FDA Warns of Treanda Solution and CSTD Incompatibility
The Food and Drug Administration (FDA) is warning healthcare professionals to not use Treanda (bendamustine HCl solution; Teva) Injection 45mg/0.5mL or 180mg/2mL with closed system transfer devices (CSTD), adapters, and syringes containing polycarbonate or acrylonitrile-butadiene-styrene (ABS).
An ingredient found in Treanda Injection called N, N-dimethylacetamide (DMA), is not compatible with polycarbonate or ABS; these devices dissolve after contact with DMA. This can result in device failure and possible product contamination. Potential serious adverse events, including skin reactions in healthcare professionals preparing and administering the product, and the risk of small blood vessel blockage in patients, may also occur.
The FDA is requiring label changes reflecting safe preparation information for both the solution and powder formulations of Treanda. If using Treanda Injection (45mg/0.5mL or 180mg/2mL), the recommendations are as follows:
- If a CSTD would be used with Treanda Injection, FDA advises healthcare professionals to verify with the CSTD manufacturer or Teva U.S. Medical Information (800-896-5855) that the CSTD is compatible with Treanda Injection prior to preparing the drug.
- FDA recommends healthcare professionals only use a polypropylene syringe with a metal needle and polypropylene hub to withdraw and transfer Treanda Injection. Polypropylene syringes are translucent in appearance.
- Treanda Injection should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.
- Treanda Injection must be withdrawn and transferred for dilution in a biosafety cabinet (BSC) or containment isolator and withdrawn and transferred using a polypropylene syringe with a metal needle and a polypropylene hub.
If using Treanda for Injection (25mg/vial or 100mg/vial), the lyophilized powder formulation, the recommendations are as follows:
- Treanda for Injection), must be reconstituted. If a CTSD or adapter is to be used as supplemental protection during preparation, only use Treanda for Injection and not the solution formulation.
- Do not mix or combine the solution and lyophilized powder formulations of Treanda.
For more information visit FDA.gov.