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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
|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.
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)
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.
Distributed by: Genzyme Corporation, 500 Kendall Street, Cambridge, MA 02142 USA. Revised: May 2011
Last reviewed on RxList: 6/24/2011
This monograph has been modified to include the generic and brand name in many instances.
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