Etelcalcetide

Etelcalcetide is a calcimimetic agent that allosterically modulates the calcium-sensing receptor (CaSR). Etelcalcetide binds to the CaSR and enhances activation of the receptor by extracellular calcium.

• PARSABIV is indicated for the treatment of secondary hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on hemodialysis. PARSABIV is a calcium-sensing receptor agonist indicated for: Secondary hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on hemodialysis.ICD-10: N18.9

• PARSABIV is contraindicated in patients with known hypersensitivity to etelcalcetide or any of its excipients. ( 4 ) Hypersensitivity PARSABIV is contraindicated in patients with known hypersensitivity to etelcalcetide or any of its excipients.contraindicated

Ensure corrected serum calcium is at or above the lower limit of normal prior to initiation, dose increase, or re-initiation. ( 2.1 ) The recommended starting dose is 5 mg administered by intravenous bolus injection three times per week at the end of hemodialysis treatment. ( 2.1 ) The maintenance dose is individualized and determined by titration based on parathyroid hormone (PTH) and corrected serum calcium response. The dose range is 2.5 to 15 mg three times per week. ( 2.1 ) The dose may be increased in 2.5 mg or 5 mg increments no more frequently than every 4 weeks. ( 2.2 ) Measure serum calcium within 1 week after initiation or dose adjustment and every 4 weeks for maintenance. ( 2.2 ) Measure PTH after 4 weeks from initiation or dose adjustment. ( 2.2 ) Decrease or temporarily discontinue PARSABIV in individuals with PTH levels below the target range. ( 2.2 ) Consider decreasing or temporarily discontinuing PARSABIV or use concomitant therapies to increase corrected serum calcium in patients with a corrected serum calcium below the lower limit of normal but at or above 7.5 mg/dL without symptoms of hypocalcemia. ( 2.2 ) Stop PARSABIV and treat hypocalcemia if the corrected serum calcium falls below 7.5 mg/dL or patients report symptoms of hypocalcemia. ( 2.2 ) Do not mix or dilute prior to administration. ( 2.3 ) Administer by intravenous bolus injection into the venous line of the dialysis circuit after hemodialysis, during rinse back or intravenously after rinse back. Administer a sufficient volume of saline, e.g.

Hypocalcemia: Sometimes severe. Severe hypocalcemia can cause paresthesias, myalgias, muscle spasms, seizures, QT prolongation, and ventricular arrhythmias. Patients predisposed to QT interval prolongation, ventricular arrhythmias, and seizures may be at increased risk and require close monitoring. Educate patients on the symptoms of hypocalcemia and advise them to contact a healthcare provider if they occur. ( 5.1 ) Worsening Heart Failure: Reductions in corrected serum calcium may be associated with congestive heart failure, however, a causal relationship to PARSABIV could not be completely excluded. Closely monitor patients for worsening signs and symptoms of heart failure. ( 5.2 ) Upper Gastrointestinal (GI) Bleeding: Patients with risk factors for upper GI bleeding may be at increased risk. Monitor patients and promptly evaluate and treat any suspected GI bleeding. ( 5.3 ) Adynamic Bone: May develop if PTH levels are chronically suppressed. If PTH levels decrease below the recommended target range, the dose of PARSABIV should be reduced or discontinued. ( 5.4 ) 5.1 Hypocalcemia PARSABIV lowers serum calcium [see Adverse Reactions (6.1) ] and can lead to hypocalcemia, sometimes severe. Significant lowering of serum calcium can cause paresthesias, myalgias, muscle spasms, seizures, QT interval prolongation, and ventricular arrhythmia.

The following adverse reactions are discussed in greater detail in other sections of the labeling: Hypocalcemia [see Warnings and Precautions (5.1) ] Worsening Heart Failure [see Warnings and Precautions (5.2) ] Upper Gastrointestinal Bleeding [see Warnings and Precautions (5.3) ] Adynamic Bone [see Warnings and Precautions (5.4) ] The most common adverse reactions (≥ 5%) were blood calcium decreased, muscle spasms, diarrhea, nausea, vomiting, headache, hypocalcemia, and paresthesia. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Amgen Inc. at 1-800-77-AMGEN (1-800-772-6436) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. The data in Table 2 are derived from two placebo-controlled clinical studies in patients with chronic kidney disease and secondary hyperparathyroidism on hemodialysis. The data reflect exposure of 503 patients to PARSABIV with a mean duration of exposure to PARSABIV of 23.6 weeks. The mean age of patients was approximately 58 years, and 60% of the patients were male. Of the total patients, 67% were Caucasian, 28% were Black or African American, 2.6% were Asian, 1.2% were Native Hawaiian or Other Pacific Islander, and 1.6% were categorized as Other.

Lactation: PARSABIV is not recommended when breastfeeding. ( 8.2 ) 8.1 Pregnancy Risk Summary There are no available data on the use of PARSABIV in pregnant women. In animal reproduction studies, effects were seen at doses associated with maternal toxicity that included hypocalcemia. In a pre- and post-natal study in rats administered etelcalcetide during organogenesis through delivery and weaning, there was a slight increase in perinatal pup mortality, delay in parturition, and transient effects on pup growth at exposures 1.8 times the human exposure for the clinical dose of 15 mg three times per week. There was no effect on sexual maturation, neurobehavioral, or reproductive function in the rat offspring. In embryo-fetal studies, when rats and rabbits were administered etelcalcetide during organogenesis, reduced fetal growth was observed at exposures 2.7 and 7 times exposures for the clinical dose, respectively. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.

