Treanda (bendamustine hydrochloride) solution by Teva: FDA safety warning


The FDA report “FDA is warning health care professionals not to use Treanda Injection (45 mg/0.5 mL or 180 mg/2 mL solution) with closed system transfer devices (CSTD), adapters, and syringes containing polycarbonate or acrylonitrile-butadiene-styrene (ABS). Most marketed CSTDs contain either polycarbonate or ABS and are not compatible with Treanda Injection (45 mg/0.5 mL or 180 mg/2 mL solution).

N, N-dimethylacetamide (DMA), an ingredient in Treanda Injection (45 mg/0.5 mL or 180 mg/2 mL solution), is incompatible with polycarbonate or ABS. Devices that contain polycarbonate or ABS dissolve when coming into contact with DMA. This can lead to device failure, possible product contamination, and potential serious adverse health consequences, including skin reactions in health care professionals preparing and administering this product and the risk of small blood vessel blockage in patients.

FDA is requiring label changes for both the solution and the powder formulations of Treanda to reflect safe preparation information.”

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