When should Renvela (sevelamer) be initiated for patients with Chronic Kidney Disease (CKD)?

From the Guidelines

Renvela (sevelamer carbonate) should be started in chronic kidney disease (CKD) patients when their serum phosphorus levels exceed the normal range (typically above 4.5-5.5 mg/dL), usually occurring in moderate to severe CKD (stages 3b-5). This recommendation is based on the latest clinical practice guideline update from the Kidney Disease: Improving Global Outcomes (KDIGO) organization, which suggests that phosphate-lowering treatment should be based on progressively or persistently elevated serum phosphate levels 1.

Key Considerations

• The typical starting dose of Renvela is 800-1600 mg three times daily with meals, adjusted based on phosphorus levels with a target range of 3.5-5.5 mg/dL.
• Dosing should be individualized, with tablets taken with meals and never crushed or chewed.
• Regular monitoring of phosphorus levels is essential, with dose adjustments every 2-4 weeks until stable.
• Renvela works by binding dietary phosphate in the gut to prevent absorption, helping to manage hyperphosphatemia which can lead to secondary hyperparathyroidism, renal osteodystrophy, and vascular calcification if left untreated.

Benefits of Renvela

• Renvela is particularly useful for CKD patients as it doesn't contain calcium or metal, reducing the risk of hypercalcemia and metal accumulation.
• Common side effects include gastrointestinal discomfort, and patients should be counseled about proper administration with meals for maximum effectiveness.

Clinical Evidence

The KDIGO guideline update suggests that phosphate-lowering therapies may only be indicated in the event of progressive or persistent hyperphosphatemia and not for prevention 1. This is supported by studies that have shown that normophosphatemia may not be an indication to start phosphate-lowering treatments, and not all phosphate binders are interchangeable 1.

Patient Counseling

Patients should be counseled about the importance of regular monitoring of phosphorus levels and the need for dose adjustments to achieve and maintain a target phosphorus range. They should also be informed about the potential side effects of Renvela and the importance of proper administration with meals to minimize gastrointestinal discomfort.

From the FDA Drug Label

INDICATIONS AND USAGE • Sevelamer hydrochloride tablets are a phosphate binder indicated for the control of serum phosphorus in patients with chronic kidney disease on dialysis. (1)

The FDA drug label does not specify when Renvela (sevelamer) should be started for CKD patients. It only indicates that sevelamer hydrochloride is used for the control of serum phosphorus in patients with chronic kidney disease on dialysis.

From the Research

Initiation of Renvela for CKD Patients

• Renvela (sevelamer carbonate) is approved in the EU for adult CKD patients who require dialysis and those who do not require dialysis with serum phosphate levels ≥ 1.78 mmol/L 2.
• In the USA, sevelamer carbonate is approved in adult CKD patients who require dialysis 2.
• The decision to start Renvela should be based on serum phosphate levels, with higher levels associated with increased mortality in CKD stages 3 to 4 patients 3.
• Sevelamer has pleiotropic effects, including improving serum lipid profile and attenuating endothelial and cardiovascular risk factors in CKD, making it a useful treatment option for patients at risk of metabolic acidosis or those requiring a phosphate binding agent that does not contain aluminum or calcium 2, 4.

Key Considerations

• Serum phosphate levels should be monitored regularly to determine the need for Renvela therapy 3.
• The treatment of hyperphosphatemia with sevelamer has been associated with reduced all-cause mortality and vascular calcification score in CKD patients 5.
• Sevelamer may be particularly useful for CKD patients with high phosphate levels, as it has been shown to reduce phosphate levels and improve cardiovascular outcomes 2, 5.
• The safety and efficacy of sevelamer have been demonstrated in numerous clinical trials, with a meta-analysis showing reduced all-cause mortality and vascular calcification score compared to calcium-based binders 5.