Indication

Sensipar® (cinacalcet) is indicated for the treatment of secondary hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on dialysis.
Sensipar® should not be used in patients with CKD who are not on dialysis because of an increased risk of low calcium levels.
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Once-daily Sensipar® (cinacalcet) manages secondary hyperparathyroidism by lowering 3 key lab values in adult patients with secondary HPT on dialysis1

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Important Safety Information

Do not use Sensipar® (cinacalcet) if you have low calcium levels. Ask your healthcare provider about the normal ranges.

Low calcium levels: Sensipar® lowers calcium and can lead to low calcium levels in your blood. Tell your healthcare provider if you have spasms, twitches, or cramps in your muscles; numbness or tingling in your fingers, toes, or around your mouth; or seizures. Life threatening events and fatal outcomes associated with low calcium levels have been reported in patients treated with Sensipar®, including in children. The safety and effectiveness of Sensipar® have not been established in children.

Low calcium levels may potentially result in abnormal heart rhythms, known as ventricular arrhythmia, and have been reported in patients taking Sensipar®. Tell your healthcare provider if you experience unusually fast or pounding heartbeat, if you have or have had heart rhythm problems or heart failure or if you take medicines that can cause heart rhythm problems while receiving Sensipar®.

Before starting Sensipar®, tell your healthcare provider if you are taking medication to prevent seizures or have had seizures in the past. Report any seizure episodes while on Sensipar®.

Use of Sensipar® with other medicines that lower calcium, including Parsabiv™ (etelcalcetide), could result in severe low calcium levels. Do not take Sensipar® with Parsabiv™. Tell your healthcare provider if you are taking Parsabiv™ or other medicines that lower calcium.

While on Sensipar®, your healthcare provider should perform repeated blood tests to monitor calcium, phosphorus, and intact parathyroid hormone (iPTH) levels.

Upper Gastrointestinal Bleeding: Gastrointestinal (GI) bleeding, mostly upper GI bleeding, has happened in patients using Sensipar®. The exact cause of GI bleeding is unknown. Tell your healthcare provider if you have stomach pain, bloody or black stool, or if you vomit bloody or black material. Also tell your healthcare provider if you have nausea or vomiting that is getting worse.

Low Blood Pressure, Worsening Heart Failure and/or Abnormal Heart Rhythm: 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®.

Adynamic Bone Disease: Very low levels of PTH should be avoided to help maintain bone health.

Side Effects: 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 healthcare provider.


You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call
1-800-FDA-1088 (332-1088).

Indication

Sensipar® (cinacalcet) is indicated for the treatment of secondary hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on dialysis.
Sensipar® should not be used in patients with CKD who are not on dialysis because of an increased risk of low calcium levels.
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 Physiol Renal Physiol. 2005;288:F253-F264. 3. Moe SM. Disorders involving calcium, phosphorus, and magnesium. Prim Care. 2008;35:215-237, v-vi. 4. Uhlig K, Berns JS, Kestenbaum B, etal. 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;55:773-799. 5. Ureña-Torres P, Bridges I, Christiano C, et al. Efficacy of cinacalcet with low-dose vitamin D in incident haemodialysis subjects with secondary hyperparathyroidism. Nephrol Dial Transplant. 2013;28:1241-1254. 6. Bringhurst FR, Demay MB, Kronenberg HM. Hormones and disorders of mineral metabolism: basic biology of mineral metabolism. In: Kronenberg HM, Melmed S, Polonsky KS, Larsen PR, eds. Williams Textbook of Endocrinology. 11th ed. Philadelphia, PA: Saunders Elsevier; 2008:1203-1223. 7. Pollak MR, Yu ASL,Taylor EN. Disorders of calcium, magnesium, and phosphate balance: disorders of phosphate homeostasis. In: Brenner BM, Levine SA, eds. Brenner & Rector's The Kidney. 8th ed. Philadelphia, PA: Saunders Elsevier; 2008:602-604. 8. Hruska KA, Mathew S, Lund R, Qiu P, Pratt R. Hyperphosphatemia of chronic kidney disease. Kidney Int. 2008;74:148-157. 9. Lorenzo JA, Canalis E, Raisz LG. Metabolic bone disease. In: Kronenberg HM, Melmed S, Polonsky KS, Larsen PR, eds. Williams Textbook of Endocrinology. 11th ed. Philadelphia, PA: Saunders Elsevier; 2008:1269-1310. 10. Goodman WG, Quarles LD. Vitamin D, calcimimetics, and phosphate-binders. In: Brenner BM, Levine SA, eds. Brenner & Rector's The Kidney. 8th ed. Philadelphia, PA: Saunders Elsevier; 2008:1904-1927. 11. Мое 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;23:369-379. 12. Data on file, Amgen; [Clinical Study Report 20070360-Incident Dialysis Study; June 27, 2012]. 13. Kaiser Family Foundation. The Medicare Prescription Drug Benefit Fact Sheet: October 2010. http://www.kff.org/medicare/upload/7044-11.pdf. Accessed July 2, 2012. 14. Centers for Medicare & Medicaid Services. Announcement of Calendar Year (CY) 2017 Medicare Advantage Capitation Rates and Medicare Advantage and Part D Payment Policies and Final Call Letter. April 2016. Available at: https://www.cms.gov/Medicare/ Health-Plans/MedicareAdvtgSpecRateStats/Downloads/Announcement2017.pdf. Accessed June 19, 2017. 15. Data on file, Amgen; [Symphony Claims Data; May 2017].