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The European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended approval of tolvaptan (Jinarc, Otuska) to slow progression of cyst developmen"...
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 2011This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 6/24/2011
Additional Renagel Information
Renagel - User Reviews
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