Hospital Pharmacy - November 2017 - 669

733478
research-article2017

HPXXXX10.1177/0018578717733478Hospital PharmacyBaker

Formulary Drug Reviews

Formulary Drug Review: Etelcalcetide

Hospital Pharmacy
2017, Vol. 52(10) 669-674
© The Author(s) 2017
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https://doi.org/10.1177/0018578717733478
DOI: 10.1177/0018578717733478
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Danial E. Baker1

Each month, subscribers to The Formulary Monograph Service receive 5 to 6 well-documented monographs on drugs
that are newly released or are in late phase 3 trials. The monographs are targeted to Pharmacy & Therapeutics
Committees. Subscribers also receive monthly 1-page summary monographs on agents that are useful for agendas
and pharmacy/nursing in-services. A comprehensive target drug utilization evaluation/medication use evaluation
(DUE/MUE) is also provided each month. With a subscription, the monographs are available online to subscribers.
Monographs can be customized to meet the needs of a facility. Through the cooperation of The Formulary, Hospital
Pharmacy publishes selected reviews in this column. For more information about The Formulary Monograph Service,
contact Wolters Kluwer customer service at 866-397-3433. The November 2017 monograph topics are Ertugliflozin,
Glecaprevir / pibrentasvir, Neratinib, Sofosbuvir, velpatasvir, voxilaprevir and SQ C1 esterase inhibitor. The MUE is
on glecaprevir, pibrentasvir.
Keywords
formulary management/P&T, nephrology, metabolic/endocrine

Generic Name: Etelcalcetide
Proprietary Name: Parsabiv (KAI Pharmaceuticals, Inc)
Approval Rating: 1S
Therapeutic Class: Calcimimetics
Similar Drugs: Cinacalcet
Sound- or Look-Alike Names: Ecallantide

Indications
Etelcalcetide (previously known as velcalcetide and AMG
416) is approved for the treatment of secondary hyperparathyroidism in adults with chronic kidney disease (CKD) on
hemodialysis.1,2,3
Etelcalcetide has not been sufficiently evaluated in adult
patients with parathyroid carcinoma, primary hyperparathyroidism, or CKD not on hemodialysis, and is not recommended for use in these populations.1

Clinical Pharmacology
Etelcalcetide is a calcimimetic agent that modulates the
calcium-sensing receptor (CaSR).1,4,5,6,7 Calcimimetic
agents bind to the CaSR and enhance activation of the
receptor by extracellular calcium. Activation of the CaSR
on parathyroid chief cells decreases parathyroid hormone
(PTH) secretion.1,4,5,6,7,8 Following intravenous (IV) administration of etelcalcetide, PTH levels decrease within 30
minutes and stay suppressed with continued administration. The reduction in PTH levels results in reductions in

calcium serum levels and attenuation of postdialytic phosphate elevation.1

Pharmacokinetics
Etelcalcetide has linear pharmacokinetics and exhibits triexponential decay following IV administration. In CKD
patients, steady-state concentrations are achieved in 7 to 8
weeks with 3-times-weekly dosing at the end of each 3- to
6-hour hemodialysis session. Etelcalcetide's effective halflife is 3 to 4 days and steady-state volume of distribution is
796 L. Etelcalcetide is predominately bound to plasma albumin by reversible covalent binding and is biotransformed in
blood by reversible disulfide exchange with endogenous thiols to form conjugates with serum albumin. Etelcalcetide is
not metabolized by cytochrome P450 enzymes. Etelcalcetide
is cleared by renal excretion in patients with normal renal
function, while hemodialysis is the predominant elimination
pathway in CKD patients requiring hemodialysis.1,9,10,11,12,13
Body weight (29-163 kg), gender, race, and age (20-93
years of age) do not influence etelcalcetide pharmacokinetics.1

Washington State University, Spokane, WA, USA

Corresponding Author:
Danial E. Baker, Director, Drug Information Center, and Professor of
Pharmacotherapy, College of Pharmacy, Washington State University, PO
Box 1495, Spokane, WA 99210-1495, USA.
Email: danial.baker@wsu.edu

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