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FDA Advisory Committee Votes in Favor of Earlier Use of Phosphate Binders in Stage 4 Kidney Disease Patients With Hyperphosphatemia
Date:10/16/2007

ncrease in mean serum phosphorus, the relative risk of death increases by six percent.

Hyperphosphatemia is managed with a combination of dialysis, diet restriction, and phosphorus-binding agents, because diet and dialysis alone generally cannot adequately control phosphorus levels. Such binders "soak up" phosphorus in the gastrointestinal tract, before it can be absorbed into the blood, and aid patients in maintaining acceptable levels of mean serum phosphorus.

FOSRENOL

FOSRENOL is indicated to reduce serum phosphate in patients with ESRD.

FOSRENOL is an effective, non-calcium, phosphate binder that reduces high phosphorus levels in ESRD patients. FOSRENOL is formulated as an easy-to-use, unflavored, chewable tablet that can be taken without water, an important consideration for ESRD patients who must restrict their fluid intake.

FOSRENOL is available in a broad range of dosage strengths comprised of 500-milligram (mg), 750-mg, and 1-g tablets. Patients taking FOSRENOL can achieve serum phosphorus target levels with as few as three tablets per day. (Dosing based on three meals per day. Number of meals per day may vary. To achieve certain doses, additional tablets may be required.)

FOSRENOL has a high affinity for phosphate and works by binding to dietary phosphorus in the gastrointestinal tract. Once bound, the FOSRENOL/phosphorus complex cannot pass into the bloodstream and is eliminated from the body, thereby decreasing mean serum phosphorus levels.

To date, FOSRENOL has been clinically tested in more than 5,200 patients globally, with nearly 1,000 of these patients having been followed for more than one year. In addition, more than 87,000 patients have been prescribed FOSRENOL in the U.S. alone. FOSRENOL has the most extensive long-term safety data package of any phosphate binder and is generally well tolerated. Trials involving patients treated with FOSRENOL showed sustained serum phosphorus reduction in a majority of p
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SOURCE Shire plc
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