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.

SUMMARY CMI

Glycophos®

Consumer Medicine Information (CMI) summary

The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist.

1. Why am I using Glycophos?

Glycophos contains the active ingredient sodium glycerophosphate and is given to provide 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 not enough to supply the needs, then intravenous nutrients or foods can be given. This is especially important for people under physical stress from illness or recent surgery. Glycophos usually given together with fats, amino acids, glucose and vitamins to provide a complete intravenous diet.

For more information, see Section 1. Why am I using Glycophos? in the full CMI.

2. What should I know before I use Glycophos?

Do not use if you have ever had an allergic reaction to Glycophos or any of the ingredients listed at the end of the CMI. Tell your doctor if you have kidney problems.

Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding.

For more information, see Section 2. What should I know before I use Glycophos? in the full CMI.

3. What if I am taking other medicines?

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

A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

4. How do I use Glycophos?

  • Your doctor will decide on the dose for you individually depending on your body weight and function.

More instructions can be found in Section 4. How do I use Glycophos? in the full CMI.

5. What should I know while using Glycophos?

Things you should do
  • 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.
Things you should not do
  • Do not stop using this medicine without consulting your health care professional
  • Do not take any other medicines without first telling your health care professional
  • Do not give this medicine to anyone else, even if they have the same condition as you
Driving or using machines
  • No effects on the ability to drive and use machines are to be expected.
Drinking alcohol
  • The effects of alcohol with Glycophos use were not studied. Your doctor will decide what you need to do.

Looking after your medicine

  • Store below 25°C. Do not use after the expiry date stated on the label.

For more information, see Section 5. What should I know while using Glycophos? in the full CMI.

6. Are there any side effects?

No known undesirable effects have been reported with the use of Glycophos according to recommendation. If you get any adverse effects, talk to your doctor or nurse. For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.



FULL CMI

Glycophos®

Active ingredient: sodium glycerophosphate

Consumer Medicine Information (CMI)

This leaflet provides important information about using Glycophos. You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions about using Glycophos.

Where to find information in this leaflet:

1. Why am I using Glycophos?
2. What should I know before I use Glycophos?
3. What if I am taking other medicines?
4. How do I use Glycophos?
5. What should I know while using Glycophos?
6. Are there any side effects?
7. Product details

1. Why am I using Glycophos?

Glycophos contains the active ingredient sodium glycerophosphate. Glycophos is a supplement to parenteral nutrition.

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

It used to provide 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.

2. What should I know before I use Glycophos?

Warnings

Do not use Glycophos if:

  • you are allergic to sodium glycerophosphate, or any of the ingredients listed at the end of this leaflet.
  • Always check the ingredients to make sure you can use this medicine.
  • 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).

Check with your doctor if you:

  • have any other medical conditions such as kidney problems as special care needs to be taken while this product is given to you
  • take any medicines for any other condition.

During treatment, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 6. Are there any side effects?

Pregnancy and breastfeeding

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.

Check with your doctor if you are pregnant or intend to become pregnant.

Talk to your doctor if you are breastfeeding or intend to breastfeed.

Use in renal impairment

Glycophos should be used with caution in patients with impaired renal function. The serum phosphate levels of all patients should be monitored regularly.

Use in elderly

No data is available for use of Glycophos® in elderly patients. Your doctor will decide what to do.

Use in Paediatrics

Glycophos is recommended for use is paediatric patients.

3. What if I am taking other medicines?

Tell your doctor or pharmacist if you are taking any other medicines, including any medicines, vitamins or supplements that you buy without a prescription from your pharmacy, supermarket or health food shop.

Some medicines may interfere with Glycophos and affect how it works.

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

Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect Glycophos.

4. How do I use Glycophos?

How much is given

  • Your doctor will decide on the correct dose for you to receive depending on your body weight and function.
  • The recommended dose for adults is 10 mL to 20 mL of Glycophos added to the infusion solution or admixture.
  • The recommended dose for children, infants and neonates is 1.0 to 1.5 mmol/kg body weight per day.
  • Follow the instructions provided and use Glycophos until your doctor or nurse tells you to stop.

