FDA Updated warnings for safe preparation and handling of Treanda Injection (solution) for intravenous administration
On March 10, 2015, the FDA issued a statement warning health care professionals not to use chemotherapy drug Treanda Injection with CSTDs, adapters and syringes containing polycarbonate or ABS.
September 14, 2015 • less than 1 minute to read
On March 10, 2015, the FDA issued a statement warning health care professionals not to use chemotherapy drug Treanda Injection (45 mg/0.5 mL or 180 mg/2 mL solution) with closed system transfer devices (CSTDs), adapters and syringes containing polycarbonate or acrylonitrile-butadiene-styrene (ABS).
As an update, FDA is providing information on specific devices tested by Treanda manufacturer Teva Pharmaceuticals and found compatible with Treanda injection. Treanda (bendamustine hydrochloride) is used to treat patients with chronic lymphocytic leukemia (CLL) and indolent B-cell non-Hodgkin lymphoma (NHL) that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen.
You can access the updated FDA statement with the list of specific devices test by Teva at: http://www.fda.gov/drugs/drugsafety/ucm437469.htm