FOSRENOL.com: For Health Care Providers – Manage Phosphorus With a Lower Pill Burden

Manage Phosphorus With a Lower Pill Burden

^aStudy design¹: In this open-label, randomized, parallel group study, patients were randomized to receive FOSRENOL^® (n=27) or sevelamer hydrochloride (n=27) for 8 weeks. Starting doses were based on serum phosphorus levels at baseline and designed to achieve a target serum phosphorus range of 3.5 to 5.5 mg/dL.

^bResponders were defined as subjects whose mean serum phosphorus level was controlled (3.5-5.5 mg/dL) from weeks 5 to 8.

Among responders, FOSRENOL^® demonstrated a nearly 2-fold reduction in serum phosphorus levels within 3 weeks
FOSRENOL^® was effective at controlling serum phosphorus levels with a reduced pill burden vs sevelamer hydrochloride

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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

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.
Tomasello S, Dhupar S, Sherman RA. Phosphate binders, K/DOQI guidelines, and compliance: the unfortunate reality. Dial Transplant. 2004;33(5):236-242.

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FOS-00024 07/08