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Bendamustine parenteral

Updated 2 Feb 2023 | Alkylating agents


Infusions containing bendamustine hydrochloride.

Drugs List

  • bendamustine 100mg powder for concentrate for solution for infusion
  • bendamustine 100mg/4ml concentrate for solution for infusion vial
  • bendamustine 180mg/4ml concentrate for solution for infusion vial
  • bendamustine 25mg powder for concentrate for solution for infusion
  • Therapeutic Indications


    B-cell chronic lymphocytic leukaemia where fludarabine inappropriate
    Combination treatment of multiple myeloma in patients over 65
    Non-Hodgkin's lymphomas - secondary therapy

    First-line treatment of chronic lymphocytic leukaemia (Binet stage B or C) in patients for whom fludarabine combination chemotherapy is not appropriate.

    Indolent non-Hodgkin's lymphomas as monotherapy in patients who have progressed during or within 6 months following treatment with rituximab or a rituximab containing regimen.

    Front line treatment of multiple myeloma (Durie-Salmon stage II with progress or stage III) in combination with prednisone for patients older than 65 years who are not eligible for autologous stem cell transplantation and who have clinical neuropathy at time of diagnosis precluding the use of thalidomide or bortezomib containing treatment.


    Whilst the doses stated below are those recommended by the manufacturer, local cancer network protocols for the relevant indication should be consulted.

    Doses may vary significantly if this agent is used as monotherapy or different combinations.
    When using this agent, specialist literature, national guidelines, cancer network protocols and Trust chemotherapy protocols should be consulted.


    Monotherapy for Chronic Lymphocytic Leukaemia
    100mg per metre squared of body surface area on days 1 and 2, every 4 weeks.

    Monotherapy for Indolent Non-Hodgkin's Lymphomas Refractory to Rituximab
    120mg per metre squared of body surface area on days 1 and 2, every 3 weeks.

    Multiple Myeloma
    120mg to 150mg per metre squared of body surface area on days 1 and 2, combined with 60mg of prednisone per metre squared of body surface area(given intravenously or orally) on days 1 to 4, every 4 weeks.

    Patients with Hepatic Impairment

    Severe hepatic impairment (serum bilirubin greater than 3mg/dl)
    Moderate hepatic impairment (serum bilirubin between 1.2 and 3.0mg/dl)
    30% dose reduction.
    Mild hepatic impairment (serum bilirubin below 1.2mg/dl)
    No dose adjustment.

    Additional Dosage Information

    Dose modifications
    Leukocyte count below 3 x 10 to the power of 9 per litre, or platelet count below 75 x 10 to the power of 9 per litre
    Interrupt or discontinue treatment. Consider resuming treatment if leukocyte count recovers to greater than 4 x 10 to the power of 9 per litre, and platelet count recovers to 100 x 10 to the power of 9 per litre.
    Non-haematological toxicity- based on worst grade experienced in previous cycle
    Grade 3: 50% dose reduction, applied on day 1 and 2 of the respective treatment cycle.
    Grade 4: Interrupt treatment.


    For intravenous infusion over 30 to 60 minutes.


    Children under 18 years
    Leucocyte count below 3 x 10 to the power of 9 / L
    Platelet count below 75 x 10 to the power of 9 / L
    Within 30 days of major surgery
    Severe hepatic impairment
    Severe myelosuppression

    Precautions and Warnings

    Leucocyte count below 4 x 10 to the power of 9 / L
    Platelet count below 100 x 10 to the power of 9/ L
    Risk factors for skin cancer
    History of cardiac disorder
    History of hepatitis B
    Moderate hepatic impairment - serum bilirubin between 1.2mg and 3mg/dl
    Severe renal impairment

    Advise ability to drive/operate machinery may be affected by side effects
    Anti-emetics may be required during therapy
    Before initiating screen all patients for hepatitis B infection
    CD4+ T-cell count below 200 per microlitre: Consider PJP prophylaxis
    Consider premedication for patients with history of infusion reactions
    Consider premedication with hypouricaemic agent
    Give pre-treatment counselling and consideration of sperm cryopreservation
    Hepatitis B: Refer prior to initiation to liver disease specialist
    Maintain adequate hydration of patient prior / during treatment
    Monitor patients for non-melanoma skin cancer prior to and during treatment
    Consult local policy on the safe use of anti-cancer drugs
    If extravasation occurs follow local policy & seek expert help immediately
    Staff: Not to be handled by pregnant staff
    Treatment to be administered by or under supervision of specialist
    Consider PTLD or PML if new or worsening neurological symptoms occur
    If rash develops, consider possibility of Stevens-Johnson Syndrome
    Increase monitoring of ECG when serum potassium below 3.5mEq/l
    Monitor ECG prior to and during treatment in existing cardiac abnormalities
    Monitor for active hepatitis B during therapy and for several months after
    Monitor full blood counts weekly
    Monitor patient for infusion-associated reactions (IARs)
    Monitor patients for signs of tumour lysis syndrome
    Monitor respiratory function
    Monitor serum potassium in patients with cardiac disorders
    Monitor uric acid levels
    Advise patient to report headaches, seizures, confusion, visual disturbance
    Advise patient to report symptoms of infection immediately
    May affect immune response to live vaccines
    Potassium supplements may be required
    Potentially mutagenic and carcinogenic
    Reactivation of hepatitis B may occur in chronic carriers
    Secondary tumours may occur as long-term sequelae
    Discontinue if Progressive multifocal leukoencephalopathy (PML) develops
    Discontinue if serious allergic or anaphylactic reaction occurs
    Discontinue if severe skin reaction occurs
    Discontinue treatment if progressive skin rash occurs
    Suspend treatment if opportunistic infection is suspected
    Interrupt treatment if grade 4 non-haematological toxicity occurs
    Reduce dose if grade 3 non-haematological toxicity occurs
    Female: Ensure adequate contraception during treatment
    Male: Contraception required during and for 6 months after treatment
    Advise patient to inform physician of any skin changes immediately

