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Amino Acid Products

Last Updated: July 12, 2018
Status: Current

Products Affected - Description
    • Aminosyn (sulfite-free) injection, ICU Medical, 10%, 1000 mL flexible container, 6 count, NDC 00409-4191-05
    • Aminosyn (sulfite-free) injection, ICU Medical, 10%, 500 mL flexible container, 12 count, NDC 00409-4191-03
    • Aminosyn (sulfite-free) injection, ICU Medical, 3.5%, 1000 mL flexible container, 6 count, NDC 00409-4196-05
    • Aminosyn (sulfite-free) injection, ICU Medical, 8.5%, 500 mL flexible container, 12 count, NDC 00409-4187-03
    • Aminosyn (sulfite-free) injection, ICU Medical, 8.5% with electrolytes, 500 mL flexible container, 12 count, NDC 00409-4203-03
    • Aminosyn II (sulfite-free) injection, ICU Medical, 10%, 1000 mL flexible container, 6 count, NDC 00409-4164-05
    • Aminosyn II (sulfite-free) injection, ICU Medical, 10%, 500 mL flexible container, 12 count, NDC 00409-4164-03
    • Aminosyn II (sulfite-free) injection, ICU Medical, 8.5%, 500 mL flexible container, 12 count, NDC 00409-4162-03
    • Aminosyn II (sulfite-free) injection, ICU Medical, 8.5% with electrolytes, 500 mL flexible container, 12 count, NDC 00409-4171-03
    • Clinisol (sulfite-free) injection, Baxter, 15%, 2000 mL flexible container, 6 count, NDC 00338-0502-06
    • Clinisol (sulfite-free) injection, Baxter, 15%, 500 mL flexible container, 24 count, NDC 00338-0502-03
    • Premasol (sulfite-free) injection, Baxter, 10%, 1000 mL flexible container, 12 count, NDC 00338-1130-04
    • Premasol (sulfite-free) injection, Baxter, 10%, 2000 mL flexible container, 6 count, NDC 00338-1130-06
    • Premasol (sulfite-free) injection, Baxter, 10%, 500 mL flexible container, 24 count, NDC 00338-1130-03
    • Premasol (sulfite-free) injection, Baxter, 6%, 500 mL flexible container, 24 count, NDC 00338-1131-03
    • Prosol (sulfite-free) injection, Baxter, 20%, 2000 mL flexible container, 6 count, NDC 00338-0499-06
    • Travasol injection, Baxter, 10%, 1000 mL flexible container, 12 count, NDC 00338-0644-04
    • Travasol injection, Baxter, 10%, 2000 mL flexible container, 6 count, NDC 00338-0644-03
    • Travasol injection, Baxter, 10%, 2000 mL flexible container, NDC 00338-0644-06
    • TrophAmine injection, BBraun, 6%, 500 mL glass container, 12 count, NDC 00264-9361-55
    • Primene (sulfite-free) injection, Baxter, 10%, 250 mL glass bottle, 10 count, NDC 00338-9577-10
    • Synthamin 17 (sulfite-free) injection, Baxter, 10%, 3000 mL bag, 3 count, NDC 00338-9575-03
    • Aminosyn HBC (sulfite-free) injection, ICU Medical, 7%, 500 mL flexible container, 12 count, NDC 00409-4168-03
    • Aminosyn-RF (sulfite-free) injection, ICU Medical, 5.2%, 500 mL flexible container, 12 count, NDC 00409-4166-03
    • FreAmine HBC injection, BBraun, 6.9%, 750 mL glass container, 6 count, NDC 00264-9350-55
    • NephrAmine injection, BBraun, 5.4%, 250 mL glass container, 6 count, NDC 00264-1909-55
Reason for the Shortage
    • Baxter has reintroduced amino acids into the distribution channel.[1]
    • Baxter has most amino acid products on allocation due to delays because of Hurricane Maria in Puerto Rico.
    • BBraun has discontinued FreAmine HBC, Nephramine, and Trophamine 6%.[2]
    • ICU Medical has Aminosyn on back order due to an ingredient shortage which has caused a supply disruption.[3]
Available Products
    • Aminosyn II (sulfite-free) injection, ICU Medical, 10%, 2000 mL flexible container, 6 count, NDC 00409-7172-17
    • Aminosyn II (sulfite-free) injection, ICU Medical, 15%, 2000 mL flexible container, 6 count, NDC 00409-7171-17
    • Aminosyn-PF (sulfite-free) injection, ICU Medical, 10%, 1000 mL flexible container, 6 count, NDC 00409-4179-05
    • Aminosyn-PF (sulfite-free) injection, ICU Medical, 7%, 500 mL flexible container, 12 count, NDC 00409-4178-03
    • FreAmine III injection, BBraun, 10%, 1000 mL glass container, 6 count, NDC 00264-9010-55
    • Plenamine injection, BBraun, 15%, 1000 mL glass container, 6 count, NDC 00264-3200-55
    • TrophAmine injection, BBraun, 10%, 500 mL glass container, 6 count, NDC 00264-9341-55
    • HepatAmine, BBraun, 8%, 500 mL glass container, 6 count, NDC 00264-9371-55
    • ProcalAmine injection, BBraun, 1000 mL glass container, 6 count, NDC 00264-1915-07

