Sevelamerdosage

2. DOSAGE AND ADMINISTRATION Patients Not Taking a Phosphate Binder. 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 Patients Switching from Calcium Acetate. In a study in 84 CKD patients on hemodialysis, a similar reduction in serum phosphorus was seen with equivalent doses (approximately mg for mg) of sevelamer hydrochloride tablets and calcium acetate. Table 2 gives recommended starting doses of sevelamer hydrochloride tablets based on a patient’s current calcium acetate dose. Table 2: Starting Dose for Dialysis Patients Switching From Calcium Acetate to Sevelamer Hydrochloride Tablets Calcium Acetate 667 mg (Tablets per meal) Sevelamer Hydrochloride Tablets 800 mg (Tablets per meal) Sevelamer Hydrochloride Tablets 400 mg (Tablets per meal) 1 tablet 1 tablet 2 tablets 2 tablets 2 tablets 3 tablets 3 tablets 3 tablets 5 tablets 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. Table 3 gives a dose titration guideline. The average dose in a Phase 3 trial designed to lower serum phosphorus to 5 mg/dL or less was approximately three sevelamer hydrochloride 800 mg tablets per meal. The maximum average daily sevelamer hydrochloride tablets dose studied was 13 g. Table 3: Dose Titration Guideline Serum Phosphorus Sevelamer Hydrochloride Tablets Dose >5.5 mg/dL Increase 1 tablet per meal at 2-week intervals 3.5 to 5.5 mg/dL Maintain current dose <3.5 mg/dL Decrease 1 tablet per meal

Starting dose is one or two 800 mg or two to four 400 mg tablets three times per day with meals.

Adjust by one tablet per meal in two-week intervals as needed to obtain serum phosphorus target (3.5 to 5.5 mg/dL).