Sevelamer Use in Chronic Kidney Disease
Sevelamer is a phosphate binder primarily used for the control of serum phosphorus in patients with chronic kidney disease (CKD) on dialysis. 1
Primary Indications
- Sevelamer is FDA-approved for controlling serum phosphorus levels in patients with chronic kidney disease on dialysis 1
- It is a non-calcium, non-aluminum phosphate binder that binds dietary phosphate in the gastrointestinal tract, preventing its absorption 2
- Sevelamer is indicated when dietary phosphorus restriction alone is insufficient to maintain normal phosphorus levels in CKD patients 3
Clinical Benefits
- Effectively lowers serum phosphorus levels similar to calcium-based phosphate binders 3
- Reduces calcium-phosphorus product, which is associated with lower cardiovascular risk 3
- Decreases LDL cholesterol levels by approximately 34%, providing additional cardiovascular benefit 3, 2
- Attenuates the progression of arterial calcifications compared to calcium-based phosphate binders 3
- May reduce mortality in incident dialysis patients (shown in the Renagel In New Dialysis Patients trial) 3
Specific Clinical Scenarios for Use
- When calcium-based phosphate binders cause hypercalcemia (serum calcium >10.2 mg/dL) 3
- When total intestinal calcium load becomes excessive with calcium-containing phosphate binders 3
- In patients with severe vascular and/or other soft-tissue calcifications 3
- When calcium-phosphorus product exceeds 55 mg²/dL² despite dietary restrictions 3
- In patients with elevated PTH levels who cannot tolerate calcium-based binders 3
Dosing Considerations
- Starting dose is based on serum phosphorus levels:
- Dose titration should aim to lower serum phosphorus to 5.5 mg/dL or less 1
- Average effective dose in clinical trials was approximately three 800 mg tablets per meal 1
Advantages Over Calcium-Based Binders
- Lower risk of hypercalcemic episodes 3
- Reduced progression of vascular calcification 3
- Beneficial effects on lipid profile (LDL reduction) 3, 4
- No contribution to calcium load, which is important in patients at risk for vascular calcification 3
Potential Limitations and Side Effects
- Major pill burden that may affect adherence and quality of life 3
- Common gastrointestinal side effects include:
- May cause metabolic acidosis more frequently than calcium-based binders 3
- Contraindicated in patients with bowel obstruction or hypersensitivity to sevelamer 1
- May reduce vitamins D, E, K and folic acid levels, requiring monitoring 1
Special Populations
- Pediatric use: Sevelamer is the only calcium- and aluminum-free phosphate binder with proven efficacy and safety in children with CKD 3
- In non-dialysis CKD patients: While some studies show efficacy 5, the FDA label specifically indicates use only for patients on dialysis 1
Monitoring Recommendations
- Regular monitoring of serum phosphorus levels to guide dose adjustments 1
- Monitor serum calcium levels to assess for hypocalcemia 1
- Monitor bicarbonate and chloride levels due to potential metabolic acidosis 1
- Monitor vitamin D, E, K and folic acid levels, especially in long-term use 1
Alternative Considerations
- If pill burden becomes unacceptable, consider intensified dialysis protocols 3
- Lanthanum carbonate is an alternative non-calcium, non-aluminum phosphate binder, but has limited long-term safety data in children 3
- Always combine phosphate binder therapy with dietary phosphate restriction and appropriate dialysis 3