L-cysteine Hydrochloride Injection Shortage

• • 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

• • 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.

• • 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.