The FOSRENOL®
Community Bulletin Program

A Program For Your Patients to Help Make the Lifestyle Changes of CKD Stage 5 Part of Their Daily Routine

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FOSRENOL® FAQs

To help you find some answers to common questions that your patients or co-workers may have about FOSRENOL®, we've provided the following list.

To watch what your colleagues have to say about FOSRENOL® and how it may benefit your patients, please review the FOSRENOL® Focus.

How Does FOSRENOL® Work?

FOSRENOL® (lanthanum carbonate), when taken during or immediately after meals, binds with phosphorus in the patients' digestive systems. This phosphorus then passes through the patients instead of getting absorbed through the bloodstream. When taken correctly, as part of patients' treatment plans to reduce the amount of phosphorus they digest, FOSRENOL® may help patients more effectively manage serum phosphorus levels.

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How Quickly Can FOSRENOL® Make an Impact in My Patients?

In a clinical study, patients who began taking FOSRENOL® had average phosphorus levels reduced below the levels recommended by Kidney Disease Outcomes Quality Initiative (K/DOQI) after two weeks.1,2

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Is FOSRENOL® a Long-Term Treatment Option For My Patients?

In the same clinical study, the patients who had their phosphorus levels reduced below K/DOQI Guidelines continued to take FOSRENOL®. Over the remaining 24-weeks of the study, these patients maintained average serum phosphorus levels that were below the K/DOQI Guidelines.1

Another clinical trial found that FOSRENOL® maintained phosphorus goal levels for 3 years in nearly 70% of patients3 (n=46).†3

† Phosphate control was defined as ≤5.6 mg/dL.

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What Is the Safety Profile of FOSRENOL®?

FOSRENOL® has a well-established long-term safety profile. In an open label trial that compared FOSRENOL® and the standard therapy, it was shown that FOSRENOL® had a similar safety profile during long-term treatment.4 Studies have found that FOSRENOL® does not cross the blood-brain barrier5 and was not shown to have clinically relevant effects on liver enzyme levels up to three years.6 Also, no significant differences in bone parameters were found in patients taking FOSRENOL® or the standard therapy.7

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Is FOSRENOL® Easy For My Patients to Take?

Pill burden has been found to be a main reason why patients taking phosphorus binders were noncompliant in their treatment.8 But FOSRENOL® is easy to take and reduces pill burden.9 For example, in a competitor's trial the average daily dose of sevelamer HCl was 7.2 grams per day, which required nine 800-mg tablets daily.10 In comparison, the maintenance dose of FOSRENOL® is as little as one tablet per meal.

‡ Dosing based on 3 meals per day. Number of meals per day may vary. To achieve certain doses, additional tablets may be required.

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Have Patients Reported Significantly Higher Preference with Calcium-Free FOSRENOL®?

In one study where patients taking sevelamer HCl or calcium acetate were converted to FOSRENOL®, patients overwhelmingly preferred FOSRENOL® after 4 weeks. 64% of patients preferred FOSRENOL®, whereas only 15% of patients preferred their previous therapies.§,||,¶,#,11

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Have Physicians Reported Significantly Higher Preference with Calcium-Free FOSRENOL®?

In the same study, physicians similarly preferred FOSRENOL® over sevelamer HCl and calcium acetate. 68% of physicians preferred FOSRENOL®, compared to 6% favoring previous therapies.§,||,¶,#,11

§ These data reflect an analysis of patient and physician preference during a 24-week, extended, dose-ranging, Phase IIIb, multicenter, parallel-group study assessing treatment with lanthanum carbonate. Physician and patient preference was assessed at Week 4.

||43.5% of patients were previously taking sevelamer HCl; 31.5% of patients were previously taking calcium acetate.

¶ Preference is based on responses to a questionnaire that asked whether physicians and patients preferred the "new medication," "previous medication," or had "equal preference."

# 21% of patients and 27% of physicians had equal preference.

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What Adverse Events Are Associated With Taking FOSRENOL®?

FOSRENOL® was studied in two long-term clinical trials, which included 1215 patients treated with FOSRENOL® and 943 with alternative therapy. Gastrointestinal adverse events, such as nausea, diarrhea, and vomiting were the most common type of event leading to discontinuation. Fourteen percent (14%) of patients in these comparative, open-label studies discontinued in the FOSRENOL®-treated group due to adverse events.

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FOSRENOL® is indicated to reduce serum phosphate in patients with end-stage renal disease.

* Maintenance of reduction was observed for up to 3 years in patients treated with FOSRENOL®.

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FOS1726 1/15/2008