Approved & therapeutic
Etelcalcetide
Parsabiv
Etelcalcetide is a synthetic peptide calcimimetic approved for secondary hyperparathyroidism in adults with chronic kidney disease on haemodialysis. It is given intravenously at the end of dialysis.
Also known as: AMG 416, velcalcetide
- Status
- Etelcalcetide is approved by the U.S. FDA and has official prescribing information.
- Evidence
- Approved labeling. Official prescribing information exists, based on clinical trials in people.
- Half-life
- Approximately 3 to 5 days in patients on haemodialysis.
- How it's taken
- Intravenous bolus into the venous line of the dialysis circuit, three times weekly
- Mechanism
- Other
How Etelcalcetide works
Etelcalcetide binds the calcium-sensing receptor on parathyroid chief cells and allosterically increases its sensitivity to extracellular calcium. The receptor therefore behaves as though calcium were higher than it is, suppressing parathyroid hormone secretion. It binds through a disulfide bond to a cysteine residue on the receptor, a mechanism distinct from the small-molecule calcimimetic cinacalcet.
What research has looked at
- Reduces parathyroid hormone in secondary hyperparathyroidism on haemodialysis, with accompanying reductions in calcium and phosphate.
- Intravenous dosing three times weekly at the end of dialysis removes the adherence problem of a daily oral drug in a population with high pill burden.
- It avoids the gastrointestinal intolerance that limits oral cinacalcet in many patients, since it bypasses the gut entirely.
Evidence level: Approved labeling. Official prescribing information exists, based on clinical trials in people. These are areas studied or reported, not promised effects.
Reported side effects and risks
- Hypocalcaemia is the principal risk and can be symptomatic, causing paraesthesias, muscle spasms, seizures and QT prolongation with ventricular arrhythmia. Calcium must be measured before initiation and monitored throughout.
- Worsening heart failure has been reported, potentially related to hypocalcaemia.
- Adynamic bone disease can develop if parathyroid hormone is over-suppressed.
- Nausea, vomiting and diarrhea, though less than with oral cinacalcet.
- Upper gastrointestinal bleeding has been reported.
Sources
- FDA approved-drug listing for etelcalcetide · U.S. Food & Drug Administration
- DailyMed prescribing information for etelcalcetide · NIH · DailyMed
- PubMed research on etelcalcetide calcimimetic hyperparathyroidism · NIH · National Library of Medicine
- DrugBank record for etelcalcetide · DrugBank
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Etelcalcetide FAQ
What is Etelcalcetide?
Etelcalcetide is a synthetic peptide calcimimetic approved for secondary hyperparathyroidism in adults with chronic kidney disease on haemodialysis. It is given intravenously at the end of dialysis.
How does Etelcalcetide work?
Etelcalcetide binds the calcium-sensing receptor on parathyroid chief cells and allosterically increases its sensitivity to extracellular calcium. The receptor therefore behaves as though calcium were higher than it is, suppressing parathyroid hormone secretion. It binds through a disulfide bond to a cysteine residue on the receptor, a mechanism distinct from the small-molecule calcimimetic cinacalcet.
Is Etelcalcetide FDA approved?
Yes. Etelcalcetide is approved by the U.S. FDA and has official prescribing information. Evidence level: approved labeling. Official prescribing information exists, based on clinical trials in people.
What is the half-life of Etelcalcetide?
Reported half-life: Approximately 3 to 5 days in patients on haemodialysis.
How is Etelcalcetide taken?
Intravenous bolus into the venous line of the dialysis circuit, three times weekly.
What side effects have been reported with Etelcalcetide?
Reported in the sources: Hypocalcaemia is the principal risk and can be symptomatic, causing paraesthesias, muscle spasms, seizures and QT prolongation with ventricular arrhythmia. Calcium must be measured before initiation and monitored throughout; Worsening heart failure has been reported, potentially related to hypocalcaemia; Adynamic bone disease can develop if parathyroid hormone is over-suppressed; Nausea, vomiting and diarrhea, though less than with oral cinacalcet; Upper gastrointestinal bleeding has been reported.
Educational summary compiled from the sources listed above. Not medical advice. Peptide Vault does not sell, source or recommend any compound. Talk to a qualified clinician before starting or changing anything.