About Renvela

Renvela^® (sevelamer carbonate) is indicated for the control of serum phosphorus in patients with Chronic Kidney Disease (CKD) on dialysis. Renvela contains sevelamer carbonate, a non-absorbed phosphate binding crosslinked polymer, free of metal and calcium. It contains multiple amines separated by one carbon from the polymer backbone. These amines exist in a protonated form in the intestine and interact with phosphate molecules through ionic and hydrogen bonding. By binding phosphate in the dietary tract and decreasing absorption, sevelamer carbonate lowers the phosphate concentration in the serum.

• Renvela has the same polymeric structure as Renagel^® (sevelamer hydrochloride)¹ with a salt change.

• Treatment with Renvela improves serum bicarbonate levels compared to Renagel.²
• Renvela contains no calcium or metal¹ and does not accumulate in the body, either in plasma or tissues.

• Calcium-based binders have been associated with calcification, even at doses below the KDOQI-recommended maximum.^3,4,5,6
• Hypercalcemia has been found to be prevalent in 50% of dialysis patients (serum calcium >9.5 mg/dL).⁷
• Lanthanum has been shown in human studies to accumulate in bone and in animal studies to accumulate in the GI tract, liver and other tissues.⁸
• Aluminum-containing agents have been associated with acute aluminum neurotoxicity, dialysis encephalopathy, aluminum bone disease, microcytic anemia and other complications.³

References

1. Renvela Package Insert, Cambridge, MA: Genzyme Corp; 2007.

2. Delmez J, Block G, Robertson J, et al. A randomized, double-blind, cross-over design study of sevelamer hydrochloride and sevelamer carbonate in patients on hemodialysis. Clin Nephrol. 2007;68(6):386-391.

3. National Kidney foundation. KDOQI clinical practice guidelines for bone metabolism and disease in chronic kidney disease. Am J Kidney Dis. 2003;42(suppl 3):S1-S201

4. Chertow GM, Burke SK, Raggi P. Sevelamer attenuates the progression of coronary and aortic calcification in hemodialysis patients. Kidney Int. 2002;62:245-252

5. Block GA, Spiegel DM, Ehrlich J, et al. Effects of sevelamer and calcium on coronary artery calcification in patients new to hemodialysis. Kidney Int. 2005;68(4):1815-1824

6. Goodman WG, Goldin J, Kuizon BD, et al. Coronary-artery calcification in young adults with end-stage renal disease who are undergoing dialysis. New Eng J Med. 2000;342:1478-1483

7. Young EW, Albert JM, Satayathum S, et al. Predictors and consequences of altered mineral metabolism: The Dialysis Outcomes and Practice Patterns Study. Kidney Int. 2005;67:1179-1187

8. FosrenolTM (lanthanum carbonate) Package Insert, Wayne, PA: Shire US, Inc.; 2007

9. Renagel Package Insert, Cambridge, MA: Genzyme Corp;2007.

Important Treatment Considerations

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. For more information, please see Full Prescribing Information for Renvela, Full Prescribing Information for Renagel or call Genzyme Medical Information at 1-800-847-0069.