Indications And Dose
Treatment of chronic lymphocytic leukaemia | Treatment of non-Hodgkin’s lymphoma | Treatment of multiple myeloma ▶BY INTRAVENOUS INFUSION ▶Adult: (consult local protocol)
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Drug reference
Treatment of chronic lymphocytic leukaemia | Treatment of non-Hodgkin’s lymphoma | Treatment of multiple myeloma ▶BY INTRAVENOUS INFUSION ▶Adult: (consult local protocol)
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Jaundice. low leucocyte count. low platelet count. major surgery less than 30 days before start of treatment. severe bone marrow suppression
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Cardiac disorders—monitor serum potassium and ECG
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NICE decisions ▶Bendamustine for the first-line treatment of chronic lymphocytic leukaemia (February 2011) NICE TA216 Bendamustine is recommended as an option for the first- line treatment of chronic lymphocytic leukaemia (Binet stage B or C) in patients for whom fludarabine combination chemotherapy is not appropriate. www.nice.org.uk/guidance/ta216 ▶Obinutuzumab with bendamustine for treating follicular lymphoma refractory to rituximab (August 2017) NICE TA472 Bendamustine in combination with obinutuzumab followed by obinutuzumab maintenance, is recommended for use within the Cancer Drugs Fund as an option for treating adults with follicular lymphoma that did not respond or progressed during or up to 6 months after treatment with rituximab or a rituximab-containing regimen, only if the conditions in the managed access agreement for obinutuzumab are followed. www.nice.org.uk/guidance/ta472 Scottish Medicines Consortium (SMC) decisions The Scottish Medicines Consortium has advised (April 2011) that bendamustine (Levact ®) is accepted for use within NHS Scotland for first-line treatment of chronic lymphocytic leukaemia (Binet stage B or C) in patients for whom fludarabine combination chemotherapy is not appropriate.
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Immune system and malignant disease MHRA/CHM ADVICE: BENDAMUSTINE (LEVACT ®): INCREASED MORTALITY OBSERVED IN RECENT CLINICAL STUDIES IN OFF- LABEL USE; MONITOR FOR OPPORTUNISTIC INFECTIONS, HEPATITIS B REACTIVATION (JULY 2017) Recent clinical trials have shown increased mortality when bendamustine was used in combination treatments outside its approved indications. In addition, a recent European review of post-marketing data has suggested that the risk of opportunistic infections for all patients receiving bendamustine treatment may be greater than previously recognised. The MHRA recommends monitoring patients for opportunistic infections as well as cardiac, neurological, and respiratory adverse events; known carriers of hepatitis B virus (HBV) should be monitored for signs and symptoms of active HBV infection. Patients should be advised to report promptly new signs of infection; consider discontinuing bendamustine if there are signs of opportunistic infections.
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→Appendix 1: alkylating agents
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▶Common or very common Alopecia. amenorrhoea. anaemia. angina pectoris. appetite decreased. arrhythmias. cardiac disorder. chills. constipation. decreased leucocytes. dehydration. diarrhoea. dizziness. fatigue. fever. haemorrhage. headache. hepatitis B reactivation. hypersensitivity. hypertension. hypokalaemia. hypotension. increased risk of infection. insomnia. mucositis. nausea. neutropenia. pain. palpitations. respiratory disorders. skin reactions. stomatitis. thrombocytopenia. tumour lysis syndrome. vomiting ▶Uncommon Bone marrow disorders. heart failure. myocardial infarction. neoplasms. pericardial effusion ▶Rare or very rare Anticholinergic syndrome. aphonia. ataxia. circulatory collapse. drowsiness. haemolysis. hyperhidrosis. infertility. multi organ failure. nervous system disorder. paraesthesia. peripheral neuropathy. sepsis. taste altered ▶Frequency not known Extravasation necrosis. hepatic failure. necrosis. renal failure. severe cutaneous adverse reactions (SCARs) SIDE-EFFECTS, FURTHER INFORMATION Secondary malignancy Use of bendamustine is associated with an increased incidence of acute leukaemias. Infections Serious and fatal infections are reported, including opportunistic infections such as Pneumocystis jirovecii pneumonia (PJP), varicella zoster virus (VZV) and cytomegalovirus (CMV)—manufacturer advises monitoring for respiratory signs and symptoms throughout treatment; patients should be advised to report new signs of infection, including fever or respiratory symptoms, promptly. Reactivation of hepatitis B is reported in patients who are chronic carriers of the virus—manufacturer advises monitoring for signs and symptoms of active hepatitis B during treatment and for several months after stopping treatment.
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Effective contraception is required during treatment in men or women, and for 6 months after treatment in men. See also Pregnancy and reproductive function in Cytotoxic drugs p. 938.
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Avoid (teratogenic and mutagenic in animal studies). See also Pregnancy and reproductive function in Cytotoxic drugs p. 938.
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Discontinue breast-feeding.
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Manufacturer advises avoid in severe impairment—no information available. Dose adjustments Manufacturer advises reduce dose by 30% in moderate impairment.
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No information available on use in patients with creatinine clearance less than 10 mL/minute.
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There can be variation in the licensing of different medicines containing the same drug. Powder for solution for infusion ▶Bendamustine hydrochloride (Non-proprietary) Bendamustine hydrochloride 25 mg Bendamustine 25mg powder for concentrate for solution for infusion vials | 1 vial P £65.98 | 5 vial P £27.75–£347.26 (Hospital only) | 20 vial P £1,241.14 (Hospital only) Bendamustine hydrochloride 100 mg Bendamustine 100mg powder for concentrate for solution for infusion vials | 1 vial P £23.55 (Hospital only) | 1 vial P £262.02 | 5 vial P £1,241.14–£1,379.04 (Hospital only)
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(consult local protocol)
First-line fragment. Read the complete Indications and Dose section above.
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