Renvela? is a phosphate binder indicated for the control of serum diarrhea (19%),dyspepsia (16%),abdominal pain (9%),flatulence (8%) and constipation (8%). (6.1) phosphorus in patients with chronic kidney disease on dialysis
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 of Renvela is 0.8 or 1.6 grams administered orally three To report SUSPECTED ADVERSE REACTIONS,contact Genzyme times per day with meals. Titrate by 0.8 g per meal in two week intervals as needed to obtain ? Switch gram-for-gram among sevelamer formulations. Further titrationmay be necessary to achieve desired phosphorus levels.
Drug interactions: Interaction studies have not been conducted in patients on dialysis. In interaction studies in healthy volunteers, Sevelamer Hydrochloride, which contains the same active moiety as Sevelamer Carbonate, decreased the bioavailability of ciprofloxacin by approximately 50% when co-administered with Sevelamer Hydrochloride in a single dose study. Consequently, Sevelamer Carbonate 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 Sevelamer 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 Sevelamer Hydrochloride, which contains the same active moiety as Sevelamer Carbonate, and levothyroxine. Closer monitoring of thyroid stimulating hormone (TSH) levels is therefore recommended in patients receiving Sevelamer Carbonate 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 Sevelamer Carbonate to patients also taking these medicinal products. In interaction studies in healthy volunteers, Sevelamer Hydrochloride, which contains the same active moiety as Sevelamer Carbonate, had no effect on the bioavailability of digoxin, warfarin, enalapril or metoprolol. Sevelamer Carbonate 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 Sevelamer Carbonate, or the physician should consider monitoring blood levels.
Bowel obstruction,Serious cases of dysphagia,bowel obstruction,and perforation have been associated with sevelamer use,some requiring hospitalization and surgery.
vomiting (22%),nausea (20%), serum diarrhea (19%),dyspepsia (16%),abdominal pain (9%),flatulence (8%) and constipation (8%). phosphorus in patients with chronic kidney disease on dialysis. ? Cases of fecal impaction and,less commonly,ileus,bowel obstruction and bowel perforation
Pregnancy Category C: There are no adequate and well-controlled studies in pregnant women. Sevelamer products should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
In CKD patients on dialysis, the maximum dose studied was 14 grams of sevelamer carbonate and 13 grams of sevelamer hydrochloride. There are no reports of overdosage with sevelamer carbonate 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.
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