Adcetris

Brentuximab vedotin

Adult w/ previously untreated CD30+ stage IV Hodgkin lymphoma (HL) in combination w/ doxorubicin, vinblastine, & dacarbazine (AVD); CD30+ HL at increased risk of relapse or progression following autologous stem cell transplant (ASCT); relapsed or refractory CD30+ HL following ASCT or at least 2 prior therapies when ASCT or multi-agent chemotherapy is not an option; previously untreated systemic anaplastic large cell lymphoma (sALCL) or other CD30-expressing peripheral T-cell lymphomas (PTCL) including angioimmunoblastic T-cell lymphoma & PTCL in combination w/ cyclophosphamide, doxorubicin, & prednisone (CHP); relapsed or refractory sALCL; CD30+ cutaneous T-cell lymphoma (CTCL) after at least 1 prior systemic therapy.

Administer as IV infusion over 30 min. Previously untreated HL in combination w/ AVD 1.2 mg/kg on days 1 & 15 each 28-day cycle for 6 cycles. Primary prophylaxis w/ growth factor support (G-CSF), beginning w/ 1st dose is recommended for all adult patients receiving combination therapy. HL at increased risk of relapse or progression 1.8 mg/kg every 3 wk. Treatment should start following recovery from ASCT based on clinical judgement & patient should receive up to 16 cycles. Relapsed or refractory HL or sALCL 1.8 mg/kg every 3 wk. Retreatment of patient who have previously responded to treatment 1.8 mg/kg every 3 wk. Alternatively, may start at the last tolerated dose. Continue treatment until disease progression or unacceptable toxicity. Patient who achieves stable disease should receive a min of 8 cycles & up to a max of 16 cycles (approx 1 yr). Previously untreated sALCL or other CD30-expressing peripheral T-cell lymphomas in combination w/ CHP 1.8 mg/kg every 3 wk for 6-8 cycles. Primary prophylaxis w/ G-CSF, beginning w/ 1st dose is recommended for all adult patients receiving combination therapy. CTCL 1.8 mg/kg every 3 wk for up to 16 cycles. Hepatic & severe renal impairment Monotherapy: 1.2 mg/kg every 3 wk. Mild hepatic impairment Combination w/ AVD: 0.9 mg/kg every 2 wk. Combination w/ CHP: 1.2 mg/kg every 3 wk.

Hypersensitivity. Combination w/ bleomycin.

Do not administer as an IV push or bolus. Progressive multifocal leukoencephalopathy; closely monitor for new or worsening neurological, cognitive, or behavioural signs or symptoms suggestive of PML. Permanently discontinue if diagnosis of PML is confirmed. Discontinue if acute pancreatitis occurs. Pulmonary toxicity, including pneumonitis, ILD & acute resp distress syndrome. Serious infections eg, pneumonia, staph bacteraemia, sepsis/septic shock (including fatal outcomes) & herpes zoster, cytomegalovirus reactivation & opportunistic infections eg, Pneumocystis jiroveci pneumonia & oral candidiasis. Immediate & delayed infusion-related reactions, anaphylactic reactions. Tumour lysis syndrome. Sensory & motor peripheral neuropathy; delay & dose reduction or discontinue in patients w/ new or worsening peripheral neuropathy. Grade 3 or 4 anaemia, thrombocytopenia & prolonged (≥1 wk) grade 3 or 4 neutropenia. Febrile neutropenia; closely monitor for fever. Severe cutaneous adverse reactions including SJS, TEN & DRESS. GI complications including intestinal obstruction, ileus, enterocolitis, neutropenic colitis, erosion, ulcer, perforation & haemorrhage. Hepatotoxicity; increased risk w/ pre-existing liver disease, comorbidities, & concomitant medications. Test liver function before initiating treatment & routinely during therapy. Hyperglycemia. Infusion site extravasation. Other CD30+ CTCL patients. May have moderate influence on the ability to drive & use machines. Renal & hepatic impairment. Men should have sperm samples frozen & stored before treatment. Women of childbearing potential should use 2 methods of effective contraception during & until 6 mth after treatment; men should not father a child during & for up to 6 mth following the last dose. Pregnancy & lactation. Childn <18 yr.

Infection, URTI; neutropenia; peripheral sensory & motor neuropathy; cough, dyspnoea; nausea, diarrhoea, vomiting, constipation, abdominal pain; rash; arthralgia, myalgia; fatigue, pyrexia; decreased wt. Herpes zoster, pneumonia, oral candidiasis; thrombocytopenia; hyperglycaemia; increased ALT/AST; chills. Monotherapy: Pruritus; infusion-related reactions. Herpes simplex; anaemia; dizziness; alopecia; back pain. Combination therapy: Anaemia, febrile neutropenia; decreased appetite; insomnia; dizziness; stomatitis; alopecia; bone/back pain. Sepsis/septic shock; pruritus; infusion-related reactions.

May increase incidence of neutropenia w/ strong CYP3A4 & P-gp inhibitors (eg, ketoconazole). Reduced plasma conc of MMAE metabolites w/ strong CYP3A4 inducer (eg, rifampicin). Pulmonary toxicity w/ bleomycin.

Targeted Cancer Therapy

L01FX05 - brentuximab vedotin ; Belongs to the class of other monoclonal antibodies and antibody drug conjugates. Used in the treatment of cancer.

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