Alkylating agent (specialist) Pregnancy: During pregnancy bendamustine should not be used unless clearly necessary; embryo-/fetolethal, teratogenic and genotoxic in nonclinical studies. Women of childbearing potential must use effective contraception before and during therapy. Contraindicated during breastfeeding.

Bendamustine hydrochloride

Brand names: Levact

Bendamustine is a bifunctional alkylating cytotoxic agent with structural features of both a nitrogen mustard and a purine analogue. It is used chiefly in the treatment of chronic lymphocytic leukaemia and certain non-Hodgkin lymphomas.

Auto-extracted from the source labelling — not yet independently clinician-verified. These values were distilled from the UK SPC (or the US label where noted) but have not had a clinician sign-off. Confirm against the current SmPC before prescribing.

Adult dose

Dose: Monotherapy for chronic lymphocytic leukaemia: 100 mg/m2 body surface area on days 1 and 2

Route: Intravenous infusion over 30-60 minutes

Frequency: Every 4 weeks, up to 6 times

Other regimens per SPC: Monotherapy for indolent non-Hodgkin's lymphomas refractory to rituximab 120 mg/m2 on days 1 and 2 every 3 weeks for at least 6 times. Multiple myeloma 120-150 mg/m2 on days 1 and 2 (with prednisone 60 mg/m2 IV or per os days 1-4) every 4 weeks for at least 3 times. Do not start if leukocytes <3,000/microlitre and/or platelets <75,000/microlitre; terminate or delay if values drop to these levels; may continue after leukocytes >4,000/microlitre and platelets >100,000/microlitre. Non-haematological toxicity: 50% dose reduction for CTC grade 3, interrupt for CTC grade 4. Infusion must be given under supervision of a physician experienced in chemotherapeutic agents. Paediatric population: safety and efficacy in children not yet established; available data insufficient to make a posology recommendation. Elderly: no evidence dose adjustment necessary.

Dose adjustments

Renal

No dose adjustment necessary if creatinine clearance >10 ml/min. Experience in patients with severe renal impairment is limited.

Dose auto-extracted from UK Summary of Product Characteristics (SPC) via the eMC; US FDA prescribing information (openFDA / DailyMed) — cross-check; US labelling may differ from UK — not yet clinician-verified. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

Hypersensitivity to the active substance or any excipient
During breast-feeding
Severe hepatic impairment (serum bilirubin >3.0 mg/dl)
Jaundice
Severe bone marrow suppression and severe blood count alterations (leukocytes <3,000/microlitre and/or platelets <75,000/microlitre)
Major surgery less than 30 days before start of treatment
Infections, especially involving leukocytopenia
Yellow fever vaccination

Side effects

Leukopenia, thrombocytopenia, lymphopenia (very common)
Nausea, vomiting (very common)
Mucosal inflammation, fatigue, pyrexia (very common)
Infection including opportunistic infection (e.g. herpes zoster, cytomegalovirus, hepatitis B)
Hypersensitivity; allergic reactions and dermatologic toxicities

Interactions

CYP1A2 inhibitors may increase bendamustine plasma concentrations and adverse reactions
CYP1A2 inducers may decrease bendamustine plasma concentrations and reduce efficacy

Clinical monograph

How it works

It forms cross-links with DNA via its alkylating group, causing single- and double-strand breaks that impair DNA replication and repair and trigger cell death.

Prescribing in practice

Profound and prolonged myelosuppression occurs; monitor the full blood count closely and withhold or reduce treatment for significant neutropenia or thrombocytopenia.
It is a specialist cytotoxic used only under supervision of an experienced oncology or haematology team.
Serious skin reactions, infusion reactions and tumour lysis syndrome have been reported; opportunistic infections may occur owing to lymphopenia.

Monitoring

Monitor the full blood count regularly throughout and between cycles, together with renal and hepatic function and signs of infection.

Counselling the patient

Report fever, sore throat, unusual bruising or bleeding, or signs of infection promptly.
Effective contraception is required during and for a period after treatment.
Attend all blood test and treatment appointments as scheduled.

Evidence & guidelines

Use is supported by registration studies and reflected in NICE technology appraisal guidance for chronic lymphocytic leukaemia and indolent non-Hodgkin lymphoma.

Reference: NICE TA216; NICE TA243; BSH lymphoma; ESMO; SmPC; Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing. The structured dose values shown have been reviewed by a clinician. Monograph status: clinician-reviewed (2026-07-04).

Curated clinical cross-links plus same-class fallbacks.

Drugs

Busulfan · Alkylating agent (specialist)

Pathways