Renagel (Sevelamer Hydrochloride) - Indications and Dosage

INDICATIONS AND USAGE

RENAGEL^® [Renagel is a Registered Trademark of Genzyme Corporation.]  (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.

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

DOSAGE FORMS AND STRENGTHS

800 mg and 400 mg Tablets.

HOW SUPPLIED/STORAGE AND HANDLING

Renagel^® 800 mg Tablets are supplied as oval, film-coated, compressed tablets, imprinted with “RENAGEL 800” containing 800 mg of sevelamer hydrochloride on an anhydrous basis, hypromellose, diacetylated monoglyceride, colloidal silicon dioxide, and stearic acid. Renagel^® 800 mg Tablets are packaged in bottles of 180 tablets.

Renagel^® 400 mg Tablets are supplied as oval, film-coated, compressed tablets, imprinted with “RENAGEL 400” containing 400 mg of sevelamer hydrochloride on an anhydrous basis, hypromellose, diacetylated monoglyceride, colloidal silicon dioxide, and stearic acid. Renagel^® 400 mg Tablets are packaged in bottles of 360 tablets.

1 Bottle of 30 ct 800 mg Tablets (NDC 58468-0021-3)

1 Bottle of 180 ct 800 mg Tablets (NDC 58468-0021-1)

1 Bottle of 360 ct 400 mg Tablets (NDC 58468-0020-1)

Storage Store at 25°C (77°F): excursions permitted to 15-30°C (59-86°F).

Do not use Renagel^® after the expiration date on the bottle.

[See USP controlled room temperature]

Protect from moisture.