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10/11/2019

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

    • Jazz Pharmaceuticals has limited stock of Erwinase batch 195K available for ordering with new handling instructions to use a 0.2-micron, low protein binding, in-line filter for IV administration.
    • There is insufficient supply for usual ordering

Estimated Resupply Dates

    • Jazz Pharmaceuticals has Erwinaze 10,000 unit vials in 1 count and 5 count from batch 195k available in limited quantities.
    • 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 (Batches 192K, 174K, 177K, 178K, 179K, 180K, 181K, 182K, 183K, 184K, 185K, 185ak, 186K, 187K, 188K, 189K,190K, and 191K). Particulate matter was seen in vials from these batches during routine inspections. Jazz states that these batches must be given intramuscularly only and NOT intravenously. Batch 191K may be given either intramuscularly or intravenously via tubing with a 0.2-micron, low-protein-binding, in-line filter. Use 5-micron filter needles when withdrawing Erwinaze from vials. The most recent letter with further details can be found at https://www.fda.gov/downloads/Drugs/DrugSafety/DrugShortages/UCM632096.pdf.
    • Jazz Pharmaceuticals has limited stock of Erwinase batch 195K available for ordering with new handling instructions to use a 0.2-micron, low protein binding, in-line filter for IV administration.

Updated

Updated October 11, 2019 by Rachael Freeman, PharmD, BCPS. Created October 11, 2018 by Michelle Wheeler, PharmD, Drug Information Specialist. © 2019, Drug Information Service, University of Utah, Salt Lake City, UT.

Disclaimer

This information is provided through the support of Vizient to ASHP solely as a service to its members, which shall not use this information for their further commercial use. The content was prepared by the Drug Information Center of University of Utah. Vizient, 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, which 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 Vizient, 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 Vizient, ASHP nor University of Utah endorses or recommends the use of any drug.

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