Drug Information Update- Updated Warnings for Safe Preparation and
Handling of Treanda (bendamustine HCl) Injection for Intravenous
FDA Division of Drug Information: Know the Moment It Happens

The Division of Drug Information (DDI) is CDER's focal point for public
inquiries. We serve the public by providing information on human drug
products and drug product regulation by FDA.


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 (See Tables 1 and 2).  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.

For more information, please visit: Treanda