Renagel

RENAGEL — sevelamer hydrochloride tablet
State of Florida DOH Central Pharmacy

1 INDICATIONS AND USAGE

RENAGEL® 1 (sevelamer hydrochloride) is indicated for the control of serum phosphorus in patients with chronic kidney disease (CKD) on dialysis. The safety and efficacy of Renagel in CKD patients who are not on dialysis have not been studied.


1
Renagel is a Registered Trademark of Genzyme Corporation.

2 DOSAGE AND ADMINISTRATION

Patients Not Taking a Phosphate Binder. The recommended starting dose of Renagel is 800 to 1600 mg, which can be administered as one or two 800 mg Renagel® Tablets or two to four 400 mg Renagel® Tablets, with meals based on serum phosphorus level. Table 1 provides recommended starting doses of Renagel for patients not taking a phosphate binder.

Table 1. Starting Dose for Dialysis Patients Not Taking a Phosphate Binder
Serum Phosphorus Renagel ® 800 mg Renagel ® 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 < 9.0 mg/dL

2 tablets three times daily with meals

3 tablets three times daily with meals

≥ 9.0 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 Renagel and calcium acetate. Table 2 gives recommended starting doses of Renagel based on a patient’s current calcium acetate dose.

Table 2. Starting Dose for Dialysis Patients Switching From Calcium Acetate to Renagel
Calcium Acetate 667 mg(Tablets per meal) Renagel® 800 mg(Tablets per meal) Renagel ® 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 Renagel. Dosage should be adjusted based on the serum phosphorus concentration with a goal of lowering serum phosphorus to 5.5 mg/dL or less. The dose may be increased or decreased 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 5.0 mg/dL or less was approximately three Renagel 800 mg tablets per meal. The maximum average daily Renagel dose studied was 13 grams.

Table 3. Dose Titration Guideline
Serum Phosphorus Renagel® Dose

>5.5 mg/dL

Increase 1 tablet per meal at 2 week intervals

3.5 — 5.5 mg/dL

Maintain current dose

<3.5 mg/dL

Decrease 1 tablet per meal

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