FDA Safety Alert Warns Against Use of Treanda with CSTDs

March 11, 2015
Lauren M. Green

The FDA has issued a safety advisory warning healthcare professionals not to use Treanda (bendamustine HCl) Injection with closed system transfer devices (CSTDs), adapters, and syringes containing polycarbonate or acrylonitrile-butadiene-styrene (ABS).

The FDA has issued a safety advisory warning healthcare professionals not to use Treanda (bendamustine HCl) Injection with closed system transfer devices (CSTDs), adapters, and syringes containing polycarbonate or acrylonitrile-butadiene-styrene (ABS).

Most marketed CSTDs contain either polycarbonate or ABS, and they are not compatible with Treanda Injection (45 mg/0.5 mL or 180 mg/2mL solution). Devices that contain polycarbonate or ABS dissolve when coming into contact with N, N-dimethylacetamide (DMA), which is an ingredient in Treanda Injection.

This hazard can lead to device failure (eg, leaking, breaking, or operational failure of CTSD components), possible product contamination, and potential serious adverse health risks for healthcare professionals preparing and administering the product, including skin reactions. There is also a risk of small blood vessel blockage in patients.

Treanda’s manufacturer, Teva Pharmaceuticals, is providing a letter with important prescribing and safety information for healthcare providers on its website (www.treandahcp.com).

Healthcare professionals are advised to only use a polypropylene syringe with a metal needle and polypropylene hub to withdraw and transfer Treanda Injection. Polypropylene syringes are translucent in appearance. In its advisory letter, Teva stressed that polycarbonate syringes, which are clear in appearance, should not be used with Treanda.

If a CSTD is to be used with the product, providers should verify with the CSTD manufacturer or Teva US Medical Information (1-800-896-5855) that the device is compatible for use with Treanda Injection prior to preparing the drug.

The FDA also is requiring label changes to reflect safe preparation information for both the solution and the powder formulations of Treanda. The drug 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 (25mg/vial or 100 mg/vial lyophilized powder). The FDA notes that if a CSTD or adaptor is to be used as supplemental protection during preparation of the powder formulation, providers should only use Treanda for Injection (25mg/vial or 100 mg/vial lyophilized powder) and not the solution.

Treanda is used to treat chronic lymphocytic leukemia and slow-growing B-cell non-Hodgkin lymphoma that has worsened within 6 months of treatment with other agents.

The full FDA advisory is available here.