FDA Further Warns Against Treanda Injection Incompatibility
The Food and Drug Administration (FDA) is warning healthcare professionals to not use Treanda Injection (bendamustine HCl solution; Teva) 45mg/0.5mL and 180mg/2mL with closed system transfer devices (CSTDs), adapters, and syringes containing polycarbonate or acrylonitrile-butadiene-styrene (ABS).
Treanda Injection contains DMA (N, N-dimethylacetamide), which is not compatible with with devices that contain polycarbonate or ABS. When devices containing polycarbonate or ABS come in contact with DMA in the drug, they have been shown to dissolve. These devices include CSTDs, adapters, and syringes. Device failure such as leaking, breaking, or operational failure of CSTD parts can result. In addition, product contamination and potential serious adverse events (eg, skin reactions, small blood vessel blockage) can occur to practitioners and patients.
The FDA recommends users to contact device manufacturers before using the specific devices listed to ensure no changes have been made to the device's material composition for compatibility with Treanda. The list of compatible devices for use with Treanda Injection based on testing by Teva (from February 2015-June 2015) are listed here.
Treanda is an alkylating agent indicated for the treatment of chronic lymphocytic leukemia (CLL) and indolent B-cell non-Hodgkin lymphoma (NHL) that has progressed during or within 6 months of treatment with rituximab or a rituximab-containing regimen.
The FDA statement does not refer to compatibility with Treanda for Injection (25mg/vial, 100mg/vial), the lyophilized powder formulation. The FDA has required label changes for both the solution and lyophilized powder formulations to reflect the following data for safe preparation and handling for intravenous administration.
For more information call (80)) 896-5855 or visit FDA.gov.