Manage your secondary hyperparathyroidism (HPT) with. Once-daily Sensipar

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1 Manage your secondary hyperparathyroidism (HT) with Once-daily Sensipar Sensipar once a day* helps lower parathyroid hormone (TH), calcium, and phosphorus in patients with secondary hyperparathyroidism (HT) on dialysis. 1 lcium TH hosphorus ill shown at actual size. *As prescribed. Sensipar is indicated for the treatment of secondary hyperparathyroidism (HT) in patients with chronic kidney disease (CKD) on dialysis. lease see on page 10.

2 Why does your parathyroid hormone (TH) level go up? When your kidneys fail, your parathyroid glands can grow too big and make too much TH. 2 Normal parathyroid glands Thyroid gland Enlarged parathyroid glands What happens when your TH level is too high? High levels of TH can change your calcium and phosphorus levels When your parathyroid glands make too much TH When your TH level is high TH lcium hosphorus hosphorus your TH level goes up. your calcium and phosphorus levels can go up, too. What is secondary HT? The medical name for this condition is secondary hyperparathyroidism, or secondary HT. 2 This condition is common in people on dialysis. 2 atients who have secondary HT may not feel any symptoms, but some might feel symptoms like: Itchy skin 4 Weak muscles 4 Bone pain 4 Do you know your TH, calcium, and phosphorus levels? 2 3 lease see on page 10.

3 How do you know if your TH, calcium, and phosphorus are too high or too low? There are goal ranges for TH, calcium, and phosphorus levels. 5 What are your goal ranges for TH, calcium, and phosphorus? Ask your dialysis care team what your goal ranges are and write them here: Date: / / Level in your body: TH Goal Range to pg/ml Your Values pg/ml High lcium to mg/dl mg/dl Goal Range hosphorus to mg/dl mg/dl Low It is important to keep your TH, calcium, and phosphorus in their goal range at the same time. It can be harmful to your health if one level is too high or too low, even if the other two are in their goal range. 6 Review your lab results every month to see if your levels are within goal range. 4 5 lease see on page 10.

4 How can high TH make your levels go up? 3,5 phosphorus and calcium You get calcium and phosphorus from the foods that you eat but too much calcium and phosphorus can also come from your bones. When TH is too high more calcium and phosphorus are released from bone and your phosphorus level can go up. Goal Range High Low = calcium; = phosphorus. When your TH level is too high, it can cause your calcium and phosphorus to be out of their goal range lease see on page 10.

5 For patients on dialysis, your doctor may prescribe Sensipar to treat your secondary HT Sensipar is a light green pill you take once a day. 1 There are 3 strengths of Sensipar pills 1 : How should I take Sensipar? Take Sensipar with food or shortly after a meal. 1 - Sensipar tablets should be taken whole. Do not crush or split the tablet mg 60 mg 90 mg (ills shown at actual size.) Your doctor may also prescribe other medicines to treat your secondary HT: hosphate binders* help you absorb less phosphorus from the food you eat. 7 Certain types of vitamin D* may help lower your TH. This medicine is usually given to you through the dialysis machine, or you may take it as a pill. 8 Take Sensipar at least 12 hours before your TH blood test. 1 What time will you take your Sensipar each day? : AM / M (Enter time) If you experience any side effects from taking Sensipar, tell your doctor or your dialysis care team right away. How is secondary HT treated? 8 Your diet is also important. Your dialysis care team may recommend a special diet plan to limit high phosphorus foods. Sensipar treatment should not be started if you have low calcium levels. Ask your doctor about the normal ranges. *hosphate binders and vitamin D are available by prescription. Before starting Sensipar, tell your doctor if you are taking medication to prevent seizures or have had seizures in the past. Report any seizure episodes while on Sensipar therapy. 9 lease see on page 10.

6 10 What Important Safety Information do you need to know about Sensipar? Sensipar treatment should not be started if you have low calcium levels. Ask your doctor about the normal ranges. Before starting Sensipar, tell your doctor if you are taking medication to prevent seizures or have had seizures in the past. Report any seizure episodes while on Sensipar therapy. Very infrequent cases of low blood pressure, worsening heart failure, and/or abnormal heart rhythm (arrhythmia) have been reported in patients with impaired heart function taking Sensipar. While on Sensipar, your doctor should perform regular blood tests to monitor calcium, phosphorus, and intact parathyroid hormone (ith) levels. Very low and very high levels of TH should be avoided to help maintain bone health. Very low levels (ith < 100 pg/ml) of TH may cause a condition your doctor may refer to as adynamic bone disease. atients with moderate to severe liver impairment should be monitored throughout treatment with Sensipar. Tell your doctor if you experience any muscle spasms, aches or cramping, tingling in your limbs, or seizures. In clinical trials, the most common side effects reported in patients were nausea, vomiting, and diarrhea. If you have any questions about this information, be sure to discuss them with your doctor. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit or call FDA-1088 ( ). How does Sensipar help lower your TH, calcium, and phosphorus into their goal range? 1,3 1 2 When you take Sensipar... And when your TH level goes down... TH lcium hosphorus it works on your parathyroid glands. It causes them to release less TH. less calcium and phosphorus are released from your bones. Very infrequent cases of low blood pressure, worsening heart failure, and/or abnormal heart rhythm (arrhythmia) have been reported in patients with impaired heart function taking Sensipar. 11 lease see accompanying Sensipar ackage Insert.

