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9/8/2016

L-cysteine Hydrochloride Injection

Products Affected - Description

    • L-cysteine hydrochloride injection, American Regent, 50 mg/mL, 10 mL vial, 25 count, NDC 00517-2050-05
    • L-cysteine hydrochloride injection, American Regent, 50 mg/mL, 50 mL vial, 5 count, NDC 00517-2064-25
    • L-cysteine hydrochloride injection, Sandoz, 50 mg/mL, 10 mL vial, 10 count, NDC 66758-0004-02
    • L-cysteine hydrochloride injection, Sandoz, 50 mg/mL, 50 mL vial, 5 count, NDC 66758-0005-02

Reason for the Shortage

    • American Regent has L-cysteine hydrochloride injection on back order due to manufacturing delays.
    • Sandoz has discontinued L-cysteine hydrochloride 50 mL vials. The 10 mL vials (NDC 66758-0004-02) were replaced with new 10 mL vials (NDC 00781-8940-95). Sandoz in cooperation with FDA is temporarily importing product from Canada to alleviate the shortage. It contains the same active ingredient. More information can be found at: http://www.fda.gov/downloads/Drugs/DrugSafety/DrugShortages/UCM511888.pdf.

Available Products

    • L-cysteine hydrochloride injection, Sandoz, 50 mg/mL, 10 mL vial, 10 count, NDC 00781-8940-95

Estimated Resupply Dates

    • American Regent has L-cysteine hydrochloride injection 10 mL and 50 mL vials on long-term back order and the company cannot estimate a release date.

Alternative Agents & Management

    • The American Society for Parenteral and Enteral Nutrition (ASPEN) has detailed recommendations for managing this shortage online at http://www.nutritioncare.org/Guidelines_and_Clinical_Practice/Clinical_Practice_Library/Parenteral_Nutrition_Cysteine_Product_Shortage_Considerations/.
    • Key recommendations include:
    • Reserve supplies for neonatal patients <1 kg or neonatal patient who are >1 kg after surgery or with sepsis.
    • Avoid use of L-cysteine if patient is receiving at least 3 gram/kg per day of protein.
    • Consider oral or enteral routes for supplementation if possible.
    • Avoid using L-cysteine for catheter patency.
    • Compound in central location and add L-cysteine as a separate product from amino acid solutions to help conserve supplies.
    • Purchase only the supply needed, do not stockpile.

Updated

Updated September 8, 2016 by Elyse MacDonald, PharmD, MS, BCPS. Created November 25, 2014 by Michelle Wheeler, PharmD, Drug Information Specialist. Copyright 2017, 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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