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

Efficacy

Control Serum Phosphorus Levels...

Mean Serum Phosphorus Levels Achieved With Calcium-Free FOSRENOL® (1)

‡ Study design: Patients underwent a 4-week open-label titration phase in which treatment was initiated at 1,500 mg and titrated by 750 mg/day at 1-week intervals up to 3,000 mg/day to achieve control (patients received an average of 3 tablets/day). In those patients who responded to FOSRENOL^® (phosphorus <5.5 mg/dL), open-label treatment was continued for an additional 4 weeks with their final titrated dose (1,500 mg, 2,250 mg, 3,000 mg). Patients then entered a 4-month open-label extension phase for a total treatment duration of 24 weeks. The standard deviation for all the data points reported above were ±1.45, ±1.58, ±1.39, ±1.31, ±0.88, ±1.23, ±1.45, ±1.44, ±1.22, ±1.47, ±1.41, ±1.46, and ±1.43, respectively. Change from baseline at all time points was statistically significant (P<.0001).

§ Baseline data were not available for 1 patient at the time of assessment.

Attained K/DOQI phosphorus goal levels (5.31 mg/dL) within 2 weeks and maintained a mean of 5.04 mg/dL throughout the 24-week study¹

...Over the Long Term

Maintained phosphorus goal levels, in a separate clinical trial, for 3 years in nearly 70% of patients (n=46)^||,3

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.

^|| Phosphate control was defined as ≤5.6 mg/dL.

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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.
Hutchison AJ, Maes B, Vanwalleghem J, et al. Long-term efficacy and tolerability of lanthanum carbonate: results from a 3-year study. Nephron Clin Pract. 2006;102:c61-c71. Available at: http://content.karger.com/ProdukteDB/produkte.asp?doi=000088932&h1=1. Accessed November 14, 2005.

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FOS1726 1/15/2008