DIQTA 1.0: Drug-Induced QT Prolongation Atlas

LURASIDONE HYDROCHLORIDE

DIR Classification Postmarketing Surveillance Drug Property Information Reference

DIR Classification

Classification:Moderate-DIQT concern

Severity Score:2.0

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

OVERDOSAGE
Cardiovascular monitoring should commence immediately, including continuous electrocardiographic monitoring for possible arrhythmias. If antiarrhythmic therapy is administered, disopyramide, procainamide, and quinidine carry a theoretical hazard of additive QT-prolonging effects when administered in patients with an acute overdose of LATUDA. Similarly, the alpha-blocking properties of bretylium might be additive to those of LATUDA, resulting in problematic hypotension.
CLINICAL PHARMACOLOGY
Pharmacodynamics
ECG Changes
The effects of LATUDA on the QTc interval were evaluated in a randomized, double-blind, multiple-dose, parallel-dedicated thorough QT study in 43 patients with schizophrenia or schizoaffective disorder, who were treated with LATUDA doses of 120 mg daily, 600 mg daily and completed the study. The maximum mean (upper 1-sided, 95% CI) increase in baseline-adjusted QTc intervals based on individual correction method (QTcI) was 7.5 (11.7) ms and 4.6 (9.5) ms, for the 120 mg and 600 mg dose groups respectively, observed at 2 to 4 hours after dosing. In this study, there was no apparent dose (exposure)-response relationship.
In short-term, placebo-controlled studies in schizophrenia and bipolar depression, no post-baseline QT prolongations exceeding 500 msec were reported in patients treated with LATUDA or placebo.

Postmarketing Surveillance

Contingency Table:

Current Drug

Other Drugs

QT Prolongation

24063

Other ADRs

28070

38353517

Odds Ratio = 1.647

Drug Property Information

ATC Code(s):

N05AE05 - lurasidone hydrochloride

N05AE - Indole derivatives
N05A - ANTIPSYCHOTICS
N05 - PSYCHOLEPTICS
N - NERVOUS SYSTEM

Active Ingredient:lurasidone hydrochloride

Active Ingredient UNII:O0P4I5851I

Drugbank ID:DB08815

PubChem Compound:213046

CTD ID:D000069056

PharmGKB:PA166129557

CAS Number:367514-87-2

Dosage Form(s):tablet, film coated

Route(s) Of Administrator:oral

Daily Dose:

60.0 mg/day N05AE05

Chemical Structure:

SMILE Code:
[H][C@@]12[C@H]3CC[C@H](C3)[C@]1([H])C(=O)N(C[C@@H]1CCCC[C@H]1CN1CCN(CC1)C1=NSC3=CC=CC=C13)C2=O

Reference

1: Comparison of Lurasidone Versus Quetiapine for the Treatment of Delirium in Critically Ill Patients.

[Fox Marlena A,Elefritz Jessica L,Huang Brandon M,Hunley Charles]
J Intensive Care Med,2020 Apr;35(4):394-399. PMID: 29357776

2: Lurasidone: an antipsychotic with antidepressant effects in bipolar depression?

[Keks Nicholas A,Hope Judy,Castle David]
Australas Psychiatry,2016 Jun;24(3):289-91. PMID: 27036122

3: Lurasidone: a new treatment option for schizophrenia.

[Owen R T]
Drugs Today (Barc),2011 Nov;47(11):807-16. PMID: 22146224

4: Lurasidone: a new drug in development for schizophrenia.

[Meyer Jonathan M,Loebel Antony D,Schweizer Edward]
Expert Opin Investig Drugs,2009 Nov;18(11):1715-26. PMID: 19780705

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