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Sevelamer Carbonate Approved in EU for Patients With Chronic Kidney Disease NEW YORK -- June 12, 2009 -- The European Commission has approved sevelamer carbonate (Renvela) for the control of serum phosphorus in patients with chronic kidney disease (CKD). The approval includes patients not on dialysis with serum phosphorus levels => 1.78 mmol/L (5.5 mg/dL), and covers both the tablet and powder formulations. "Hyperphosphatemia is a significant risk factor for cardiovascular disease in patients with CKD, and frequently starts before patients reach dialysis," said Markus Ketteler, MD, Klinikum Coburg, Academic Teaching Hospital of the University of Würzburg, Würzburg, Germany. "[Sevelamer carbonate]h is an important addition to the therapeutic options available to nephrologists, and gives them the opportunity to treat hyperphosphatemia earlier." Sevelamer is contraindicated in patients with hypophosphatemia or bowel obstruction. Caution should be exercised in patients with dysphagia, swallowing disorders, severe gastrointestinal (GI) motility disorders including severe constipation or major GI tract surgery. Common adverse events reported with sevelamer include vomiting, nausea, diarrhoea, dyspepsia, abdominal pain, and constipation. Other events reported include pruritus, rash, fecal impaction, and intestinal obstruction. SOURCE: Genzyme E-mail this page to a friend or colleague! To print, use this version