Patient receiving chemotherapy

Photo by Rhoda Baer

Last March, the US Food and Drug Administration (FDA) issued a statement warning healthcare professionals not to use the chemotherapy drug Treanda Injection (bendamustine hydrochloride) with closed system transfer devices (CSTDs), adapters, and syringes containing polycarbonate or acrylonitrile-butadiene-styrene (ABS).

Now, the FDA is providing a list of devices that were tested and deemed compatible with the drug (see the tables below).

The devices were tested by Treanda’s manufacturer, Teva Pharmaceuticals.

Treanda is used to treat patients with chronic lymphocytic leukemia and indolent B-cell non-Hodgkin lymphoma that has progressed during or within 6 months of treatment with rituximab or a rituximab-containing regimen.

Treanda is available in 2 formulations: a solution, Treanda Injection (45 mg/0.5 mL or 180 mg/2 mL solution), and a lyophilized powder, Treanda for Injection (25 mg/vial or 100 mg/vial lyophilized powder). The information discussed here is referring to compatibility with the solution, Treanda Injection.

Treanda Injection contains N, N-dimethylacetamide (DMA), which is incompatible with devices that contain polycarbonate or ABS. Devices including CSTDs, adapters, and syringes that contain polycarbonate or ABS have been shown to dissolve when they come in contact with DMA in the drug.

This incompatibility leads to device failure, such as leaking, breaking, or operational failure of CSTD components; possible product contamination; and potential serious adverse health consequences to practitioners, such as skin reactions, or to patients, including the risk of small blood vessel blockage if the product is contaminated with dissolved ABS or polycarbonate.

Users should contact device manufacturers prior to using the specific devices listed below to ensure there have been no changes made to the material composition of the devices and that the devices are compatible with Treanda use.

Table 1. The compatibility of Treanda Injection with specific CSTDs, syringes, vial adapters, and gloves (based on testing conducted by Teva from February 2015 through June 2015).

Component tested	Component brand name (part number)
Closed system transfer devices (CSTDs)	BD Phaseal System consisting of: BD Phaseal Protector P14 (REF 515100), BD Phaseal Injector Luer Lock N35 (REF 515003), BD Phaseal Infusion Adapter C100 (REF 515306), BD syringe 5 mL (REF 309646 and 309657)
Vial adapters	Baxter CHEMO-AIDE Dispensing Pin (REF 2N9106) Medimop Swabable Vial Adapter (REF 8070101) Alaris Smartsite (REF 2202E and 2203E)
Polypropylene syringes	BD (Becton Dickinson), 5 mL (REF 309646) and 3 mL (REF 309657) Covidien Monoject, 5 mL (REF 1180600777) and 3 mL (REF 1180300777) B. Braun, 5 mL (REF 4617053V-02) and 3 mL (REF 4610303-02) Air-Tite Norm Jet, 5 mL (REF 4050.X00V0) and 3 mL (REF 4020.X00V0) Medline, 5 mL (REF SYR105010) and 3 mL (REF SYR103010) Terumo, 5 mL (REF SS-05L)
Disposable gloves*	ChemoPlus (REF CT0194-1) EP-Blue (REF 181350) Jackson Safety G29 (REF 49824) NeoPro (REF NPG-888) NitriDerm (REF 182350) Purple (REF 50604) Purple KC 500 (REF 55084) UltraSense EC (REF USE-880)

*Part numbers reflect a specific size glove used in the compatibility tests.

Table 2. The IV administration set found to be compatible with Treanda Injection after dilution in a 500 mL 0.9% sodium chloride IV infusion bags (based on testing conducted by Teva from February 2015 through June 2015*).

Component tested

Brand name (part number)

IV administration sets

B. Braun Safeline (REF NF3482) and AdditIV (REF V1921)

Baxter DuoVent Spike (REF 2C7575) and Clearlink System (2H8480)

BD Phaseal Secondary set (REF 515301)

ICU Medical Clave (REF CH3011)

*Compatibility studies did not include testing with 2.5% dextrose/0.45% sodium chloride injection. However, the results of these studies are not expected to change. So either diluent, 0.9% sodium chloride or 2.5% dextrose/0.45% sodium chloride injection, can be used with Treanda injection.

The FDA required label changes for both the solution and the powder formulations of Treanda to include information for safe preparation and handling for IV administration. See the full prescribing information for details.

For more details on the compatibility of Treanda Injection with specific CSTDs, syringes, vial adapters, gloves, and IV administration sets, see Teva’s Dear Health Care Provider letter.

Adverse events or quality problems associated with the use of Treanda products can be reported to the FDA’s MedWatch Adverse Event Reporting Program.

FDA updates warning about Treanda