Active Ingredient: Sevelamer
Sevelamer is indicated for the control of hyperphosphataemia in adult patients receiving haemodialysis or peritoneal dialysis.
Sevelamer is also indicated for the control of hyperphosphataemia in adult patients with chronic kidney disease (CKD) not on dialysis with serum phosphorus ≥1.78 mmol/l.
Sevelamer 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 to control the development of renal bone disease.
For this indication, competent medicine agencies globally authorize below treatments:
For:
Regimen A: Oral, 2.4 grams sevelamer, divided 3 times daily to meals.
Regimen B: Oral, 4.8 grams sevelamer, divided 3 times daily to meals.
The recommended starting dose of sevelamer carbonate is 2.4 g or 4.8 g per day based on clinical needs and serum phosphorus level. Sevelamer carbonate must be taken three times per day with meals.
| Serum phosphorus level in patients | Total daily dose of sevelamer carbonate to be taken over 3 meals per day |
|---|---|
| 1.78-2.42 mmol/l (5.5-7.5 mg/dl) | 2.4 g* |
| >2.42 mmol/l (>7.5 mg/dl) | 4.8 g* |
* Plus subsequent titrating, see section "Titration and maintenance"
For patients previously on phosphate binders (sevelamer hydrochloride or calcium based), sevelamer carbonate should be given on a gram for gram basis with monitoring of serum phosphorus levels to ensure optimal daily doses.
Serum phosphorus levels must be monitored and the dose of sevelamer carbonate titrated by 0.8 g three times per day (2.4 g/day) increments every 2-4 weeks until an acceptable serum phosphorus level is reached, with regular monitoring thereafter.
Patients taking sevelamer carbonate should adhere to their prescribed diets.
In clinical practice, treatment will be continuous based on the need to control serum phosphorus levels and the daily dose is expected to be an average of approximately 6 g per day.
It should be taken with food and not on an empty stomach.
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