Renvela® (Chinese brand name: Nuoweile®) is the commercial brand name of Sevelamer Carbonate Tablets, a non-calcium, non-aluminum oral phosphate binder developed by Sanofi. It binds dietary phosphate within the intestinal tract to form insoluble complexes excreted via feces, lowering serum phosphorus to prevent and treat hyperphosphatemia and related mineral bone disorder in chronic kidney disease patients.
Main Indications
Control of serum phosphorus levels in adult patients with chronic kidney disease on dialysis (hemodialysis or peritoneal dialysis);
Management of hyperphosphatemia for adult non-dialysis chronic kidney disease patients with elevated blood phosphorus.
Clinical Research
Global multicenter phase III pivotal trials demonstrated that sevelamer carbonate effectively reduces serum phosphate without inducing hypercalcemia, lowering the risk of vascular calcification, secondary hyperparathyroidism and renal osteodystrophy compared with calcium-based phosphate binders;
Registration clinical trials enrolling Chinese dialysis patients confirmed stable phosphorus-lowering efficacy and consistent efficacy and safety outcomes compared with global study populations;
Long-term real-world studies in Chinese nephrology departments verified its cardiovascular protective benefit by slowing arterial calcification progression during long-term maintenance treatment.
Common Side Effects
Severe adverse reactions: Severe intestinal obstruction, intestinal perforation, severe hypersensitivity reaction;
Common mild adverse reactions: Nausea, vomiting, abdominal distension, constipation, diarrhea, flatulence, dyspepsia.
Approval Status in China
Renvela® (Sevelamer Carbonate Tablets, specification: 0.8g per tablet, 30 tablets per bottle, Sanofi original imported drug) obtained NMPA marketing approval in 2009. It is a prescription oral phosphate-lowering medicine for long-term management of hyperphosphatemia in chronic kidney disease patients.
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