Generic Name and Formulations:
Brentuximab vedotin 50mg/vial; lyophilized pwd for IV infusion after reconstitution; preservative-free.
Seattle Genetics, Inc.
Indications for ADCETRIS:
Previously untreated Stage III or IV classical Hodgkin lymphoma (cHL), in combination with chemotherapy. Classical Hodgkin lymphoma (cHL) in patients at high risk of relapse or progression as post-autologous hematopoietic stem cell transplant (auto-HSCT) consolidation. Classical Hodgkin lymphoma (cHL) after failure of auto-HSCT or after failure of ≥2 prior multi-agent chemotherapy regimens in patients who are not auto-HSCT candidates. Systemic anaplastic large cell lymphoma (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.
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. 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.
Progressive multifocal leukoencephalopathy (PML).
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.
CD30-directed antibody-drug conjugate.
See Contraindications. Potentiated by strong CYP3A4 inhibitors (eg, ketoconazole) or P-gp inhibitors; monitor closely. May be antagonized by potent CYP3A4 inducers (eg, rifampin).
Neutropenia, anemia, peripheral sensory neuropathy, nausea, fatigue, constipation, diarrhea, vomiting, pyrexia.