Bendamustine


Thông tin thuốc gốc
Chỉ định và Liều dùng
Intravenous
Chronic lymphocytic leukaemia
Adult: 100 mg/m2 infused over 30-60 min on days 1 and 2 of a 28-day cycle for up to 6 cycles. For severe haematological or non-haematological toxicity: Reduce dose to 50 mg/m2 on days 1 and 2 of each cycle. If severe haematological toxicity recurs, further reduce dose to 25 mg/m2 on days 1 and 2 of each cycle. May consider dose re-escalation in subsequent cycles.

Intravenous
Multiple myeloma
Adult: 120-150 mg/m2 infused over 30-60 min on days 1 and 2 of a 28-day cycle. IV or oral prednisone may be given at a dose of 60 mg/m2 on days 1-4 of the cycle.

Intravenous
Non-Hodgkin's lymphoma
Adult: 120 mg/m2 infused over 30-60 min on days 1 and 2 of a 21-day cycle for up to 8 cycles. For severe haematological or non-haematological toxicity: Reduced to 90 mg/m2 on days 1 and 2 of each cycle. If severe toxicity recurs, further reduce dose to 60 mg/m2 on days 1 and 2 of each cycle.
Hepatic Impairment
Moderate: Reduce dose by 30%.
Hướng dẫn pha thuốc
Reconstitute powd for inj by adding 5 mL or 20 mL of sterile water for inj to a vial containing 25 mg or 100 mg, respectively to provide a soln containing 5 mg/mL. The lyophilised powd should be dissolved w/in 5 min, shake well to facilitate dissolution. W/in 30 min of reconstitution, the appropriate volume should be withdrawn from the vial to further dilute in 500 mL of either NaCl 0.9% inj or dextrose 2.5% and NaCl 0.45% inj to a final concentration of 0.2-0.6 mg/mL.
Chống chỉ định
Patient w/ history of hypersensitivity (e.g. anaphylaxis and anaphylactoid reactions); jaundice, severe bone marrow suppression, low leukocyte or platelet count. Severe hepatic impairment. Major surgery <30 days prior to treatment.
Thận trọng
Mild to moderate hepatic and renal impairment. Pregnancy and lactation.
Phản ứng phụ
Malignant and pre-malignant disease; pyrexia, nausea, vomiting, cough, headache, fatigue, diarrhoea, constipation, anorexia, wt decrease, rash, stomatitis, lymphopenia, anaemia, thrombocytopenia, leucopenia, neutropenia.
Potentially Fatal: Myelosuppression, tumour lysis syndrome which may lead to acute renal failure, infections (e.g. sepsis, pneumonia, septic shock), Stevens-Johnson syndrome, toxic epidermal necrolysis. Rarely, severe anaphylatic and anaphylactoid reactions.
IV/Parenteral: D
Thông tin tư vấn bệnh nhân
This drug may cause fatigue, if affected, avoid driving or operating machinery.
MonitoringParameters
Monitor K and uric acid levels. Monitor leukocytes, platelets, Hb and neutrophils wkly.
Quá liều
Symptoms: Cardiotoxicity, thrombocytopenia. Management: May perform bone marrow transplantation and transfusions to control haematological effects. It is dialysable to a small extent.
Tương tác
May increase plasma levels w/ CYP1A2 inhibitors (e.g. ciprofloxacin, fluvoxamine). May reduce plasma levels w/ CYP1A2 inducers (e.g. omeprazole and tobacco smoking).
Tác dụng
Description: Bendamustine is an antineoplastic alkylating agent. It interferes w/ DNA replication and RNA transcription that leads to disruption of nucleic acid function. It is also active against inert and dividing cells.
Pharmacokinetics:
Absorption: Time to peak plasma concentration: At the end of infusion.
Distribution: Distributes freely into RBC. Volume of distribution: Approx 20-25 L. Plasma protein binding: Approx 95%.
Metabolism: Extensively hepatic; via hydrolysis to monohydroxy-bendamustine (HP1) and dihydroxy-bendamustine (HP2) as metabolites w/ low cytotoxic activity; by CYP1A2 isoenzyme to N-desmethyl-bendamustine (M4) and γ-hydroxyl-bendamustine (M3) as active minor metabolites.
Excretion: Mainly via faeces (approx 90%). Elimination half-life: Approx 40 min (as bendamustine); approx 3 hr (as M3); approx 30 min (as M4).
Bảo quản
Store below 25°C, prior to reconstitution. Protect from light.
Phân loại MIMS
References
Anon. Bendamustine. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 02/09/2014.

Buckingham R (ed). Bendamustine Hydrochloride. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 02/09/2014.

Joint Formulary Committee. Bendamustine Hydrochloride. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 02/09/2014.

McEvoy GK, Snow EK, Miller J et al (eds). Bendamustine Hydrochloride. AHFS Drug Information (AHFS DI) [online]. American Society of Health-System Pharmacists (ASHP). https://www.medicinescomplete.com. Accessed 02/09/2014.

TREANDA Injection, Powder Lyophilized for solution (Cephalon, Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 02/09/2014.

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