Sevelamer Carbonate is indicated for the management of hyperphosphataemia in adult patients undergoing haemodialysis or peritoneal dialysis. It is also indicated for controlling hyperphosphataemia in adult patients with chronic kidney disease who are not on dialysis and have a serum phosphorus level ≥1.78 mmol/L. Sevelamer Carbonate should be used as part of a comprehensive treatment plan, which may include calcium supplements, 1,25-dihydroxy Vitamin D3, or its analogues to help manage renal bone disease.

Sevelamer carbonate is a non-absorbed, phosphate-binding, cross-linked polymer that does not contain metal or calcium. It has multiple amine groups positioned close to the polymer backbone. In the intestine, these amine groups become protonated and bind with phosphate through ionic and hydrogen bonding. By binding phosphate in the gastrointestinal tract and reducing its absorption, Sevelamer Carbonate effectively lowers serum phosphate (phosphorus) levels.

Starting dose: The recommended starting dose of Sevelamer Carbonate is 2.4 g (Three Sevelamer 800 mg tablets or Three Sevelamer 800 mg sachets of powder for oral suspension) or 4.8 g (Six Sevelamer 800 mg tablets or Six Sevelamer 800 mg sachets of powder for oral suspension) per day based on clinical needs and serum phosphorus level. Sevelamer Carbonate tablet or suspension must be taken three times per day with meals.

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.

Titration and Maintenance: Serum phosphorus levels must be monitored and the dose of Sevelamer Carbonate titrated 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.

Paediatric population: The safety and efficacy of Sevelamer Carbonate has not been established in children below the age of 18 years. Sevelamer Carbonate is not recommended in children below the age of 18 years.

Method of administration for Sevelamer Carbonate tablet: Tablets should be swallowed intact and should not be crushed, chewed, or broken into pieces prior to administration.

Method of administration for Sevelamer Carbonate powder for oral suspension: Each sachet of 800 mg of powder is to be dispersed in 30 ml or 6 teaspoons of water prior to administration. The suspension should be ingested within 30 minutes after being prepared.

Drug interaction studies in dialysis patients have not been conducted. In studies involving healthy volunteers, Sevelamer Hydrochloride (which has the same active component as Sevelamer Carbonate) reduced the bioavailability of ciprofloxacin by about 50% when co-administered. Therefore, Sevelamer Carbonate should not be taken at the same time as ciprofloxacin.

Reduced blood levels of ciclosporin, mycophenolate mofetil, and tacrolimus have been observed in transplant patients when used together with Sevelamer Hydrochloride, although no clinical consequences such as graft rejection were reported. However, potential interaction cannot be ruled out, and careful monitoring of blood levels is recommended during combined use and after discontinuation.

Very rare cases of hypothyroidism have been reported when Sevelamer Hydrochloride is used with levothyroxine. Therefore, monitoring of thyroid-stimulating hormone (TSH) levels is advised in patients receiving Sevelamer Carbonate with levothyroxine.

Patients receiving anti-arrhythmic or anti-seizure medications were not included in clinical trials; therefore, caution is advised when prescribing Sevelamer Carbonate in such cases.

In healthy volunteer studies, Sevelamer Hydrochloride showed no effect on the bioavailability of digoxin, warfarin, enalapril, or metoprolol. As Sevelamer Carbonate is not systemically absorbed, it may still affect the absorption of other medicines. Drugs for which reduced bioavailability may significantly affect safety or efficacy should be taken at least 1 hour before or 3 hours after Sevelamer Carbonate, or blood level monitoring should be considered.

Sevelamer Carbonate is contraindicated in patients with bowel obstruction. It is also contraindicated in individuals with known hypersensitivity to sevelamer carbonate, sevelamer hydrochloride, or any of the formulation components.

Sevelamer carbonate is not systemically absorbed after oral administration; therefore, maternal use is not expected to cause fetal exposure. However, it may reduce serum levels of fat-soluble vitamins and folic acid in pregnant women.

Since it is not absorbed systemically, breastfeeding is not expected to expose the infant to Sevelamer carbonate. Nevertheless, it may lower maternal levels of fat-soluble vitamins and folic acid, which should be considered during use.

Pediatric Use: The safety and effectiveness of Sevelamer Carbonate in reducing serum phosphorus have been evaluated in children aged 6 years and older with chronic kidney disease (CKD). In clinical studies, it appeared less effective in children with low baseline phosphorus levels, particularly those under 13 years of age and those not receiving dialysis. Based on its mechanism of action, Sevelamer Carbonate is expected to reduce serum phosphorus in pediatric CKD patients. Most adverse effects observed were gastrointestinal in nature and were considered related or possibly related to treatment. No new safety concerns were identified in pediatric trials.

Use in children below 6 years of age has not been studied.

Geriatric Use: Clinical studies did not include a sufficient number of patients aged 65 years and older to determine whether their response differs from younger patients. However, available clinical experience has not shown any significant differences in safety or efficacy between elderly and younger individuals. In general, dose selection in elderly patients should be done with caution, usually starting at the lower end of the dosing range.

In patients with CKD on dialysis, doses up to 14 g of sevelamer carbonate and 13 g of sevelamer hydrochloride have been studied. There are no reported cases of overdose with either formulation. Since sevelamer is not systemically absorbed, the risk of systemic toxicity is considered very low.

Drugs used for lowering serum phosphorus in patients with end-stage renal disease (ESRD)

Store in a cool, dry place, protected from light.