Consumer medicine information

Glycophos

Sodium glycerophosphate

BRAND INFORMATION

Brand name

Glycophos

Active ingredient

Sodium glycerophosphate

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Glycophos.

What is in this leaflet

This leaflet answers some common questions about Glycophos®. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.

All medicines have risks and benefits. Your doctor has weighed the risks of you given Glycophos® against any benefits they expect it will have for you.

Please read this leaflet carefully. If you have any questions or are unsure about anything, please ask your doctor or pharmacist.

Keep this leaflet. You may need to read it again.

What is Glycophos® used for

Glycophos® is a sterile concentrate solution which provides the body with phosphate by the intravenous route. It can be used in adults and children. When the intake of nutrients or food into the mouth or directly into the gut is not possible, or it is not enough to supply the body’s needs, then intravenous nutrients or foods can be given. This is especially important for people whose bodies are under physical stress from illness or recent surgery. During illness or after surgery the body requires nutrition or food.

It is usually given together with fats, amino acids, glucose and vitamins to provide a complete intravenous diet.

Before you are given Glycophos®

You must NOT use this product:

  • if you are allergic (hypersensitive) to any of the ingredients of Glycophos®
  • if you are suffering from dehydration
  • if you have high phosphate levels in the blood
  • if you have high sodium levels in the blood
  • if you have serious kidney disease without access to dialysis
  • if you are in acute shock
  • if you are in an unstable condition, such as after serious trauma, uncontrolled diabetes, acute heart attack, stroke, blood clot, metabolic acidosis (a disturbance resulting in too much acid in the blood), serious infection (severe sepsis), coma and if you don’t have enough body fluid (hypotonic dehydration).

Special care has to be taken while this product is given to you. Tell your doctor if you have:

  • kidney problems

If during the infusion you get fever, rash, swelling, difficulty in breathing, chills, sweating, nausea or vomiting, tell the health care professional immediately because these symptoms might be caused by an allergic reaction or that you have been given too much of the medicine.

Your doctor may regularly need to check your blood for liver function tests and other values.

Please tell your doctor if you have recently taken some medicines, even without prescription.

Tell your doctor if you are pregnant or plan to become pregnant or are breastfeeding. Glycophos® should only be given to pregnant or breast-feeding women if the doctor finds it necessary.

How Glycophos® is given

How much will be given

Your doctor will decide on the dose for you individually depending on your body weight and function. Glycophos® will be given to you by a health care professional.

How is it given

Glycophos® is usually mixed in the bag of amino acids, glucose and/or fats, vitamins and given as a continuous infusion into a central vein. An electronic pump may be used to control the speed of the infusion.

If you are given too much (overdose)

This rarely happens as Glycophos® is usually administered under the care of a trained health care professional in a hospital or clinic setting.

If you have any concerns immediately telephone your doctor or contact the Poisons Information Centre (Australia: 13 11 26).

Side Effects

Like all medicines, Glycophos® can cause side effects, although not everybody gets them. No known undesirable effects have been reported with the use of Glycophos® according to the recommendation.

Tell your doctor or pharmacist if you notice any of the following and they worry you:

  • nausea and vomiting
  • flatulence
  • abdominal pain
  • swelling of hands, ankles or feet
  • fast heart beat
  • difficulty in breathing
  • lack of appetite
  • low or high blood pressure
  • slight increase in body temperature
  • chills
  • dizziness
  • headaches
  • hypersensitivity reactions (skin rash)
  • sensations of hot and cold
  • pain in the neck, back, bones, chest
  • paleness.

If any of these side effects occurs, or if you notice any side effects not listed in this leaflet, please contact your doctor or a pharmacist.

Storage

Glycophos® should be stored below 25°C. As with any medicine, Glycophos® should be stored out of the reach of children.

The contents of each vial of Glycophos® is for single use in one patient only. Any unused Glycophos® should be discarded.

The expiry date of Glycophos® is on the label of the pack. Glycophos® should not be used if the expiry date has passed.

Product Description

What it looks like

Glycophos® Concentrated injection solution for infusion is a sterile, clear, colourless solution essentially free from visible particles which is supplied in 20 mL plastic ampoules. It is for addition to infusion solutions.

Ingredients

Each 1 mL of Glycophos® contains 306.1 mg of sodium glycerophosphate hydrate equivalent to 216 mg of sodium glycerophosphate.

