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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dosing

Dosing & Monitoring

Flexible dosing allows responsiveness to each patient’s specific secondary HPT needs1

getting-started

Getting started with Parsabiv™

How to switch from Sensipar® (cinacalcet) to Parsabiv™

Ensure your patient discontinues use of Sensipar® tablets for at least 7 days prior to starting Parsabiv™1

Initiating patients on Parsabiv™1

  • Ensure corrected serum calcium is at or above the lower limit of normal* prior to Parsabiv™ initiation, a dose increase, or reinitiation after dosing interruption
  • Initiate Parsabiv™ at 5 mg, 3 times per week1
  • Administer Parsabiv™ by intravenous bolus injection into the venous line of the dialysis circuit at the end of the hemodialysis treatment during rinse back or IV after rinse back1
  • Do not administer Parsabiv™ more frequently than 3 times per week1
  • If a regularly scheduled hemodialysis treatment is missed, DO NOT administer any missed doses. Resume Parsabiv™ at the end of the next hemodialysis treatment at the prescribed dose1
  • If doses of Parsabiv™ are missed for more than 2 weeks, reinitiate Parsabiv™ at the recommended starting dose of 5 mg (or 2.5 mg if that was the patient’s last dose)1

Lower limit of reference range in phase 3 trials was 8.3 mg/dL.1,16

for-nurses-video

Administration, storage, and handling video

This video, geared specifically towards nurses, shows how to store and administer Parsabiv™, the first intravenously administered calcimimetic. 
dosing-and-titration

Only Parsabiv™ (etelcalcetide) offers flexible dosing that you control with IV administration1

Lab monitoring during Parsabiv™ (etelcalcetide) treatment

An In-Depth Look at Parsabiv™ Dosing and Administration

Titrate up or down as needed based on PTH and corrected serum calcium

Titrating up:
  • Increase the dose of Parsabiv™ in 2.5 mg or 5 mg increments until PTH is within recommended target range and corrected serum calcium is within normal range
  • Increase no more frequently than every 4 weeks up to a maximum dose of 15 mg three times per week
Titrating down:
  • Decrease or temporarily discontinue Parsabiv™ when PTH is below target range
  • Consider decreasing or temporarily discontinuing Parsabiv™, or use concomitant therapies,* when corrected serum calcium is below lower limit of normal but ≥ 7.5 mg/dL without symptoms of hypocalcemia
Reinitiating Parsabiv™:
  • If dose is stopped, reinitiate Parsabiv™ at a lower dose when PTH is within target range and hypocalcemia has been corrected
Concomitant therapies include calcium, calcium-containing phosphate binders, and/or vitamin D sterols or increases in dialysate calcium concentration. Lower limit of reference range in phase 3 trials was 8.3 mg/dL.1,16
calcium-management

Managing calcium in patients taking Parsabiv™1

Calcium reductions were most prominent early in treatment18

Mean corrected calcium was maintained above the lower limit of normal for up to 78 weeks18
  • Refer to recommendations on monitoring and managing calcium in patients taking Parsabiv™
Placebo-controlled treatment period: results are combined from two 26-week, randomized, double-blind, placebo-controlled studies comparing Parsabiv™ with placebo in patients with CKD on hemodialysis with iPTH > 400 pg/mL and corrected calcium ≥ 8.3 mg/dL (N = 1023). Patients in both treatment arms could be treated with vitamin D sterols and/or phosphate binders. Mean baseline iPTH in the Parsabiv™ group and placebo group were 847 pg/mL and 836 pg/mL, respectively. The primary endpoint of each study was the proportion of patients who achieved a > 30% reduction from baseline in mean iPTH during the efficacy assessment period (defined as weeks 20 through 27, inclusive).1,2,15
Open-label extension: data pooled for patients receiving Parsabiv™ across two placebo-controlled parent studies and a subsequent open-label extension (OLE) study, starting from the baseline of the parent study until the end or the prespecified cutoff date of the OLE study, whichever was earlier. Weeks 27 to 31 were the 30-day drug-free period (the 30-day follow-up period of the phase 3 study before entry into the extension study).2 During the OLE, the starting dose of Parsabiv™ for all subjects was 5 mg. The Parsabiv™ dose could be increased at OLE weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum iPTH ≤ 300 pg/mL while maintaining appropriate serum cCa concentrations. Investigators were blinded to iPTH results during the first 10 weeks of treatment. Subsequent dose adjustment was determined by the investigator per protocol guidelines.19
Starting at week 27, no study drug was administered as part of a 30-day follow-up while patients transitioned studies.2 Value represents cCa measured at the first hemodialysis session in week 79.18

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. 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. 14. Data on file, Amgen; [Clinical Study Report 20120229; 2014]. 15. Data on file, Amgen; [Clinical Study Report 20120230; 2014]. 16. 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. 17. Data on file, Amgen; [Integrated Summary of Safety; 2015]. 18. Data on file, Amgen; [Average Weekly Dose Vitamin D; 2017]. 19. Data on file, Amgen; [Combined Phase 3 Lab Values Multiple Imputation Approach; 2017]. 20. Data on file, Amgen; [Combined Phase 3 Lab Values Over Time; 2016]. 21. Data on file, Amgen; [Clinical Study Report 20120231; 2015]. 22. Data on file, Amgen; [Integrated Summary of Efficacy; 2015]. 23. Data on file, Amgen; [Summary of Clinical Safety; 2015]. 24. 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.