FDA Warns Against Treanda Injections with Closed System Transfer Devices

Federal drug regulators issued a safety alert on Tuesday, warning healthcare professionals against using Treanda Injections with closed system transfer devices (CSTD), adapters and syringes containing polycarbonate or acrylonitrile-butadiene-styrene (ABS), indicating that it may cause serious health problems.

In a safety alert was issued on March 10, the FDA indicated that the warning information for Treanda Injections (45 mg/0.5 mL or 180 mg/2mL solution) will be updated following at least 40 complaints involving incompatibility problems, which may result in skin reactions among health care professionals preparing the product and a risk of blood vessel blockage among patients.

The alert warns against using Treanda with polycarbonate or ABS, which are contacted in most closed system transfer devices (CSTDs).

Healthcare providers use CSTDs to prepare and administer hazardous drugs for intravenous infusion, including many chemotherapy drugs.

Polycarbonate and ABS are not compatible with Treanda Injection., which also contain N-dimethylacetamide (DMA), which may cause devices that contain polycarbonate or ABS to dissolve when coming into contact with the ingredient.

The dissolving action can lead to device failure, possible product contamination, and potential serious health side effects for healthcare providers and patients.

Treanda Injections are used to treat non-Hodgkin’s lymphoma and chronic lymphocytic leukemia, offering patients a reduced treatment time, since the infusion takes about an hour to complete and can be done on an outpatient basis.

Serious side effects of Treanda have previously resulted in FDA warnings, following severe skin reactions suffered by several patients. In 2009, the FDA warned about the risk of Stevens-Johnson syndrome from Treanda use in combination with allopurinol. The skin condition causes severe burns and rashes over large portions of the body, and may lead to death in some cases.

FDA Recommendations Regarding Treanda Injections

The FDA safety alert recommends that healthcare workers stop using Treanda with CSTDs or vial adapters and syringes that contain polycarbonate or ABS. However, in cases where CSTD use is necessary, the FDA advises health care professionals to verify with the CSTD manufacturers that the device is compatible with Treanda before preparing the drug.

The FDA also recommended the injections only be used with a polypropylene syringe with a metal needle and polypropylene hub to withdraw and transfer Treanda injections.

The injections should be inspected visually for particulate matter and discoloration before being administered, and must be withdrawn and transferred for dilution in a biosafety cabinet or containment isolator.