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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About FOSRENOL^®

Calcium-Free FOSRENOL^® delivers the potent efficacy your patients need with as few as 1 tablet per meal^†

K/DOQI goals attained and maintained^1,2
One calcium-free tablet with every meal^†
Well-established long-term safety profile

(Tablets not shown to actual size)

Covered by 85% of Medicare D programs

Prescribed to more than 105,000 patients in the United States³

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 three 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

Data on file, Shire US Inc.
Eknoyan G, Levin A, Levin NW, for the National Kidney Foundation. Am J Kidney Dis. 2003;42(No. 4, suppl 3):S1-S201.
Verispan's Total Patient Tracker, December 2004—November 2007.

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FOS1726 1/15/2008

The FOSRENOL® Community Bulletin Program

About FOSRENOL®

Calcium-Free FOSRENOL® delivers the potent efficacy your patients need with as few as 1 tablet per meal†