| Katherine, a mother of two from the | | | | The change worked for Katherine. Instead |
| suburbs of Orlando, Florida, was | | | | of the 12 tablets she was taking per day |
| diagnosed with type 2 diabetes shortly | | | | on a previous phosphate binder, |
| after her 30th birthday. Two decades | | | | Katherine now takes fewer than five |
| later, her diabetes led to kidney | | | | tablets a day. |
| failure. Unfortunately, this scenario is | | | | The new medication has enabled Katherine |
| not uncommon, as diabetes is the leading | | | | to consistently maintain her phosphorus |
| cause of kidney failure in the United | | | | levels within the recommended |
| States, accounting for nearly half of | | | | guidelines. Katherine's new binder also |
| the people who begin treatment each | | | | is a chewable tablet, which she prefers, |
| year. | | | | because like all dialysis patients, she |
| When the kidneys stop working normally, | | | | needs to restrict the amount of water |
| it is called chronic kidney disease | | | | she drinks each day. While Katherine has |
| (CKD). In Katherine's case, the disease | | | | not experienced any side effects related |
| advanced to its most severe form, CKD | | | | to FOSRENOL(R), her doctor did advise |
| Stage 5, which occurs when an individual | | | | her that individuals taking the |
| has lost at least 85 percent of his or | | | | medication may experience nausea or |
| her kidney function and begins dialysis. | | | | vomiting, which generally lessen over |
| Of the 20 million Americans who have | | | | time as patients continue with their |
| some form of kidney disease, more than | | | | treatment. |
| 530,000 are on dialysis. Dialysis | | | | Thanks to dialysis, diet and her newly |
| performs tasks that healthy kidneys do, | | | | prescribed phosphate binder therapy, |
| such as remove wastes, control excess | | | | Katherine is successfully managing her |
| salt and water balance, and maintain | | | | health and staying active. On most days, |
| blood pressure. | | | | she can be found in her swimming pool |
| The overall management of kidney disease | | | | with her children and grandchildren. |
| is challenging and can lead to a variety | | | | This patient account reflects one |
| of additional problems. In Katherine's | | | | person's experience with |
| case, she developed hyperphosphatemia | | | | hyperphosphatemia, CKD Stage 5 and her |
| (hi-per-FOS-fuh-TE-me-uh)-high levels of | | | | treatment with FOSRENOL(R). This |
| phosphorus in the blood-which can lead | | | | information is not intended as a |
| to serious long-term health problems | | | | substitute for medical advice. |
| over time, such as mineral deposits in | | | | Note to Editors: Important Safety |
| the heart and blood vessels, bone | | | | Information: During clinical trials, the |
| disease and even death. | | | | most common side effects of FOSRENOL(R) |
| Fortunately, there are treatments | | | | were gastrointestinal, and included |
| available to help patients control their | | | | nausea, vomiting, and diarrhea. Nausea |
| kidney disease and limit the impact of | | | | and vomiting generally lessened over |
| hyperphosphatemia. Through a combination | | | | time as patients continued with their |
| of dialysis, diet and phosphate binder | | | | treatment. Patients who stopped |
| therapy, patients can manage their | | | | treatment usually reported |
| phosphorus levels. In addition to going | | | | gastrointestinal side effects as the |
| to dialysis three times a week, | | | | reason for stopping. Other side effects |
| Katherine follows a diet that limits | | | | reported in trials included dialysis |
| foods high in phosphorus, such as dairy | | | | graft complications, headache, abdominal |
| products and dark soda. But phosphorus | | | | pain, and low blood pressure. Although |
| is found in most foods, so patients | | | | studies were not designed to detect |
| often cannot reach target blood | | | | differences in risk of bone fracture and |
| phosphorus levels through dietary | | | | mortality, there were no differences |
| restriction and dialysis alone. Many | | | | demonstrated in patients treated with |
| patients, including Katherine, need to | | | | FOSRENOL(R) compared to alternative |
| take phosphate binders at meals and | | | | therapy for up to 3 years. The duration |
| snacks to help further control their | | | | of treatment exposure and time of |
| phosphorus levels. Phosphate binders are | | | | observation in the clinical program were |
| prescription medications which "soak up" | | | | too short to conclude that FOSRENOL(R) |
| phosphorus in the gastrointestinal tract | | | | does not affect the risk of bone |
| before it can be absorbed into the | | | | fracture or mortality beyond 3 years. |
| blood, thereby helping patients maintain | | | | While lanthanum has been shown to |
| target blood phosphorus levels. | | | | accumulate in the GI tract, liver, and |
| Because phosphate binders need to be | | | | bone in animals, the clinical |
| taken with each meal, finding an | | | | significance in humans is unknown. If |
| effective binder that fits each | | | | you suffer from acute stomach ulcer, |
| individual patient's needs can be | | | | colon inflammation and colon ulcers, |
| challenging. In April 2005, a member of | | | | Crohn's disease, or bowel obstruction, |
| Katherine's health care team recommended | | | | it is important to know that patients |
| that she change her phosphate binder to | | | | with these conditions were not included |
| FOSRENOL(R) because it could reduce the | | | | in FOSRENOL(R) clinical studies-please |
| number of tablets she had to take each | | | | discuss with your doctor. |
| day. | | | | |