Each 1 mL of Glycophos® corresponds to 1 mmol of glycerophosphate and 2 mmol of sodium.

Glycophos® also contains the excipients hydrochloric acid and water for injections.

It does not contain any preservative.

Osmolality: 2760 mOsm/kg water pH: 7.4

Glycophos® does not contain gluten, lactose, sucrose, tartrazine or any other azo dyes.

Pack size
Box of 20 x 20 mL ampoules
AUST R 312021

Further Information

More detailed information is available from your doctor or pharmacist. Therefore, if you have any concerns about the information or about Glycophos®, please ask your doctor or pharmacist.

Sponsor

Fresenius Kabi Australia Pty Ltd.
Level 2, 2 Woodland Way
Mount Kuring-gai, NSW 2080
Australia.

Date of preparation

This leaflet was prepared in July 2019.

Published by MIMS March 2020

BRAND INFORMATION

Brand name

Glycophos

Active ingredient

Sodium glycerophosphate

Schedule

S4

 

1 Name of Medicine

Sodium glycerophosphate.

2 Qualitative and Quantitative Composition

Sodium glycerophosphate 4.32 g/20 mL ampoule.
Each 1 mL of Glycophos contains 306.1 mg of sodium glycerophosphate hydrate, equivalent to 216 mg of sodium glycerophosphate.
Each 1 mL of Glycophos corresponds to 1 mmol of phosphate and 2 mmol of sodium.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Glycophos concentrated injection solution for infusion is a sterile, clear, colourless solution essentially free from visible particles.
Osmolality: 2760 mOsm/kg water.
pH: 7.4.

4 Clinical Particulars

4.1 Therapeutic Indications

Glycophos is indicated in adult and paediatric patients as a supplement to parenteral nutrition to meet the daily requirements of phosphate.

4.2 Dose and Method of Administration

Method of administration.

For intravenous infusion only. Glycophos must not be given undiluted. The infusion duration depends on the admixture; the infusion must be administered over a period of at least 8 hours.

Dosage (dose and interval).

Adults.

The recommended dosage should be individualized to each patient's phosphorus status and needs. Approximately 15 mmol of phosphate is provided by a litre of lipid emulsions or amino acid solutions. This should be considered when supplementing phosphate from Glycophos. The normal requirements during PN can be met by using 10 to 20 mL of Glycophos added to the infusion solution or admixture for which compatibility has been proven.

Paediatric population.

The recommended dosage should be individualized to each patient's phosphorous status and needs. The recommended dose for children, infants and neonates is 1.0 to 1.5 mmol/kg body weight per day.

Instructions for use.

Glycophos must not be given undiluted.
For single use in one patient only. Any excess infusion solution in an opened package must be discarded and must not be kept for later use.

Compatibility.

Additions should be made aseptically.
Glycophos is used as an additive to TPN admixtures in compounded bags where compatibility data are available. Compatibility of Glycophos has been demonstrated for use with the named branded products SMOFlipid, Aminoven 10%, Addaven, Soluvit N and Vitalipid N in defined amounts and standard IV solutions of glucose and electrolytes in defined concentrations.
Glycophos can also be added to the SmofKabiven and Kabiven range of products.
In addition:
up to 10 mL of Glycophos and 10 mmol of calcium (as calcium chloride) can be added to 1000 mL of glucose 50 mg/mL;
up to 20 mL of Glycophos and 20 mmol of calcium (as calcium chloride) can be added to 1000 mL of glucose 200 mg/mL;
up to 60 mL of Glycophos and 24 mmol of calcium (as calcium chloride) can be added to 1000 mL of glucose 500 mg/mL.

Infusion time.

The infusion duration depends on the admixture; the infusion must be administered over a period of at least 8 hours.

Stability.

When additions are made to an infusion solution, the infusion should be completed within 24 hours at 20-25°C from the time of preparation to avoid microbiological contamination.

4.3 Contraindications

Glycophos should not be given to patients in a state of dehydration or with hypernatraemia, hyperphosphataemia, severe renal insufficiency or shock.

4.4 Special Warnings and Precautions for Use

Identified precautions.

Glycophos should be used with caution in patients with impaired renal function. The serum phosphate levels of all patients should be monitored regularly.
Glycophos must not be given undiluted.

Use in the elderly.

No data available.

Paediatric use.

Glycophos is recommended for use in paediatric patients.

