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Amino Acid Products

Last Updated: April 9, 2018
Status: Current

Amino Acid Products

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%, 2000 mL flexible container, 6 count, NDC 00409-7172-17
    • 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, 15%, 2000 mL flexible container, 6 count, NDC 00409-7171-17
    • 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
    • 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
    • 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, 10%, 500 mL glass container, 6 count, NDC 00264-9341-55
    • 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
    • HepatAmine, BBraun, 8%, 500 mL glass container, 6 count, NDC 00264-9371-55
    • NephrAmine injection, BBraun, 5.4%, 250 mL glass container, 6 count, NDC 00264-1909-55
    • ProcalAmine injection, BBraun, 1000 mL glass container, 6 count, NDC 00264-1915-07
Reason for the Shortage
    • Baxter has most amino acid products on allocation due to delays because of Hurricane Maria in Puerto Rico. [1]
    • BBraun has all amino acid on allocation due to increased demand.[2]
    • Pfizer has Aminosyn on back order due to an ingredient shortage which has caused a supply disruption. Pfizer has obtained the ingredient, but does not yet have an estimated date as to when manufacturing will resume.[3]
Available Products
    • 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

Estimated Resupply Dates

    • Baxter has their amino acid products on allocation.[1]
    • BBraun has their amino acid products on allocation.[2]
    • ICU Medical has Aminosyn II 15% 2000 mL bags and 10% 2000 mL bags on back order and the company estimates a release date of late-April 2018. These are not restricted to current customers. All other Aminosyn presentations are on back order and the company estimates a release date in 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 and February 28, 2018.
    2. BBraun. Customer Service (personal communications). June 12 and December 6, 2017.
    3. ICU Medical. Customer Service (personal communications or website). September 6 and December 6, 2017, February 28, and April 2 and 9, 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 April 9, 2018 by Michelle Wheeler, 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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