FOSRENOL.com: For Healthcare Providers – FOSRENOL® Binding Affinity, Capacity & Stability

The information and graphics on this page are not intended to show a comparison of clinical efficacy or safety and are solely limited to affinity, capacity, and stability.

*Data are based on healthy volunteers and may not translate to ESRD patients.

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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 aluminium-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.
Autissier V, Damment SJP, Henderson RA. Relative in vitro efficacy of the phosphate binders lanthanum carbonate and sevelamer hydrochloride. J Pharm Sci. 2007;96(10):2818-2827.
Renagel [package insert]. Cambridge, MA: Genzyme Corporation; 2007.
Strózecki P, Ostrowski J, Majczynska I, et al. Does sevelamer hydrochloride (Renagel) influence 25(OH)D3 and 1,25(OH)2D3 level in haemodialysis patients? International Federation of Clinical Chemistry and Laboratory Medicine Web site. http://www.ifcc.org/index.php?option=com_wrapper&Itemid=109. Published December 2005. Accessed January 24, 2008.
PhosLo [package insert]. Boca Raton, FL: Fresenius Medical Care; 2003.

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