    Patients with lymphocytopenia and low CD-4 positive T-cell counts have an increased susceptibility to opportunistic infections during and up to 9 months after discontinuing treatment, particularly in patients treated with concomitant rituximab.

    Progressive Multifocal Leukoencephalopathy Syndrome (PML)
    Progressive multifocal leukoencephalopathy syndrome (PML) has been reported in some patients treated with this agent, usually in combination with rituximab or obinutuzumab. If patients present with symptoms indicating PML such as worsening neurological, cognitive or behavioural signs or symptoms, an MRI should be performed. If PML is diagnosed, treatment should be permanently discontinued.

    Patients treated with bendamustine hydrochloride may experience myelosuppression. In the event of treatment-related myelosuppression, leukocytes, platelets, haemoglobin, and neutrophils must be monitored at least weekly. Prior to the initiation of the next cycle of therapy, the following parameters are recommended: Leukocyte and/or platelet values greater than 4000 per microlitre or greater than 100,000 per microlitre respectively.

    Pregnancy and Lactation


    Bendamustine is contraindicated during pregnancy.

    The manufacturer recommends that bendamustine should not be used during pregnancy unless clearly necessary. In non-clinical studies bendamustine was shown to be mutagenic and teratogenic. If the use of bendamustine is absolutely necessary during pregnancy or inadvertent pregnancy occurs during treatment, the woman should be advised of the possible risk for severe adverse effects in the embryo and fetus.


    Bendamustine is contraindicated during breastfeeding.

    Use of bendamustine when breastfeeding is contraindicated by the manufacturer. The manufacturer recommends that breastfeeding must be discontinued during bendamustine treatment. It is not known whether this agent or its metabolites are excreted in human breast milk. Effects on exposed infants are unknown.

    The effect of concurrent therapies must also be considered.

    Side Effects

    Acute myeloid leukaemia
    Anaphylactic reaction
    Anaphylactic shock
    Anaphylactoid reaction
    Angina pectoris
    Anticholinergic effects
    Atrial fibrillation
    Blood urea increased
    Bone marrow failure
    Cardiac disorders
    Cardiac failure
    Circulatory failure
    Cytomegalovirus infection
    Drug rash with eosinophilia and systemic symptoms (DRESS)
    Gastro-intestinal haemorrhage
    Haemoglobin decrease
    Hepatic failure
    Hypersensitivity reactions
    Increase in alkaline phosphatase
    Increase in creatinine
    Increase in serum ALT/AST
    Maculopapular rash
    Mucosal inflammation
    Multiorgan failure
    Myelodysplastic syndrome
    Myocardial infarction
    Neurological disorders
    Opportunistic infections
    Pericardial effusion
    Peripheral neuropathy
    Pneumocystis jiroveci pneumonia
    Progressive multifocal leukoencephalopathy (PML)
    Pulmonary disorder
    Pulmonary fibrosis
    Reactivation of hepatitis B
    Renal failure
    Serum bilirubin increased
    Skin disorder
    Stevens-Johnson syndrome
    Toxic epidermal necrolysis
    Tumour lysis syndrome


    It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

    The following number will direct the caller to the relevant local centre (0844) 892 0111

    Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( ) or if this is unavailable at the backup site ( ).

    Further Information

    Last Full Review Date: February 2019

    Reference Sources

    Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 9th edition (2011) ed. Briggs, G., Freeman, R. and Yaffe, S. Lippincott Williams & Wilkins, Philadelphia.

    Summary of Product Characteristics: Bendamustine hydrochloride 25mg/ml concentrate for solution for infusion. Accord UK Ltd. February 2022.
    Summary of Product Characteristics: Levact 2.5mg/ml powder for concentrate for solution for infusion. Napp Pharmaceuticals Ltd. January 2019.
    Summary of Product Characteristics: Bendamustine powder for concentrate for solution for infusion. Actavis UK Ltd. February 2018.
    Summary of Product Characteristics: Bendamustine hydrochloride 2.5mg/ml powder for concentrate for solution for infusion. Accord UK Ltd. December 2020.
    Summary of Product Characteristics: Bendamustine hydrochloride 2.5mg/ml powder for concentrate for solution for infusion. Dr Reddy's UK Ltd. February 2019.
    Summary of Product Characteristics: Bendamustine hydrochloride 180mg/4mg/ml powder for concentrate for solution for infusion. Dr Reddy's UK Ltd. February 2019.

    HPRA Safety Notice June 2017
    Last accessed: 25 August 2017.

    MHRA Drug Safety Update July 2017
    Available at:
    Last accessed: 25 August 2017.

    MHRA Drug Safety Update March 2021 Available at:
    Last accessed: 16 March 2022.
    NICE Evidence Services
    Available at:
    Last accessed: 16 March 2022.

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    Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content

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