Renosev

Renosev tablet is indicated for the control of hyperphosphataemia in adult patients receiving haemodialysis or peritoneal dialysis. Renosev tablet is also indicated for the control of hyperphosphataemia in adult patients with chronic kidney disease not on dialysis with serum ... Read more Renosev tablet is indicated for the control of hyperphosphataemia in adult patients receiving haemodialysis or peritoneal dialysis. Renosev tablet is also indicated for the control of hyperphosphataemia in adult patients with chronic kidney disease not on dialysis with serum phosphorus 1.78 mmol/l. Renosev tablet 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.

Sevelamer carbonate, a non-absorbed phosphate binding crosslinked polymer, free of metal and calcium. It contains multiple amines separated by one carbon from the polymer backbone. These amines exist in a protonated form in the intestine and interact with phosphate molecules through ionic and hydrogen bonding. By binding phosphate in the gastrointestinal tract and decreasing absorption, sevelamer carbonate lowers the phosphate concentration in the serum (serum phosphorus).

Starting dose : The recommended starting dose of Sevelamer Carbonate is 2.4 gm (Three Sevelamer 800 mg tablets) or 4.8 gm (Six Sevelamer 800 mg tablets) 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.

Interaction studies have not been conducted in patients on dialysis. In interaction studies in healthy volunteers, Renosev Hydrochloride, which contains the same active moiety as Renosev, decreased the bioavailability of ciprofloxacin by approximately 50% when co-administered with Renosev Hydrochloride in a single dose study. Consequently, Renosev should not be taken simultaneously with ciprofloxacin. Reduced levels of ciclosporin, mycophenolate mofetil and tacrolimus have been reported in transplant patients when co-administered with Renosev Hydrochloride without any clinical consequences (i.e graft rejection). The possibility of an interaction cannot be excluded and a close monitoring of blood concentrations of ciclosporin, mycophenolate mofetil and tacrolimus should be considered during the use of combination and after its withdrawal. Very rare cases of hypothyroidism have been reported in patients co-administered Renosev Hydrochloride, which contains the same active moiety as Renosev, and levothyroxine. Closer monitoring of thyroid stimulating hormone (TSH) levels is therefore recommended in patients receiving Renosev and levothyroxine. Patients taking anti-arrhythmic medicinal products for the control of arrhythmias and anti-seizure medicinal products for the control of seizure disorders were excluded from clinical trials. Caution should be exercised when prescribing Renosev to patients also taking these medicinal products. In interaction studies in healthy volunteers, Renosev Hydrochloride, which contains the same active moiety as Renosev, had no effect on the bioavailability of digoxin, warfarin, enalapril or metoprolol. Renosev is not absorbed and may affect the bioavailability of other medicinal products. When administering any medicinal product where a reduction in the bioavailability could have a clinically significant effect on safety or efficacy, the medicinal product should be administered at least one hour before or three hours after Renosev, or the physician should consider monitoring blood levels.

Sevelamer Carbonate is contraindicated in patients with bowel obstruction. Sevelamer Carbonate is contraindicated in patients with known hypersensitivity to sevelamer carbonate, sevelamer hydrochloride, or to any of the excipients.

Sevelamer carbonate is not absorbed systemically following oral administration and maternal use is not expected to result in fetal exposure to the drug. Clinical Considerations Sevelamer carbonate may decrease serum levels of fat soluble vitamins and folic acid in pregnant women. Sevelamer carbonate is not absorbed systemically by the mother following oral administration, and breastfeeding is not expected to result in exposure of the child to Sevelamer carbonate. Clinical Considerations Sevelamer carbonate may decrease serum levels of fat soluble vitamins and folic acid in pregnant women.

In CKD patients on dialysis, the maximum dose studied was 14 grams of Renosev and 13 grams of sevelamer hydrochloride. There are no reports of overdosage with Renosev or sevelamer hydrochloride in patients. Since sevelamer is not absorbed, the risk of systemic toxicity is low.

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