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 an additional study, no significant differences in bone parameters* were observed between patients treated with FOSRENOL^® or standard therapy over 2 years²

^*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.

^aStudy design³: One-year, randomized trial of FOSRENOL^® vs calcium carbonate in 98 dialysis patients. Histomorphic analysis was performed on paired bone biopsies for each patient at baseline and after 1 year of treatment (FOSRENOL^®, n=33; calcium carbonate, n=30), and the incidence of ROD (adynamic bone disease, hyperparathyroidism, or osteomalacia) is shown.

^aStudy design⁴: One-year, randomized, open-label study of FOSRENOL^® vs calcium carbonate in 98 dialysis patients. Activation frequency (osteoblast and osteoclast activity) was assessed at baseline and after 1 year of therapy (FOSRENOL^®, n=33; calcium carbonate, n=30).

Patients treated with FOSRENOL^® showed improved bone histology and less evolution toward low-turnover bone disease after 1 year of therapy compared with patients treated with calcium carbonate³
There was no evidence of aluminum-like bone toxicity after 1 year of FOSRENOL^® therapy^3,4

^aStudy design³: One-year, randomized trial of FOSRENOL vs calcium carbonate in 98 dialysis patients of which 63 paired bone biopsies were analyzed. Bone biopsies at baseline and after 1 year of treatment were evaluated for adynamic bone disease, hyperparathyroidism, osteomalacia, or mixed ROD (FOSRENOL^®, n=33; calcium carbonate, n=30).

More patients who received FOSRENOL^® had normal bone biopsies after 1 year (15%) compared with patients who received calcium carbonate (3%)
75% of patients with adynamic bone, osteomalacia, or hyperparathyroidism at baseline who received FOSRENOL^® showed a normalization of bone turnover compared with 46% in the calcium group
Patients treated with FOSRENOL^® for 1 year showed less evolution toward low bone turnover compared with those treated with calcium carbonate

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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.

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FOS-00024 07/08