Metabolism

The pharmacokinetics of etelcalcetide is linear and does not change over time following single (5 to 60 mg) and multiple intravenous doses (2.5 to 20 mg) in chronic kidney disease patients with secondary hyperparathyroidism requiring hemodialysis. Etelcalcetide exhibited tri-exponential decay following intravenous administration.

There is no clinical experience with PARSABIV overdosage. Overdosage of PARSABIV may lead to hypocalcemia with or without clinical symptoms and may require treatment. Although PARSABIV is cleared by dialysis, hemodialysis has not been studied as a treatment for PARSABIV overdosage. In the event of overdosage, corrected serum calcium should be checked and patients should be monitored for symptoms of hypocalcemia, and appropriate measures should be taken [see Warnings and Precautions (5.1) ] .

• Feb 7, 2017NDANDA208325Kai Pharms Inc

1. 1Underdose2478.6%
2. 2Shunt Stenosis2047.1%
3. 3Nausea1916.7%
4. 4Hypocalcaemia1495.2%
5. 5Product Storage Error1495.2%
6. 6Blood Parathyroid Hormone Increased1455.1%
7. 7Shunt Occlusion1274.4%
8. 8Blood Calcium Decreased1244.3%
9. 9Diarrhoea1164.0%
10. 10Vomiting1073.7%
11. 11Circumstance Or Information Capable Of Leading To Medication Error822.9%
12. 12Death822.9%
13. 13Drug Ineffective762.7%
14. 14Fall742.6%
15. 15Cardiac Failure662.3%

The 10 most recently updated of 23 ClinicalTrials.gov registrations naming Etelcalcetide as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• A Phase 3 Study of Etelcalcetide in Children With Secondary Hyperparathyroidism Receiving Hemodialysis
  Recruiting · Phase 3 · Interventional · 24 enrolled · Amgen
  NCT03969329updated 2026-03-23
• A Trial of Etelcalcetide in Pediatric Participants With Secondary Hyperparathyroidism and Chronic Kidney Disease on Hemodialysis
  Recruiting · Phase 3 · Interventional · 56 enrolled · Amgen
  NCT03633708updated 2026-02-27
• MT1013 Injection for the Treatment of Secondary Hyperparathyroidism in Patients With Chronic Kidney Disease
  Completed · Phase 2 · Interventional · 115 enrolled · Shaanxi Micot Pharmaceutical Technology Co., Ltd.
  NCT06690242updated 2026-02-05
• Use of ETElcalcetidefor pReserving vitamiN K-dependent proteIn activiTY ITAlian Study
  Not yet recruiting · Observational · 160 enrolled · Istituto di Fisiologia Clinica CNR
  NCT06352957updated 2024-04-08
• The Effect of Etelcalcetide on CKD-MBD
  Completed · Phase 2 · Interventional · 22 enrolled · Thomas Nickolas, MD MS
  NCT03960437updated 2023-09-21
• A Study to Investigate the Influence of PTH-lowering by Etelcalcetide (Parsabiv®) on the Calcification Propensity of Serum in Dialysis Patients
  Completed · Phase 2 · Interventional · 37 enrolled · Prim. Priv. Doz. Dr. Daniel Cejka
  NCT03795558updated 2022-03-23
• Head-to-Head Study of Etelcalcetide and Cinacalcet in Asian Hemodialysis Patients With Secondary Hyperparathyroidism (SHPT)
  Completed · Phase 3 · Interventional · 637 enrolled · Amgen
  NCT03299244updated 2021-04-30
• Effect of Etelcalcetide on Cardiac Hypertrophy in Hemodialysis Patients
  Completed · Phase 4 · Interventional · 62 enrolled · Rainer Oberbauer
  NCT03182699updated 2020-06-09
• Effect of Active Vitamin D and Etelcalcetide on Human Osteoclasts in Patients With Chronic Kidney Disease
  Completed · Observational · 21 enrolled · Hospices Civils de Lyon
  NCT03527511updated 2020-03-31
• A Phase 1 Study to Evaluate PK, Safety and Tolerability of AMG 416
  Completed · Phase 1 · Interventional · 33 enrolled · Amgen
  NCT03283098updated 2020-02-10

Frequently asked questions

How does Etelcalcetide work?

Etelcalcetide is a calcimimetic agent that allosterically modulates the calcium-sensing receptor (CaSR). Etelcalcetide binds to the CaSR and enhances activation of the receptor by extracellular calcium.

What is Etelcalcetide used for?

According to FDA labeling, Etelcalcetide carries indications including: PARSABIV is indicated for the treatment of secondary hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on hemodialysis. PARSABIV is a calcium-sensing receptor agonist indicated for: Secondary hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on hemodialysis.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Etelcalcetide?

Etelcalcetide is classified as Other anti-parathyroid agents, Calcium-sensing Receptor Agonist, Increased Calcium-sensing Receptor Sensitivity, Decreased PTH Secretion.

What are the brand names for Etelcalcetide?

Etelcalcetide is marketed under brand names including Parsabiv.

What are the contraindications for Etelcalcetide?

Etelcalcetide labeling lists contraindications including: PARSABIV is contraindicated in patients with known hypersensitivity to etelcalcetide or any of its excipients. ( 4 ) Hypersensitivity PARSABIV is contraindicated in patients with known hypersensitivity to etelcalcetide or any of its excipients.. Always consult the full prescribing information and a clinician.