brentuximab vedotin




Concise Prescribing Info
Brentuximab vedotin
Adult patients w/ previously untreated CD30+ stage IV Hodgkin lymphoma (HL) in combination w/ doxorubicin, vinblastine & dacarbazine; relapsed or refractory CD30+ HL following autologous stem cell transplant (ASCT) or at least 2 prior therapies when ASCT or multi-agent chemotherapy is not a treatment option & at increased risk of relapse or progression following ASCT; relapsed or refractory systemic anaplastic large cell lymphoma (sALCL); CD30+ cutaneous T-cell lymphoma (CTCL) after at least 1 prior systemic therapy. Adult patients w/ previously untreated sALCL or other CD30-expressing peripheral T-cell lymphoma (PTCL) including angioimmunoblastic T-cell lymphoma & PTCL not otherwise specified in combination w/ cyclophosphamide, doxorubicin & prednisone.
Dosage/Direction for Use
Previously untreated HL 1.2 mg/kg IV infusion over 30 min on days 1 & 15 of each 28-day cycle for 6 cycles in combination w/ doxorubicin, vinblastine & dacarbazine. HL, sALCL & PTCL 1.8 mg/kg IV infusion over 30 min every 3 wk. Patient who achieve stable disease Min: 8 cycles & up to max: 16 cycles. CTCL Up to 16 cycles. Hepatic & severe renal impairment Monotherapy: 1.2 mg/kg IV infusion over 30 min every 3 wk. Mild hepatic impairment Combination w/ AVD: 0.9 mg/kg IV infusion over 30 min every 2 wk. Combination w/ CHP: 1.2 mg/kg IV infusion over 30 min every 3 wk.
Hypersensitivity. Combination use w/ bleomycin.
Special Precautions
Infusion-related reactions. Not to be administered as IV push or bolus. Discontinue use if Stevens-Johnson syndrome, toxic epidermal necrolysis occurs & progressive multifocal leukoencephalopathy or acute pancreatitis is confirmed. Delay & reduce dose or discontinue use in patients w/ new or worsening peripheral neuropathy. Patients w/ rapidly proliferating tumor & high tumor burden; elevated BMI w/ or w/o history of DM. Monitor for emergence of possible serious & opportunistic infections. Perform prompt diagnostic evaluation for new or worsening pulmonary & GI symptoms. Monitor complete blood count & serum glucose prior to & during treatment. Routinely monitor liver function during treatment. Primary prophylaxis w/ G-CSF is recommended for all patients beginning w/ 1st dose. Controlled Na diet. Renal & hepatic impairment. Women & men of childbearing potential should use effective contraception during & 6 mth after last dose. Not to be used during pregnancy. Lactation. Childn <18 yr.
Adverse Reactions
Infection, upper resp tract infection; neutropenia, anemia, febrile neutropenia; decreased appetite; insomnia; peripheral sensory & motor neuropathy, dizziness; cough, dyspnea; nausea, diarrhea, vomiting, constipation, abdominal pain, stomatitis; rash, pruritus, alopecia; arthralgia, myalgia, bone & back pain; fatigue, pyrexia, infusion-related reactions; decreased wt.
Drug Interactions
Increased MMAE exposure w/ strong CYP3A4 & P-gp inhibitor eg, ketoconazole. Reduced MMAE exposure w/ strong CYP3A4 inducer eg, rifampicin.
ATC Classification
L01XC12 - brentuximab vedotin ; Belongs to the class of monoclonal antibodies, other antineoplastic agents. Used in the treatment of cancer.
Adcetris powd for infusion 50 mg
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