FOSRENOL.com: For Health Care Providers

The safety of FOSRENOL^® has been studied in over 5500 patients¹

—Despite the challenge of CKD Stage 5 mortality for long-term data, a number of patients (N=22) taking FOSRENOL^® have been followed for more than 5 years

FOSRENOL^® has not shown signs of aluminum-like toxicity^2-5
In clinical trials, treatment-related adverse events were largely gastrointestinal in nature and abated over time with continued dosing
No clinically significant liver abnormalities have been seen with long-term FOSRENOL^® administration^6,7

^aStudy design⁶: An open-label, parallel-group, active comparator-controlled trial was conducted in which 1359 patients with serum phosphorus concentration >5.9 mg/dL were randomized to receive either lanthanum carbonate (n=682) or their prestudy phosphate-binding agent (n=677). After a 6-week dose titration period, patients in both arms received maintenance phosphate binder therapy for a total treatment duration of 2 years. Data show the percent of patients with new abnormal values in liver function tests during the 2-year study.

^b78% of patients were receiving calcium-based therapy at baseline; 16% of patients were receiving sevelamer hydrochloride at baseline.

^aStudy design⁷: A pooled analysis from 4 controlled comparative phase III clinical trials of lanthanum carbonate. Data are mean values at baseline (n=46, 87, and 88 for AST, ALT, and bilirubin, respectively) and year 6 (n=17).

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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 405-03.
Malluche HH; on behalf of the Lanthanum Study Group. Safety of lanthanum carbonate on bone: a 2-year randomized, comparator-controlled trial. Poster presented at: the National Kidney Foundation Clinical Meeting; May 4-8, 2005; Washington, DC.
D’Haese PC, Spasovski GB, Sikole A, et al. A multicenter study on the effects of lanthanum carbonate (Fosrenol) and calcium carbonate on renal bone disease in dialysis patients. Kidney Int. 2003;63(suppl 85):S73-S78.
Freemont AJ, Hoyland JA, Denton J; on behalf of the Lanthanum Carbonate SPD405-303 Study Group. The effects of lanthanum carbonate and calcium carbonate on bone abnormalities in patients with end-stage renal disease. Clin Nephrol. 2005;64(6):428-437.
Altmann 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 standard phosphate-binder therapy. Kidney Int. 2007;71(3):252-259.
Finn WF; on behalf of the SPD 405-307 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(3):191-202.
Hutchison AJ, Pratt RD. Lanthanum carbonate: no evidence of adverse effects on liver with up to 6 years of treatment in patients with stage 5 CKD. Poster presented at: the 39th annual meeting of the American Society of Nephrology; November 14-19, 2006; San Diego, CA. Abstract F-PO093.

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FOS-00024 07/08