Active Ingredient: Sucroferric oxyhydroxide
Sucroferric oxyhydroxide is indicated for the control of serum phosphorus levels in adult chronic kidney disease (CKD) patients on haemodialysis (HD) or peritoneal dialysis (PD).
Sucroferric oxyhydroxide is indicated for the control of serum phosphorus levels in paediatric patients 2 years of age and older with CKD stages 4-5 (defined by a glomerular filtration rate <30 mL/min/1.73 m²) or with CKD on 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.
For this indication, competent medicine agencies globally authorize below treatments:
For:
Regimen A: In case that patient age in years is ≥ 2 and patient age in years is ≤ 6, oral, in total between 500 milligrams sucroferric oxyhydroxide and 1,250 milligrams sucroferric oxyhydroxide, daily to meals. The maximum allowed total dose is 1,250 milligrams sucroferric oxyhydroxide daily.
Regimen B: In case that patient age in years is ≥ 6 and patient age in years is ≤ 9, oral, in total between 750 milligrams sucroferric oxyhydroxide and 2,500 milligrams sucroferric oxyhydroxide, daily to meals. The maximum allowed total dose is 2,500 milligrams sucroferric oxyhydroxide daily.
Regimen C: In case that patient age in years is ≥ 9 and patient age in years is ≤ 12, oral, in total between 1,000 milligrams sucroferric oxyhydroxide and 3,000 milligrams sucroferric oxyhydroxide, daily to meals. The maximum allowed total dose is 3,000 milligrams sucroferric oxyhydroxide daily.
Sucroferric oxyhydroxide is also available as 125 mg oral powder in sachet for use in paediatric patients 2 to <12 years of age. The choice of the formulation depends on patient’s age, preference, characteristics and compliance. When transitioning between formulations, the same recommended dose should be used. Recommended starting doses and dose titrations of sucroferric oxyhydroxide for paediatric patients 2 to <12 years of age are shown in the the following table.
Recommended starting doses and dose titrations for paediatric patients 2 to <12 years of age:
| Patient age (years) | Daily starting dose | Dose increases or decreases | Maximum recommended daily dose |
|---|---|---|---|
| ≥2 to <6 | 500 mg | 125 or 250 mg | 1,250 mg |
| ≥6 to <9 | 750 mg | 125, 250 or 375 mg | 2,500 mg |
| ≥9 to <12 | 1,000 mg | 250 or 500 mg | 3,000 mg |
For patients 2 to <6 years of age oral powder should be administered, as the chewable tablet formulation is not appropriate for this age group.
For patients 6 to <12 years of age sucroferric oxyhydroxide chewable tablets may be prescribed instead of or in combination with sucroferric oxyhydroxide oral powder in case the daily dose is 1,000 mg iron or more.
Serum phosphorus levels must be monitored and the dose of sucroferric oxyhydroxide up or down titrated in increments per day every 2–4 weeks until an acceptable serum phosphorus level is reached, with regular monitoring afterwards.
The safety and efficacy of sucroferric oxyhydroxide in children below the age of 2 years has not been established. No data are available.
It must be taken with meals. In order to maximise the adsorption of dietary phosphate, the total daily dose should be divided across the meals of the day. Patients are not required to drink more fluid than they normally would and should adhere to their prescribed diets.
For:
Oral, in total between 1,500 milligrams sucroferric oxyhydroxide and 3,000 milligrams sucroferric oxyhydroxide, daily to meals. The maximum allowed total dose is 3,000 milligrams sucroferric oxyhydroxide daily.
The recommended starting dose is 1,500 mg iron (3 tablets) per day, divided across the meals of the day.
Serum phosphorus levels must be monitored and the dose of sucroferric oxyhydroxide up or down titrated in increments of 500 mg iron (1 tablet) per day every 2–4 weeks until an acceptable serum phosphorus level is reached, with regular monitoring afterwards.
In clinical practice, treatment will be based on the need to control serum phosphorus levels, though patients who respond to sucroferric oxyhydroxide therapy usually achieve optimal serum phosphorus levels at doses of 1,500–2,000 mg iron per day (3 to 4 tablets).
If one or more doses are missed, the normal dose of the medicinal product should be resumed with the next meal.
The maximum recommended dose is 3,000 mg iron (6 tablets).
It must be taken with meals. In order to maximise the adsorption of dietary phosphate, the total daily dose should be divided across the meals of the day. Patients are not required to drink more fluid than they normally would and should adhere to their prescribed diets.
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