The FOSRENOL^®
Community Bulletin Program

A Program For Your Patients to Help Make the Lifestyle Changes of CKD Stage 5 Part of Their Daily Routine

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Dosing

Simple Dosing That's Preferred

The agent in FOSRENOL^® is two to three times more potent than sevelamer hydrochloride on a gram-for-gram basis.¹

FOSRENOL^®
FOSRENOL®

Sevelamer hydrochloride¹
Sevelamer hydrochloride(1)

Tablets not shown to actual size.

The maintenance dose of FOSRENOL^® is as few as 1 tablet per meal (3 tablets per day)*

Tablets not shown representative of actual size.

The average daily dose of sevelamer HCl in a Phase III trial was approximately 7.2g/day (nine 800-mg tablets daily).¹

The information and graphics on this page are not intended to show a comparison of clinical efficacy or safety and are solely limited to dosage and administration.

Manage Patients with 1 Tablet Per Meal^†

Pill burden was a main reason patients using binders were noncompliant.² Calcium-free FOSRENOL^® reduces pill burden³

Recommended initial daily dose is 750 mg to 1.5 g
FOSRENOL^® is not to be taken on an empty stomach; take during, or immediately after, meals
Tablets are to be chewed completely before swallowing—intact tablets are not to be swallowed

FOSRENOL^® is indicated to reduce serum phosphate in patients with end-stage renal disease.

* Maintenance of reduction was observed for up to 3 years in patients treated with FOSRENOL^®.

^† Dosing based on 3 meals per day. Number of meals per day may vary. To achieve certain doses, additional tablets may be required.

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Important Safety Information

The most common adverse events were gastrointestinal, such as nausea and vomiting, and generally abated over time with continued dosing
The most common side effects leading to discontinuation in clinical trials were gastrointestinal events (nausea, vomiting, and diarrhea)
Other side effects reported in trials included dialysis graft complications, headache, abdominal pain, and hypotension
Although studies were not designed to detect differences in risk of fracture and mortality, there were no differences demonstrated in patients treated with FOSRENOL^® compared to alternative therapy for up to 3 years
The duration of treatment exposure and time of observation in the clinical program were too short to conclude that FOSRENOL^® does not affect the risk of fracture or mortality beyond 3 years
While lanthanum has been shown to accumulate in the GI tract, liver, and bone in animals, the clinical significance in humans is unknown
Patients with acute peptic ulcer, ulcerative colitis, Crohn's disease, or bowel obstruction were not included in FOSRENOL^® clinical studies. Caution should be used in patients with these conditions
FOSRENOL^® should not be taken by patients who are nursing or pregnant
FOSRENOL^® should not be taken by patients who are under 18 years of age

References

Renagel [package insert]. Cambridge, Mass: Genzyme Corporation; 2004.
Tomasello S, Dhupar S, Sherman RA. Phosphate binders, K/DOQI guidelines, and compliance: the unfortunate reality. Dial Transplant. 2004;33:236-242.
Vemuri N, Pratt R, Michelis MF, Matalon A. Conversion to lanthanum carbonate monotherapy maintains serum phosphorus control and reduces tablet burden in patients with chronic kidney disease stage 5. Poster presented at: the National Kidney Foundation 2007 Spring Clinical Meetings; April 10-14, 2007; Orlando, Fla.

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FOS1726 1/15/2008