Effects on laboratory tests.

No data available.

Long term parenteral nutrition.

The use of Glycophos for long-term parenteral nutrition has limited clinical experience and precautions need to be taken while using Glycophos for an extended duration. Glycophos may be used for a longer duration depending on the clinical judgement of the healthcare professional.

4.5 Interactions with Other Medicines and Other Forms of Interactions

No interactions with other drugs have been observed, but a moderate fall in serum phosphate can be seen during carbohydrate infusions.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

The potential effects of Glycophos on fertility and general reproductive performance have not been determined in animal studies.
Animal reproduction studies or clinical investigations during pregnancy have not been carried out with Glycophos. However, the requirements of phosphate in a pregnant woman are slightly increased compared to non-pregnant women.
No adverse events are to be expected when Glycophos is administered during pregnancy.
 It is not known whether Glycophos can enter maternal milk. Glycophos should be used during lactation only if clearly needed.

4.7 Effects on Ability to Drive and Use Machines

No effects on the ability to drive and use machines are to be expected.

4.8 Adverse Effects (Undesirable Effects)

Glycophos is generally safe and very well-tolerated in recommended doses.
In two (2) phase I studies, Glyc-001-C P1 and KABI-0003-C P1, conducted in healthy individuals, TEAEs were coded using MeDRA. The incidence of TEAEs reported in these studies is provided in Table 1.
In two (2), two-way cross-over healthy adult trials, the observed drug-related Treatment-Emergent Adverse Events (TEAEs) with investigator implied causality in both Glycophos and comparator pooled groups are presented in Table 2.
No other adverse reactions have been reported with glycerophosphate.

Post marketing.

From 1993 until June 2017, 98 adverse drug reactions (ADRs) were reported in 46 patients. These included 4 serious listed ADRs in 2 patients (central line infection, blood pressure decreased, tremor, and rash), all from spontaneous or regulatory authority reports, and 28 serious unlisted ADRs in 13 patients; 5 serious unlisted ADRs in 2 patients were from clinical studies (body temperature increase, sweating, sepsis, chills, malaise), and 23 serious unlisted ADRs in 11 patients were from spontaneous or regulatory authority reports (cardiac arrest, tachycardia, lip oedema, vomiting, administration site reaction, fever [2 cases], hyperpyrexia, chills, allergic reaction, Pantoea agglomerans infection [3 cases], salmonella infection, oxygen saturation decreased, hypernatremia, hypoglycaemia, tremor, unresponsive to stimuli, respiratory symptoms (includes dyspnoea) [2 cases], rash, petechial).

Reporting of suspected adverse effects.

Reporting suspected adverse reactions after registration of the medicinal product is important. It allows continued monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions at https://www.tga.gov.au/reporting-problems.

4.9 Overdose

No adverse effects of an overdose have been reported. Most patients in need of intravenous nutrition have an increased capacity to handle glycerophosphate. Also see Section 4.3 Contraindications.
For information on the management of overdose, contact the Poison Information Centre on 131126 (Australia) or 0800 764 766 (New Zealand).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Glycerophosphate is a metabolic intermediate in fat metabolism.

Clinical trials.

