Renvela (sevelamer carbonate)

The following drug information is obtained from various newswires, published medical journal articles, and medical conference presentations.

Company:

Approval Status:

Approved October 2007

Specific Treatments:

control of serum phosphorus in patients with chronic kidney disease on dialysis

Therapeutic Areas

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General Information

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 is specifically indicated for the control of serum phosphorus in patients with chronic kidney disease on dialysis.

Renvela is supplied as a tablet designed for oral administration. The recommended initial dose is as follows:
Patients Not Taking a Phosphate Binde:
Serum phosphorus >5.5 and <7.5 mg/dL: Renvela 800 mg 1 tablet three times daily with meals.
Serum phosphorus ≥7.5 and <9.0 mg/dL: Renvela 800 mg 2 tablets three times daily with meals.
Serum phosphorus ≥9.0 mg/dL Renvela 800 mg 2 tablets three times daily with meals.
Patients Switching from Sevelamer Hydrochloride
Sevelamer carbonate should be prescribed on a gram per gram basis. Further titration to the desired phosphate levels may be necessary. The highest daily dose of sevelamer carbonate studied was 14 grams in CKD patients on dialysis.
Patients Switching From Calcium Acetate
The dose schedule of Renvela should match the dose schedule of the current calcium acetate dose. I.e. if current calcium acetate dose is 1 tablet per meal, the Renvela dose should be 1 tablet per meal.
Dose Titration for All Patients Taking Renvela
The dose should be increased or decreased by one tablet per meal at two week intervals, as necessary, with the goal of controlling serum phosphorus within the target range of 3.5 mg/dL to 5.5 mg/dL.

Clinical Results

FDA Approval
The FDA approval of Renvela was based on a double-blind, active controlled, cross-over study in 79 hemodialysis patients with two 8- week treatment periods. Stage 5 CKD patients on hemodialysis were entered into a five-week sevelamer hydrochloride run-in period and received, in random order, sevelamer carbonate 800 mg tablets and sevelamer hydrochloride 800 mg tablets for eight weeks each, with no intervening washout. Study dose during the cross-over period was determined based on the sevelamer hydrochloride dose during the run-in period on a gram per gram basis. The phosphate levels at the end of each of the two cross-over periods were similar. Average actual daily dose was 6 g/day for both treatments.

Side Effects

Adverse events associated with the use of Renvela may include, but are not limited to, the following:

  • Vomiting
  • Nausea
  • Diarrhea
  • Dyspepsia
  • Abdominal pain
  • Flatulence
  • Constipation

Mechanism of Action

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.

Literature References

Fan S, Ross C, Mitra S, Kalra P, Heaton J, Hunter J, Plone M, Pritchard N A randomized, crossover design study of sevelamer carbonate powder and sevelamer hydrochloride tablets in chronic kidney disease patients on haemodialysis. Nephrology, Dialysis, Transplantation : Official Publication of the European Dialysis and Transplant Association - European Renal Association 2009 Aug 7

Delmez J, Block G, Robertson J, Chasan-Taber S, Blair A, Dillon M, Bleyer AJ A randomized, double-blind, crossover design study of sevelamer hydrochloride and sevelamer carbonate in patients on hemodialysis. Clinical Nephrology 2007 Dec;68(6):386-91

Additional Information

For additional information regarding Renvela or elevated serum phosphorus in patients with chronic kidney disease on dialysis, please visit the Renvela web page.