FOSRENOL.com: For Healthcare Providers – Start Your CKD Stage 5 Patients Earlier on FOSRENOL®

Patient Profile

Name: Patricia Q.^*
History:

African-American female
History of type 2 diabetes mellitus (diagnosed at age 22)
Originally diagnosed with chronic kidney disease (CKD) stage 3 at age 55

Mild hyperphosphatemia

Patient is 60 years old, recently diagnosed with CKD Stage 5, and has started dialysis
Serum phosphorus, 6.0 mg/dL
Serum calcium, 8.4 mg/dL
Ca x P, 50 mg²/dL²
Serum iPTH, 210 pg/mL
Serum albumin, 3.8 g/dL

Moderate hyperphosphatemia

Patient is 62 years old and has been taking a calcium-based phosphate binder, but now shows evidence of hypercalcemia
Serum phosphorus, 6.3 mg/dL
Serum calcium, 11.1 mg/dL
Ca x P, 70 mg²/dL²
Serum iPTH, 550 pg/mL
Now on vitamin D therapy
Serum albumin, 3.6 g/dL

Severe hyperphosphatemia

Patient is 64 years old and has been taking a resin-based binder, but serum phosphorus levels have been in and out of K/DOQI targets for the past 1.5 years. She has been uncontrolled for the past 2 months
Serum phosphorus, 7.8 mg/dL
Serum calcium, 9.5 mg/dL
Ca x P, 74 mg²/dL²
Serum iPTH, 280 pg/mL
Serum albumin, 3.2 g/dL

*Fictional case study.

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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

FOSRENOL [package insert]. Wayne, PA: Shire US Inc.; 2007.
Renagel [package insert]. Cambridge, MA: Genzyme Corporation; 2007.
PhosLo [package insert]. Boca Raton, FL: Fresenius Medical Care; 2003.
Vemuri N, Chaudhry A, Weres J, Zhang P. Lanthanum carbonate provides serum phosphorus control with a reduced tablet burden. Poster presented at: the 43rd European Renal Association/ European Dialysis and Transplant Association Congress; July 15-18, 2006; Glasgow, UK.
Tomasello S, Dhupar S, Sherman RA. Phosphate binders, K/DOQI guidelines, and compliance: the unfortunate reality. Dial Transplant. 2004;33(5):236-242.
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.
Pratt RD, Smyth M. Lanthanum carbonate is effective in reducing serum phosphorus with fewer tablets than sevelamer hydrochloride: a pilot study. Poster presented at: World Congress of Nephrology 2007. April 21-25, 2007; Rio de Janeiro, Brazil.
Data on file, Shire US Inc., SPD 405-02.
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.
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