How to take Glycophos

  • Glycophos will be given to you by a health care professional.
  • 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 forget to use Glycophos

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 use too much Glycophos

If you think that you have used too much Glycophos, you may need urgent medical attention.

You should immediately:

  • phone the Poisons Information Centre
    (by calling 13 11 26), or
  • contact your doctor, or
  • go to the Emergency Department at your nearest hospital.

You should do this even if there are no signs of discomfort or poisoning.

5. What should I know while using Glycophos?

Things you should do

Call your doctor straight away if you:

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

Remind any doctor, dentist, pharmacist or nurse you visit that you are using Glycophos.

Things you should not do

  • Do not stop using this medicine without consulting your health care professional.

Driving or using machines

Be careful before you drive or use any machines or tools until you know how Glycophos affects you.

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

Drinking alcohol

Tell your doctor if you drink alcohol.

The effects of alcohol with Glycophos use were not studied. Your doctor will decide what you need to do.

Looking after your medicine

Glycophos is usually administered under the care of a trained health care professional in a hospital or clinic setting. Follow the instructions in the carton on how to take care of your medicine properly.

Store below 25°C in a cool dry place away from moisture, heat or sunlight; for example, do not store it:

  • in the bathroom or near a sink, or
  • in the car or on window sills.

Keep it where young children cannot reach it.

When to discard your medicine

When Glycophos is added 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. Any excess infusion solution in an opened package must be discarded and must not be kept for later use.

Do not use this medicine after the expiry date which is stated on the carton label and embossed on the ampoule. The expiry date refers to the last day of that month.

Your doctor and hospital pharmacist are responsible for the correct storage, use and disposal of Glycophos.

Getting rid of any unwanted medicine

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

Do not use this medicine after the expiry date.

6. Are there any side effects?

All medicines can have side effects. If you do experience any side effects, most of them are minor and temporary. However, some side effects may need medical attention.

See the information below and, if you need to, ask your doctor or nurse if you have any further questions about side effects.

Less serious side effects

Less serious side effectsWhat to do
  • Low blood calcium level
  • Headache
  • Back pain
Speak to your doctor if you have any of these less serious side effects and they worry you.

Serious side effects

Serious side effectsWhat to do
  • Infection in infusion line
  • Decreased blood pressure
  • Tremor
  • Rash
Call your doctor straight away or go straight to the Emergency Department at your nearest hospital if you notice any of these serious side effects.

Tell your doctor or nurse if you notice anything else that may be making you feel unwell.

Other side effects not listed here may occur in some people.

Reporting side effects

After you have received medical advice for any side effects you experience, you can report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems. By reporting side effects, you can help provide more information on the safety of this medicine.

Always make sure you speak to your doctor or pharmacist before you decide to stop taking any of your medicines.

7. Product details

This medicine is only available with a doctor's prescription.

What Glycophos contains

Active ingredient
(main ingredient)		Sodium glycerophosphate 4.32 g/20 mL ampoule
Sodium glycerophosphate hydrate 306.1 mg per 1 mL (equivalent to 216 mg sodium glycerophosphate)
Other ingredients
(inactive ingredients)		hydrochloric acid
water for injections
Potential allergensnone

Do not take this medicine if you are allergic to any of these ingredients.

This product contains 1 mmol of phosphate and 2 mmol of sodium per 1 mL dose.

What Glycophos looks like

Glycophos Concentrated injection solution for infusion is a sterile, clear, colourless solution essentially free from visible particles. It is for addition to infusion solutions.

Glycophos is supplied in 20 mL plastic ampoules. Each carton contains 20 x 20 mL ampoules. (Aust R 312021).

Who distributes Glycophos

Fresenius Kabi Australia Pty Limited
Level 2, 2 Woodland Way
Mount Kuring-gai NSW 2080
Australia
Telephone: 1300 361 004

This leaflet was prepared in March 2023.

Published by MIMS April 2024

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