From the Guidelines
Sevelamer should not be held in patients with impaired renal function, as it is crucial for controlling hyperphosphatemia and preventing related complications. Sevelamer, a phosphate binder, is specifically indicated for controlling hyperphosphatemia in chronic kidney disease, particularly in patients on dialysis 1. The medication works by binding dietary phosphate in the gastrointestinal tract, preventing its absorption and helping maintain appropriate phosphate levels. Discontinuing sevelamer in renally impaired patients can lead to dangerous hyperphosphatemia, which contributes to bone disease, vascular calcification, and increased mortality risk.
Some key points to consider when using sevelamer in patients with impaired renal function include:
- The standard dosing ranges from 800-1600 mg three times daily with meals, adjusted based on serum phosphate levels 1.
- If a patient experiences severe constipation or other gastrointestinal side effects, dose adjustment rather than complete discontinuation is typically preferred.
- During acute illness or periods of decreased oral intake, temporary dose reduction might be appropriate, but complete cessation should be avoided unless specifically indicated.
- Regular monitoring of phosphate levels is essential to guide dosing adjustments in these patients.
It's also important to note that decisions about phosphate-lowering treatment should be based on progressively or persistently elevated serum phosphate, and not all phosphate binders are interchangeable 1. However, sevelamer is a valuable treatment option for patients with impaired renal function, and its use should be guided by individual patient needs and serum phosphate levels.
From the FDA Drug Label
The safety and efficacy of sevelamer hydrochloride tablets in CKD patients who are not on dialysis have not been studied. The answer to whether you can hold sevelamer in patients with impaired renal function is:
- No explicit information is provided in the drug label regarding holding sevelamer in patients with impaired renal function.
- The label does mention that the safety and efficacy of sevelamer hydrochloride tablets in CKD patients who are not on dialysis have not been studied, implying a lack of direct guidance for patients with impaired renal function not on dialysis.
- Sevelamer is indicated for the control of serum phosphorus in patients with chronic kidney disease (CKD) on dialysis, suggesting its use is tailored for those undergoing dialysis.
- Caution should be exercised when considering the use of sevelamer in patients with impaired renal function, especially if they are not on dialysis, due to the lack of studied safety and efficacy in this population 2.
From the Research
Sevelamer in Patients with Impaired Renal Function
- Sevelamer is a phosphate binder used to treat hyperphosphatemia in patients with chronic kidney disease (CKD) or end-stage renal disease (ESRD) 3, 4, 5.
- The efficacy of sevelamer in lowering serum phosphate levels has been demonstrated in several studies, including a comparative clinical study with lanthanum carbonate 3 and a review of its use in patients with ESRD on haemodialysis 4.
- Sevelamer has been shown to be generally well-tolerated, with a lower risk of hypercalcaemic episodes compared to calcium-based phosphate binders 4, 5.
- However, rare complications such as deposition of sevelamer crystals in the gastrointestinal tract, leading to lower gastrointestinal bleeding, have been reported 6.
Use of Sevelamer in Specific Patient Populations
- Sevelamer has been used in pediatric patients with ESRD, with reported efficacy in lowering serum phosphorus concentrations and acceptable calcium-phosphorus product 7.
- In patients with impaired renal function, sevelamer may be a valuable option for managing hyperphosphatemia, particularly in those with a high risk of cardiovascular calcification or hypercalcaemia 4, 5.
Considerations for Holding Sevelamer
- Sevelamer should be held or discontinued in patients who experience gastrointestinal symptoms such as bleeding or abdominal pain, as these may be indicative of sevelamer crystal deposition 6.
- Patients with impaired renal function should be closely monitored for changes in serum phosphate, calcium, and parathyroid hormone levels, as well as for signs of gastrointestinal complications, while receiving sevelamer therapy 3, 4, 5.