Bendamustine hydrochloride

HEPATIC IMPAIRMENT (safety ceiling, section 4.2): no dose adjustment in mild hepatic impairment (serum bilirubin less than 1.2 mg/dl); a 30% DOSE REDUCTION is recommended in moderate hepatic impairment (serum bilirubin 1.2 to 3.0 mg/dl); no data in severe hepatic impairment (bilirubin greater than 3.0 mg/dl), which is a contraindication. Source is the eMC SPC for Bendamustine hydrochloride 180 mg/4 ml concentrate for solution for infusion. OTHER INDICATIONS in the same 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 to 150 mg/m2 on days 1 and 2 with prednisone 60 mg/m2 intravenously or orally on days 1 to 4, every 4 weeks for at least 3 times. Infusion must be administered under the supervision of a physician qualified and experienced in the use of chemotherapeutic agents. Do not start treatment if leukocytes have dropped below 3,000/microlitre and/or platelets below 75,000/microlitre; terminate or delay treatment if counts fall to these levels; treatment can be continued after leukocytes rise above 4,000/microlitre and platelets above 100,000/microlitre. Leukocyte and platelet nadir is reached after 14 to 20 days with regeneration after 3 to 5 weeks; strict monitoring of the blood count is recommended during therapy-free intervals. Non-haematological toxicity dose reductions are based on the worst CTC grade in the preceding cycle; any individually calculated reduced dose must be given on days 1 and 2 of the respective cycle. Elderly: there is no evidence that dose adjustments are necessary. Paediatric: safety and efficacy in children have not yet been established and current data are insufficient to make a posology recommendation. US labelling (openFDA, Apotex, 2025) differs and gives 120 mg/m2 intravenously over 60 minutes on days 1 and 2 of a 21-day cycle, up to 8 cycles, for NHL, with reduction to 90 mg/m2 then 60 mg/m2 for toxicity.