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FDA Issues Safety Warning for Treanda (Bendamustine) Solution

Product is incompatible with certain closed-system transfer devices, adapters, and syringes

The FDA is warning health care professionals not to use Treanda injection (45 mg/0.5 mL or 180 mg/2 mL solution) (Teva) 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), the agency says.

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.

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

Treanda is available in two formulations: a solution, Treanda injection (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). CSTDs are devices that are used to prepare and administer hazardous drugs for intravenous infusion, such as chemotherapy drugs.

If a CSTD is to be used with Treanda injection (45 mg/0.5 mL or 180 mg/2 mL solution), the FDA advises health care professionals to verify with the CSTD manufacturer or with Teva U.S. Medical Information (1-800-896-5855) that the CSTD is compatible with Treanda injection (45 mg/0.5 mL or 180 mg/2 mL solution) prior to preparing the drug.

The FDA recommends that health care professionals use only a polypropylene syringe with a metal needle and polypropylene hub to withdraw and transfer Treanda injection. Polypropylene syringes are translucent in appearance.

Treanda injection (45 mg/0.5 mL or 180 mg/2 mL solution) should be inspected visually for particulate matter and discoloration prior to administration whenever the solution and the container permit. In addition, the product must be withdrawn and transferred for dilution in a biosafety cabinet or containment isolator.

If health care providers use Treanda for injection (25 mg/vial or 100 mg/vial lyophilized powder), the product must be must be reconstituted. If a CTSD or adaptor is to be used as supplemental protection during preparation, health care providers should use only Treanda for injection (25 mg/vial or 100 mg/vial lyophilized powder) and not the solution formulation.

The solution and lyophilized powder formulations of Treanda should not be mixed or combined.

Source: FDA; March 10, 2015.

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