Leukemias, lymphomas, and other hematologic cancers:

Indications for: ADCETRIS

Previously untreated Stage III or IV classical Hodgkin lymphoma (cHL), in combination with doxorubicin, vinblastine, and dacarbazine. Treatment of cHL in patients at high risk of relapse or progression as post-autologous hematopoietic stem cell transplant (auto-HSCT) consolidation. Treatment of cHL after failure of auto-HSCT or after failure of ≥2 prior multi-agent chemotherapy regimens in patients who are not auto-HSCT candidates. Previously untreated systemic anaplastic large cell lymphoma (sALCL) or other CD30-expressing peripheral T-cell lymphomas (PTCL), including angioimmunoblastic T-cell lymphoma and PTCL not otherwise specified, in combination with cyclophosphamide, doxorubicin, and prednisone. Treatment of sALCL after failure of ≥1 prior multi-agent chemotherapy regimen. Primary cutaneous anaplastic large cell lymphoma (pcALCL) or CD30-expressing mycosis fungoides (MF) in patients who have received prior systemic therapy.

Adult Dosage:

Give by IV infusion over 30mins. Premedicate patients with prior infusion-related reaction with APAP, antihistamine, and corticosteroid for subsequent doses. Untreated Stage III/IV (intiate G-CSF starting with Cycle 1): 1.2mg/kg up to max 120mg/dose every 2 weeks; continue until max 12 doses, disease progression or unacceptable toxicity. Untreated sALCL or PTCL: 1.8mg/kg up to max 180mg/dose every 3 weeks with each cycle of chemotherapy for 6–8 doses; for PTCL: initiate G-CSF starting with Cycle 1. Others: 1.8mg/kg up to max 180mg/dose every 3 weeks; continue until disease progression or unacceptable toxicity. cHL consolidation: initiate within 4–6 weeks post-auto-HSCT or upon recovery from auto-HSCT; max 16 cycles. MF or pcALCL: max 16 cycles. Mild hepatic impairment (Child-Pugh A): (untreated Stage III/IV): 0.9mg/kg up to max 90mg every 2 weeks; (others): 1.2mg/kg up to 120mg every 3 weeks. Dose modifications: see full labeling.

Children Dosage:

Not established.

ADCETRIS Contraindications:

Concomitant bleomycin.

Boxed Warning:

Progressive multifocal leukoencephalopathy (PML).

ADCETRIS Warnings/Precautions:

Risk of JC virus infection. Monitor for progressive multifocal leukoencephalopathy (PML); withhold dose if suspected and discontinue if confirmed. Monitor for neuropathy; delay, change dose, or discontinue if new or worsening symptoms occur. Monitor for infusion-related reactions; permanently discontinue and treat if anaphylaxis occurs. Monitor CBCs prior to each dose and frequently for fever or Grade 3 or 4 neutropenia; delay, reduce, discontinue dose or consider G-CSF prophylaxis if develops. Increased risk of tumor lysis syndrome in rapidly proliferating tumor/high tumor burden patients; monitor closely. Monitor for emergence of bacterial, fungal, or viral infections. Monitor for pulmonary toxicity; if symptoms occur, withhold dose during evaluation and until improvement. Monitor liver enzymes and bilirubin; delay, change dose, or discontinue if hepatotoxicity occurs. Severe renal impairment (CrCl <30mL/min) or moderate or severe hepatic (Child-Pugh B/C) impairment: avoid. Discontinue if serious skin reactions (eg, SJS, TEN) occur. GI complications: evaluate and treat if new or worsening GI symptoms develop. Embryo-fetal toxicity. Females and males of reproductive potential should use effective contraception during and for ≥6 months after final dose. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended.

ADCETRIS Classification:

CD30-directed antibody-drug conjugate.

ADCETRIS Interactions:

See Contraindications. Potentiated by strong CYP3A4 inhibitors (eg, ketoconazole); monitor closely. May be antagonized by potent CYP3A4 inducers (eg, rifampin).

Adverse Reactions:

Peripheral neuropathy, fatigue, nausea, diarrhea, neutropenia, upper RTI, pyrexia, constipation, vomiting, alopecia, decreased weight, abdominal pain, anemia, stomatitis, lymphopenia, mucositis.

Generic Drug Availability:


How Supplied:

Single-use vial—1