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Trace Elements Injection

[13 August 2014]

Products Affected - Description

Adult Trace Element Products
Multitrace, American Regent
Multitrace-5 Regular, 10 mL vial (NDC 00517-8510-25)
Multitrace-5 Concentrate 1 mL vial (NDC 00517-8201-25)
Multitrace-5 Concentrate 10 mL vial (NDC 00517-8210-25)
 
Pediatric Trace Element Products
Multitrace, American Regent
Multitrace-4 Pediatric, 3 mL vial (NDC 00517-9203-25)

Trace elements, American Regent
Trace elements-4 pediatric injection, 10 mL vial (NDC 00517-9310-25)

Reason for the Shortage

  • American Regent has trace element injection on back order due to manufacturing delays.1,2      
  • American Regent is the sole supplier of FDA-approved combined trace elements.
  • In cooperation with FDA, Fresenius Kabi USA is providing Addamel N (adult trace element injection) and Peditrace (pediatric trace element injection) to the US market to help alleviate the shortage. Addamel N and Peditrace are manufactured in an FDA-approved facility in Norway by Fresenius Kabi AG, the parent company of Fresenius Kabi, USA.3 

Available Products

Adult Trace Element Products
Multitrace, American Regent4
Multitrace-4 Concentrate, 1 mL vial (NDC 00517-7201-25)
Multitrace-4 Concentrate, 10 mL vial (NDC 00517-7210-25)
Multitrace-4 Regular, 10 mL vial (NDC 00517-7410-25)
 

Imported Product
Addamel N, Fresenius Kabi USA5
Addamel N Concentrate, 10 mL ampule (NDC 63323-0143-97)

Pediatric Trace Element Products
Multitrace, American Regent4
Multitrace-4 Neonatal, 2 mL vial (NDC 00517-6202-25)

Imported Product
Peditrace, Fresenius Kabi USA5
Peditrace Concentrate, 10 mL vial (NDC 63323-0147-10)

Estimated Resupply Dates

  • American Regent has Multitrace-4 pediatric 3 mL vials, Multitrace-5 regular 10 mL vials, Multitrace-5 Concentrate 1 mL and 10 mL vials on back order and the company cannot estimate a release date.4
  • American Regent has Trace Elements-4 Pediatric injection on back order and the company cannot estimate a release date.4

Implications for Patient Care

Trace elements are commonly used in parenteral nutrition solutions to prevent deficiencies.6

Safety

  • Dosing differs between the imported and FDA approved product. Use caution when switching between products.3
  • Bar coding systems should not be used with Addamel N ampules or Peditrace vials as incorrect information may be provided if the item is scanned.3
  • Addamel N contains iron and compatibility testing with US products containing intravenous fat emulsion have not been conducted.3
  • Report any offers to sell Addamel N or Peditrace by an entity other than Fresenius Kabi to drugshortages@fda.hhs.gov. Fresenius Kabi USA will only be releasing product to the following distributors: Amerisource Bergen, McKesson, Cardinal, Morris & Dickson, and HD Smith.

Alternative Agents & Management

  • Addamel N is supplied in a 10 mL single dose ampule and contains zinc chloride, copper chloride, manganese chloride, chromic chloride, sodium selenite, ferric chloride, sodium molybdate, potassium iodide, and sodium fluoride. Addamel Nis preservative-free. Fresenius Kabi USA has a Dear Healthcare professional letter that summarizes the key differences between products.
  • Peditrace is supplied in a 10 mL single dose vial and contains zinc chloride, copper chloride, manganese chloride, sodium selenite, potassium iodide, and sodium fluoride. Peditrace does not contain chromium and is preservative-free.8 Fresenius Kabi USA has a Dear Healthcare professional letter that summarizes the key differences between products.
  •  Additional information regarding the use of Peditrace in the preterm and term newborn population with regard to iodine and fluoride content is available.
  • Product labeling for Addamel N injection is available on the Daily Med website.
  • Product labeling for Peditrace injection is available on the Daily Med website.
  • The American Society for Parenteral and Enteral Nutrition (ASPEN) has detailed recommendations for managing this shortage.
  • Key recommendations include:
    • Reserve supplies for neonatal or pediatric patients or other vulnerable groups such as patients with short bowel or malabsorption syndromes.
    • Avoid use of pediatric trace elements for adult patients.
    • Adult trace element products are not recommended for pediatric patients.
    • Consider oral or enteral multivitamin or multi-mineral products for supplementation if possible.
    • Avoid using trace elements additives in IV fluids.
    • Increase vigilance of signs and symptoms of trace element deficiencies.
    • Purchase only the supply needed, do not stockpile.
  • American Society for Parenteral and Enteral Nutrition published a position paper regarding parenteral multivitamin and multi-trace element products. This paper provides dosing recommendations and a summary of European trace elements compared to products available in the US.10

Related Shortages

References

  1. Luitpold Pharmaceuticals. Press Release. Accessed May 28, 2013.
  2. Luitpold Pharmaceuticals. Press Release. Accessed May 28, 2013.
  3. Fresenius Kabi USA. Dear Healthcare Professional Letters (customer letter). Accessed May 29, 2013.
  4. American Regent Laboratories (personal communications and website). November 1 and 16, December 4, 2012; January 4 and 21, February 20, March 4, 18, and 20, April 9, May 9 and 28, June 4, July 29, September 5 and 19, October 31, November 26, 2013; January 2, 15, 16, and 27, March 13, May 1, June 16, July 3 and 30, and August 12, 2014.
  5. Fresenius Kabi (personal communications). May 28, June 4, 24, and 27, July 29, September 5 and 19, November 26, 2013; January 1, May 1, June 5, and July 1, 2014. 
  6. Lexi-Drugs Online. Hudson, OH: Lexi-Comp, Inc.; 2013.
  7. Fresenius Kabi. Addamel N Concentrate for Infusion [product information]. Halden, Norway: Fresenius Kabi Norge AS, 2008.
  8. Fresenius Kabi. Peditrace Concentrate for Solution for Infusion [product information]. Halden, Norway: Fresenius Kabi Norge AS, 2008.
  9. American Society for Parenteral and Enteral Nutrition. Parenteral Nutrition Electrolyte / Mineral Product Shortage Considerations.  Accessed May 28, 2013.
  10. Vanek VW, Borum P, Buchman A, Fessler TA, et al. A.S.P.E.N. position paper: recommendations for changes in commercially available parenteral multivitamin and multi-trace element products. Nutr Clin Pract. 2012 Aug;27(4):440-91.

Updated

Updated August 13, 2014 by Michelle Wheeler, PharmD, Drug Information Specialist. Created May 29, 2013 by Jane Chandramouli, PharmD, Drug Information Specialist and Erin R Fox, PharmD, Director, Drug Information Service. Copyright 2014, Drug Information Service, University of Utah, Salt Lake City, UT.

Disclaimer

This information is provided through the support of Novation 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. Novation, 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 Novation, 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 Novation, ASHP nor University of Utah endorses or recommends the use of any drug.

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