Label: ADCETRIS- brentuximab vedotin injection, powder, lyophilized, for solution

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Biologic Licensing Application

Drug Label Information

Updated February 19, 2025

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

    WARNING: PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY (PML)

    JC virus infection resulting in PML and death can occur in patients receiving ADCETRIS [see Warnings and Precautions (5.9), Adverse Reactions (6.1)].

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  • 1 INDICATIONS AND USAGE
    1.1 Previously Untreated Stage III or IV Classical Hodgkin Lymphoma (cHL), in Combination with Chemotherapy - ADCETRIS is indicated for the treatment of adult patients with previously untreated ...
  • 2 DOSAGE AND ADMINISTRATION
    2.1 Recommended Dosage - The recommended ADCETRIS dosage is provided in Table 1. Administer ADCETRIS as a 30-minute intravenous infusion. For recommended dosage for patients with renal or hepatic ...
  • 3 DOSAGE FORMS AND STRENGTHS
    For injection: 50 mg of brentuximab vedotin as a sterile, white to off-white lyophilized, preservative-free cake or powder in a single-dose vial for reconstitution.
  • 4 CONTRAINDICATIONS
    ADCETRIS is contraindicated with concomitant bleomycin due to pulmonary toxicity (e.g., interstitial infiltration and/or inflammation) [see Adverse Reactions (6.1)].
  • 5 WARNINGS AND PRECAUTIONS
    5.1 Peripheral Neuropathy - ADCETRIS treatment causes a peripheral neuropathy that is predominantly sensory. Cases of peripheral motor neuropathy have also been reported. ADCETRIS-induced ...
  • 6 ADVERSE REACTIONS
    The following clinically significant adverse reactions are described elsewhere in the labeling: • Peripheral Neuropathy [see Warnings and Precautions (5.1)] • Anaphylaxis and Infusion Reactions ...
  • 7 DRUG INTERACTIONS
    7.1 Effect of Other Drugs on ADCETRIS - CYP3A4 Inhibitors: Co-administration of ADCETRIS with ketoconazole, a potent CYP3A4 inhibitor, increased exposure to MMAE [see Clinical Pharmacology ...
  • 8 USE IN SPECIFIC POPULATIONS
    8.1 Pregnancy - Risk Summary - ADCETRIS can cause fetal harm based on the findings from animal studies and the drug’s mechanism of action [see Clinical Pharmacology (12.1)]. In animal ...
  • 10 OVERDOSAGE
    There is no known antidote for overdosage of ADCETRIS. In case of overdosage, the patient should be closely monitored for adverse reactions, particularly neutropenia, and supportive treatment ...
  • 11 DESCRIPTION
    ADCETRIS (brentuximab vedotin) is a CD30-directed antibody and microtubule inhibitor conjugate consisting of three components: 1) the chimeric IgG1 antibody cAC10, specific for human CD30, 2) the ...
  • 12 CLINICAL PHARMACOLOGY
    12.1 Mechanism of Action - CD30 is a member of the tumor necrosis factor receptor family and is expressed on the surface of sALCL cells and on Hodgkin Reed-Sternberg (HRS) cells in cHL. CD30 is ...
  • 13 NONCLINICAL TOXICOLOGY
    13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility - Carcinogenicity studies with brentuximab vedotin or the small molecule (MMAE) have not been conducted. MMAE was genotoxic in the rat ...
  • 14 CLINICAL STUDIES
    14.1 Classical Hodgkin Lymphoma - Randomized Clinical Trial in Previously Untreated Stage III or IV Classical Hodgkin Lymphoma (Study 5: ECHELON-1, NCT01712490) The efficacy of ADCETRIS in ...
  • 15 REFERENCES
    1. OSHA Hazardous Drugs. OSHA. [Accessed on 30 July 2013, from http://www.osha.gov/SLTC/hazardousdrugs/index.html]
  • 16 HOW SUPPLIED/STORAGE AND HANDLING
    How Supplied - ADCETRIS (brentuximab vedotin) for Injection is supplied as a sterile, white to off-white preservative-free lyophilized cake or powder in individually-boxed single-dose ...
  • 17 PATIENT COUNSELING INFORMATION
    Peripheral Neuropathy - Advise patients that ADCETRIS can cause a peripheral neuropathy. They should be advised to report to their health care provider any numbness or tingling of the hands or ...
  • PACKAGE LABEL
    NDC 51144-050-01 - ADCETRIS® (brentuximab vedotin)  FOR INJECTION - 50 mg/vial - Single-dose vial. Discard unused portion. Reconstitution and dilution required - For intravenous use only ...
  • INGREDIENTS AND APPEARANCE
    Product Information