Leukemias, lymphomas, and other hematologic cancers:

Indications for: ADCETRIS

Adults with previously untreated Stage III or IV classical Hodgkin lymphoma (cHL), in combination with doxorubicin, vinblastine, and dacarbazine. Pediatric patients aged ≥2yrs with previously untreated high risk cHL, in combination with doxorubicin, vincristine, etoposide, prednisone, and cyclophosphamide. Adults with cHL at high risk of relapse or progression as post-autologous hematopoietic stem cell transplant (auto-HSCT) consolidation. Adults with cHL after failure of auto-HSCT or after failure of ≥2 prior multi-agent chemotherapy regimens in patients who are not auto-HSCT candidates. Adults with 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. Adults with sALCL after failure of ≥1 prior multi-agent chemotherapy regimen. Adults with primary cutaneous anaplastic large cell lymphoma (pcALCL) or CD30-expressing mycosis fungoides (MF) 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 (initiate 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:

<2yrs (high risk cHL) and <18yrs (all other indications): not established. Give by IV infusion over 30mins. Premedicate patients with prior infusion-related reaction with APAP, antihistamine, and corticosteroid for subsequent doses. ≥2yrs: High risk cHL (initiate G-CSF starting with Cycle 1): 1.8mg/kg up to max 180mg every 3 weeks with each cycle of chemotherapy for max 5 doses. Mild hepatic impairment (Child-Pugh A): 1.2mg/kg up to 120mg every 3 weeks. Dose modifications: see full labeling.

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 serum glucose; if hyperglycemia develops, treat as clinically indicated. 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. Advise females and males of reproductive potential to 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, thrombocytopenia, febrile neutropenia.

Generic Drug Availability:

NO

How Supplied:

Single-use vial—1