Sunday, August 16, 2009

FDA approves Renvela

Renvela® is an effective first-line monotherapy for controlling serum phosphorus in patients with Chronic Kidney Disease (CKD) — on dialysis without calcium or metal1 accumulation. Renvela offers all the advantages of Renagel®, with the added benefit of a carbonate buffer.

Renvela® (sevelamer carbonate) and Renagel® (sevelamer hydrochloride) are indicated for the control of serum phosphorus in patients with Chronic Kidney Disease (CKD) on dialysis. 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, diarrhea, dyspepsia, abdominal pain, and constipation. Other events reported include pruritus, rash, fecal impaction, and intestinal obstruction. Drug-drug interactions may occur with some medications and should be taken into consideration when instructing patients how to take sevelamer. Patients should be informed to take sevelamer with meals and to adhere to their prescribed diets