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Indication and Limitations of Use

Sensipar® (cinacalcet) is indicated for the treatment of secondary hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on dialysis.
Sensipar® is not indicated for use in patients with CKD who are not on dialysis because of an increased risk of hypocalcemia.

FOR ADULT PATIENTS ON DIALYSIS
WITH SECONDARY HPT

FULL PRESCRIBING INFORMATION INDICATION IMPORTANT SAFETY INFORMATION OTHER INDICATIONS FOR PATIENTS

Secondary HPT therapies have complementary effects on PTH, phosphorus, and calcium1,3-7

chart-secondary-hcp
Ca = calcium; HPT = hyperparathyroidism; P = phosphorus; PTH = parathyroid hormone.

PTH, PHOSPHORUS, AND CALCIUM

Changes in PTH, phosphorus, and calcium levels over 12 months after initiation of vitamin D and phosphate binders8*

MEAN CHANGES IN LEVELS FOR PATIENTS ON DIALYSIS RECEIVING VITAMIN D AND PHOSPHATE BINDERS*

Data pooled from the database of a large dialysis provider. Total database N = 69,492 on IV vitamin D therapy, of whom 67,399 patients were prescribed either calcitriol (n = 38,378) or paricalcitol (n = 29,021). Results based on a historical cohort analysis of patients initiated on paricalcitol between 1999 and 2001. During a 12-month follow-up analysis, the mean percentage change from baseline was calculated for each patient at 3, 6, and 12 months. Target value for iPTH was < 300 pg/mL. Most patients also received phosphate binders. No specific therapies were suggested. At 3, 6, and 12 months, the mean doses of paricalcitol per administration were 4.2 μg, 4.3 μg, and 4.3 μg, respectively.8

*Results shown for patients treated with paricalcitol only.

†For each point vs baseline between groups.

INITIATION OF SECONDARY HPT THERAPIES

Increasing levels of PTH and calcium were present at the time of Sensipar® (cinacalcet) initiation9

CHART AUDIT ANALYSIS

Sensipar® End-Stage Renal Disease (ESRD) Dialysis Patient Chart Audit. Survey conducted Q2 2014. Chart audit data gathered over a period from March 24, 2014 to May 5, 2014 from 144 nephrologists and included 537 patients on dialysis. Each nephrologist provided patient information from 3–5 patients on dialysis who were diagnosed with secondary HPT. Data from a subset of nephrologists (n = 34) who were classified as having > 5% of patients initiated on Sensipar® at iPTH ≤ 500 pg/mL and who would not start a patient on Sensipar® with the following laboratory values: iPTH: 530 pg/mL, calcium: 9.6 mg/dL, phosphorus: 5.5 mg/dL are shown. N numbers for individual laboratory values varied based on availability.9

HPT = hyperparatyhroidism; iPTH = intact parathyroid hormone; PTH = parathyroid hormone.
  • Sensipar® is indicated in patients with secondary HPT on dialysis with iPTH > 300 pg/mL and calcium  8.4 mg/dL
  • Sensipar® is not indicated for use in patients with CKD who are not on dialysis because of an increased risk of hypocalcemia

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Important Safety Information

Contraindication: Sensipar® (cinacalcet) treatment initiation is contraindicated if serum calcium is less than the lower limit of the normal range (8.4 mg/dL).

Hypocalcemia: Sensipar® lowers serum calcium and can lead to hypocalcemia. Life threatening events and fatal outcomes associated with hypocalcemia have been reported in patients treated with Sensipar®, including pediatric patients. The safety and effectiveness of Sensipar® have not been established in pediatric patients.

Decreases in serum calcium can prolong the QT interval, potentially resulting in ventricular arrhythmia. Cases of QT prolongation and ventricular arrhythmia have been reported in patients treated with Sensipar®. Patients with conditions that predispose to QT interval prolongation and ventricular arrhythmia may be at increased risk for QT interval prolongation and ventricular arrhythmias if they develop hypocalcemia due to Sensipar®. Closely monitor corrected serum calcium and QT interval in patients at risk receiving Sensipar®.

Significant reductions in calcium may lower the threshold for seizures. Monitor serum calcium levels in patients with seizure disorders on Sensipar®.

