Gadoxetate Disodium (1 brand name, 1 dosage form, 1 route)
Available dosage forms: SOLUTION.
Routes of administration: INTRAVENOUS.
Brand Names
- EOVIST
Boxed Warning
Risk Associated with Intrathecal Use Intrathecal administration of gadolinium-based contrast agents (GBCAs) can cause serious adverse reactions including death, coma, encephalopathy, and seizures. EOVIST is not approved for intrathecal use [see Warnings and Precautions (5.1)]. Nephrogenic Systemic Fibrosis GBCAs increase the risk for nephrogenic systemic fibrosis (NSF) among patients with impaired elimination of the drugs. Avoid use of EOVIST in these patients unless the diagnostic information is essential and not available with non-contrasted MRI or other modalities. NSF may result in fatal or debilitating fibrosis affecting the skin, muscle and internal organs. The risk for NSF appears highest among patients with: Chronic, severe kidney disease (GFR < 30 mL/min/1.73m2), or Acute kidney injury. Screen patients for acute kidney injury and other conditions that may reduce renal function. For patients at risk for chronically reduced renal function (for example, age > 60 years, hypertension or diabetes), estimate the glomerular filtration rate (GFR) through laboratory testing. For patients at highest risk for NSF, do not exceed the recommended EOVIST dose and allow a sufficient period of time for elimination of the drug from the body prior to any re-administration [see Warnings and Precautions (5.2)].
Indications and Usage
EOVIST is indicated for use in magnetic resonance imaging (MRI) of the liver to detect and characterize lesions in adult and pediatric patients, including term neonates, with known or suspected focal liver disease.
Contraindications
EOVIST is contraindicated in patients with history of severe hypersensitivity reactions to EOVIST [see Warnings and Precautions (5.3)].
Adverse Reactions
The following clinically significant adverse reactions are discussed elsewhere in the labeling: Nephrogenic systemic fibrosis [see Warnings and Precautions (5.2)] Hypersensitivity reactions [see Contraindications (4) and Warnings and Precautions (5.3)]
Drug Interactions
Serum Iron Test EOVIST contains caloxetate trisodium that can interfere with serum iron determination using complexometric methods (for example, ferrocene complexation method) and may result in falsely high or low values for up to 24 hours after the administration of EOVIST. Conduct serum iron tests either before or at least 24 hours following administration of EOVIST.
Mechanism of Action
Gadoxetate is a paramagnetic molecule that develops a magnetic moment when placed in a magnetic field. The magnetic moment alters the relaxation rates of water protons in its vicinity in the body, leading to an increase in signal intensity (brightness) of tissues. Gadoxetate is selectively taken up by hepatocytes, resulting in increased signal intensity in liver tissue.
Overdosage
In case of inadvertent overdosage in patients with severely impaired renal and/or hepatic function, EOVIST can be partially removed by hemodialysis [see Clinical Pharmacology (12.3)]. For additional overdose management recommendations, consider contacting the Poison Help line at 1-800-222-1222 or consulting a medical toxicologist.