Indication and Limitations of Use:

Parsabiv™ (etelcalcetide) is indicated for the treatment of secondary hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on hemodialysis.

Parsabiv™ has not been studied in adult patients with parathyroid carcinoma, primary hyperparathyroidism, or with CKD who are not on hemodialysis and is not recommended for use in these populations.

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Important Safety Information

Contraindication: Parsabiv™ (etelcalcetide) is contraindicated in patients with known hypersensitivity to etelcalcetide or any of its excipients. Hypersensitivity reactions, including pruritic rash, urticaria, and face edema, have occurred.

Hypocalcemia: Parsabiv™ lowers serum calcium and can lead to hypocalcemia, sometimes severe. Significant lowering of serum calcium can cause QT interval prolongation and ventricular arrhythmia. 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 Parsabiv™. Closely monitor corrected serum calcium and QT interval in patients at risk on Parsabiv™.

Significant reductions in corrected serum calcium may lower the threshold for seizures. Patients with a history of seizure disorder may be at increased risk for seizures if they develop hypocalcemia due to Parsabiv™. Monitor corrected serum calcium in patients with seizure disorders on Parsabiv™.

Concurrent administration of Parsabiv™ with another oral calcimimetic could result in severe, life-threatening hypocalcemia. Patients switching from cinacalcet to Parsabiv™ should discontinue cinacalcet for at least 7 days prior to initiating Parsabiv™. Closely monitor corrected serum calcium in patients receiving Parsabiv™ and concomitant therapies known to lower serum calcium.

Measure corrected serum calcium prior to initiation of Parsabiv™. Do not initiate in patients if the corrected serum calcium is less than the lower limit of normal. Monitor corrected serum calcium within 1 week after initiation or dose adjustment and every 4 weeks during treatment with Parsabiv™. Measure PTH 4 weeks after initiation or dose adjustment of Parsabiv™. Once the maintenance dose has been established, measure PTH per clinical practice.

Worsening Heart Failure: In Parsabiv™ clinical studies, cases of hypotension, congestive heart failure, and decreased myocardial performance have been reported. Closely monitor patients treated with Parsabiv™ for worsening signs and symptoms of heart failure.

Upper Gastrointestinal Bleeding: In clinical studies, 2 patients treated with Parsabiv™ in 1253 patient years of exposure had upper gastrointestinal (GI) bleeding at the time of death. The exact cause of GI bleeding in these patients is unknown and there were too few cases to determine whether these cases were related to Parsabiv™.

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 Parsabiv™. Monitor patients for worsening of common Parsabiv™ GI adverse reactions and for signs and symptoms of GI bleeding and ulcerations during Parsabiv™ therapy.

Adynamic Bone: Adynamic bone may develop if PTH levels are chronically suppressed.

Adverse Reactions: In clinical trials of patients with secondary HPT comparing Parsabiv™ to placebo, the most common adverse reactions were blood calcium decreased (64% vs. 10%), muscle spasms (12% vs. 7%), diarrhea (11% vs. 9%), nausea (11% vs. 6%), vomiting (9% vs. 5%), headache (8% vs. 6%), hypocalcemia (7% vs. 0.2%), and paresthesia (6% vs. 1%).

Indication

Parsabiv™ (etelcalcetide) is indicated for the treatment of secondary hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on hemodialysis.

Limitations of Use:

Parsabiv™ has not been studied in adult patients with parathyroid carcinoma, primary hyperparathyroidism, or with CKD who are not on hemodialysis and is not recommended for use in these populations.

References: 1. Parsabiv™ (etelcalcetide) prescribing information, Amgen. 2. Data on file, Amgen; [Summary of Clinical Efficacy; 2015]. 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. Alexander ST, Hunter T, Walter S, et al. Critical cysteine residues in both the calcium-sensing receptor and the allosteric activator AMG 416 underlie the mechanism of action. Mol Pharmacol. 2015;88:853-865. 9. Sensipar® (cinacalcet) prescribing information, Amgen. 10. Data on file, Amgen; [Report R20130052; 2014]. 11. Chen P, Olsson Gisleskog P, Perez-Ruixo JJ, et al. Population pharmacokinetics and pharmacodynamics of the calcimimetic etelcalcetide in chronic kidney disease and secondary hyperparathyroidism receiving hemodialysis. CPT Pharmacometrics Syst Pharmacol. 2016;5:484-494. 12. Ma JN, Owens M, Gustafsson M, et al. Characterization of highly efficacious allosteric agonists of the human calcium-sensing receptor. J Pharmacol Exp Ther. 2011;337:275-284. 13. Data on file, Amgen; [Clinical Study Report 20120229; 2014]. 14. Data on file, Amgen; [Clinical Study Report 20120230; 2014]. 15. Block GA, Bushinsky DA, Cunningham J, et al. Effect of etelcalcetide vs placebo on serum parathyroid hormone in patients receiving hemodialysis with secondary hyperparathyroidism: two randomized clinical trials. JAMA. 2017;317:146-155. 16. Data on file, Amgen; [Integrated Summary of Safety; 2015]. 17. Data on file, Amgen; [Combined Phase 3 Lab Values Multiple Imputation Approach; 2017]. 18. Data on file, Amgen; [Combined Phase 3 Lab Values Over Time; 2016]. 19. Data on file, Amgen; [Clinical Study Report 20120231; 2015]. 20. Data on file, Amgen; [Summary of Clinical Safety; 2015]. 21. Centers for Medicare & Medicaid Services (CMS), HHS. Medicare Program; End-Stage Renal Disease Prospective Payment System, and Quality Incentive Program. Final Rule. Fed Regist. 2015;80(215):68967-69077.