Gadoteric Acid

Introduction: Gadoteric Acid is a paramagnetic molecule that develops a magnetic moment when placed in a magnetic field. The magnetic moment enhances the relaxation rates of water protons in its vicinity, leading to an increase in signal intensity (brightness) of tissues.

How it works: When placed in a magnetic field, gadoteric acid shortens the T1 and T2 relaxation times in target tissues. It helps to detect and visualize areas with disruption of the blood brain barrier (BBB) and/or abnormal vascularity.

Important Information: For adult and pediatric patients (including term neonates), the recommended dose is 0.2 mL/kg (0.1 mmol/kg) body weight administered as an intravenous bolus injection. Contrast MRI can begin immediately following injection.

• MRI in brain (intracranial), spine and associated tissues
• Detection of areas with disruption of the blood brain barrier (BBB)
• Detection of abnormal vascularity

Contrast medium for diagnostic procedures

Gadolinium-based contrast agent

Gadoteric acid is a paramagnetic molecule that develops a magnetic moment when placed in a magnetic field. The magnetic moment enhances the relaxation rates of water protons in its vicinity, leading to an increase in signal intensity (brightness) of tissues. When placed in a magnetic field, gadoteric acid shortens the T1 and T2 relaxation times in target tissues.

Gadoteric acid increases MRI signal intensity by decreasing proton relaxation times in tissues, allowing clear visualization of areas with blood-brain barrier disruption and abnormal vascularity.

Adult and Pediatric Dose (including term neonates):

• Recommended dose: 0.2 mL/kg (0.1 mmol/kg) body weight
• Administer as intravenous bolus injection (manually or by power injector)
• Flow rate for adults: approximately 2 mL/second
• Flow rate for pediatric patients: 1-2 mL/second
• May be followed by normal saline flush to ensure complete injection
• Contrast MRI can begin immediately following injection

* Use as directed by the registered physician

Intravenous (IV) injection. Draw into syringe immediately before use. Vial is intended for one patient only. Injection can be given manually or by power injector.

If you miss a dose, consult your doctor.

Common Side Effects (in clinical studies):

• Nausea
• Headache
• Injection site pain
• Injection site coldness
• Burning sensation

Serious Side Effects: Nephrogenic systemic fibrosis (NSF), anaphylactoid/anaphylactic reactions.

Precautions:

• Nephrogenic Systemic Fibrosis (NSF) has occurred in patients with impaired elimination of GBCAs.
• Higher than recommended dosing or repeat dosing appear to increase the risk.
• Hypersensitivity: Anaphylactoid/anaphylactic reactions may occur - monitor patients closely.
• Avoid use in severe kidney disease (GFR <30 mL/min/1.73m²).

Contraindications:

• Hypersensitivity to Gadoteric Acid or any of its components

Drug Interactions: No significant interactions known.

Food Interactions: No interaction found/established.

Use in Pregnancy: Pregnancy Category C. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Use in Lactation: It is not known whether Gadoteric Acid is excreted in human milk. Limited data suggests 0.01-0.04% of maternal dose is excreted in breast milk. Exercise caution.

Pediatric Use: Safety and efficacy established in patients 2 years and older (including term neonates).

Geriatric Use: Elderly patients are more likely to have decreased renal function - caution required.

Renal Impairment: Avoid use in severe kidney disease (GFR <30 mL/min/1.73m²). Risk of Nephrogenic Systemic Fibrosis.

Hepatic Impairment: No known restrictions.

Overdose: In case of overdose, Gadoteric Acid can be removed from the body by haemodialysis.

Storage: Store at 25°C. If solidification occurs due to cold, bring to room temperature (minimum 90 minutes). If solids persist, discard the vial.

Gadoteric Acid Injection