Indication
Renvela (sevelamer carbonate) is used to control phosphorus levels in patients with chronic kidney disease (CKD) on dialysis.
Important Safety Information
- Do not use Renvela if you have a history of bowel obstruction
- Talk to your doctor if you have had difficulty swallowing or swallowing disorders; or if you have had digestive tract surgery or other digestive disorders, including severe constipation
- Uncommon cases of bowel obstruction and perforation have been reported. Your doctor should monitor bicarbonate and chloride blood levels. Vitamins D, E, K (clotting factors), and folic acid blood levels should also be monitored by your doctor
- The most frequently occurring side effects observed with sevelamer carbonate tablets were nausea and vomiting
- Side effects with sevelamer carbonate powder taken three times a day were similar to those reported for sevelamer carbonate tablets
- The most common side effects with sevelamer hydrochloride, which contains the same active ingredient as sevelamer carbonate, included: vomiting, nausea, diarrhea, indigestion, abdominal pain, flatulence, and constipation
- Cases of fecal impaction and, less commonly, slow bowel activity, bowel obstruction, and bowel perforation have been reported
- Take Renvela with meals and adhere to your prescribed diet
- Talk to your doctor when taking Renvela with other medications
- Promptly contact your doctor if you experience severe abdominal pain, new or worsening constipation, or other severe intestinal symptoms while on Renvela
Please see full Prescribing Information (PDF).
References
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Delmez J, Block G, Robertson J, et al. A randomized, double-blind, crossover design study of sevelamer hydrochloride and sevelamer carbonate in patients on hemodialysis. Clin Nephrol. 2007;68:386-391.
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Data on file, Genzyme Corp.
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Renvela [package insert]. Cambridge, MA: Genzyme Corp; 2010.