The efficacy and safety of Glycophos as a supplement to parenteral nutrition to meet the daily requirements of phosphorus has been examined in one randomised, prospective, double-blind, parallel-group study in neonates. In the study 41 neonates aged < 1 month were administered 1 mmol/kg/day phosphate from either Glycophos (19 patients) or inorganic phosphate (22 patients), administered as part of each patient's parenteral nutrition regimen over 24 hours/day for up to 7 days.
Premature discontinuation of the study, due to the unforeseen difficulties in the timely recruitment of patients resulted in 18 on inorganic phosphate and 17 on glycerophosphate completing the study.
In the study the primary efficacy variables were AUC for serum phosphate and serum calcium with secondary variables accumulated urinary phosphate and urinary calcium. The ratio of AUCs for serum phosphate and serum calcium for patients who received Glycophos to those who received inorganic phosphate were 2.15 for serum phosphate and 1.21 for serum calcium. Statistical significance for the difference could not be shown between the two groups for the primary efficacy variables (AUCs for serum calcium and serum phosphate). For the secondary efficacy variables, accumulated urinary phosphate (AeP) and urinary calcium (AeCa) ratios for patients who received Glycophos to those who received inorganic phosphate were 1.10 for serum phosphate and 0.61 for serum calcium. There were no differences in adverse events between the two treatment groups, and no adverse events were considered to be related to treatment.
A study comparing bioavailability of phosphate from a parenteral all-in-one solution (Kabiven Peripheral) with that from Glycophos was a double blind, randomised two sequence, two treatment crossover study in 10 healthy adults. Subjects received Glycophos and Kabiven Peripheral providing equimolar amounts of phosphate (0.101 mmol/kg). The primary PK variables were AUC0-36h, Cmax, and Css, and secondary variables included tmax, lambdaz, t1/2, and Ae. Additionally, the areas under the serum concentration-time curves during the infusion (from Hour 0 to Hour 8; AUC0-8h), the 8 hours immediately following the infusion (from Hour 8 to Hour 16; AUC8-16h), and the last hours of the observation period (from Hour 16 through Hour 36; AUC16-36h) were also calculated. The 90% CI of the ratio for Kabiven Peripheral/Glycophos for all primary parameters (AUC0-36h, Cmax, and Css) were within the range of 0.8 to 1.25; thus, bioequivalence for inorganic phosphate concentration in serum of both treatments was accepted. The Ae of inorganic phosphate was greater with administration of Glycophos compared to Kabiven Peripheral (the lower limit of the 90% CI (0.6266) was below 0.8, rejecting bioequivalence between both investigational products). Also, statistical significance for the difference was not shown (p = 0.0694).
There is limited clinical trial data available on the use of Glycophos but there is considerable postmarketing experience on the use of glycerophosphate.

5.2 Pharmacokinetic Properties

To become bio-available, it is necessary for the phosphate group to be hydrolysed from the glycerophosphate molecule. The hydrolysis occurs maximally at a plasma concentration of > 0.7 mmol/L. The release of phosphate into the incubation medium over a 2-hour period corresponded to a hydrolysis rate of 0.12 mmol/L/h for glycerophosphate. Subsequent studies on 3 other samples using lower glycerophosphate concentrations gave a mean hydrolysis rate of approximately 0.09 mmol/L/h. Assuming that all hydrolysis of glycerophosphate takes place in plasma, about 12-15 mmol of sodium glycerophosphate will be hydrolysed each day in individuals with normal serum alkaline phosphatase. The accuracy of these kinetic rates of hydrolysis in vitro in relation to the rates in vivo has not been established.
No pharmacokinetic data is available for infants.

5.3 Preclinical Safety Data

No data available.

Genotoxicity.

No data available.

Carcinogenicity.

No data available.

6 Pharmaceutical Particulars

6.1 List of Excipients

Hydrochloric acid (pH adjuster), water for injections.

6.2 Incompatibilities

Glycophos may only be added to or mixed with other medicinal products for which compatibility has been documented. For compatibility information, please see Section 4.2 Dose and Method of Administration.

6.3 Shelf Life

Shelf life before mixing.

3 years. The expiry date can be found on the packaging.

Shelf life after mixing.

Chemical and physical in-use stability of the mixed product has been demonstrated for 24 hours at 20-25°C.
To reduce microbiological hazard, use as soon as practicable after dilution. If storage is necessary, hold at 2°-8°C for not more than 24 hours or 6 hours at room temperature.

6.4 Special Precautions for Storage

Store below 25°C.
Do not use after the expiry date stated on the label.
Product is for single use in one patient only. Discard any residue.

6.5 Nature and Contents of Container

The product is contained in a 20 mL polypropylene ampoule.

Pack size.

Box of 20 x 20 mL ampoules, AUST R 312021.

6.6 Special Precautions for Disposal

For single use in one patient only. Any excess infusion solution in an opened package must be discarded and must not be kept for later use.

Disposal.

In Australia, any unused medicinal product or waste material should be disposed in accordance with local requirement.

6.7 Physicochemical Properties

Chemical structure.

Sodium glycerophosphate hydrate.
Empirical formula: C3H7Na2O6P, x H2O where the degree of hydration (x) = 4 to 6.
Molecular weight: 234.05 g/mol (hydrated); 216.05 g/mol (anhydrous).

CAS number.

55074-41-1 (hydrated).
1334-74-3 (anhydrous).

7 Medicine Schedule (Poisons Standard)

Australia: Not Scheduled.
New Zealand: General Sale Medicine.

Summary Table of Changes