FDA warns against use of certain closed system transfer devices with Treanda Injection

FDA has issued a warning to healthcare professionals to stop using closed system transfer devices (CSTDs) containing acrylonitrile-butadiene-styrene (ABS) with Treanda Injection because of the risk of leakage and failure of the devices, and possible product contamination.

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Treanda is used to treat patients with chronic lymphocytic leukemia and indolent B-cell non-Hodgkins lymphoma that has progressed during or following treatment with rituximab.

Treanda is available in two formulations, a solution, Treanda Injection (bendamustine hydrochloride; 45 mg/0.5 mL or 180 mg/2 mL solution), and a lyophilized powder, Treanda for Injection (25 mg/vial or 100 mg/vial lyophilized powder).

Closed system transfer devices are used to prepare and administer hazardous drugs for intravenous infusion. CSTDs are usually marked as containing polycarbonate or ABS and are not compatible with Treanda Injection, according to the FDA safety alert, published in March.

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40 notices

Teva Pharmaceuticals, the manufacturer of the drug, had received 40 notices of the problem with Treanda since December 2014. FDA also received a complaint from a pharmacist about the incompatibility of the devices with the drug.

“Teva investigated the complaints and found that N, N-dimethylacetamide (DMA), an ingredient in Treanda Injection, is incompatible with polycarbonate or ABS. Devices that contain polycarbonate or ABS dissolve when coming into contact with DMA,” FDA noted.

Adverse effects

Potential adverse effects resulting from product contamination include the risk of possible small blood-vessel blockage in patients receiving the drug, as well as skin reactions in the healthcare workers preparing and administering the drug. No adverse events associated with this problem have been reported to FDA.

Teva will update the product labeling for safe preparation of the solution and powder formulations of Treanda, in compliance with FDA’s request. FDA also is requesting that healthcare professionals use a polypropylene syringe with a metal needle and a polypropylene hub for the withdrawal and transfer of Treanda.