Important Safety Information

• Renvela is contraindicated in patients with bowel obstruction. • Caution should be exercised in patients with dysphagia, swallowing disorders, and severe gastrointestinal (GI) motility disorders including severe constipation or major GI tract surgery.  View additional Important Safety Information.

Efficacy

Renvela® (sevelamer carbonate): The benefit of effectively lowering serum phosphorus levels in CKD patients on dialysis

  • In several randomized studies, sevelamer has been shown to control serum phosphorus in CKD patients on dialysis1-4
  • Delmez: Double-blind, randomized, crossover study to compare the effects of sevelamer carbonate to sevelamer hydrochloride over 8 weeks for each treatment on the control of serum phosphorus, lipids and bicarbonate levels in 79 hemodialysis patients1
  • Chertow: Randomized study to compare targeted concentrations of serum phosphorus, calcium, intact parathyroid hormone and calcification of the coronary arteries and thoracic aorta with sevelamer and calcium-based phosphate binders in 200 hemodialysis patients over 52 weeks2
  • Block: Randomized study to assess the degree of coronary artery calcification over 18 months in 129 patients new to hemodialysis receiving calcium containing phosphate binders or sevelamer hydrochloride3
  • Fan: Multi-center, open-label, randomized, crossover study to compare safety and efficacy of sevelamer carbonate with sevelamer hydrochloride over 4 weeks for each treatment in 31 hemodialysis patients4

Renvela tablets or for oral suspension is an effective first-line monotherapy for controlling serum phosphorus in CKD patients on dialysis:

  • Three 800 mg tablets taken as directed with meals and snacks1,5‡; or
  • One 2.4 g packet of powder taken with meals6

‡ In some studies, sevelamer may have been given with snacks, as long as the prescribed daily dose was not exceeded. In a clinical trial, the average prescribed dose was three 800 mg tablets per meal.1,5

Information on Reimbursement

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Renvela for Oral Suspension Video

For more information about Renvela powder and how to prepare it, watch this instructional video.

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Contact Us

Sanofi US
500 Kendall Street
Cambridge, MA 02142

Tel: 617-252-7500
Fax: 617-252-7600
Toll free: 800-847-0069

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Indication

Renvela is indicated for the control of serum phosphorus in patients with CKD on dialysis.

Important Safety Information

  • Renvela is contraindicated in patients with bowel obstruction.
  • Caution should be exercised in patients with dysphagia, swallowing disorders, and severe gastrointestinal (GI) motility disorders, including severe constipation or major GI tract surgery.
  • The most frequently occurring adverse reactions in a short-term study with sevelamer carbonate tablets were nausea and vomiting.
  • In a short-term study of sevelamer carbonate powder dosed three times daily, 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, nausea, diarrhea, dyspepsia, abdominal pain, flatulence, and constipation.
  • Other events reported include pruritus, rash, fecal impaction and, less commonly, ileus, bowel obstruction, and bowel perforation.
  • Uncommon cases of difficulty swallowing the Renvela tablet have been reported. Caution should be exercised in these patients and consideration given to using sevelamer suspension in patients with a history of difficulty swallowing.
  • Drug-drug interactions may occur with some medications and should be taken into consideration when instructing patients how to take Renvela.
  • Serum bicarbonate and chloride levels should be monitored.
  • Follow patients for reduced vitamins D, E, and K (coagulation parameters) and folic acid levels.
  • Patients should be informed to take Renvela with meals and to adhere to their prescribed diets.

Please see full Prescribing Information (PDF).

References

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

  2. Chertow GM, Burke SK, Raggi P; for Treat to Goal Working Group. Sevelamer attenuates the progression of coronary and aortic calcification in hemodialysis patients. Kidney Int. 2002;62:245-252.

  3. 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;68:1815-1824.

  4. Fan S, Ross C, Mitra S, et al. A randomized, crossover design study of sevelamer carbonate powder and sevelamer hydrochloride tablets in chronic kidney disease patients on haemodialysis. Nephrol Dial Transplantation. 2009;24:3794-3799.

  5. Data on file, Genzyme Corp.

  6. Renvela [package insert]. Cambridge, MA: Genzyme Corp; 2010.