Adcetris

Adcetris

brentuximab vedotin

Manufacturer:

Takeda

Distributor:

Zuellig
Concise Prescribing Info
Contents
Brentuximab vedotin
Indications/Uses
Adults 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 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) or other CD30-expressing peripheral T-cell lymphomas (PTCL), in combination w/ chemotherapy. Adults w/ previously untreated sALCL or other CD30-expressing PTCL including angioimmunoblastic T-cell lymphoma & PTCL not otherwise specified, in combination w/ cyclophosphamide, doxorubicin, & prednisone; relapsed or refractory sALCL; CD30+ cutaneous T-cell lymphoma (CTCL) after at least 1 prior systemic therapy.
Dosage/Direction for Use
Administer as IV infusion over 30 min. Previously untreated HL 1.2 mg/kg on days 1 & 15 each 28-day cycle for 6 cycles in combination w/ AVD. Primary prophylaxis w/ growth factor support (G-SF) is recommended beginning w/ 1st dose. 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. Previously untreated sALCL or other CD30-expressing peripheral T-cell lymphomas in combination w/ chemotherapy (cyclophosphamide, doxorubicin & prednisone) 1.8 mg/kg every 3 wk for 6-8 cycles. Primary prophylaxis w/ G-CSF, beginning w/ 1st dose is recommended for all patients w/ previously untreated sALCL or other CD30-expressing peripheral T-cell lymphomas receiving combination therapy. Relapsed or refractory 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. Should 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). 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 therapy: 0.9 mg/kg every 3 wk.
Contraindications
Special Precautions
Do not administer as IV push or bolus. Closely monitor for new or worsening neurological, cognitive, or behavioural signs or symptoms suggestive of progressive multifocal leukoencephalopathy (PML); new or worsening abdominal pain suggestive of acute pancreatitis. Permanently discontinue if diagnosis of PML is confirmed. Discontinue if acute pancreatitis is confirmed; Stevens-Johnson syndrome & toxic epidermal necrolysis occur. Perform prompt diagnostic evaluation in the event of new or worsening pulmonary symptoms (eg, cough, dyspnoea) or GI symptoms. Carefully monitor during treatment for the emergence of possible serious & opportunistic infections. Immediate & delayed infusion-related reactions (IRR); patients who have experienced prior IRR should be premed (including paracetamol, an antihistamine & a corticosteroid) for subsequent infusion. Immediately & permanently discontinue if anaphylactic reaction occurs. Risk of tumor lysis syndrome in patients w/ rapidly proliferating tumor & high tumor burden. Delay & reduce dose or discontinue in patients experiencing new or worsening peripheral neuropathy. Grade 3 or 4 anaemia, thrombocytopenia, & prolonged (≥1 wk) Grade 3 or 4 neutropenia may occur; febrile neutropenia. Monitor CBC prior to administration of each dose. Increased risk of hepatotoxicity in patients w/ preexisting liver disease, comorbidities, & concomitant medications; test liver function before initiating treatment & routinely monitor. Hyperglycaemia in patients w/ elevated BMI w/ or w/o history of DM. 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. Elderly >65 yr.
Adverse Reactions
Infection, upper resp tract infection; neutropenia; peripheral sensory & motor neuropathy; cough, dyspnoea; nausea, diarrhoea, vomiting, constipation, abdominal pain; alopecia; rash; arthralgia, myalgia; fatigue, pyrexia; decreased wt. Pneumonia, herpes simplex, oral candidiasis; thrombocytopenia; hyperglycaemia; increased ALT/AST; back pain. Monotherapy: Pruritus; infusion-related reactions. Herpes zoster; anaemia; dizziness; alopecia; back pain. Combination therapy: Anaemia, febrile neutropenia; decreased appetite; dizziness; stomatitis; alopecia; bone/back pain; insomnia. Sepsis/septic shock; pruritus; infusion-related reactions.
Drug Interactions
May increase incidence of neutropenia w/ strong CYP3A4 & P-gp inhibitors (eg, ketoconazole). Reduced plasma conc of MMAE metabolites w/ rifampicin. Unacceptable pulmonary toxicity w/ bleomycin.
MIMS Class
Targeted Cancer Therapy
ATC Classification
L01XC12 - brentuximab vedotin ; Belongs to the class of monoclonal antibodies, other antineoplastic agents. Used in the treatment of cancer.
Presentation/Packing
Form
Adcetris infusion conc 50 mg
Packing/Price
1's
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