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

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