Sucroferric oxyhydroxide oral
- Drugs List
- Therapeutic Indications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
Oral formulations of sucroferric oxyhydroxide.
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.
The recommended starting dose is 1500mg per day, divided across the meals of the day.
Serum phosphorus levels must be monitored and the dose of sucroferric oxyhydroxide titrated up or down in increments of 500mg per day every 2 to 4 weeks until an acceptable serum phosphorus level is reached. Patients who respond to therapy usually achieve optimal serum phosphorus levels at doses of 1500mg to 2000mg per day.
If one or more doses are missed, the normal dose of the product should be resumed with the next meal.
The maximum recommended dose is 3000mg per day.
Children aged 12 to 18 years
(See Dosage; Adult)
Children aged 9 to 12 years
Initial dose: 1000mg
Dose increases or decreases: 250mg or 500mg
Maximum daily dose: 3000mg
Children aged 6 to 9 years
For doses lower than 1000mg or increments smaller than 500mg, the chewable tablets are not appropriate.
Initial dose: 750mg
Dose increases or decreases: 125mg, 250mg or 375mg
Maximum daily dose: 2500mg
Additional Dosage Information
When transitioning between formulations, the same recommended dose should be used.
Children under 6 years
Hereditary fructose intolerance
Precautions and Warnings
Children 6 to 12 years
Glucose-galactose malabsorption syndrome
History of major gastrointestinal surgery
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
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 ).
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
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).
Gastroesophageal reflux disease
Product taste abnormal
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 ).
Last Full Review Date: November 2018
Summary of Product Characteristics: Velphoro 500mg chewable tablets. Vifor Fresenius Medical Care Renal Pharma UK Ltd. Revised November 2020.
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Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
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