Indication

Renvela is indicated for the control of serum phosphorus in patients with CKD on dialysis.

Important Safety Information

• Renvela is contraindicated in patients with bowel obstruction.
• Caution should be exercised in patients with dysphagia, swallowing disorders, and severe gastrointestinal (GI) motility disorders, including severe constipation or major GI tract surgery.
• The most frequently occurring adverse reactions in a short-term study with sevelamer carbonate tablets were nausea and vomiting.
• In a short-term study of sevelamer carbonate powder dosed three times daily, adverse events were similar to those reported for sevelamer carbonate tablets.
• In long-term studies with sevelamer hydrochloride, which contains the same active moiety as sevelamer carbonate, the most common adverse events included vomiting, nausea, diarrhea, dyspepsia, abdominal pain, flatulence, and constipation.
• Other events reported include pruritus, rash, fecal impaction and, less commonly, ileus, bowel obstruction, and bowel perforation.
• Uncommon cases of difficulty swallowing the Renvela tablet have been reported. Caution should be exercised in these patients and consideration given to using sevelamer suspension in patients with a history of difficulty swallowing.
• Drug-drug interactions may occur with some medications and should be taken into consideration when instructing patients how to take Renvela.
• Serum bicarbonate and chloride levels should be monitored.
• Follow patients for reduced vitamins D, E, and K (coagulation parameters) and folic acid levels.
• Patients should be informed to take Renvela with meals and to adhere to their prescribed diets.

Please see full Prescribing Information (PDF).