Adcetris雅詩適

Adcetris

brentuximab vedotin

Manufacturer:

Takeda

Distributor:

Zuellig
/
Firma Chun Cheong
Concise Prescribing Info
Contents
Brentuximab vedotin
Indications/Uses
Previously untreated CD30+ Stage IV Hodgkin lymphoma (HL) in combination w/ doxorubicin, vinblastine & dacarbazine. CD30+ HL in patients at increased risk of relapse or progression following autologous stem cell transplant (ASCT). Relapsed or refractory CD30+ Hodgkin lymphoma (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.
Dosage/Direction for Use
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 started 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). 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 started 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; symptoms of neuropathy; 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. Monitor complete blood counts 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. May alter male fertility. Men are advised not to father a child during therapy & for up to 6 mth after last dose. Pregnancy & lactation. Safety & efficacy in childn <18 yr have not been established.
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, decreased wt, myalgia, abdominal pain. Combination therapy: Alopecia, anaemia, stomatitis, febrile neutropenia, bone pain, insomnia, decreased appetite, back pain, dizziness.
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.
MIMS Class
Targeted Cancer Therapy
ATC Classification
L01FX05 - brentuximab vedotin ; Belongs to the class of other monoclonal antibodies and antibody drug conjugates. Used in the treatment of cancer.
Presentation/Packing
Form
Adcetris powd for infusion 50 mg
Packing/Price
1's
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