Brentuximab vedotin


Thông tin thuốc gốc
Chỉ định và Liều dùng
Intravenous
Hodgkin's disease
Adult: In patients with previously untreated CD-30 positive cases in combination with doxorubicin, vinblastine, and dacarbazine: 1.2 mg/kg via infusion over 30 minutes on days 1 and 15 for each 28-day cycle for 6 cycles. In patients with increased risk of relapsed or progression or with relapsed or refractory cases following autologous stem cell transplant (ASCT): 1.8 mg/kg  given via infusion over 30 minutes every 3 weeks. Max: 16 cycles. Patient weighing >100 kg: Use 100 kg in dose calculation. Continue treatment until disease progression or unacceptable toxicity. Dose reduction, dosing interruption, or discontinuation may be required according to individual safety and tolerability (refer to detailed product guideline).

Intravenous
Anaplastic large cell lymphoma
Adult: In patients with relapsed or refractory cases: 1.8 mg/kg via infusion over 30 minutes every 3 weeks up. Min: 8 cycles. Max: 16 cycles. Patient weighing >100 kg: Use 100 kg in dose calculation. Dose reduction, dosing interruption, or discontinuation may be required according to individual safety and tolerability (refer to detailed product guideline).

Intravenous
CD-30 positive cutaneous T-cell lymphoma
Adult: In patient with at least 1 prior systemic therapy: 1.8 mg/kg via infusion over 30 minutes every 3 weeks. Max: 16 cycles. Patient weighing >100 kg: Use 100 kg in dose calculation. Dose reduction, dosing interruption, or discontinuation may be required according to individual safety and tolerability (refer to detailed product guideline).
Renal Impairment
CrCl (mL/min)  Dosage
 <30 As monotherapy: Initially, 1.2 mg/kg via infusion over 30 minutes every 3 weeks. In combination with chemotherapy: Contraindicated.
Hepatic Impairment
As monotherapy: Initially, 1.2 mg/kg via infusion over 30 minutes every 3 weeks. In combination with chemotherapy: Mild (Child-Pugh A): 0.9 mg/kg via infusion over 30 minutes every 3 weeks. Moderate to severe (Child-Pugh B or C): Contraindicated.
Hướng dẫn pha thuốc
Reconstitute vial labelled as containing 50 mg with 10.5 mL sterile water for injection to a final concentration of 5 mg/mL.
Chống chỉ định
Severe renal and moderate or severe hepatic impairment in combination with chemotherapy. Co-administration with bleomycin. Lactation.
Thận trọng
Patient with antibodies to brentuximab vedotin; pre-existing gastrointestinal involvement of underlying lymphoma; previous therapies or underlying diseases causing immunosuppression; rapidly proliferating tumour and high tumour burden or risk factors for tumour lysis syndrome; elevated baseline liver enzymes; elevated BMI with or without history of diabetes mellitus. Mild to moderate renal and mild hepatic impairment.
Phản ứng phụ
Significant: Immediate and delayed infusion-related reactions, anaphylactic reactions; tumour lysis syndrome, peripheral neuropathy (sensory and motor), haematological toxicities (e.g. Grade 3 or 4 anaemia, thrombocytopenia, prolonged neutropenia); febrile neutropenia; hyperglycaemia; increased serum transaminase levels.
Cardiac disorders: Dyspnoea, supraventricular arrhythmia.
Gastrointestinal disorders: Nausea, diarrhoea, vomiting, constipation, abdominal pain, stomatitis (combination therapy).
General disorders and admin site conditions: Fatigue, pyrexia.
Investigations: Increased ALT/AST, decreased weight.
Metabolism and nutrition disorders: Hyperglycaemia, decreased appetite (combination therapy), peripheral oedema.
Musculoskeletal and connective tissue disorders: Arthralgia, myalgia, back pain, muscle spasms, chills.
Nervous system disorders: Headache.
Psychiatric disorders: Insomnia.
Respiratory, thoracic and mediastinal disorders: Upper respiratory tract infection, cough.
Skin and subcutaneous tissue disorders: Rash, pruritus, alopecia.
Potentially Fatal: John Cunningham virus reactivation resulting to progressive multifocal leukoencephalopathy; acute pancreatitis; pulmonary toxicity (e.g. pneumonitis, interstitial lung disease, acute respiratory distress syndrome); serious infections (e.g. pneumonia, septic shock); Stevens-Johnson syndrome, toxic epidermal necrolysis; hepatotoxicity; gastrointestinal complications (e.g. intestinal obstruction, ileus, enterocolitis, neutropenic colitis, erosion, ulcer, perforation, haemorrhage.
Thông tin tư vấn bệnh nhân
This drug may cause dizziness, if affected, do not drive or operate machinery.
MonitoringParameters
Monitor complete CBC with differential prior to each dose; LFT and renal function. Perform pregnancy test to women of reproductive potential prior to treatment initiation. Monitor for tumour lysis syndrome; signs or symptoms of leukoencephalopathy and neuropathy, dermatologic toxicity, infusion reaction, pulmonary toxicity (e.g. cough, dyspnoea), gastrointestinal toxicity, infection.
Tương tác
Increased serum concentration of MMAE with strong CYP3A4 and P-gp inhibitors (e.g. ketoconazole). Decreased serum concentration of MMAE with strong CYP3A4 inducers (e.g. rifampicin). May diminish therapeutic effect of live vaccines.
Potentially Fatal: Pulmonary toxicity with bleomycin.
Tác dụng
Description: Brentuximab vedotin is an antibody drug conjugate (ADC) which binds to CD30-expressing tumour cells. It forms a complex which is internalised within the cells and releases monomethylauristatin E (MMAE) via proteolytic cleavage. MMAE binds to tubules and disrupts microtubule network thereby inducing cell cycle arrest and apoptotic death of CD30-expressing tumour cells.
Pharmacokinetics:
Absorption: Time to peak plasma concentration: At the end of infusion (ADC); approx 1-3 days after the end of infusion (MMAE).
Distribution: Volume of distribution: Approx 6-10 L (ADC). Plasma protein binding: 68-82% (MMAE).
Metabolism: Metabolised primarily via oxidation by CYP3A4/5 (small fraction of MMAE).
Excretion: Via faeces (approx 72% as MMAE); urine (approx 24% as MMAE). Elimination half-life: Approx 4-6 days (ADC); approx 3-4 days (MMAE).
Bảo quản
Store between 2-8°C. Do not freeze. Protect from light.
Phân loại MIMS
Phân loại ATC
L01XC12 - brentuximab vedotin ; Belongs to the class of monoclonal antibodies, other antineoplastic agents. Used in the treatment of cancer.
References
Adcetris Lyophilized Powder for Solution (Seattle Genetics, Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 04/06/2019.

Anon. Brentuximab Vedotin. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 04/06/2019.

Brentuximab Vedotin. Drugs and Lactation Database (LactMed) [Internet]. Bethesda, MD. U.S. National Library of Medicine. https://www.ncbi.nlm.nih.gov/books/NBK501922/. Accessed 20/06/2019.

Buckingham R (ed). Brentuximab Vedotin. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 04/06/2019.

Joint Formulary Committee. Brentuximab Vedotin. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 13/06/2019.

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