Sensipar® (cinacalcet) treatment should not be started if you have low calcium levels. Ask your doctor about the normal ranges. Life threatening events and fatal outcomes associated with low calcium levels have been reported in patients treated with Sensipar®, including in children.
Low calcium levels may potentially result in abnormal heart rhythms, known as ventricular arrhythmia, and have been reported in patients taking Sensipar®.
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®.
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.
While on Sensipar®, your doctor should perform repeated blood tests to monitor calcium, phosphorus, and intact parathyroid hormone (iPTH) levels. Very low and very high levels of PTH should be avoided to help maintain bone health. Very low levels (iPTH < 100 pg/mL) of PTH may cause a condition your doctor may refer to as adynamic bone disease.
Patients 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 www.fda.gov/medwatch or call 1-800-FDA-1088 (332-1088).
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 adult 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) 2016 Medicare Advantage Capitation Rates and Medicare Advantage and Part D Payment Policies and Final Call Letter. April 2015. Available at: https://www.cms.gov/Medicare/ Health-Plans/MedicareAdvtgSpecRateStats/Downloads/Announcement2016.pdf. Accessed November 9, 2015. 15. Data on file, Amgen; [IMS FIA Health Claims Data for All Patients; July 2015].