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Sodium Phosphate Injection

[21 October 2014]

Products Affected - Description

Inorganic Phosphate Injection  
Sodium phosphate injection, American Regent
3 mmol/mL, 5 mL vials (NDC 00517-3405-25)
3 mmol/mL, 15 mL vial (NDC 00517-3415-25)
3 mmol/mL, 50 mL via (NDC 00517-3450-25)
 
Organic Phosphate Injection
Imported Product
Glycophos Injection, Fresenius Kabi7
1 mMol/mL, 20 mL vial (NDC 63323-0241-20)

Reason for the Shortage

  • American Regent has sodium phosphate injection on back order due to manufacturing delays.1,2 
  • American Regent has issued a statement that all lots of sodium phosphate have potential for crystallization. Do not use if any particles are present.3,4   
  • Hospira had sodium phosphate injection on shortage due to manufacturing delays.5
  • In cooperation with FDA, Fresenius Kabi USA is providing Glycophos (sodium glycerophosphate) injection to the US market to help alleviate the shortage. Glycophos is manufactured in an FDA-approved facility in Norway by Fresenius Kabi AG.6
  • Fresenius Kabi launched sodium phosphate injection in mid-January 2014.7

Available Products

Inorganic Phosphate Injection
Sodium phosphate injection, Fresenius Kabi
3 mmol/mL, 5 mL vial, 25 count (NDC 63323-0170-05)
3 mmol/mL, 15 mL vial, 25 count (NDC 63323-0170-15)
 
Sodium phosphate injection, Hospira
3 mmol/mL, 15 mL vial (NDC 00409-7391-72)

Estimated Resupply Dates

  • American Regent has sodium phosphate 3 mmol/mL 5 mL, 15 mL, and 50 mL vials on back order and the company estimates a release date of December 2014 for the 15 mL and 50 mL vials and cannot estimate a release date for the 5 mL vials.4
  • Fresenius Kabi has Glycophos injection, the imported organic phosphate injection, on back order and the company estimates a release date of 4th quarter 2014.7

Implications for Patient Care

Phosphate injection products are used to treat and prevent hypophosphatemia.8

Safety

  • Dosing differs between the imported and FDA approved product. Use caution when switching between products.6
  • Bar coding systems should not be used on Glycophos vials as incorrect information may be provided if the item is scanned.6
  • Glycophos is preservative free and for single use only.6
  • Compatibility data are limited for Glycophos.9
  • Glycophos must be administered over at least 8 hours.10     
  • Report any offers to sell Glycophos by an entity other than Fresenius Kabi to drugshortages@fda.hhs.gov. Fresenius Kabi will only be releasing product to the following distributors: Amerisource Bergen, McKesson, Cardinal, Morris & Dickson, and HD Smith.

Alternative Agents & Management

  • Glycophos contains sodium glycerophosphate, an organic phosphate that is different from any phosphate product available in the US. Glycophos is supplied in a 20 mL single dose vial and one milliliter of Glycophos contains 1 mmol of phosphate and 2 mEq of sodium. Glycophos does not contain a preservative and the product must be diluted before administration.9 Fresenius Kabi USA has a Dear Healthcare professional letter that summarizes the key differences between products.
  • Product labeling for Glycophos injection is available.
  • Compatibility information of Vamin 18 EF (amino acid solution not available in the US) is discussed in the Glycophos product labeling. To provide clinicians the various components of Vamin 18 EF, the product description is available online.
  • A randomized crossover study compared pharmacokinetic parameters and adverse events of Glycophos and sodium phosphate when given to healthy adults. Both study medications were diluted in normal saline and given as a single infusion over 4 hours with a washout period of 7 days between doses. Pharmacokinetic parameters and adverse events were similar in both treatment groups.11
  • A randomized crossover study compared pharmacokinetic parameters and adverse events of Glycophos and a total parenteral solution (TPN), Kabiven, containing sodium glycerophosphate and phospholipids when given to healthy adults. Glycophos was diluted in normal saline to the same concentration as the TPN formulation and given at the same rate and dose with a washout period between doses. Pharmacokinetic parameters and adverse events were similar in both treatment groups.12
  • Limited compatibility data are available for Glycophos (sodium glycerophosphate). However, the product labeling for Kabiven, a TPN product not available in the US, contains lipids, amino acids, electrolytes, and sodium glycerophosphate.   Information is available for Kabiven Labeling.   Glycophos is compatible with normal saline at a variety of concentrations. Glycophos 20 mMol (20 mL) may be added to quantities of 0.9% sodium chloride ranging from 50 mL to 1000 mL.10 Glycophos is compatible with calcium chloride solutions as described in the product labeling.9 No data are available regarding compatibility with calcium gluconate.10
  • Data on file at Fresenius Kabi showed at least equal solubility of Glycophos compared to inorganic phosphate. Therefore, when comparing equal concentrations of inorganic phosphate and Glycophos, data for the inorganic phosphate should be comparable to Glycophos for solubility.7
  • Fresenius Kabi has product labeling for various parenteral nutrition components, including compatibility information with Glycophos and Vamin solutions mentioned in the Glycophos product information, on their website. Clinicians can access this information but must register first at Fresenius Kabi. There is typically a 24 hour delay from the time of registration to access. Clinicians must provide their license number.
  • The American Society for Parenteral and Enteral Nutrition (ASPEN) has detailed recommendations for managing this shortage.13 