Estimated Resupply Dates

    • Baxter has their amino acid products on allocation.[1]
    • ICU Medical has Aminosyn 3.5% 1000 mL bags, Aminosyn 8.5% 500 mL and 500 mL with electrolytes bags, Aminosyn 10% 500 mL and 1000 mL bags, Aminosyn II 8.5% 500 mL and 500 mL with electrolytes bags, and Aminosyn II 10% 500 mL and 1000 mL bags on back order and the company estimates a release date of 1st quarter 2019.[3]

Implications for Patient Care

    • Travasol product information now includes dosage information for pediatric patients. Travasol product information can be found at https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8543b5be-0f43-4891-9e56-d7c39fe839b5. A comparison chart of Premasol and Travasol is available at https://www.nutritioncare.org/uploadedFiles/Documents/Guidelines_and_Clinical_Resources/Comparison%20Chart%20of%20Premasol%20and%20Travasol.pdf.

Safety

    • ASPEN provides recommendations for managing shortages of parenteral nutrition products. See their website for more details (https://www.nutritioncare.org/Guidelines_and_Clinical_Resources/Product_Shortages/Product_Shortage_Management/).
    • Imported products have an international barcode that may not be recognized on U.S. scanning systems. Manually input the product into the scanning system and follow procedures to ensure the correct drug product is being administered to patients.
    • Primene 10% and Synthamin 17 10% have not been tested for aluminum content. Consider this when administering to preterm infants, term infants less than 1 month of age, or patients with renal impairment.[4-5]
    • Use a filter during administration of all formulations of Primene and trace elements to remove visible particulate matter. For 2-in-1 (amino acid and carbohydrate) parenteral nutrition, use a 0.2 micron filter to remove particulate matter that may be formed with the use of trace elements. For 3-in-1 (lipid, amino acid, and carbohydrate) parenteral nutrition, use a 1.2 micron filter to remove particulate matter.[4]

Alternative Agents & Management

    • FDA in conjunction with Baxter is allowing temporary importation of amino acid solutions from Italy and the United Kingdom. There are 2 different solutions being imported at this time:
    • 1. Primene (sulfite-free) injection (NDC 00338-9577-10) - 10%, 250 mL glass bottle, 10 count (imported from Italy)
    • Additional information and table comparing Primene 10% and Premasol 6% is available at https://www.fda.gov/downloads/Drugs/DrugSafety/DrugShortages/UCM587200.pdf.
    • 2. Synthamin 17 (sulfite-free) injection (NDC 00338-9575-03) - 10%, 3000 mL bag, 3 count (imported from United Kingdom)
    • Additional information and table comparing Travasol 10% and Synthamin 17 10% is available at https://www.fda.gov/downloads/Drugs/DrugSafety/DrugShortages/UCM584416.pdf
    • Call Baxter to place an order at 888-229-0001.

References

    1. Baxter. Customer Service (personal communications). September 6, 2017, January 3, February 28, June 8, and July 9, 2018.
    2. BBraun. Customer Service (personal communications). June 12 and December 6, 2017; and July 10, 2018.
    3. ICU Medical. Customer Service (personal communications or website). September 6 and December 6, 2017, February 28, April 2 and 9, May 1, and July 10, 2018.
    4. Baxter. Dear Healthcare Professional Letter. https://www.fda.gov/downloads/Drugs/DrugSafety/DrugShortages/UCM587200.pdf November 30, 2017. Accessed December 6, 2017.
    5. Baxter. Dear Healthcare Professional Letter. https://www.fda.gov/downloads/Drugs/DrugSafety/DrugShortages/UCM584416.pdf Accessed December 15, 2017.

Updated

Updated July 12, 2018 by Leslie Jensen, PharmD, Drug Information Specialist. Created March 3, 2017 by Leslie Jensen, PharmD, Drug Information Specialist. Copyright 2018, Drug Information Service, University of Utah, Salt Lake City, UT.

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