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Gadoteric acid

Generic Name
Gadoteric acid
Brand Names
Dotarem
Drug Type
Small Molecule
Chemical Formula
C16H25GdN4O8
CAS Number
72573-82-1
Unique Ingredient Identifier
QVF9Y6955W

Overview

Gadoteric acid is a macrocycle-structured gadolinium-based MRI contrast agent. It is composed of the organic acid DOTA (1,4,7,10-tetraazacyclododecane-1,4,7,10-tetraacetic acid) used for its chelating properties, and gadolinium (Gd3+). As a paramagnetic molecule, gadoterate develops a magnetic moment when placed in a magnetic field. This magnetic moment enhances the relaxation rates of water protons in its vicinity, leading to an increase in signal intensity (brightness) of tissues. More specifically, it reduces the T1 relaxation time (and to some extent the T2 and T2* relaxation times) in NMR, which is the source of its clinical utility. Increased signal brightness allows it to be used in imaging of blood vessels and of inflamed or diseased tissue where the blood vessels become 'leaky'. Gadoteric acid, as the FDA approved product Dotarem, is indicated for intravenous use with magnetic resonance imaging (MRI) in brain (intracranial), spine and associated tissues in adult and pediatric patients (2 years of age and older) to detect and visualize areas with disruption of the blood brain barrier (BBB) and/or abnormal vascularity.

Background

Gadoteric acid is a macrocycle-structured gadolinium-based MRI contrast agent. It is composed of the organic acid DOTA (1,4,7,10-tetraazacyclododecane-1,4,7,10-tetraacetic acid) used for its chelating properties, and gadolinium (Gd3+). As a paramagnetic molecule, gadoterate develops a magnetic moment when placed in a magnetic field. This magnetic moment enhances the relaxation rates of water protons in its vicinity, leading to an increase in signal intensity (brightness) of tissues. More specifically, it reduces the T1 relaxation time (and to some extent the T2 and T2* relaxation times) in NMR, which is the source of its clinical utility. Increased signal brightness allows it to be used in imaging of blood vessels and of inflamed or diseased tissue where the blood vessels become 'leaky'. Gadoteric acid, as the FDA approved product Dotarem, is indicated for intravenous use with magnetic resonance imaging (MRI) in brain (intracranial), spine and associated tissues in adult and pediatric patients (2 years of age and older) to detect and visualize areas with disruption of the blood brain barrier (BBB) and/or abnormal vascularity.

Indication

Gadoteric acid is indicated for intravenous use with magnetic resonance imaging (MRI) in brain (intracranial), spine and associated tissues in adult and pediatric patients (2 years of age and older) to detect and visualize areas with disruption of the blood brain barrier (BBB) and/or abnormal vascularity.

Associated Conditions

No associated conditions information available.

FDA Approved Products

Gadoterate Meglumine
Manufacturer:Fresenius Kabi USA, LLC
Route:INTRAVENOUS
Strength:376.9 mg in 1 mL
Approved: 2023/08/31
NDC:65219-086
DOTAREM
Manufacturer:Guerbet LLC
Route:INTRAVENOUS
Strength:376.9 mg in 1 mL
Approved: 2023/01/10
NDC:67684-2000
CLARISCAN
Manufacturer:GE Healthcare
Route:INTRAVENOUS
Strength:376.9 mg in 1 mL
Approved: 2022/12/30
NDC:0407-2943
CLARISCAN
Manufacturer:GE Healthcare
Route:INTRAVENOUS
Strength:376.9 mg in 1 mL
Approved: 2022/12/30
NDC:0407-2943
DOTAREM
Manufacturer:Guerbet LLC
Route:Intravenous
Strength:376.9 mg in 1 mL
Approved: 2022/04/27
NDC:67684-2001

Singapore Approved Products

DOTAGRAF SOLUTION FOR INJECTION 0.5 MMOL/ML
Manufacturer:Sanochemia Pharmazeutika GmbH
Form:INJECTION, SOLUTION
Strength:279.32mg/ml (equivalent to 0.5 mmol/ml)
Online:Yes
Approved: 2020/07/06
Approval:SIN15973P
DOTAREM INJECTION 27.932 g/ 100 ml
Manufacturer:GUERBET
Form:INJECTION
Strength:27.932 g/ 100 ml
Online:Yes
Approved: 1996/11/18
Approval:SIN09008P
CLARISCAN SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE 0.5 MMOL/ML
Manufacturer:GE Healthcare AS (Oslo Site)
Form:INJECTION, SOLUTION
Strength:279.3mg/ml
Online:Yes
Approved: 2019/05/24
Approval:SIN15694P
CLARISCAN SOLUTION FOR INJECTION IN VIAL 0.5 MMOL/ML
Manufacturer:GE Healthcare AS (Oslo Site)
Form:INJECTION, SOLUTION
Strength:279.3mg/ml
Online:Yes
Approved: 2019/05/24
Approval:SIN15693P

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