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7/16/2020

Asparaginase Erwinia chrysanthemi

Products Affected - Description

    • Erwinaze lyophilized powder for injection, Jazz Pharmaceuticals, 10,000 unit, vial, 1 count, NDC 57902-0249-01
    • Erwinaze lyophilized powder for injection, Jazz Pharmaceuticals, 10,000 unit, vial, 5 count, NDC 57902-0249-05

Reason for the Shortage

    • Erwinaze supply disruption is due to ongoing manufacturing issues and capacity constraints at Porton Biopharma Limited, the sole manufacturer of Erwinaze. Erwinaze is distributed by Jazz Pharmaceuticals.

Available Products

    • There is insufficient supply for usual ordering

Estimated Resupply Dates

    • Jazz Pharmaceuticals has Erwinaze 10,000 unit vials in 1 count and 5 count on back order and the company estimates product will be available in early-August 2020.
    • There is a new process for ordering Erwinaze. Additional information regarding the new ordering process is available at www.erwinazesupply.com.

Safety

    • Jazz Pharmaceuticals sent Dear Health Care Provider letters regarding the administration of certain batches of Erwinaze. Particulate matter was seen in vials from these batches during routine inspections. Use 5-micron filter needles when withdrawing Erwinaze from vials and use a 0.2 micron, low protein binding, in-line filter attached to the primary IV tubing for administration. See https://erwinazesupply.com/product-updates/ for additional details.

Updated

Updated July 16, 2020 by Leslie Jensen, PharmD, Drug Information Specialist. Created October 11, 2018 by Michelle Wheeler, PharmD, Drug Information Specialist. © 2020, Drug Information Service, University of Utah, Salt Lake City, UT.

Disclaimer

Drug Shortage Bulletins are copyrighted by the Drug Information Service of the University of Utah and provided by ASHP as its exclusive authorized distributor. ASHP and the University of Utah make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information, and specifically disclaim all such warranties. Users of this information are advised that decisions regarding the use of drugs and drug therapies are complex medical decisions and that in using this information, each user must exercise his or her own independent professional judgment. Neither ASHP nor the University of Utah assumes any liability for persons administering or receiving drugs or other medical care in reliance upon this information, or otherwise in connection with this Bulletin. Neither ASHP nor the University of Utah endorses or recommends the use of any particular drug. Any application of this information for any purpose shall be limited to personal, non-commercial use.

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