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Renvela

KDOQI and KDIGO clinical practice guidelines2,3

Managing serum phosphorus levels is a key component of treating chronic kidney disease (CKD) patients on dialysis.2,3

KDOQI
The National Kidney Foundation's Kidney Disease Outcomes Quality Initiative

KDIGO
Kidney Disease: Improving Global Outcomes

KDOQI/KDIGO clinical practice guidelines2,3
Stage Serum phosphorus
KDOQI 5D Maintained between 3.5 and 5.5 mg/dL (A)
KDIGO 5D Toward normal (2.5 to 4.5 mg/dL) (2C)
 
Rating the strength of KDOQI guideline recommendations2
Grade Recommendation
A It is strongly recommended that clinicians routinely follow the guideline for eligible patients. There is strong evidence that the practice improves health outcomes.
B It is recommended that clinicians routinely follow the guidelines for eligible patients. There is moderately strong evidence that the practice improves health outcomes.
CPR It is recommended that clinicians consider following the guidelines for eligible patients. This recommendation is based on either weak evidence or on the opinions of the Work Group and reviewers that the practice might improve health outcomes.
The strength of each guideline recommendation is based on the quality of the supporting evidence as well as additional considerations.2
KDIGO grading of recommendations3
Grade for strength
of recommendation
Strength Wording Grade for quality of
evidence
Quality of
evidence
Level 1 Strong “We recommend... should” A High
B Moderate
Level 2 Weak “We suggest...might” C Low
D Very low

KDIGO Chart KDIGO Chart

Grade Level 1 “We recommend”3

  • Most patients should receive the recommended course of action.

Grade Level 2 “We suggest”3

  • Different choices will be appropriate for different patients. Each patient needs help to arrive at a management decision consistent with her or his values and preferences.

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 with Medicare Part D and Medicaid prescription drug coverage (dual-eligible) represent the majority of patients on dialysis (44%).1 These patients pay less than $8.25 or less per fill.4
Certain restrictions may apply.

Learn more

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®.
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References:

  1. Data on file, Sanofi US. August 2016.
  2. 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.
  3. 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.
  4. Find Your Level of Extra Help (Part D). The Official U.S. Government Site for Medicare. https://www.medicare.gov/your-medicare-costs/help-paying-costs/extra-help/level-of-extra-help.html. Accessed November 30, 2016.

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.