ADCETRIS is a CD30-directed antibody-drug conjugate indicated for treatment of patients with:

• Classical Hodgkin lymphoma (HL) after failure of autologous hematopoietic stem cell transplantation (auto-HSCT) or after failure of at least two prior multi-agent chemotherapy regimens in patients who are not auto-HSCT candidates (1.1).
• Classical HL at high risk of relapse or progression as post-auto-HSCT consolidation (1.2).
• Systemic anaplastic large cell lymphoma (sALCL) after failure of at least one prior multi-agent chemotherapy regimen (1.3).
  Accelerated approval was granted for the sALCL indication based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

• Administer only as an intravenous infusion over 30 minutes every 3 weeks.
• The recommended dose is 1.8 mg/kg (2).
• Reduce dose in patients with mild hepatic impairment (2).

For injection: 50 mg lyophilized powder in a single-use vial (3).
CONTRAINDICATIONS

Concomitant use with bleomycin due to pulmonary toxicity (4).
WARNINGS AND PRECAUTIONS

• Peripheral neuropathy: Monitor patients for neuropathy and institute dose modifications accordingly (5.1).
• Anaphylaxis and infusion reactions: If an infusion reaction occurs, interrupt the infusion.  If anaphylaxis occurs, immediately discontinue the infusion (5.2).
• Hematologic toxicities: Monitor complete blood counts prior to each dose of ADCETRIS.  Closely monitor patients for fever.  If Grade 3 or 4 neutropenia develops, consider dose delays, reductions, discontinuation, or G-CSF prophylaxis with subsequent doses (5.3).
• Serious infections and opportunistic infections: Closely monitor patients for the emergence of bacterial, fungal or viral infections (5.4).
• Tumor lysis syndrome: Closely monitor patients with rapidly proliferating tumor or high tumor burden (5.5).
• Hepatotoxicity: Monitor liver enzymes and bilirubin (5.8).
• Pulmonary Toxicity: Monitor patients for new or worsening symptoms (5.10).
• Serious dermatologic reactions: Discontinue if Stevens-Johnson syndrome or toxic epidermal necrolysis occurs (5.10).
• Embryo-fetal toxicity: Fetal harm can occur.  Advise pregnant women of the potential hazard to the fetus (5.12).

The most common adverse reactions (≥20%) were:

• Relapsed classical HL and relapsed sALCL: neutropenia, peripheral sensory neuropathy, fatigue, nausea, anemia, upper respiratory tract infection, diarrhea, pyrexia, rash, thrombocytopenia, cough, and vomiting (6.1).
• Classical HL post-auto-HSCT consolidation: neutropenia, peripheral sensory neuropathy, thrombocytopenia, anemia, upper respiratory tract infection, fatigue, peripheral motor neuropathy, nausea, cough, and diarrhea (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.

Concomitant use of strong CYP3A4 inhibitors or inducers, or P-gp inhibitors, has the potential to affect the exposure to monomethyl auristatin E (MMAE) (7.1).

Moderate or severe hepatic impairment or severe renal impairment: MMAE exposure and adverse reactions are increased.  Avoid use (5.6,  5.7,