fatal, mucocutaneous reactions can occur in patients receiving rituximab products [see Warnings and Precautions (5.2)].

    Hepatitis B Virus (HBV) Reactivation

    HBV reactivation can occur in patients treated with rituximab products, in some cases resulting in fulminant hepatitis, hepatic failure, and death. Screen all patients for HBV infection before treatment initiation, and monitor patients during and after treatment with TRUXIMA. Discontinue TRUXIMA and concomitant medications in the event of HBV reactivation [see Warnings and Precautions (5.3)].

    Progressive Multifocal Leukoencephalopathy (PML), including fatal PML, can occur in patients receiving rituximab products [see Warnings and Precautions (5.4) and Adverse Reactions (6.1)].

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  • 1 INDICATIONS AND USAGE
    1.1 Non–Hodgkin's Lymphoma (NHL) TRUXIMA (rituximab-abbs) is indicated for the treatment of adult patients with: Relapsed or refractory, low-grade or follicular, CD20-positive, B-cell NHL as a ...
  • 2 DOSAGE AND ADMINISTRATION
    2.1 Important Dosing Information - Administer only as an Intravenous Infusion [see Dosage and Administration (2.8)]. Do not administer as an intravenous push or bolus. TRUXIMA should only be ...
  • 3 DOSAGE FORMS AND STRENGTHS
    Injection: TRUXIMA is a clear to opalescent, colorless to pale yellow solution for intravenous infusion: 100 mg/10 mL (10 mg/mL) in a single-dose vial - 500 mg/50 mL (10 mg/mL) in a single-dose ...
  • 4 CONTRAINDICATIONS
    None.
  • 5 WARNINGS AND PRECAUTIONS
    5.1 Infusion-Related Reactions - Rituximab products can cause severe, including fatal, infusion-related reactions. Severe reactions typically occurred during the first infusion with time to onset ...
  • 6 ADVERSE REACTIONS
    The following clinically significant adverse reactions are discussed in greater detail in other sections of the labeling: Infusion-related reactions [see Warnings and Precautions (5.1)] Severe ...
  • 7 DRUG INTERACTIONS
    Formal drug interaction studies have not been performed with rituximab products. In patients with CLL, rituximab did not alter systemic exposure to fludarabine or cyclophosphamide. In clinical ...
  • 8 USE IN SPECIFIC POPULATIONS
    8.1 Pregnancy - Risk Summary - Based on human data, rituximab products can cause adverse developmental outcomes including B-cell lymphocytopenia in infants exposed to in-utero [see Clinical ...
  • 11 DESCRIPTION
    Rituximab-abbs is a genetically engineered chimeric murine/human monoclonal IgG1 kappa antibody directed against the CD20 antigen. Rituximab-abbs has an approximate molecular weight of 145 ...
  • 12 CLINICAL PHARMACOLOGY
    12.1 Mechanism of Action - Rituximab-abbs is a monoclonal antibody. Rituximab products target the CD20 antigen expressed on the surface of pre-B and mature B-lymphocytes. Upon binding to CD20 ...
  • 13 NONCLINICAL TOXICOLOGY
    13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility - No long-term animal studies have been performed to establish the carcinogenic or mutagenic potential of rituximab products or to ...
  • 14 CLINICAL STUDIES
    14.1 Relapsed or Refractory, Low-Grade or Follicular, CD20-Positive, B-Cell NHL - The safety and effectiveness of rituximab in relapsed, refractory CD20+ NHL were demonstrated in 3 single-arm ...
  • 16 HOW SUPPLIED/STORAGE AND HANDLING
    TRUXIMA (rituximab-abbs) injection is a sterile, clear to opalescent, colorless to pale yellow, preservative-free solution for intravenous infusion supplied as a carton containing one 100 mg/10 ...
  • 17 PATIENT COUNSELING INFORMATION
    Advise the patient to read the FDA-approved patient labeling (Medication Guide). Infusion-Related Reactions - Inform patients about the signs and symptoms of infusion-related reactions. Advise ...
  • SPL UNCLASSIFIED SECTION
    TRUXIMA® [rituximab-abbs] TRUXIMA® is a registered trademark of CELLTRION, Inc - Manufactured by: CELLTRION, Inc. 20, Academy-ro 51 beon-gil, Yeonsu-gu, Incheon - 22014, Republic of Korea - US ...
  • MEDICATION GUIDE
    This Medication Guide has been approved by the U.S. Food and Drug Administration - Revised: 03/2020 - MEDICATION GUIDE - TRUXIMA® (trux-ee'-mah) (rituximab-abbs) injection - What is ...
  • PRINCIPAL DISPLAY PANEL - 100mg Vial Carton
    NDC 63459-103-10 - Truxima® (rituximiab-abbs) Injection - 100 mg/10 mL - (10 mg/mL) For Intravenous Use - after Dilution - One single-dose vial. Discard unused portion. ATTENTION PHARMACIST: PROVIDE ...
  • PRINCIPAL DISPLAY PANEL - 500 mg Vial Carton
    NDC 63459-104-50 Truxima® (rituximiab-abbs) Injection - 500 mg/50 mL (10 mg/mL) For Intravenous Use after Dilution One single-dose vial. Discard unused portion. ATTENTION PHARMACIST: PROVIDE ...
  • INGREDIENTS AND APPEARANCE
    Product Information