Adcetris

In combination w/ doxorubicin, vinblastine & dacarbazine (AVD) for previously untreated CD30+ stage IV Hodgkin lymphoma (HL) in adults. CD30+ HL in adults at increased risk of relapse or progression following autologous stem cell transplant (ASCT). Relapsed or refractory CD30+ HL in adults following ASCT, or following at least 2 prior therapies when ASCT or multi-agent chemotherapy is not a treatment option. In combination w/ cyclophosphamide, doxorubicin & prednisone (CHP) for previously untreated systemic anaplastic large cell lymphoma (sALCL) or other CD30-expressing peripheral T-cell lymphomas (PTCL) including angioimmunoblastic T-cell lymphoma & PTCL not otherwise specified in adults. Relapsed or refractory sALCL in adults. CD30+ cutaneous T-cell lymphoma (CTCL) in adults 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 of each 28-day cycle for 6 cycles. Primary prophylaxis w/ growth factor support (G-CSF), beginning w/ 1st dose, is recommended for all adult 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 has 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 or better should receive min 8 cycles & up to max 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 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 (PML); 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 is confirmed. 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 jirovecii pneumonia & oral candidiasis. Monitor for the emergence of possible serious & opportunistic infections. Immediate & delayed infusion-related reactions, anaphylactic reactions. Immediately & permanently discontinue if anaphylactic reaction occurs. Tumour lysis syndrome. Sensory & motor peripheral neuropathy; delay & dose reduction or discontinuation may be required 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 monitor patients. Hyperglycaemia. Infusion site extravasation. Closely monitor the infusion site for possible infiltration. Monitor CBC prior to administration of each dose. Caution in other CD30+ CTCL patients. Na content in excipients. May have moderate influence on the ability to drive & use machines eg, dizziness. Limited experience in patients w/ renal & hepatic impairment. Avoid treatment in combination w/ chemotherapy in patients w/ severe renal impairment; moderate & severe 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. Should not be used during pregnancy unless benefit to mother outweighs potential foetal risk. Discontinue breast-feeding or discontinue/abstain from therapy taking into account a potential risk of breast-feeding for the child & benefit of therapy for the woman. Safety & efficacy have not been established in 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.

Rx