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.

Clinical Practice Guidelines

KDIGO guidelines: Suggested target ranges for calcium, phosphorus, and PTH

KDIGO is a global nonprofit foundation dedicated to improving the care and outcomes of patients with kidney disease worldwide.

Clinical Guidelines

Control phosphorus with phosphate binders in CKD patients on dialysis

Consider the following parameters when choosing a binder1:

  • CKD stage
  • Evaluation of CKD-MBD components
  • Concomitant therapies
  • Side-effect profile
KDIGO

Vascular calcification in CKD patients on dialysis1

For detection of the presence/absence of calcification, the use of commonly available modalities is suggested:

  • Lateral abdominal X-ray  (vascular)
  • Echocardiogram (valvular)

If vascular calcification is present in two or more sites, consideration should be given to prescription of a non–calcium-containing phosphate binder.2

Information on Reimbursement

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500 Kendall Street
Cambridge, MA 02142

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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. Kidney Disease: Improving Global Outcomes (KDIGO) CKD–MBD Work Group. KDIGO clinical practice guideline for the diagnosis, evaluation, prevention, and treatment of chronic kidney disease–mineral and bone disorder (CKD–MBD). Kidney Int. 2009;76(suppl 113):S1-S130.

  2. National Kidney Foundation. KDOQI clinical practice guidelines for cardiovascular disease in dialysis patients. Am J Kidney Dis. 2005;45(suppl 3):S1-S153.