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etelcalcetide; velcalcetide (Parsabiv)
Indications:
- secondary hyperparathyroidism in adults with chronic renal failure on hemodialysis
Dosage:
- start 5 mg IV bolus 3 times per week after hemodialysis
- individualize maintenance dose by titration based on serum parathyroid hormone and corrected serum calcium
- dosage range: 2.5-15 mg IV 3 times per week.
- 2.5 mg/0.5 mL, 5 mg/mL & 10 mg/2mL single use vials
Adverse effects:
- hypocalcemia
- muscle spasms
- diarrhea, nausea, vomiting,
- headache, paresthesia
Mechanism of action:
- calcium-sensing receptor agonist
General
endocrine agent
calcimimetic
Database Correlations
PUBCHEM correlations
References
- Windle ML.
FDA New Drug and Biologic Approvals -- 2017 Year-in-Review
Medscape - Jan 11, 2018.
https://reference.medscape.com/viewarticle/890871
- U.S. Food and Drug Administration.
Novel Drug Approvals for 2017.
https://www.fda.gov/Drugs/DevelopmentApprovalProcess/DrugInnovation/ucm537040.htm
- Block GA, Bushinsky DA, Cheng S
Effect of Etelcalcetide vs Cinacalcet on Serum Parathyroid
Hormone in Patients Receiving Hemodialysis With Secondary
Hyperparathyroidism: A Randomized Clinical Trial.
JAMA. 2017 Jan 10;317(2):156-164.
PMID: 28097356
- 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 Jan 10;317(2):146-155.
PMID: 28097355
- Parsabiv. HIGHLIGHTS OF PRESCRIBING INFORMATION
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208325Orig1s000Lbledt.pdf