7 Why is it important to take Sensipar every day, as your doctor prescribes? Sensipar helps lower TH, calcium, and phosphorus if you take it every day, as your doctor prescribes. 1 If you stop taking Sensipar, your TH, calcium, and phosphorus levels may increase. There may be a program that can help you afford Sensipar. If you are paying more than $6.60 per month, there may be a program that can help you afford Sensipar. 9 Talk to your dialysis care team about these programs before you fill your Sensipar prescription. You can learn more by contacting Amgen Assist at or If you have difficulty filling your Sensipar prescription, tell your dialysis care team. While on Sensipar, your doctor should perform regular blood tests to monitor calcium, phosphorus, and intact parathyroid hormone (ith) levels. Very low and very high levels of TH should be avoided to help maintain bone health. Very low levels (ith < 100 pg/ml) of TH may cause a condition your doctor may refer to as adynamic bone disease. atients with moderate to severe liver impairment should be monitored throughout treatment with Sensipar. Tell your doctor if you experience any muscle spasms, aches or cramping, tingling in your limbs, or seizures

8 Questions to ask your dialysis care team References 1. Sensipar (cinacalcet) prescribing information, Amgen. 2. Rodriguez M, Nemeth E, Martin D. The calcium-sensing receptor: a key factor in the pathogenesis of secondary hyperparathyroidism. Am J hysiol Renal hysiol. 2005;288:F253-F Moe SM. Disorders involving calcium, phosphorus, and magnesium. rim re Clin Office ract. 2008;35: Lorenzo JA, nalis E, Raisz LG. Chapter 28 - Metabolic bone disease: hyperparathyroid bone disease. In: Kronenberg HM, Melmed S, olonsky KS, Larsen R, eds. Williams Textbook of Endocrinology. 11th ed. hiladelphia, A: Saunders Elsevier; 2008: Uhlig K, Berns JS, Kestenbaum B, et al. KDOQI US commentary on the 2009 KDIGO clinical practice guideline for the diagnosis, evaluation, and treatment of CKD mineral and bone disorder (CKD-MBD). Am J Kidney Dis. 2010;55: Danese MD, Belozeroff V, Smirnakis K, Rothman KJ. Consistent control of mineral and bone disorder in incident hemodialysis patients. Clin J Am Soc Nephrol. 2008;3: Goodman WG, Quarles LD. Chapter 56 - Vitamin D, calcimimetics, and phosphate-binders. In: Brenner BM, Levine SA, eds. Brenner & Rector s The Kidney. Vol 2. 8th ed. hiladelphia, A: Saunders Elsevier; 2008: Moe SM, Drüeke TB. Management of secondary hyperparathyroidism: the importance and the challenge of controlling parathyroid hormone levels without elevating calcium, phosphorus, and calcium-phosphorus product. Am J Nephrol. 2003;23: Centers for Medicare & Medicaid Services website. Announcement of lendar Year (CY) 2013 Medicare Advantage capitation rates and Medicare Advantage and art D payment policies and final call letter. Available at: lans/medicareadvtgspecratestats/downloads/announcement2013.pdf. Accessed April 25,

9 Important facts about Sensipar Sensipar helps lower TH, calcium, and phosphorus at the same time for patients with secondary HT on dialysis. 1 Sensipar treatment should not be started if you have low calcium levels. Ask your doctor about the normal ranges. Take Sensipar with food or shortly after a meal. 1 It s important to take Sensipar every day, as your doctor prescribes. 1 In clinical trials, the most common side effects reported in patients were nausea, vomiting, and diarrhea. 1 If you pay more than $6.60 per month, there may be a program that can help you afford Sensipar. Ask your dialysis care team to learn more. 9 For more information, visit lease see on page 10. lease see accompanying Sensipar ackage Insert Amgen Inc. All rights reserved. Not for Reproduction R2-V

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