DIQTA 1.0: Drug-Induced QT Prolongation Atlas

GADOXETATE DISODIUM

Classification:Ambiguous

Severity Score:1.0

NONCLINICAL TOXICOLOGY
Animal Toxicology and/or Pharmacology
A dose-related increase in QTc which was resolved by 30 minutes post dosing was observed in dogs when given a single dose of EOVIST. The increase was noted when given in doses equal to or greater than 0.1 mmol/kg (2.2 times the human dose). Maximum increase in QTcF was equal to or less than 20 ms at doses up to 0.5 mmol/kg (11 times the human dose).
A gait disturbance was observed in 1 of 3 mice when given EOVIST at a dose of approximately 1.1 mmol/kg (3.6 times the human dose); the disturbance occurred at 30 minutes post dosing and resolved at 4 hours post dosing.
Local intolerance reactions, including moderate interstitial hemorrhage, edema, and focal muscle fiber necrosis, were observed after intramuscular administration of EOVIST [see Warning and Precautions (5.5)].

Current Drug

Other Drugs

QT Prolongation

24092

Other ADRs

38381587

Odds Ratio = N/A

ATC Code(s):

Active Ingredient:GADOXETATE DISODIUM

Active Ingredient UNII:HOY74VZE0M

Drugbank ID:DB14578

PubChem Compound:N/ADIR Classification

CTD ID:C073590

PharmGKB:

CAS Number:22541-19-1

Dosage Form(s):injection, solution

Route(s) Of Administrator:intravenous

Daily Dose:

Chemical Structure:

SMILE Code:
[Gd+3]

N/A