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Safety

Confidence In Long-Term Safety

A well-established long-term safety profile

Does not cross the blood-BRAIN barrier and does not adversely affect cognitive function versus standard therapy¹
No clinically relevant effect shown on LIVER enzyme levels up to 3 years. The analysis included patients (n=1,236) who received FOSRENOL^® in 4 Phase III clinical studies and an open-label extension study²
No significant differences in BONE parameters between patients (n=62) treated with FOSRENOL^® or standard therapy after 2 years of treatment^†,3

In a long-term, multicenter, open-label comparison trial between FOSRENOL^® (n=196) and standard therapy (n=321)⁴

"...lanthanum carbonate showed a safety profile that is similar to the overall profile of the standard therapy arm during long-term treatment."

—W.F Finn, MD⁴

Approved in more than 30 countries⁵
Prescribed to more than 105,000 patients in the United States⁶

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^®.

^† Parameters measured included mineralization lag time, osteoid thickness, activation frequency, number of osteoclasts/bone perimeter, number of osteoblasts/bone perimeter, erosion depth, and osteoid surface/bone surface.

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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

Altman P, Barnett ME, Finn WF, on behalf of the SPD405-307 Lanthanum Carbonate Study Group. Cognitive Function in stage 5 chronic kidney disease patients on hemodialysis: no adverse effects of lanthanum carbonate compared with other standard phosphate-binder therapy. Kidney Int. 2007;71:252-259.
Hutchison A. Analysis of liver function and hepatobiliary adverse event data from over 2000 dialysis patients participating in clinical trials on the new phosphate binder lanthanum carbonate. Poster presented at: the 42nd Congress of the ERA-EDTA; June 4-7, 2005; Istanbul, Turkey.
Malluche HH, on behalf of the Lanthanum Study Group. Safety of lanthanum carbonate on bone: 2-year randomized, comparator-controlled trial. Poster presented at: the National Kidney Foundation Clinical Meeting; May 4-8, 2005; Washington, DC.
Finn WF, on behalf of the SPD405-307 Lanthanum Study Group. Lanthanum carbonate versus standard therapy for the treatment of hyperphosphatemia: safety and efficacy in chronic maintenance hemodialysis patients. Clin Nephrol. 2006;65:191-202.
Data on file, Shire US Inc.
Verispan's Total Patient Tracker, December 2004-November 2007.

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FOS1726 1/15/2008