Products Affected - Description
Inorganic Phosphate Injection
Sodium Phosphate injection, American Regent
3 mmol/mL, 5 mL vial, 25 count (NDC 00517-3405-25)
3 mmol/mL, 15 mL vial, 25 count (NDC 00517-3415-25)
3 mmol/mL, 50 mL vial, 25 count (NDC 00517-3450-25)
Organic Phosphate Injection
Glycophos injection, Fresenius Kabi
1 mmol/mL, 20 mL vial, 1 count (NDC 63323-0241-20)
Reason for the Shortage
- American Regent has sodium phosphate injection on shortage due to manufacturing delay.1
- Fresenius Kabi states the reason for the shortage was increased demand.2
- Hospira had sodium phosphate injection on shortage due to manufacturing delay.3
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, 25 count (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 cannot estimate a release date.1
- Fresenius Kabi has imported Glycophos available with an expiration date of <7 months.2
Implications for Patient Care
Phosphate injection products are used to treat and prevent hypophosphatemia.4
- Dosing differs between the imported and FDA approved product. Use caution when switching between products.5
- Bar coding systems should not be used on Glycophos vials as incorrect information may be provided if the item is scanned.5
- Glycophos is preservative-free and for single use only.5
- Compatibility data are limited for Glycophos.6
- Glycophos must be administered over at least 8 hours.7
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.6 Fresenius Kabi USA has a Dear Healthcare professional letter that summarizes the key differences between products.
- Product labeling for Glycophos injection.
- 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.8
- 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.9
- 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. 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.7 Glycophos is compatible with calcium chloride solutions as described in the product labeling.6 No data are available regarding compatibility with calcium gluconate.7
- 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.10
- American Regent Laboratories (personal communications and website). March 10 and 30, April 27, May 24, June 22, July 27, and August 25, 2016.
- Fresenius Kabi (personal communications). March 10 and 30, April 22, May 23, June 20, July 22, and August 18, 2016.
- Hospira (personal communications and website). March 10 and 30, April 27, May 24, June 23, July 27, and August 25, 2016.
- Lexi-Drugs Online. Hudson, OH: Lexi-Comp, Inc.; 2016.
- Fresenius Kabi USA. Dear Healthcare Professional Letters (customer letter). Accessed May 29, 2013.
- Fresenius Kabi USA, LLC. Glycophos Concentrate for Solution for Infusion [product information]. Halden, Norway: Fresenius Kabi Norge AS, 2013.
- Fresenius Kabi. Glycophos - information regarding dilution, compatibility, and administration rate. Data on File. Fresenius Kabi. Received July 2, 2013.
- Topp H, Hochfeld O, Bark S, et al. Glycerophosphate is interchangeable with inorganic phosphate in terms of safety and serum pharmacokinetics. Pharmacology. 2011;88(3-4):193-200.
- Topp H, Hochfeld O, Bark S, et al. Glycerophosphate does not interact with components of parenteral nutrition. Pharmacology. 2011;88(1-2):114-20.
- Fresenius Kabi (personal communications). July 16, 2013.
Updated August 25, 2016 by Michelle Wheeler, PharmD, Drug Information Specialist. Created March 10, 2016 by Jane Chandramouli, PharmD, Drug Information Specialist. Copyright 2016, Drug Information Service, University of Utah, Salt Lake City, UT.
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