Patient Assistance Program

FOSRENOL® | at Hand Is Designed to Provide Assistance to Patients Taking FOSRENOL®.

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Collaborating With Colleagues

Making a positive contribution toward the health of your patients doesn't only include discussions with your patients. It also involves being an active member of the renal health team and working with physicians to provide your input and recommendations concerning patients' treatment when necessary.

To help you answer some of the questions physicians may have for you, we've included some sample questions and answers. Since patients and circumstances are different, the answers posted here may not be applicable in all cases.

Q. I want to provide valuable recommendations to the physician I work with regarding beneficial changes to my patients' treatment regimens. How can I present my case effectively and get the physician's attention?

A. The more information you have about patients' treatment regimens, the better you'll be able to communicate with physicians and help guide them to make positive changes for your patients. Among the areas that you can be knowledgeable about include the specifics of your patients' condition, if they are compliant in taking their medications and how well the patients have responded to dietary adjustments and dialysis treatments. You can also work to identify what kind of phosphate binder your patients are taking and how the particulars of that medication may or may not address some of the issues your patients are experiencing.

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Q. The physician I work with only prescribes FOSRENOL® for patients who have severely elevated phosphate levels or only after trying all other options. I know many of my patients could benefit from FOSRENOL®. Is there anything I can do to change this mindset?

A. Controlling the phosphorus levels of your ESRD patients is critical. Long-term effects of hyperphosphatemia include bone disease, vascular calcification, and increased mortality. Work with your prescribing physician to be sure that he or she is aware of the efficacy and binding potential of FOSRENOL® and how choosing FOSRENOL® as a first-line treatment may benefit your patients. In a clinical trial, FOSRENOL® has been found to reduce mean serum phosphate levels within K/DOQI Guidelines after only two weeks, with as few as one tablet per meal.†,1,2

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Q. The physician I work with prefers to prescribe other non-calcium based phosphate binders. How can I present the benefits of FOSRENOL® compared to these other binders?

A. The number of pills that your patients may need to take as part of their treatment can be overwhelming. As a result, pill burden is a main reason that patients often cite as a reason they are noncompliant with their treatment.3 In this area, FOSRENOL® may help. For instance, the active ingredient in FOSRENOL® is two to three times more potent than sevelamer hydrochloride on a gram-for-gram basis.4 As a result, patients taking FOSRENOL® can manage their condition effectively with one FOSRENOL® tablet per meal. In comparison, the average daily dose of sevelamer hydrochloride in a Phase III trial was approximately nine 800-mg tablets daily.

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Q. The feedback I get from the physicians on my team is that they have concerns about the safety of FOSRENOL®. What do I need to know about FOSRENOL® to ease their concerns?

A. FOSRENOL® has a well-established safety profile and the most robust safety data of any current phosphate binder on the market. In an open label comparative trial between FOSRENOL® and the standard therapy, FOSRENOL® had a similar safety profile during long-term treatment.5 FOSRENOL® does not cross the blood-brain barrier and does not adversely affect cognitive function when compared to the standard therapy.6 In addition, FOSRENOL® has shown no clinically relevant effect on liver enzyme levels up to 3 years.7 Also, after 2 years no significant differences in bone parameters have been shown, compared to similar patients prescribed with the standard therapy.8 Also, FOSRENOL® has been prescribed to over 105,000 patients in the United States9 and has been approved in over 30 countries.1

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Q. What information can I offer to my patients that have financial concerns about FOSRENOL®?

A. For many patients, FOSRENOL® may actually be a less expensive option because it may require fewer doses. In a Phase III trial, the average daily dose of sevelamer hydrochloride was approximately nine 800-mg tablets daily.4 Patients taking FOSRENOL® may be able to manage their condition effectively with as few as one tablet per meal (three tablets per day). For the patients taking sevelamer hydrochloride, this difference can amount to approximately 180 fewer pills per month!

For your patients who are in financial need and have no coverage for FOSRENOL®, there is a patient assistance program that may help. The FOSRENOL® | at Hand program works to determine patients' financial eligibility and then determines if it may be able to provide FOSRENOL® for free or at a reduced cost to your patients. FOSRENOL® is covered by 85 percent of Medicare Part D programs. For these patients, if they cannot afford their co-payments or co-insurance or are facing a gap in coverage, the FOSRENOL® | at Hand program may be able to assist them as well.

To learn more about the FOSRENOL® | at Hand program, click here.

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Q. Members of my Renal Care Team have heard patients complain about chewing with FOSRENOL®. How do we develop a plan that can help motivate patients to be compliant?

A. FOSRENOL® requires as few as one tablet per meal but other phosphate binders may require more tablets and doses throughout the day. As a result, patients typically require fewer FOSRENOL® tablets to control serum phosphorus levels.

Additionally, instruction patients on how to properly take FOSRENOL® can go a long way. Remind patients that it must be chewed, but it can incorporated as part of their meals. Also, since FOSRENOL® is chewable, it does not require additional fluid intake. Intact tablets of FOSRENOL® should never be swallowed, and FOSRENOL® should also not be taken on an empty stomach, but only during or immediately after meals.

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Q. My clinic manager is convinced that the main solution to help patients with their phosphorus goals is keeping them compliant with their medications. Compliance is obviously important—I think some features of FOSRENOL® make it a good option for many patients. How can I express this?

A. Due to the fact that FOSRENOL® may require fewer doses than other phosphate binders, it can be a good option that's easy for your patients to take over time. FOSRENOL® can be taken with as few as 1 tablet per meal and is a long-term treatment option that lowers phosphorus levels within K/DOQI Guidelines and maintains them. In fact, in one clinical trial, FOSRENOL® maintained phosphorus goal levels for 3 years in 70 percent of the participants (n=46).‡,10 This combination means that patients taking FOSRENOL® may see a dramatic difference in the number of tablets that they need to take over weeks, months and years. It's also important to note that FOSRENOL® has been prescribed to over 105,000 patients in the United States9 and has been approved in over 30 countries.1

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Q. My physicians and co-workers are not familiar with FOSRENOL®. Where can I direct them to learn more?

A. To learn more about FOSRENOL®, direct physicians and co-workers to www.FOSRENOL.com where they can find information that deals with the specific concerns of the entire renal team, online interactive programs, and exclusive resources like the low-phosphorus Kidney Friendly Comfort Foods cookbook. Another excellent resource is the Clinic Corner where renal professionals can find valuable materials to help them in their everyday practice. They can even view stories and observations from other renal dietitians working with patients with CKD Stage 5.

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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®.

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

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

Visit www.ClinicCorner.com

FOS1726 1/15/2008