Adcetris雅詩適

Adcetris

brentuximab vedotin

Manufacturer:

Takeda

Distributor:

Zuellig
/
Firma Chun Cheong
Concise Prescribing Info
Contents
Brentuximab vedotin
Indications/Uses
Adult patients w/ previously untreated CD30+ Stage IV Hodgkin lymphoma (HL) in combination w/ doxorubicin, vinblastine & dacarbazine; relapsed or refractory CD30+ Hodgkin lymphoma (HL) following autologous stem cell transplant (ASCT) or following at least 2 prior therapies when ASCT or multi-agent chemotherapy is not a treatment option; CD30+ HL 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.
Dosage/Direction for Use
Previously untreated HL 1.2 mg/kg IV infusion over 30 min on day 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 or sALCL 1.8 mg/kg IV infusion over 30 min every 3 wk. Patients who have previously responded to treatment w/ Adcetris may be started w/ 1.8 mg/kg IV infusion over 30 min every 3 wk, or at 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.
Contraindications
Hypersensitivity. Concomitant use w/ bleomycin.
Special Precautions
Closely monitor for new or worsening neurological, cognitive or behavioural signs or symptoms suggestive of progressive multifocal leukoencephalopathy; new or worsening abdominal pain suggestive of acute pancreatitis; new or worsening pulmonary symptoms; emergence of possible serious & opportunistic infections; immediate & delayed infusion-related reactions during & after infusion; new or worsening GI symptoms; febrile neutropenia. Discontinue use if anaphylaxis, Stevens-Johnson syndrome or toxic epidermal necrolysis occurs. Patients w/ rapidly proliferating tumour & high tumour burden are at risk of tumour lysis syndrome. Patients experiencing new or worsening peripheral neuropathy may require delay & dose reduction or discontinuation of treatment. Monitor CBC prior to administration of each dose. Perform liver function tests before treatment initiation & routinely monitor during treatment. Reports of hyperglycaemia in patients w/ elevated BMI w/ or w/o DM. Moderate influence on the ability to drive & use machines. Patients w/ renal or hepatic impairment. Patients on controlled Na diet. Women of childbearing potential should use 2 methods of contraception during treatment & until 6 mth after therapy. Men are advised not to father a child during therapy & for up to 6 mth after last dose. Pregnancy & lactation. Childn <18 yr.
Adverse Reactions
Infections, peripheral sensory neuropathy, nausea, fatigue, diarrhoea, pyrexia, upper resp tract infection, neutropenia, rash, cough, vomiting, arthralgia, peripheral motor neuropathy, infusion-related reactions, pruritus, constipation, dyspnoea, wt decreased, myalgia, abdominal pain. Alopecia, anaemia, stomatitis, febrile neutropenia, bone pain, insomnia, decreased appetite, headache, back pain, ALT increased.
Drug Interactions
Increased incidence of neutropenia w/ a strong CYP3A4 & P-gp inhibitors eg, ketoconazole. Reduced plasma conc of MMAE metabolites w/ strong CYP3A4 inducers eg, rifampicin. Risk of pulmonary toxicity w/ bleomycin.
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 powd for infusion 50 mg
Packing/Price
1's
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