What is the appropriate dosing for Sevelamer (Renagel), a phosphate binder?

From the FDA Drug Label

The recommended starting dose of sevelamer hydrochloride tablets is 800 to 1600 mg, which can be administered as one or two 800 mg sevelamer hydrochloride tablets or two to four 400 mg sevelamer hydrochloride tablets, with meals based on serum phosphorus level. Table 1 provides recommended starting doses of sevelamer hydrochloride tablets for patients not taking a phosphate binder Table 1: Starting Dose for Dialysis Patients Not Taking a Phosphate Binder Serum Phosphorus Sevelamer Hydrochloride Tablets 800 mg Sevelamer Hydrochloride Tablets 400 mg

5.5 and <7.5 mg/dL 1 tablet three times daily with meals 2 tablets three times daily with meals ≥7. 5 and <9 mg/dL 2 tablets three times daily with meals 3 tablets three times daily with meals ≥9 mg/dL 2 tablets three times daily with meals 4 tablets three times daily with meals Dose Titration for All Patients Taking Sevelamer Hydrochloride Tablets. Adjust dosage based on the serum phosphorus concentration with a goal of lowering serum phosphorus to 5. 5 mg/dL or less. Increase or decrease by one tablet per meal at two-week intervals as necessary.

The recommended starting dose of sevelamer hydrochloride tablets is 800 to 1600 mg, administered with meals based on serum phosphorus level.

• For patients not taking a phosphate binder, the starting dose can be:

• 1 tablet (800 mg) three times daily with meals for serum phosphorus levels >5.5 and <7.5 mg/dL
• 2 tablets (800 mg) three times daily with meals for serum phosphorus levels ≥7.5 and <9 mg/dL
• 2 tablets (800 mg) three times daily with meals for serum phosphorus levels ≥9 mg/dL

• Dose titration should be based on serum phosphorus concentration, with a goal of lowering serum phosphorus to 5.5 mg/dL or less.
• The dose can be increased or decreased by one tablet per meal at two-week intervals as necessary 1.

From the Research

Sevelamer dosing should start at 800 mg three times daily with meals for adults with hyperphosphatemia due to chronic kidney disease, with a target range of 3.5-5.5 mg/dL, as evidenced by the most recent study 2.

Key Considerations

• The dose should be adjusted based on serum phosphorus levels, with titration occurring every 2-4 weeks in increments of 800 mg per meal until phosphorus control is achieved, with maximum doses typically around 12-13 g daily.
• Sevelamer should always be taken with meals as it works by binding dietary phosphate in the gastrointestinal tract, preventing its absorption.
• The medication is available as sevelamer hydrochloride (Renagel) or sevelamer carbonate (Renvela), with the carbonate form generally preferred due to less risk of metabolic acidosis.
• Patients should swallow tablets whole with adequate fluid and not crush or chew them.
• Common side effects include gastrointestinal discomfort, constipation, and nausea.
• Sevelamer may interact with certain medications by binding to them, so other oral medications should be taken at least one hour before or three hours after sevelamer to minimize potential interactions.

Supporting Evidence

• A 2023 study 2 compared the efficacy of lanthanum carbonate and sevelamer carbonate as phosphate binders in chronic kidney disease, finding that lanthanum carbonate was more effective in lowering serum phosphate concentrations.
• Another study from 2022 3 evaluated the effects of sevelamer carbonate versus calcium acetate on vascular calcification, inflammation, and endothelial dysfunction in chronic kidney disease, finding that sevelamer carbonate had favorable effects on anti-inflammatory and vascular calcification biomarkers.
• A 2016 meta-analysis 4 compared sevelamer with calcium-based binders for treatment of hyperphosphatemia in CKD, finding that patients receiving sevelamer had lower all-cause mortality and reduced risk of hypercalcemia.

Clinical Implications

• Sevelamer dosing should be individualized based on patient response and serum phosphorus levels.
• Regular monitoring of serum phosphorus, calcium, and parathyroid hormone levels is necessary to adjust sevelamer dosing and prevent potential side effects.
• Patients should be educated on the importance of taking sevelamer with meals and swallowing tablets whole to ensure optimal efficacy and minimize potential interactions with other medications.