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Chemo Drug Dissolves Material in Some Chemotherapy Preparation Devices; Injury Risk


The FDA warned health care professionals not to use Treanda Injection (45 mg/0.5 mL or 180 mg/2 mL solution) with closed system transfer devices (CSTD), adapters, and syringes containing polycarbonate or acrylonitrile-butadiene-styrene (ABS). Most marketed CSTDs, devices that are used to prepare and administer hazardous drugs for intravenous infusion such as chemotherapy drugs, contain either polycarbonate or ABS and are not compatible with Treanda Injection.

 

Treanda (bendamustine hydrochloride), manufactured by Teva, is used to treat patients with chronic lymphocytic leukemia (CLL) and indolent B-cell non-Hodgkins lymphoma (NHL) that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen.

 

N, N-dimethylacetamide (DMA), an ingredient in Treanda Injection, is incompatible with polycarbonate or ABS. Devices that contain polycarbonate or ABS dissolve when coming into contact with DMA. This can lead to device failure, possible product contamination, and potential serious adverse health consequences, including skin reactions in health care professionals preparing and administering this product and the risk of small blood vessel blockage in patients.

 

Since December 2014, the manufacturer has received 40 complaints of this incompatibility issue, which was recently brought to the FDA’s attention. The FDA also received a notification of device incompatibility with the use of Treanda Injection (45 mg/0.5 mL or 180 mg/2 mL solution) from a pharmacist. These incompatibility issues included leaking of the CSTD, breaking or operational failure of the CSTD components, and a cloudy appearance or presence of particulate matter in the intravenous (IV) bag after dilution.

 

Treanda is available in two formulations, a solution, Treanda Injection (45 mg/0.5 mL or 180 mg/2 mL solution); and a lyophilized powder, Treanda for Injection (25mg/vial or 100 mg/vial lyophilized powder). The FDA is requiring label changes for both the solution and the powder formulations of Treanda to reflect safe preparation information. The FDA recommends health care 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, while devices that contain polycarbonate or ABS are clear.

 

Treanda Injection (45 mg/0.5 mL or 180 mg/2 mL solution) should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. Treanda Injection (45 mg/0.5 mL or 180 mg/2 mL solution) 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 100 mg/vial lyophilized powder), it must be reconstituted. If a CTSD or adaptor is to be used as supplemental protection during preparation, only use Treanda for Injection (25mg/vial or 100 mg/vial lyophilized powder) and not the solution formulation. Do not mix or combine the solution and lyophilized powder formulations of Treanda.

 

See the FDA Drug Safety Announcement

 

See also Medical Law Perspectives, May 2013 Report: Drugs, Dosage, and Damage: Physician Liability for Prescribing or Administering Medication

 

See also Medical Law Perspectives, October 2012 Report: Mistakes in Diagnosing Cancer: Liability Concerns for Misdiagnosis, Failure to Diagnose, and Delayed Diagnosis

 

 

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