For U.S. Healthcare Professionals Only
+|Aa|-
Renvela

Renvela® has been shown to significantly decrease mean serum phosphorus1

Sevelamer tablets are proven to control
serum phosphorous levels in CKD patients on dialysis1,2

Sevelamer tablets are proven to control serum phosphorous levels in CKD patients on dialysis1,2

Study Design2

  • This was an 8-week, double-blind, randomized, crossover study that compared the effects of sevelamer carbonate and sevelamer hydrochloride on the control of serum phosphorus, lipids, and bicarbonate levels in 79 hemodialysis patients.

Results

  • Mean serum phosphorus was 4.6 mg/dL and 4.7mg/dL during sevelamer carbonate and sevelamer hydrochloride treatments, respectively

Safety

  • Patients treated with sevelamer carbonate experienced the following GI adverse events: nausea (9.6%), vomiting (8.2%), diarrhea (2.7%), gastroesophageal reflux disease (1.4%), dyspepsia (1.4%), and abdominal pain (2.7%)
Sevelamer powder is proven to control
serum phosphorous levels in CKD patients on dialysis 1,3

Sevelamer powder is proven to control serum phosphorous levels in CKD patients on dialysis 1,3

Study Design3

  • This was a multicenter, open-label, randomized crossover-design study that compared the safety and efficacy of sevelamer carbonate for oral suspension (powder) with sevelamer hydrochloride tablets over 4 weeks for each treatment in 31 hemodialysis patients.

Results

  • Mean serum phosphorus was 5.0 mg/dL during sevelamer cabonate powder treatment and 5.2 mg/dL during sevelamer hydrochloride tablet treatment

Safety

  • Four adverse events in 3 (9.7%) patients (nausea and vomiting in 1 patient, nausea in 1 patient, and constipation in 1 patient) that occurred during sevelamer carbonate treatement were assessed as treatment related

Study Design

  • Patients were stratified by site and the presence of diabetes at screening and were randomized to 52 weeks of open-label treatment with either an active control (n=101) or sevelamer hydrochloride (n=99).1,4
  • Study outcomes included the targeted concentrations of serum phosphorus.1

Results1

At week 52, using last-observation carried forward, sevelamer and active control both significantly decreased mean serum phosphorus levels by 5.4 mg/dL and 5.5 mg/dL, respectively.

Renvela® lowers mean total and low-density lipoprotein (LDL) cholesterol.1

  • In clinical trials of sevelamer hydrochloride, both the mean total and LDL cholesterol declined by 15% to 31%.

Indication

Renvela® (sevelamer carbonate) is used to control phosphorus levels in adults and children 6 years of age and older with chronic kidney disease (CKD) on dialysis.

Renagel® (sevelamer hydrochloride) is indicated for the control of serum phosphorus in patients with chronic kidney disease (CKD) on dialysis.

Important Safety Information

Sevelamer is contraindicated in patients with bowel obstruction and in patients with known hypersensitivity to sevelamer carbonate or sevelamer hydrochloride or to any of the excipients.

Please see additional Important Safety Information.

Please see Full Prescribing Information for Renvela® or Full Prescribing Information for Renagel®

Patients in the 90-day waiting period for Medicare may qualify for the Renassist® Patient Assistance Program and could receive Renvela® at no cost for the entire 90 days if they apply early enough.
Certain restrictions may apply.

Learn more at Renassist.com.

Indication

Renvela® (sevelamer carbonate) is used to control phosphorus levels in adults and children 6 years of age and older with chronic kidney disease (CKD) on dialysis.

Renagel® (sevelamer hydrochloride) is indicated for the control of serum phosphorus in patients with chronic kidney disease (CKD) on dialysis.

Important Safety Information

  • Sevelamer is contraindicated in patients with bowel obstruction and in patients with known hypersensitivity to sevelamer carbonate or sevelamer hydrochloride or to any of the excipients.
  • Caution should be exercised in patients with dysphagia, swallowing disorders, and 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, 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 Renagel or Renvela tablet have been reported. Caution should be exercised in these patients and consideration given to using Renvela 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 sevelamer.
  • 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 sevelamer with meals and to adhere to their prescribed diets.

Please see Full Prescribing Information for Renvela® or Full Prescribing Information for Renagel®.
Click here to learn more about Sanofi's commitment to fighting counterfeit drugs.

References:

  1. Renvela [package insert]. Cambridge, MA: Genzyme Corp.
  2. 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.
  3. 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.
  4. 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.

Important Safety Information

Sevelamer is contraindicated in patients with bowel obstruction and in patients with known hypersensitivity to sevelamer carbonate or sevelamer hydrochloride or to any of the excipients. Click here to read more.