• Dosage and Administration (2) (08/2009)

• Starting dose of Renvela is 0.8 or 1.6 grams administered orally three times per day with meals. (2.1)
• Titrate by 0.8 g per meal in two week intervals as needed to obtain serum phosphorus target (3.5 to 5.5 mg/dL). (2.1)
• Switch gram-for-gram among sevelamer formulations. Further titration may be necessary to achieve desired phosphorus levels. (2.1)

• Serious cases of dysphagia, bowel obstruction, and perforation have been associated with sevelamer use, some requiring hospitalization and surgery. (5.1)

• Most of the safety experience is with sevelamer tablets. The most frequently occurring adverse reactions in a short term study with sevelamer carbonate tablets (8-week cross-over) study were: nausea (3%) and vomiting (3%). In a short term study of sevelamer carbonate powder, 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 (22%), nausea (20%), diarrhea (19%), dyspepsia (16%), abdominal pain (9%), flatulence (8%) and constipation (8%). (6.1)
• Cases of fecal impaction and, less commonly, ileus, bowel obstruction and bowel perforation have been reported. (6.2)

To report SUSPECTED ADVERSE REACTIONS, contact Genzyme Corporation at 1-800-847-0069 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

• Sevelamer decreases the bioavailability of ciprofloxacin by approximately 50%. (7.1)
• Sevelamer did not alter the pharmacokinetics of single doses of digoxin, warfarin, enalapril, metoprolol, or iron. (7)
• When administering an oral medication where a reduction in the bioavailability of that medication would have a clinically significant effect on its safety or efficacy, administer the drug at least one hour before or three hours after Renvela, and monitor blood levels of the drug. (7.7)