FOSRENOL.com: For Health Care Providers

Optimal management for hyperphosphatemia includes diet, dialysis and medication.

*Data based on healthy volunteers and may not translate to CKD Stage 5 patients.
†Phosphorus 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., SPD 405-01.
Burke SK, Slatopolsky EA, Goldberg DI. Renagel, a novel calcium- and aluminum-free phosphate binder, inhibits phosphate absorption in normal volunteers. Nephrol Dial Transplant. 1997;12(8):1640-1644.
Sheikh MS, Maguire JA, Emmett M, et al. Reduction of dietary phosphorus absorption by phosphorus: a theoretical, in vitro, and in vivo study. J Clin Invest. 1989;83:66-77.
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(2):c61-c71.
Salsuky IB, Goodman WG. Managing phosphate retention: is a change necessary? Nephrol Dial Transplant. 2000;15(11):1738-1742.
Finn WF. Phosphorus management in end-stage renal disease. Sem Dial. 2005:18(1):8-12.

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FOS-00024 07/08