Other safety alerts
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| The United States: Treanda (bendamustine hydrochloride) Solution by Teva: FDA Statement - Not Compatible with Closed System Transfer Devices, Adapters, and Syringes Containing Polycarbonate or Acrylonitrile-Butadiene-Styrene |
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FDA is warning 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 contain either polycarbonate or ABS and are not compatible with Treanda Injection (45 mg/0.5 mL or 180 mg/2 mL solution).
N, N-dimethylacetamide (DMA), an ingredient in Treanda Injection (45 mg/0.5 mL or 180 mg/2 mL solution), 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.
FDA is requiring label changes for both the solution and the powder formulations of Treanda to reflect safe preparation information. 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). Closed system transfer devices are devices that are used to prepare and administer hazardous drugs for intravenous infusion, such as chemotherapy drugs.
Health care professionals should stop using Treanda Injection (45 mg/0.5 mL or 180 mg/2 mL solution) with CSTDs or vial adapters and syringes containing polycarbonate or ABS. If using Treanda Injection (45 mg/0.5 mL or 180 mg/2 mL solution), health care professionals should verify with the CSTD manufacturer or Teva U.S. Medical Information (1-800-896-5855) that the CSTD is compatible with Treanda Injection (45 mg/0.5 mL or 180 mg/2 mL solution) prior to preparing the drug. Details of the recommendation can be found in the website of the FDA.
If using Treanda for Injection (25mg/vial or 100 mg/vial lyophilized powder), healthcare professionals are advised that:
• Treanda for Injection (25mg/vial or 100 mg/vial lyophilized powder), 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.
Please refer to the following website in FDA for details:
http://www.fda.gov/Safety/MedWatch/../ucm437626.htm
In Hong Kong, Treanda for Inj 100mg (HK-59067) and Treanda for Inj 25mg (HK-62300) are both in powder formulation registered by Ivax Asia Ltd. They are prescription-only medicines and do not contain DMA according to the registered information. Base on the available information, the FDA's announcement regarding incompatibility of Treanda solution with certain CSTD should have no impact on the products registered in Hong Kong.
Ends/ Wednesday, March 11, 2015
Issued at HKT 16:00
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