Product Dossier
GLYCOPHOS
Product Dossier for GLYCOPHOS (sodium glycerophosphate, Fresenius Kabi). ARTG record, PBS listing, PBAC outcomes, AusPAR — compiled by arcimedes.
- Sponsor: Fresenius Kabi
- Active ingredient: sodium glycerophosphate
- Therapeutic area: Other
- Related brand: PeriOLIMEL
- Related brand: SMOFKABIVEN
- Related brand: OLICLINOMEL
- Same area: APO-CLONIDINE
- Same area: DIAMOX
What it is
GLYCOPHOS is sodium glycerophosphate. Each 20 mL ampoule contains 4.32 g of sodium glycerophosphate, with each 1 mL containing 306.1 mg of sodium glycerophosphate hydrate, equivalent to 216 mg of sodium glycerophosphate. GLYCOPHOS is a sterile, clear, colourless concentrated injection solution for infusion. Glycerophosphate is a metabolic intermediate in fat metabolism.
Approved indications
— Supplement to parenteral nutrition to meet the daily requirements of phosphate in adult and paediatric patients.
Dosing overview
For adults, the recommended dosage should be individualised to each patient's phosphorus status and needs, with normal requirements during parenteral nutrition met by using 10 to 20 mL of GLYCOPHOS added to the infusion solution. For children, infants and neonates, the recommended dosage should be individualised to each patient's phosphorous status and needs, with a recommended dose of 1.0 to 1.5 mmol/kg body weight per day. GLYCOPHOS is for intravenous infusion only, must not be given undiluted, and the infusion must be administered over a period of at least 8 hours.
Key safety warnings
GLYCOPHOS should be used with caution in patients with impaired renal function, and serum phosphate levels of all patients should be monitored regularly. The use of GLYCOPHOS for long-term parenteral nutrition has limited clinical experience and precautions need to be taken while using it for an extended duration, although it may be used for a longer duration depending on the clinical judgement of the healthcare professional. A moderate fall in serum phosphate can be seen during carbohydrate infusions.
Contraindications
GLYCOPHOS should not be given to patients in a state of dehydration or with hypernatraemia, hyperphosphataemia, severe renal insufficiency or shock.
Regulatory history
GLYCOPHOS was first listed on the ARTG on 14 November 2019 (ARTG 312021). The product was approved for registration on 13 November 2019 for use in adult and paediatric patients as a supplement to parenteral nutrition to meet daily phosphate requirements, based on a positive assessment of its quality and clinical evidence supporting its safety and efficacy as an organic phosphate source.