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.
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
is an ORGANIC phosphate
which is a different type of phosphate than the INORGANIC phosphate
injection products currently marketed in the U.S.
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.
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.
aluminum content of Glycophos
is not more than 550 mcg/L.
does NOT contain a preservative
and is intended for single use.
Strict aseptic technique must always be maintained.
is for administration to a single patient and is NOT intended for
must be diluted before administration.
is contraindicated in patients
in a state of dehydration or with hypernatremia, hyperphosphatemia, severe
renal insufficiency or shock.
and ordering contact Customer Service Department 1-888-386-1300.
Suggested Readings and Resources
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.
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.
I, Powell C, Williams AF. Sodium glycerophosphate in the treatment of
neonatal hypophosphataemia. Arch
Dis Child. 1995;73:F44-F45.
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.
DF. Compounding TPN admixtures: then and now. JPEN J Parenter Enteral Nutr.
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.
W, Hardy G. Phosphate supplementation for hypophosphataemia and parenteral
nutrition. Curr Opin Clin
Nutr Metab Care. 2001; 4:227-233.
RK, Heisel CF, Vermillion BR, Christensen JM, Minc L. Aluminum content of
neonatal parenteral nutrition solutions. Nutr
Clin Pract. 2017; 32:266-270.
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;
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.
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.
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.
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.
CL, Jiménez NV, Peidro J. Stability of parenteral nutrition admixtures
containing organic phosphates. Clin
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.
H, Hochfeld O, Bark S, et al. Glycerophosphate does not interact with components
of parenteral nutrition. Pharmacology.
H, Hochfeld O, Bark S, et al. Glycerophosphate is interchangeable with
inorganic phosphate in terms of safety and serum pharmacokinetics. Pharmacology.