Adcetris

Previously untreated CD30+ stage III or IV Hodgkin lymphoma (HL) in combination w/ doxorubicin, vinblastine & dacarbazine. CD30+ HL at increased risk of relapse or progression following autologous stem cell transplant (ASCT). Relapsed or refractory CD30+ HL following ASCT or following at least 2 prior therapies when ASCT or multi-agent chemotherapy is not a treatment option. Previously untreated systemic anaplastic large cell lymphoma (sALCL) in combination w/ cyclophosphamide, doxorubicin & prednisone. Relapsed or refractory sALCL. CD30+ cutaneous T-cell lymphoma (CTCL) after at least 1 prior systemic therapy.

Adult 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 at increased risk of relapse or progression 1.8 mg/kg IV infusion over 30 min every 3 wk, up to 16 cycles. Relapsed or refractory HL 1.8 mg/kg IV infusion over 30 min every 3 wk. Patients who have previously responded to treatment w/ Adcetris may be retreated at 1.8 mg/kg IV infusion over 30 min every 3 wk, or alternatively may be started at the last tolerated dose. Patients who achieve stable disease or better should receive a min of 8 cycles & up to a max of 16 cycles (approx 1 yr). Previously untreated sALCL 1.8 mg/kg IV infusion over 30 min every 3 wk for 6-8 cycles, in combination w/ cyclophosphamide, doxorubicin & prednisone. Relapsed or refractory sALCL 1.8 mg/kg IV infusion over 30 min every 3 wk. Patients who have previously responded to treatment w/ Adcetris may be retreated at 1.8 mg/kg IV infusion over 30 min every 3 wk, or alternatively may be started at the last tolerated dose. Patients who achieve stable disease or better should receive a min of 8 cycles & up to a max of 16 cycles (approx 1 yr). CTCL 1.8 mg/kg IV infusion over 30 min every 3 wk, up to 16 cycles. Patient w/ hepatic impairment or severe renal impairment 1.2 mg/kg IV infusion over 30 min every 3 wk. Patient w/ mild hepatic impairment 0.9 mg/kg IV infusion over 30 min every 2 wk, in combination w/ doxorubicin, vinblastine & dacarbazine; or 1.2 mg/kg IV infusion over 30 min every 3 wk, in combination w/ cyclophosphamide, doxorubicin & prednisone.

Hypersensitivity. Combined use w/ bleomycin.

Must not be administered as IV push or bolus. Should be administered through a dedicated IV line & must not be mixed w/ other medicinal products. Monitor for immediate & delayed infusion-related reactions during & after infusion. Monitor infusion site for possible infiltration during administration. Monitor for new or worsening neurological, cognitive, or behavioural signs or symptoms, which may be suggestive of progressive multifocal leukoencephalopathy. Monitor for new or worsening abdominal pain, which may be suggestive of acute pancreatitis. Monitor for new or worsening pulmonary symptoms. Monitor for emergence of possible serious & opportunistic infections during treatment. Monitor patients w/ rapidly proliferating tumour & high tumour burden who are at risk of tumour lysis syndrome. Monitor for symptoms of peripheral neuropathy. Monitor CBC prior to administration of each dose. Monitor for febrile neutropenia. Monitor for severe cutaneous adverse reactions. Monitor for new or worsening GI symptoms. Perform LFT before initiating treatment & routinely monitor during treatment. Monitor serum glucose in any patient who experiences hyperglycaemia. Use w/ caution in other CD30+ CTCL patients after careful consideration of potential benefit-risk on an individual basis. Contains 13.2 mg Na per vial, equiv to 0.7% of WHO-recommended max daily intake of 2 g Na for an adult. Moderate influence on the ability to drive & use machines. Limited experience in patients w/ renal & hepatic impairment. Avoid use in combination w/ chemotherapy in patients w/ severe renal impairment, or moderate & severe hepatic impairment. Women of childbearing potential should use 2 methods of effective contraception during treatment & until 6 mth after treatment. Men should not father a child during treatment & for up to 6 mth following the last dose. Should not be used during pregnancy unless benefit to mother outweighs potential risks to foetus. Discontinue breastfeeding or discontinue/abstain from therapy. Safety & efficacy in childn <18 yr have not been established.

Infections, peripheral sensory neuropathy, nausea, fatigue, diarrhoea, pyrexia, neutropenia, URTI, arthralgia, rash, cough, vomiting, peripheral motor neuropathy, constipation, dyspnoea, myalgia, decreased wt, abdominal pain. Monotherapy: Pruritus, infusion-related reactions. Combination therapy: Alopecia, anaemia, stomatitis, febrile neutropenia, decreased appetite, insomnia, bone pain, back pain, dizziness.

Increased exposure to monomethyl auristatin E (MMAE) w/ ketoconazole (strong CYP3A4 & P-gp inhibitor). Reduced plasma conc of MMAE metabolites w/ rifampicin (strong CYP3A4 inducer). Risk of 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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