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. Read More
  • 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. Close
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Only one calcimimetic lowers and maintains key sHPT lab values with IV administration you control1
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Only one calcimimetic lowers and maintains

key sHPT lab values with IV administration you control1

Not an actual Parsabiv® vial. The displayed vial is for illustrative purposes only.

sHPT = secondary hyperparathyroidism; IV = intravenous; PTH = parathyroid hormone; cCa = corrected calcium; P = phosphate.

Parsabiv® gives you control over calcimimetic delivery at the end of hemodialysis1

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CONTROL

delivery with IV administration1
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LOWER

3 key secondary HPT lab values1,*
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MAINTAIN

lab reductions up to 78 weeks1,†

*Results are combined from two 26-week, randomized, double-blind, placebo-controlled studies comparing Parsabiv® with placebo in patients with chronic kidney disease (CKD) on hemodialysis.

Open-label extension (OLE): data pooled for patients receiving Parsabiv® across two placebo-controlled parent studies and a subsequent 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.2

An overview of sHPT and an introduction to Parsabiv®

Learn more about the first and only IV calcimimetic1

Parsabiv® is the first and only IV calcimimetic1

While Parsabiv® and oral cinacalcet are both calcimimetics, these are two distinctly different drugs

Parsabiv®

Directly targets the CaSR and lowers the threshold1,3-5 for receptor activation by Ca2+
  • Binds directly to the extracellular domain of the CaSR1,3
  • Synthetic peptide3
  • Steady state reached in 7-8 weeks1
Parsabiv®
Oral cinacalcet
Ca = calcium; CaSR = calcium-sensing receptor.

Oral cinacalcet

Directly targets the CaSR and lowers the threshold3,6,7 for receptor activation by Ca2+
  • Binds to the transmembrane domain of the CaSR3,6,7
  • Small molecule compound7
  • Steady state reached within 7 days6
Parsabiv®
Oral cinacalcet

Parsabiv®

Directly targets the CaSR and lowers the threshold1,3-5 for receptor activation by Ca2+
  • Binds directly to the extracellular domain of the CaSR1,3
  • Synthetic peptide3
  • Steady state reached in 7-8 weeks1
Ca = calcium; CaSR = calcium-sensing receptor.

Oral cinacalcet

Directly targets the CaSR and lowers the threshold3,6,7 for receptor activation by Ca2+
  • Binds to the transmembrane domain of the CaSR3,6,7
  • Small molecule compound7
  • Steady state reached within 7 days6
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CLINICAL DATA

See how Parsabiv® performed in clinical studies

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REIMBURSEMENT

Parsabiv® reimbursement options are available for patients

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CARE TEAM CORNER

Parsabiv® videos and information specifically for dietitians, nurses, and technicians

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Important Safety Information for Parsabiv®

Contraindication: Parsabiv® (etelcalcetide) is contraindicated in patients with known hypersensitivity to etelcalcetide or any of its excipients. Hypersensitivity reactions, including face edema and anaphylactic reaction, 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

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Important Safety Information for Parsabiv®

Contraindication: Parsabiv® (etelcalcetide) is contraindicated in patients with known hypersensitivity to etelcalcetide or any of its excipients. Hypersensitivity reactions, including face edema and anaphylactic reaction, 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.

Please see Parsabiv® full Prescribing Information.

References: 1. Parsabiv® (etelcalcetide) prescribing information, Amgen. 2. Data on file, Amgen; [Summary of Clinical Efficacy; 2015]. 3. Alexander ST, et al. Mol Pharmacol. 2015;88:853-865. 4. Data on file, Amgen; [Report R20130052, 2014]. 5. Chen P, et al. CPT Pharmacometrics Syst Pharmacol. 2016;5:484-494. 6. Sensipar® (cinacalcet) prescribing information, Amgen. 7. Ma JN, et al. J Pharmacol Exp Ther. 2011;337:275-284.