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).