          Key recommendations include:

    • Reserve supplies for neonatal or pediatric patients or other vulnerable groups such as patients with short bowel or malabsorption syndromes.
    • Use standardized premixed parenteral nutrition containing electrolytes and minerals whenever possible.
    • Use premixed electrolyte and mineral products whenever possible.
    • Avoid use of injectable electrolytes and minerals as supplements in patients receiving enteral nutrition.
    • Monitor serum concentrations of electrolytes and increase vigilance of signs and symptoms of electrolyte and mineral deficiencies.
    • Purchase only the supply needed, do not stockpile.

Related Shortages

References

  1. Luitpold Pharmaceuticals. Press Release. Accessed May 28, 2013.
  2. Luitpold Pharmaceuticals. Press Release. Accessed May 28, 2013.
  3. American Regent. Press Release.  Accessed April 16, 2013.
  4. American Regent Laboratories (personal communications and website). December 12, 2012; January 16, February 4 and 20, March 18, April 9, 22, 25, and 29, May 23 and 28, June 4, 12, and 27, July 17, August 6, 16, and 23, September 19, October 31, 2013; January 16 and 24, February 11, 26, and 28, March 7, 25 and 28, April 14, May 1, 12, and 22, June 26, August 1, 7, and 28, September 8, and October 1 and 21, 2014.
  5. Hospira (personal communications and website). December 12, 2012; January 16, February 4 and 20, March 18, April 9, 22, 25, and 29, May 23 and 28, June 4, 12, and 25, July 18, August 5, 16, and 26, September 19, November 1, 2013; January 17 and 24, February 11 and 26, March 3, 10, 25, and 31, April 14, May 1, 12, and 23, June 26, August 1, 7, and 28, September 8, and October 1 and 21, 2014.
  6. Fresenius Kabi USA. Dear Healthcare Professional Letters (customer letter).  Accessed May 29, 2013.
  7. Fresenius Kabi (personal communications). May 28, June 4, 13, and 27, July 16, August 25, September 19, 2013; January 24, February 11, 25, and 28, March 7, 25, and 28, April 11, May 1, 12, and 21, June 25, July 30, August 7 and 27, September 8, and October 1 and 13, 2014.
  8. Lexi-Drugs Online. Hudson, OH: Lexi-Comp, Inc.; 2013.
  9. Fresenius Kabi. Glycophos Concentrate for Solution for Infusion [product information]. Halden, Norway: Fresenius Kabi Norge AS, 2008.
  10. Fresenius Kabi. Glycophos – information regarding dilution, compatibility, and administration rate. Data on File. Fresenius Kabi. Received July 2, 2013.
  11. Topp H, Hochfeld O, Bark S, Grossmann M, Joukhadar C, Westphal M, Straatsma H, Rothenburger M. Glycerophosphate is interchangeable with inorganic phosphate in terms of safety and serum pharmacokinetics. Pharmacology. 2011;88(3-4):193-200. doi: 10.1159/000331341. Epub 2011 Oct 4. PubMed PMID: 21986180.
  12. Topp H, Hochfeld O, Bark S, Grossmann M, Joukhadar C, Westphal M, Straatsma H, Rothenburger M. Glycerophosphate does not interact with components of parenteral nutrition. Pharmacology. 2011;88(1-2):114-20. doi: 0.1159/000330066. Epub 2011 Aug 25. PubMed PMID: 21865768.
  13. American Society for Parenteral and Enteral Nutrition. Parenteral Nutrition Electrolyte / Mineral Product Shortage Considerations.  Accessed May 28, 2013.

Updated

Updated October 21, 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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