HIGHLIGHTS OF PRESCRIBING INFORMATION
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 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)

Dosage And Administration 2
•Tablets: 800 mg (3)
Contraindications
•Bowel obstruction. (4)
Warnings And Precautions
•The safety and efficacy of Renvela in patients with dysphagia, swallowing disorders, severe GI motility disorders including severe constipation, or major GI tract surgery have not been established. Uncommon cases of bowel obstruction and perforation have been reported (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%). (6.1) 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)
1 INDICATIONS AND USAGE
Renvela® (sevelamer carbonate) is indicated for the control of serum phosphorus in patients with chronic kidney disease (CKD) on dialysis. 

2 DOSAGE AND ADMINISTRATION
Because of the rapid reaction with the hydrochloric acid in the stomach, the dosing of Renvela powder or tablet is anticipated to be similar to that of the sevelamer hydrochloride salt or tablet.

2.1 General Dosing Information
Renvela should be given three times a day with meals.

Patients Not Taking a Phosphate Binder.  The recommended starting dose of Renvela is 0.8 to 1.6 g with meals based on serum phosphorus level. Table1 provides recommended starting doses of Renvela for patients not taking a phosphate binder.

Table 1. Starting Dose for Dialysis Patients Not Taking a Phosphate Binder Serum Phosphorus   Renvela® 8