Concurrent administration of Sensipar® with calcium-lowering drugs including other calcimimetics could result in severe hypocalcemia. Parsabiv™ (etelcalcetide) and Sensipar® should not be given together. Closely monitor serum calcium in patients receiving Sensipar® and concomitant therapies known to lower serum calcium levels.

Serum calcium and serum phosphorus should be measured within 1 week and PTH should be measured 1 to 4 weeks after initiation or dose adjustment of Sensipar®. Once the maintenance dose has been established, serum calcium and serum phosphorus should be measured approximately monthly, and PTH every 1 to 3 months.

Upper Gastrointestinal Bleeding: Cases of gastrointestinal (GI) bleeding, mostly upper GI bleeding, have occurred in patients using calcimimetics, including Sensipar®, from postmarketing and clinical trial sources. The exact cause of GI bleeding in these patients is unknown.

Patients with risk factors for upper GI bleeding, such as known gastritis, esophagitis, ulcers or severe vomiting, may be at increased risk for GI bleeding with Sensipar®. Monitor patients for worsening of common Sensipar® GI adverse reactions and for signs and symptoms of GI bleeding and ulcerations during Sensipar® therapy.

Hypotension, Worsening Heart Failure and/or Arrhythmias: In Sensipar® postmarketing use, isolated, idiosyncratic cases of hypotension, worsening heart failure, and/or arrhythmia were reported in patients with impaired cardiac function. The causal relationship to Sensipar® therapy could not be completely excluded and may be mediated by reductions in serum calcium levels.

Adynamic Bone: Adynamic bone disease may develop if intact parathyroid hormone (iPTH) levels are suppressed below 100 pg/mL.

Adverse Reactions: In clinical trials of patients with secondary HPT comparing Sensipar® to placebo, the most commonly reported side effects were nausea (31% vs. 19%), vomiting (27% vs. 15%), and diarrhea (21% vs. 20%).

Indication

Sensipar® (cinacalcet) is indicated for the treatment of secondary hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on dialysis.

Limitations of Use:

Sensipar® is not indicated for use in patients with CKD who are not on dialysis because of an increased risk of hypocalcemia.

Please see accompanying Sensipar® full Prescribing Information.
References: 1. Sensipar® (cinacalcet) prescribing information, Amgen. 2. Data on file, Amgen; [Cinacalcet Integrated Analyses of Efficacy; 2003]. 3. Goodman WG. Calcium and phosphorus metabolism in patients who have chronic kidney disease. Med Clin North Am. 2005;89:631-647. 4. Hruska KA, Mathew S, Lund R, Qiu P, Pratt R. Hyperphosphatemia of chronic kidney disease. Kidney Int. 2008;74:148-157. 5. Wesseling-Perry K, Harkins GC, Wang HJ, et al. The calcemic response to continuous parathyroid hormone (PTH)(1-34) infusion in end-stage kidney disease varies according to bone turnover: a potential role for PTH(7-84). J Clin Endocrinol Metab. 2010;95:2772-2780. 6. Komaba H, Shiizaki K, Fukagawa M. Pharmacotherapy and interventional treatments for secondary hyperparathyroidism: current therapy and future challenges. Expert Opin Biol Ther. 2010;10:1729-1742. 7. 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. 8. Teng M, Wolf M, Lowrie E, Ofsthun N, Lazarus JM, Thadhani R. Survival of patients undergoing hemodialysis with paricalcitol or calcitriol therapy. N Engl J Med. 2003;349:446-456. 9. Data on file, Amgen; [ESRD Dialysis Patient Chart Audit; Q2 2014]. 10. Kidney Disease: Improving Global Outcomes (KDIGO) CKD-MBD Update Work Group. KDIGO 2017 Clinical Practice Guideline Update for the Diagnosis, Evaluation, Prevention, and Treatment of Chronic Kidney Disease–Mineral and Bone Disorder (CKD-MBD). Kidney Int Suppl. 2017;7:1–59. 11. Messa P, Macário F, Yaqoob M, et al. The OPTIMA study: assessing a new cinacalcet (Sensipar/Mimpara) treatment algorithm for secondary hyperparathyroidism. Clin J Am Soc Nephrol. 2008;3:36-45. 12. 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. 13. Data on file, Amgen; [Clinical Study Report 20070360–Incident Dialysis Study; June 27, 2012]. 14. Data on file, Amgen; [Pooled Phase 3 PTH and Calcium Reductions by Baseline Calcium Analysis; November 2012]. 15. Brunelli SM, Dluzniewski P, Cooper K, Do T, Sibbel S, Bradbury BD. Serum calcium reductions among patients on hemodialysis initiating cinacalcet. Poster presented at: The American Society of Nephrology Renal Week; November 11-16, 2014; Philadelphia, PA. 16. Food and Drug Administration Center for Drug Evaluation and Research. Clinical review for NDA 21-688. Available at: http://www.accessdata.fda.gov/ drugsatfda_docs/nda/2004/21-688_Sensipar.cfm. Accessed June 21, 2015. 17. Data on file, Amgen; [Pooled Phase 3 Concurrent Achievement of PTH and Serum Phosphorus Targets During the Efficacy Assessment Phase; November 2014]. 18. Data on file, Amgen; [Cinacalcet New to Brand Patient Persistency; 2008-2014]. 19. Centers for Medicare & Medicaid Services (CMS). Implementation of the transitional drug add-on payment adjustment. Transmittal R1889OTN. https://www.cms.gov/Regulations-and-Guidance/ Guidance/ Transmittals/2017Downloads/R1889OTN.pdf. Accessed August 17, 2017.
EXPAND CLOSE
Important Safety Information

