DIQTA 1.0: Drug-Induced QT Prolongation Atlas

NERATINIB

DIR Classification Postmarketing Surveillance Drug Property Information Reference

DIR Classification

Classification:Ambiguous

Severity Score:1.0

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

CLINICAL PHARMACOLOGY
Pharmacodynamics
Cardiac Electrophysiology
The effect of NERLYNX on the QTc interval was evaluated in a randomized, placebo, and positive-controlled, double-blind, single-dose, crossover study in 60 healthy subjects. At 140% the therapeutic exposures of NERLYNX, there was no clinically relevant effect on the QTc interval.

Postmarketing Surveillance

Contingency Table:

Current Drug

Other Drugs

QT Prolongation

24091

Other ADRs

6242

38375345

Odds Ratio = 0.256

Drug Property Information

ATC Code(s):

L01EH02 - neratinib

L01EH -
L01E -
L01 - ANTINEOPLASTIC AGENTS
L - ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS

Active Ingredient:NERATINIB MALEATE

Active Ingredient UNII:9RM7XY23ZS

Drugbank ID:DB11828

PubChem Compound:9915743

CTD ID: C487932

PharmGKB:

CAS Number:698387-09-6

Dosage Form(s):tablet

Route(s) Of Administrator:oral

Daily Dose:

Chemical Structure:

SMILE Code:
CCOC1=C(NC(=O)\C=C\CN(C)C)C=C2C(NC3=CC=C(OCC4=CC=CC=N4)C(Cl)=C3)=C(C=NC2=C1)C#N

Reference

1: Neratinib after trastuzumab-based adjuvant therapy in patients with HER2-positive breast cancer (ExteNET): a multicentre, randomised, double-blind, placebo-controlled, phase 3 trial.

[Chan Arlene,Delaloge Suzette,Holmes Frankie A,Moy Beverly,Iwata Hiroji,Harvey Vernon J,Robert Nicholas J,Silovski Tajana,Gokmen Erhan,von Minckwitz Gunter,Ejlertsen Bent,Chia Stephen K L,Mansi Janine,Barrios Carlos H,Gnant Michael,Buyse Marc,Gore Ira,Smith John,Harker Graydon,Masuda Norikazu,Petrakova Katarina,Zotano Angel Guerrero,Iannotti Nicholas,Rodriguez Gladys,Tassone Pierfrancesco,Wong Alvin,Bryce Richard,Ye Yining,Yao Bin,Martin Miguel,ExteNET Study Group]
Lancet Oncol,2016 Mar;17(3):367-377. PMID: 26874901

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