Drugs List

Therapeutic Indications

Uses

Hyperphosphataemia in chronic renal failure patients on haemodialysis
Hyperphosphataemia in patients on continuous ambulatory peritoneal dialysis

Sucroferric oxyhydroxide should be used within the context of a multiple therapeutic approach, which could include calcium supplement, 1,25-dihydroxy vitamin D3 or one of its analogues, or calcimimetics to control the development of renal bone disease.

Contraindications

Children under 6 years
Haemochromatosis
Hereditary fructose intolerance

Precautions and Warnings

Children 6 to 12 years
Breastfeeding
Diabetes mellitus
Glucose-galactose malabsorption syndrome
History of major gastrointestinal surgery
Pregnancy
Severe gastrointestinal disorder
Severe hepatic impairment
Within 3 months of peritonitis

Preparation contains sucrose
Advise patient to take with or after food
Diabetic control may need adjustment
Monitor serum phosphate levels
May affect the gastro-intestinal absorption of other drugs
Dietary restrictions should be maintained
Advise patient stools may be discoloured

The chewable tablet formulation is not appropriate for children aged 2 to 6 years.

Discoloured stool may visually mask gastrointestinal bleeding.

Patients with severe hepatic disorders have not been included in clinical studies with sucroferric oxyhydroxide. However, no evidence of hepatic impairment or significant alteration of hepatic enzymes were observed in clinical studies.

There is no clinical data available in patients with early stages of renal impairment.

The chewable tablets contain starch. Patients with diabetes should be aware that one tablet is equivalent to 0.116 bread units or approximately 1.4g of carbohydrates.

When administering any product that is already known to interact with iron or has the potential to interact with sucroferric oxyhydroxide, the product should be administered at least one hour before or two hours after sucroferric oxyhydroxide.

Pregnancy and Lactation

Pregnancy

Sucroferric oxyhydroxide should be used with caution in pregnancy. At the time of writing, there are no available clinical data from the use of sucroferric oxyhydroxide on exposed human pregnancies.

Reproductive and developmental toxicity studies in animals revealed no risk with respect to pregnancy, embryonic/foetal development, parturition or postnatal development.

The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Lactation

Sucroferric oxyhydroxide should be used with caution in breastfeeding women. At the time of writing, there are no available data from the use of sucroferric oxyhydroxide in breastfeeding women. Since absorption of iron from sucroferric oxyhydroxide is minimal, excretion of iron from sucroferric oxyhydroxide in breast milk is unlikely. A decision on whether to continue breast feeding or to continue therapy with sucroferric oxyhydroxide should be made taking into account the benefit of breastfeeding to the child and the benefit of therapy to the mother.

Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1

Side Effects

Abdominal discomfort
Abdominal distension
Abdominal pain
Black faeces
Constipation
Dental discolouration
Diarrhoea
Dyspepsia
Dysphagia
Dyspnoea
Fatigue
Flatulence
Gastritis
Gastroesophageal reflux disease
Headache
Hypercalcaemia
Hypocalcaemia
Nausea
Product taste abnormal
Pruritus
Rash
Tongue discolouration
Vomiting

Presentation

Oral formulations of sucroferric oxyhydroxide.

Drugs List

Therapeutic Indications

Uses

Hyperphosphataemia in chronic renal failure patients on haemodialysis
Hyperphosphataemia in patients on continuous ambulatory peritoneal dialysis

Sucroferric oxyhydroxide should be used within the context of a multiple therapeutic approach, which could include calcium supplement, 1,25-dihydroxy vitamin D3 or one of its analogues, or calcimimetics to control the development of renal bone disease.

Dosage

Adults

Children

Additional Dosage Information

Contraindications

Children under 6 years
Haemochromatosis
Hereditary fructose intolerance

Precautions and Warnings

Children 6 to 12 years
Breastfeeding
Diabetes mellitus
Glucose-galactose malabsorption syndrome
History of major gastrointestinal surgery
Pregnancy
Severe gastrointestinal disorder
Severe hepatic impairment
Within 3 months of peritonitis

Preparation contains sucrose
Advise patient to take with or after food
Diabetic control may need adjustment
Monitor serum phosphate levels
May affect the gastro-intestinal absorption of other drugs
Dietary restrictions should be maintained
Advise patient stools may be discoloured

The chewable tablet formulation is not appropriate for children aged 2 to 6 years.

Discoloured stool may visually mask gastrointestinal bleeding.

Patients with severe hepatic disorders have not been included in clinical studies with sucroferric oxyhydroxide. However, no evidence of hepatic impairment or significant alteration of hepatic enzymes were observed in clinical studies.

There is no clinical data available in patients with early stages of renal impairment.

The chewable tablets contain starch. Patients with diabetes should be aware that one tablet is equivalent to 0.116 bread units or approximately 1.4g of carbohydrates.

When administering any product that is already known to interact with iron or has the potential to interact with sucroferric oxyhydroxide, the product should be administered at least one hour before or two hours after sucroferric oxyhydroxide.

Pregnancy and Lactation

Pregnancy

Sucroferric oxyhydroxide should be used with caution in pregnancy. At the time of writing, there are no available clinical data from the use of sucroferric oxyhydroxide on exposed human pregnancies.

Reproductive and developmental toxicity studies in animals revealed no risk with respect to pregnancy, embryonic/foetal development, parturition or postnatal development.

The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Lactation

Sucroferric oxyhydroxide should be used with caution in breastfeeding women. At the time of writing, there are no available data from the use of sucroferric oxyhydroxide in breastfeeding women. Since absorption of iron from sucroferric oxyhydroxide is minimal, excretion of iron from sucroferric oxyhydroxide in breast milk is unlikely. A decision on whether to continue breast feeding or to continue therapy with sucroferric oxyhydroxide should be made taking into account the benefit of breastfeeding to the child and the benefit of therapy to the mother.

Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1

Counselling

Tablets must be chewed or crushed, but should not be swallowed whole.

Advise patient to take with or just after food.

Advise patient that dietary restrictions should be maintained.

Advise patient that their stools may be discoloured (black).

Side Effects

Abdominal discomfort
Abdominal distension
Abdominal pain
Black faeces
Constipation
Dental discolouration
Diarrhoea
Dyspepsia
Dysphagia
Dyspnoea
Fatigue
Flatulence
Gastritis
Gastroesophageal reflux disease
Headache
Hypercalcaemia
Hypocalcaemia
Nausea
Product taste abnormal
Pruritus
Rash
Tongue discolouration
Vomiting

Overdosage

It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

The following number will direct the caller to the relevant local centre (0844) 892 0111

Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Further Information

Last Full Review Date: November 2018

Reference Sources

Summary of Product Characteristics: Velphoro 500mg chewable tablets. Vifor Fresenius Medical Care Renal Pharma UK Ltd. Revised November 2020.