Contraindication: Sensipar® (cinacalcet) treatment initiation is contraindicated if serum calcium is less than the lower limit of the normal range (8.4 mg/dL).

Hypocalcemia: Sensipar® lowers serum calcium and can lead to hypocalcemia. Life threatening events and fatal outcomes associated with hypocalcemia have been reported in patients treated with Sensipar®, including pediatric patients. The safety and effectiveness of Sensipar® have not been established in pediatric patients.

Decreases in serum calcium can prolong the QT interval, potentially resulting in ventricular arrhythmia. Cases of QT prolongation and ventricular arrhythmia have been reported in patients treated with Sensipar®. Patients with conditions that predispose to QT interval prolongation and ventricular arrhythmia may be at increased risk for QT interval prolongation and ventricular arrhythmias if they develop hypocalcemia due to Sensipar®. Closely monitor corrected serum calcium and QT interval in patients at risk receiving Sensipar®.

Significant reductions in calcium may lower the threshold for seizures. Monitor serum calcium levels in patients with seizure disorders on Sensipar®.

Concurrent administration of Sensipar® with calcium-lowering drugs including other calcimimetics could result in severe hypocalcemia. Parsabiv™ (etelcalcetide) and Sensipar® should not be given together. Closely monitor serum calcium in patients receiving Sensipar® and concomitant therapies known to lower serum calcium levels.

Serum calcium and serum phosphorus should be measured within 1 week and PTH should be measured 1 to 4 weeks after initiation or dose adjustment of Sensipar®. Once the maintenance dose has been established, serum calcium and serum phosphorus should be measured approximately monthly, and PTH every 1 to 3 months.

Upper Gastrointestinal Bleeding: Cases of gastrointestinal (GI) bleeding, mostly upper GI bleeding, have occurred in patients using calcimimetics, including Sensipar®, from postmarketing and clinical trial sources. The exact cause of GI bleeding in these patients is unknown.

Patients with risk factors for upper GI bleeding, such as known gastritis, esophagitis, ulcers or severe vomiting, may be at increased risk for GI bleeding with Sensipar®. Monitor patients for worsening of common Sensipar® GI adverse reactions and for signs and symptoms of GI bleeding and ulcerations during Sensipar® therapy.

Hypotension, Worsening Heart Failure and/or Arrhythmias: In Sensipar® postmarketing use, isolated, idiosyncratic cases of hypotension, worsening heart failure, and/or arrhythmia were reported in patients with impaired cardiac function. The causal relationship to Sensipar® therapy could not be completely excluded and may be mediated by reductions in serum calcium levels.

