Bendamustine


Concise Prescribing Info
Indications/Uses
Listed in Dosage.
Dosage/Direction for Use
Adult : IV Chronic lymphocytic leukaemia 100 mg/m2 infused over 30-60 min on days 1 and 2 of a 28-day cycle for up to 6 cycles. 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. Non-hodgkin's lymphoma 120 mg/m2 infused over 30-60 min on days 1 and 2 of a 21-day cycle for up to 8 cycles. 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. Multiple myeloma 120-150 mg/m2 infused over 30-60 min on days 1 and 2 of a 28-day cycle. IV or oral prednisone: 60 mg/m2 on days 1-4 of the cycle.
Dosage Details
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%.
Reconstitution
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 W/in 30 min of reconstitution, the appropriate volume should be withdrawn from the vial to further dilute in 500 mL of either NaCl 0.9% inj or dextrose 2.5% and NaCl 0.45% inj to a final concentration of 0.2-0.6 mg/mL.
Contraindications
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.
Special Precautions
Mild to moderate hepatic and renal impairment. Pregnancy and lactation.
Adverse Reactions
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
Patient Counseling Information
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.
Overdosage
Symptoms: Cardiotoxicity, thrombocytopenia. Management: May perform bone marrow transplantation and transfusions to control haematological effects. It is dialysable to a small extent.
Drug Interactions
May increase plasma levels w/ CYP1A2 inhibitors (e.g. ciprofloxacin, fluvoxamine). May reduce plasma levels w/ CYP1A2 inducers (e.g. omeprazole and tobacco smoking).
Action
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).
Storage
Store below 25°C, prior to reconstitution. Protect from light.
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.

Disclaimer: This information is independently developed by MIMS based on Bendamustine from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2020 MIMS. All rights reserved. Powered by MIMS.com
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