Bendamustine Injection is Only Compatible with Some Dose-Preparation Devices

by pharmacy on April 1, 2015

bendamustine-injectionTeva pharmaceuticals announced in early March that – due to incompatibility between an ingredient in their Treanda (bendamustine) injection and components of some closed system transfer devices, adapters, and syringes – some may experience failure of equipment and/or contamination of the drug.

The company’s official announcement instructs healthcare providers to no longer use the injection, the liquid formula of bendamustine hydrochloride, with any dose separation equipment that contains acrylonitrile butadiene styrene or polycarbonate.

According to the FDA, the incompatibility has demonstrated itself in a number of ways including: leakage, operational failure of closed system transfer devices, breakage, and drug contamination, resulting in the production of solutions that are cloudy in appearance or have visible particulate matter.

This particular product became available in the United States in the middle of November 2014. Before it can be given to a patient, it must be transferred to a 500 mL infusion bag. Prior to this release, the drug has only been supplied as a lyophilized powder that required reconstitution before it was transferred to an infusion bag.

Since the end of 2014, the FDA says Teva has received 40 complaints about the formula’s incompatibility with dosage preparation equipment. One pharmacy complained directly to the FDA. Teva was able to trace the drug device problem to N,N-dimethylacetamide,  an ingredient in the liquid formula.

According to Teva and the FDA, Any health care providers who prepare the liquid formula for administration to patients should do so only by using syringes that are made of polypropylene. They should have a metal needle and polypropylene hub. These are designed to transfer, rather than store, the medication. These syringes are translucent, and polycarbonate syringes are clear.

Most closed system transfer devices are compatible with the liquid formula, however, any devices that contain polycarbonate, or acetonitrile butadiene styrene can cause issues. If you are not sure about what is used in your hospital or pharmacy’s closed system transfer device, contact the manufacturer or the US medical information group to confirm compatibility.

The FDA has now required Teva to include stickers or adhesive labels that let pharmacies know the drug is not for use with devices that contain polycarbonate or acetonitrile butadiene styrene.

Teva has now said they will make the lyophilized powder available to facilities as soon as possible. This is to assist facilities where a closed system transfer device or adapters are used as protection from the drug.

According to the National Institute for Occupational Safety and Health, bendamustine is a hazardous drug. As a result of this designation, healthcare workers must always use personal protective equipment and engineering controls, such as the use of a closed system transfer device, when working with the IV solution.

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