"The U.S. Food and Drug Administration today approved Procysbi (cysteamine bitartrate) for the management of nephropathic cystinosis in children and adults. Procysbi was granted orphan product designation because it is intended to treat a rare dis"...
FOSRENOL is a phosphate binder indicated to reduce serum phosphate in patients with end stage renal disease (ESRD).
Management of elevated serum phosphorus levels in end stage renal disease patients usually includes all of the following: reduction in dietary intake of phosphate, removal of phosphate by dialysis and reduction of intestinal phosphate absorption with phosphate binders.
DOSAGE AND ADMINISTRATION
Divide the total daily dose of FOSRENOL and take with or immediately after meals. The recommended initial total daily dose of FOSRENOL is 1500 mg. Titrate the dose every 2-3 weeks until an acceptable serum phosphate level is reached. Monitor serum phosphate levels as needed during dose titration and on a regular basis thereafter.
In clinical studies of ESRD patients, FOSRENOL doses up to 4500 mg were evaluated. Most patients required a total daily dose between 1500 mg and 3000 mg to reduce plasma phosphate levels to less than 6.0 mg/dL. Doses were generally titrated in increments of 750 mg/day.
Information for FOSRENOL Chewable Tablets
Chew or crush FOSRENOL Chewable Tablets completely before swallowing. Do not swallow intact FOSRENOL Chewable Tablets.
Information for FOSRENOL Oral Powder
Sprinkle FOSRENOL Oral Powder on a small quantity of applesauce or other similar food and consume immediately. Do not open until ready to use. Do not store FOSRENOL Oral Powder for future use once mixed with food. As FOSRENOL Oral Powder is insoluble, do not attempt to dissolve in liquid for administration.
Consider using the oral powder formulation in patients with poor dentition.
Dosage Forms And Strengths
FOSRENOL Chewable Tablets: 500 mg, 750 mg, and 1000 mg.
FOSRENOL Oral Powder: 750 mg and 1000 mg.
Storage And Handling
FOSRENOL Chewable Tablets
FOSRENOL is supplied as a chewable tablet in three dosage strengths for oral administration: 500 mg tablets, 750 mg tablets, and 1000 mg tablets. Each chewable tablet is white to off-white round, flat with a bevelled edge, and debossed on one side with 'S405' and the dosage strength corresponding to the content of elemental lanthanum.
500 mg Patient Pack (2 bottles of 45 tablets, NDC 54092-252-45, per each patient pack) NDC 54092-252-90.
750 mg Patient Pack (6 bottles of 15 tablets, NDC 54092-253-15, per each patient pack) NDC 54092-253-90.
1000 mg Patient Pack (9 bottles of 10 tablets, NDC 54092-254-10, per each patient pack) NDC 54092-254-90.
FOSRENOL Oral Powder
FOSRENOL Oral Powder is supplied in two dosage strengths for oral administration: 750 mg and 1000 mg. Each 750 mg and 1000 mg stick pack contains 2.1 g and 2.8 g oral powder, respectively, packed in a polyethylene terephthalate/aluminium/polyethylene laminate.
|Strength||Carton of 10 Stick Packs||Patient Pack of 9 Cartons|
|750 mg||NDC 54092-256-01||NDC 54092-256-02|
|1000 mg||NDC 54092-257-01||NDC 54092-257-02|
Storage -Store at 25°C (77°F): excursions permitted to 15-30°C (59-86°F). [See USP controlled room temperature].
FOSRENOL Chewable Tablets
manufactured by Patheon Manufacturing Services LLC, 5900 Martin Luther King Jr.
Highway, Greenville, NC 27834.
FOSRENOL Oral Powder manufactured by Catalent Germany Schorndorf GmbH, Steinbeisstrasse 1-2 D-73614 Schorndorf Germany.
Manufactured for Shire US Inc., Wayne, PA 19087. Revised: Sep 2014
Last reviewed on RxList: 10/9/2014
This monograph has been modified to include the generic and brand name in many instances.
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