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Important Safety Information Prescribing Information www.fosrenol.com www.fosrenolontrack.com FOSRENOL (lanthanum carbonate) is indicated to reduce serum phosphate in patients with end stage renal disease. IMPORTANT SAFETY INFORMATION • FOSRENOL is contraindicated in patients with bowel obstruction, ileus, and fecal impaction. Click here to read more Important Safety Information This is a promotional message from DoctorDirectory.com on behalf of Shire. This material is intended specifically and exclusively for US Healthcare Professionals. Dear Mutombo Kankonde, MD: Dietary Challenges Associated with the Management of ESRD Struggling with the Renal Diet Ronald is a patient undergoing hemodialysis who has been receiving therapy three times weekly for the last 1.5 years. He is obese with a BMI of 33.0 and readily admits to having difficulty following dietary recommendations. Despite dietary intervention in the past, Ronald’s protein intake is high and his serum phosphorus is trending up. ...Is Ronald Ready for Noncalcium Binder Therapy? Start Noncalcium Binder Therapy with FOSRENOL (lanthanum carbonate) Efficacy in placebo-controlled trial7 aRandomized, double-blind, placebo-controlled, parallel-group trial evaluating the control of serum phosphorus with FOSRENOL (lanthanum carbonate) or placebo. Hemodialysis patients (N=126) with serum phosphorus >5.9 mg/dL after the predosing washout phase entered a 6-week, open-label FOSRENOL dose titration phase (750-mg initial daily dose divided with meals; titration up to 3000 mg in order to achieve phosphorus control [≤5.9 mg/dL]). Patients who entered the randomization phase were randomized to continue FOSRENOL (n=49) or received placebo (n=44) for 4 weeks. Mean serum phosphorus levels at the end of dose titration were 5.49 ± 1.48 mg/dL in patients subsequently randomized to continue FOSRENOL and 5.62 ± 1.61 mg/dL in patients subsequently randomized to placebo. Safety Information – Most common adverse events during randomized treatment were nausea (6.0% vs 4.5% [ FOSRENOL vs placebo]), vomiting (6.0% vs 2.3%), diarrhea (4.0% vs 6.8%), and dialysis graft occlusion (6.0% vs 2.3%) Sustained reduction of serum phosphorus in patients who remained on therapy8–10 Abbreviation: ITT, Intent to Treat aOptional 2-year extension phase of an initial 6-month, randomized, open-label trial comparing FOSRENOL (lanthanum carbonate) to calcium carbonate with a 6-month, open-label extension phase. Data shown are from patients who received FOSRENOL throughout the 3-year study. Dotted line represents the target for controlled serum phosphorus, defined as ≤ 5.6 mg/dL. • Phosphorus reductions maintained for up to 3 years (n=46) 8,9 Safety Information • Adverse events in long-term extension studies 9 – In the initial 6-month extension, 23% of patients discontinued because of adverse events; the most common adverse events included nausea (15%) vomiting (14%), diarrhea (12%), and hypotension (11%) – In the optional 2-year extension, 2.4% of adverse events led to withdrawal; the most common adverse events included diarrhea (4%), abdominal pain (3%), and nausea (3%) the content of this article has been removed.  it was not meant for public consumption! • • • • • • • • • •