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 intravenous infusion
Initial U.S. Approval: 2011
INDICATIONS AND USAGE
ADCETRIS is a CD30-directed antibody-drug conjugate indicated for:
The treatment of patients with Hodgkin lymphoma after failure of autologous stem cell transplant (ASCT) or after failure of at least two prior multi-agent chemotherapy regimens in patients who are not ASCT candidates(1.1).
The treatment of patients with systemic anaplastic large cell lymphoma after failure of at least one prior multi-agent chemotherapy regimen (1.2).
These indications are based on response rate. There are no data available demonstrating improvement in patient reported outcomes or survival with ADCETRIS.
DOSAGE AND ADMINISTRATION
The recommended dose is 1.8 mg/kg administered only as an intravenous infusion over 30 minutes every 3 weeks (2).
Continue treatment until a maximum of 16 cycles, disease progression or unacceptable toxicity.
DOSAGE FORMS AND STRENGTHS
50 mg single-use vial (3).
CONTRAINDICATIONS
None (4).
WARNINGS AND PRECAUTIONS
Peripheral neuropathy: Treating physicians should monitor patients for neuropathy and institute dose modifications accordingly (5.1).
Infusion reactions: If an infusion reaction occurs, the infusion should be interrupted and appropriate medical management instituted. If anaphylaxis occurs, the infusion should be discontinued immediately and appropriate medical management instituted (5.2).
Neutropenia: Monitor complete blood counts prior to each dose of ADCETRIS. If Grade 3 or 4 neutropenia develops, manage by dose delays, reductions or discontinuation (5.3).
Tumor Lysis Syndrome: Patients with rapidly proliferating tumor and high tumor burden are at risk of tumor lysis syndrome and these patients should be monitored closely and appropriate measures taken (5.4).
Stevens-Johnson syndrome: If Stevens-Johnson syndrome occurs, discontinue ADCETRIS and administer appropriate medical therapy (5.5).
Progressive Multifocal Leukoencephalopathy (PML): A fatal case of PML has been reported in a patient who received 4 chemotherapy regimens prior to receiving ADCETRIS (5.6).
Use in pregnancy: Fetal harm can occur. Pregnant women should be advised of the potential hazard to the fetus (5.7).
ADVERSE REACTIONS
The most common adverse reactions (≥20%) are neutropenia, peripheral sensory neuropathy, fatigue, nausea, anemia, upper respiratory tract infection, diarrhea, pyrexia, rash, thrombocytopenia, cough, and vomiting (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Seattle Genetics, Inc. at 1-855-473-2436 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
DRUG INTERACTIONS
Patients who are receiving strong CYP3A4 inhibitors concomitantly with ADCETRIS should be closely monitored for adverse reactions (7.1).
USE IN SPECIFIC POPULATIONS
None (8).
See 17 for PATIENT COUNSELING INFORMATION 
Revised: 08/2011
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1 INDICA