RECENT MAJOR CHANGES

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

INDICATIONS AND USAGE

• Renvela® is a phosphate binder indicated for the control of serum phosphorus in patients with chronic kidney disease on dialysis. (1)

DOSAGE AND ADMINISTRATION

• Starting dose of Renvelais 0.8 or1.6 grams administered orally three times per day with meals. (2.1)
• Titrateby0.8 gper 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)

DOSAGE FORMS AND STRENGTHS

• Tablets: 800 mg (3)
• Powder: 0.8 g and 2.4 g packet (3)

CONTRAINDICATIONS

• Bowel obstruction. (4)

WARNINGS AND PRECAUTIONS

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

ADVERSE REACTIONS

• 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

DRUG INTERACTIONS

• 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)