Adynamic Bone: Adynamic bone disease may develop if intact parathyroid hormone (iPTH) levels are suppressed below 100 pg/mL.

Adverse Reactions: In clinical trials of patients with secondary HPT comparing Sensipar® to placebo, the most commonly reported side effects were nausea (31% vs. 19%), vomiting (27% vs. 15%), and diarrhea (21% vs. 20%).

Indication

Sensipar® (cinacalcet) is indicated for the treatment of secondary hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on dialysis.

Limitations of Use:

Sensipar® is not indicated for use in patients with CKD who are not on dialysis because of an increased risk of hypocalcemia.

Please see accompanying Sensipar® full Prescribing Information.
References: 1. Sensipar® (cinacalcet) prescribing information, Amgen. 2. Data on file, Amgen; [Cinacalcet Integrated Analyses of Efficacy; 2003]. 3. Goodman WG. Calcium and phosphorus metabolism in patients who have chronic kidney disease. Med Clin North Am. 2005;89:631-647. 4. Hruska KA, Mathew S, Lund R, Qiu P, Pratt R. Hyperphosphatemia of chronic kidney disease. Kidney Int. 2008;74:148-157. 5. Wesseling-Perry K, Harkins GC, Wang HJ, et al. The calcemic response to continuous parathyroid hormone (PTH)(1-34) infusion in end-stage kidney disease varies according to bone turnover: a potential role for PTH(7-84). J Clin Endocrinol Metab. 2010;95:2772-2780. 6. Komaba H, Shiizaki K, Fukagawa M. Pharmacotherapy and interventional treatments for secondary hyperparathyroidism: current therapy and future challenges. Expert Opin Biol Ther. 2010;10:1729-1742. 7. 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. 8. Teng M, Wolf M, Lowrie E, Ofsthun N, Lazarus JM, Thadhani R. Survival of patients undergoing hemodialysis with paricalcitol or calcitriol therapy. N Engl J Med. 2003;349:446-456. 9. Data on file, Amgen; [ESRD Dialysis Patient Chart Audit; Q2 2014]. 10. Kidney Disease: Improving Global Outcomes (KDIGO) CKD-MBD Update Work Group. KDIGO 2017 Clinical Practice Guideline Update for the Diagnosis, Evaluation, Prevention, and Treatment of Chronic Kidney Disease–Mineral and Bone Disorder (CKD-MBD). Kidney Int Suppl. 2017;7:1–59. 11. Messa P, Macário F, Yaqoob M, et al. The OPTIMA study: assessing a new cinacalcet (Sensipar/Mimpara) treatment algorithm for secondary hyperparathyroidism. Clin J Am Soc Nephrol. 2008;3:36-45. 12. 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. 13. Data on file, Amgen; [Clinical Study Report 20070360–Incident Dialysis Study; June 27, 2012]. 14. Data on file, Amgen; [Pooled Phase 3 PTH and Calcium Reductions by Baseline Calcium Analysis; November 2012]. 15. Brunelli SM, Dluzniewski P, Cooper K, Do T, Sibbel S, Bradbury BD. Serum calcium reductions among patients on hemodialysis initiating cinacalcet. Poster presented at: The American Society of Nephrology Renal Week; November 11-16, 2014; Philadelphia, PA. 16. Food and Drug Administration Center for Drug Evaluation and Research. Clinical review for NDA 21-688. Available at: http://www.accessdata.fda.gov/ drugsatfda_docs/nda/2004/21-688_Sensipar.cfm. Accessed June 21, 2015. 17. Data on file, Amgen; [Pooled Phase 3 Concurrent Achievement of PTH and Serum Phosphorus Targets During the Efficacy Assessment Phase; November 2014]. 18. Data on file, Amgen; [Cinacalcet New to Brand Patient Persistency; 2008-2014]. 19. Centers for Medicare & Medicaid Services (CMS). Implementation of the transitional drug add-on payment adjustment. Transmittal R1889OTN. https://www.cms.gov/Regulations-and-Guidance/ Guidance/ Transmittals/2017Downloads/R1889OTN.pdf. Accessed August 17, 2017.