FDA Approves Temporary Importation of Glycophos

The FDA Drug Shortages Program has informed ASPEN that Fresenius Kabi USA has received approval for the temporary importation of Glycophos, sodium glycerophosphate injection. This product is marketed in Europe, and is manufactured in the Fresenius Kabi Norway plant.

Please note that there are some key differences in the formulation and labeling between the current U.S. marketed phosphate injection products and the imported product, Glycophos. The Dear Healthcare Professional Letter should be read carefully.

Notable differences are:

Glycophos is an ORGANIC phosphate which is a different type of phosphate than the INORGANIC phosphate injection products currently marketed in the U.S.

Organic phosphates tend to be more calcium compatible.  

  • This means at higher concentrations; solutions of calcium and phosphate may exist together without precipitating into an insoluble salt complex.
  • In high pH solutions (admixture above pH 6.0), organic phosphate is less likely to precipitate.

Glycophos contains 1 mmol of phosphate per 1 mL of solution as compared to the phosphates currently marketed in the U.S. which contain 3 mmol of phosphate per 1 mL.

The aluminum content of Glycophos is not more than 550 mcg/L.

Glycophos does NOT contain a preservative and is intended for single use. 

  • Strict aseptic technique must always be maintained.  
  • Glycophos is for administration to a single patient and is NOT intended for multiple use. 
  • Glycophos must be diluted before administration.

Glycophos is contraindicated in patients in a state of dehydration or with hypernatremia, hyperphosphatemia, severe renal insufficiency or shock.

For Glycophos availability and ordering contact Customer Service Department 1-888-386-1300.

Suggested Readings and Resources

Bouchoud L, Fonzo-Christie C, Sadghipour F, Bonnabry P. Maximizing calcium and phosphate content in neonatal parenteral nutrition solutions using organic calcium and phosphate salts.  JPEN J Parenter Enteral Nutr. 2010;34:542-545.

Chessex P, Pineault M,  Brisson G, Delvin EE, Glorieux FH. Role of the source of phosphate salt in improving the mineral balance of parenterally fed low birth weight infants. J Pediatr. 1990;116:765-772. 

Costello I, Powell C, Williams AF. Sodium glycerophosphate in the treatment of neonatal hypophosphataemia.  Arch Dis Child. 1995;73:F44-F45.

Draper HH, Yuen DE, Whyte RK. Calcium glycerophosphate as a source of calcium and phosphorus in total parenteral nutrition solutions. JPEN J Parenter Enteral Nutr. 1991;15:176-180.

Driscoll DF. Compounding TPN admixtures: then and now. JPEN J Parenter Enteral Nutr. 2003;27:433-444.

Hanning RM, Atkinson SA, Whyte RK. Efficacy of calcium glycerophosphate vs conventional mineral salts for total parenteral nutrition in low-birth-weight infants: a randomized clinical trial.  Am J Clin Nutr. 1991;54:903-908.

Hicks W, Hardy G. Phosphate supplementation for hypophosphataemia and parenteral nutrition. Curr Opin Clin Nutr Metab Care. 2001; 4:227-233.

Huston RK, Heisel CF, Vermillion BR, Christensen JM, Minc L. Aluminum content of neonatal parenteral nutrition solutions. Nutr Clin Pract. 2017; 32:266-270.

Joy J AP, Franke R, Bistrian BR, Nehne J, Newton DW, Driscoll DF.  Calcium and phosphate compatibility in low-osmolarity parenteral nutrition admixtures intended for peripheral vein administration.  JPEN J Parenter Enteral Nutr. 2010; 34:46-54.

McKay M, Anderson C. Physical compatibility of sodium glycerophosphate and calcium gluconate in pediatric parenteral nutrition solutions. JPEN J Parenter Enteral Nutr. 2015; 39: 725-728.

McKay M, Anderson C. Physical compatibility of calcium chloride and sodium glycerophosphate in pediatric parenteral nutrition solutions. JPEN J Parenter Enteral Nutr. 2016;40:1166-1169.

Pereira-da-Silva L, Costa AB, Pereira L, et al.  Early high calcium and phosphorus Intake by parenteral nutrition prevents short-term bone strength decline in preterm infants.  J Pediatr Gastroenterol Nutr. 2011;52:203-209.

Raupp P, Kries RV, Pfahl HG, Manz F. Glycero-vs glucose-phosphate in parenteral nutrition of premature infants: a comparative in vitro evaluation of calcium/phosphorus compatibility. JPEN J Parenter Enteral Nutr.  1991;15:469-473.

Ronchera-Oms CL, Jiménez NV, Peidro J. Stability of parenteral nutrition admixtures containing organic phosphates. Clin Nutr. 1995;14:373-380.

Skouroliakou M, Matthaiou C, Chiou A, et al.  Physiochemical stability of parenteral nutrition supplied as all-in-one for neonates. JPEN J Parenter Enteral Nutr.  2008;32:201-209.  

Topp H, Hochfeld O, Bark S, et al. Glycerophosphate does not interact with components of parenteral nutrition. Pharmacology.  2011;88:114-120.

Topp H, Hochfeld O, Bark S, et al. Glycerophosphate is interchangeable with inorganic phosphate in terms of safety and serum pharmacokinetics. Pharmacology. 2011;88:193-200.