DIQTA 1.0: Drug-Induced QT Prolongation Atlas

ETELCALCETIDE

DIR Classification Postmarketing Surveillance Drug Property Information Reference

DIR Classification

Classification:Most-DIQT concern

Severity Score:4.0

Description in Drug Labeling: View Full Labeling: SPL in DailyMed | PDF

WARNINGS AND PRECAUTIONS
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.
QT Interval Prolongation and Ventricular Arrhythmia
In the combined placebo-controlled studies, more patients treated with PARSABIV experienced a maximum increase from baseline of greater than 60 msec in the QTcF interval (0% placebo versus 1.2% PARSABIV). In these studies, the incidence of a maximum post-baseline predialysis QTcF > 500 msec in the placebo and PARSABIV groups was 1.9% and 4.8%, respectively [see Adverse Reactions (6.1)]. Patients with congenital long QT syndrome, history of QT interval prolongation, family history of long QT syndrome or sudden cardiac death, and other 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 receiving PARSABIV.
ADVERSE REACTIONS
Clinical Trials Experience
QTc Interval Prolongation Secondary to Hypocalcemia
In the combined placebo-controlled studies, more patients treated with PARSABIV experienced a maximum increase from baseline of greater than 60 msec in the QTcF interval (0% placebo versus 1.2% PARSABIV). The patient incidence of maximum post-baseline predialysis QTcF > 500 msec in the placebo and PARSABIV groups was 1.9% and 4.8%, respectively.

Postmarketing Surveillance

Contingency Table:

Current Drug

Other Drugs

QT Prolongation

24082

Other ADRs

3813

38377774

Odds Ratio = 4.18

Drug Property Information

ATC Code(s):

H05BX04 - etelcalcetide

H05BX0 -
H05BX - Other anti-parathyroid agents
H05B - ANTI-PARATHYROID AGENTS
H05 - CALCIUM HOMEOSTASIS
H - "SYSTEMIC HORMONAL PREPARATIONS, EXCL. "

Active Ingredient:ETELCALCETIDE HYDROCHLORIDE

Active Ingredient UNII:72PT5993DU

Drugbank ID:DB12865

PubChem Compound:71511839

CTD ID: C583569

PharmGKB:

CAS Number:1262780-97-1

Dosage Form(s):injection, solution

Route(s) Of Administrator:intravenous

Daily Dose:

2.1 mg/day H05BX04

Chemical Structure:

SMILE Code:
C[C@@H](NC(=O)[C@@H](CCCNC(N)=N)NC(=O)[C@@H](CCCNC(N)=N)NC(=O)[C@@H](CCCNC(N)=N)NC(=O)[C@@H](C)NC(=O)[C@@H](CSSC[C@H](N)C(O)=O)NC(C)=O)C(=O)N[C@H](CCCNC(N)=N)C(N)=O

Reference

1: Nonclinical Safety Profile of Etelcalcetide, a Novel Peptide Calcimimetic for the Treatment of Secondary Hyperparathyroidism.

[Fielden Mark R,Dean Charles,Black Kurt,Sawant Satin G,Subramanian Raju,Tomlinson James E,Walter Sarah,Zimmermann Cameron,Griggs Mark W,McKeon Marie E,Lewis Elise M,Beevers Carol,Pyrah Ian]
Int J Toxicol,2016 May;35(3):294-308. PMID: 26941242

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