Gadoxetate

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.

• 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. EOVIST is a gadolinium-based contrast agent 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.

• EOVIST is contraindicated in patients with history of severe hypersensitivity reactions to EOVIST [see Warnings and Precautions (5.3) ] .contraindicated

Recommended dose is 0.025 mmol/kg actual body weight (equivalent to 0.1 mL/kg) administered by intravenous injection at 1 mL/sec to 2 mL/sec. ( 2.1 ) See Full Prescribing Information for administration and imaging instructions. ( 2.2 , 2.3 ) 2.1 Recommended Dose The recommended dose of EOVIST for adult and pediatric patients, including term neonates, is 0.025 mmol/kg actual body weight (equivalent to 0.1 mL/kg) administered intravenously at a recommended rate of 1 mL/sec to 2 mL/sec. 2.2 Administration and Drug Handling EOVIST is for intravenous use only and must not be administered intrathecally [see Warnings and Precautions (5.1) ]. Use aseptic technique when preparing and administering EOVIST. Visually inspect EOVIST for particulate matter and discoloration prior to administration. Do not use the solution if it is discolored or if particulate matter is present. Use EOVIST immediately after obtaining appropriate dose from vial. Pierce the rubber stopper only once. Discard any unused portion of an EOVIST vial. Do not mix EOVIST with other medications and do not administer EOVIST in the same intravenous line simultaneously with other medications. Flush the intravenous cannula with 0.9% Sodium Chloride Injection after EOVIST injection. 2.3 Imaging Liver lesions are detected and characterized with pre-contrast MRI and EOVIST MRI obtained during dynamic and hepatocyte imaging phases. Perform a pre-contrast MRI, inject EOVIST, and begin dynamic imaging approximately 15 seconds to 25 seconds after completion of the injection.

Hypersensitivity Reactions: Anaphylactic and other hypersensitivity reactions with cardiovascular, respiratory and cutaneous manifestations, ranging from mild to severe reactions including shock can occur. Monitor patients closely for need of emergency cardiorespiratory support ( 5.3 ) Gadolinium Retention: Gadolinium is retained for months or years in brain, bone, and other organs. ( 5.4 ) 5.1 Risk Associated with Intrathecal Use Intrathecal administration of GBCAs can cause serious adverse reactions including death, coma, encephalopathy, and seizures. The safety and effectiveness of EOVIST have not been established with intrathecal use. EOVIST is not approved for intrathecal use [see Dosage and Administration (2.2) ]. 5.2 Nephrogenic Systemic Fibrosis GBCAs increase the risk for nephrogenic systemic fibrosis (NSF) among patients with impaired elimination of the drugs. Avoid use of EOVIST among these patients unless the diagnostic information is essential and not available with non-contrast enhanced MRI or other modalities. The GBCA-associated NSF risk appears highest for patients with chronic, severe kidney disease (GFR < 30 mL/min/1.73m 2 ) as well as patients with acute kidney injury. The risk appears lower for patients with chronic, moderate kidney disease (GFR 30 to 59 mL/min/1.73m 2 ) and little, if any, for patients with chronic, mild kidney disease (GFR 60 to 89 mL/min/1.73m 2 ). NSF may result in fatal or debilitating fibrosis affecting the skin, muscle and internal organs.

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) ] Most common adverse reactions (incidence ≥ 0.5%) are nausea, headache, feeling hot, dizziness, and back pain. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Bayer HealthCare Pharmaceuticals Inc. at 1-888-84-BAYER (1-888-842-2937) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. Adverse Reactions in Adults The safety of EOVIST was evaluated in 1,989 adult subjects who received EOVIST in clinical trials. Overall, 59% of the subjects were male, and the racial and ethnic distribution was 64% White, 22% Asian, 3% Hispanic or Latino, 2% Black or African American, and 0.5% other ethnic groups. The average age was 57 years (age range from 19 to 84 years). Table 1 lists adverse reactions that occurred in ≥ 0.1% of subjects who received the recommended dose of EOVIST in clinical trials.

Pregnancy: Use only if imaging is essential during pregnancy and cannot be delayed. ( 8.1 ) 8.1 Pregnancy Risk Summary GBCAs cross the placenta and result in fetal exposure. In human placental imaging studies, contrast was visualized in the placenta and fetal tissues after maternal GBCA administration. Based on animal studies, use of GBCAs during pregnancy may result in fetal gadolinium retention. Published epidemiological studies on the association between GBCAs and adverse fetal outcomes have reported inconsistent findings and have important methodological limitations (see Data ). In animal reproduction studies, no teratogenicity was observed with repeated daily intravenous administration of gadoxetate disodium to rats during organogenesis at doses up to 32 times the recommended single human dose; however, an increase in preimplantation loss was noted at doses 3.2 times the single human dose. Post implantation loss was observed with repeated daily intravenous administration of gadoxetate disodium to rabbits on gestation days 6 through 18 at doses 26 times the recommended single human dose (see Data ) . Because of the potential risks of gadolinium to the fetus, use EOVIST only if imaging is essential during pregnancy and cannot be delayed. The background risk of major birth defects and miscarriage for the indicated population is unknown.

Metabolism

Distribution Gadoxetate exhibits a biphasic mode of action: first, distribution in the extracellular space after injection and subsequently, selective uptake by hepatocytes (and biliary excretion) due to the lipophilic (EOB) moiety. After intravenous administration, the plasma concentration time profile of gadoxetate is characterized by a bi-exponential decline.

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.

• Jul 3, 2008NDANDA022090Bayer Hlthcare

1. 1Rash16036%
2. 2Pain15535%
3. 3Paraesthesia15435%
4. 4Arthralgia15335%
5. 5Burning Sensation15335%
6. 6Hypoaesthesia15335%
7. 7Muscle Spasms15335%
8. 8Gadolinium Deposition Disease15235%
9. 9Injury15235%
10. 10Asthenia15034%
11. 11Confusional State15034%
12. 12Fatigue15034%
13. 13Inflammation15034%
14. 14Mass14733%
15. 15Anxiety8018%

The 10 most recently updated of 70 ClinicalTrials.gov registrations naming Gadoxetate as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Gadopiclenol vs Gadoxetate MRI for Liver Lesions
  Enrolling by invitation · Observational · 23 enrolled · Icahn School of Medicine at Mount Sinai
  NCT06596616updated 2026-04-22
• Comparison of Contrast Agents in Liver Magnetic Resonance (MR) for the Detection of Hepatic Metastases
  Terminated · Phase 4 · Interventional · 10 enrolled · University of Colorado, Denver
  NCT04973007updated 2026-04-22
• Assessing Changes in Gadoxetate Metabolism by the Liver Using MRI
  Completed · Observational · 12 enrolled · Sheffield Teaching Hospitals NHS Foundation Trust
  NCT07541807updated 2026-04-21
• Abbreviated MRI Using Gadoxetic Acid Versus CT for Surveillance of Recurrent HCC After Curative Treatment
  Recruiting · Interventional · 455 enrolled · Asan Medical Center
  NCT06537193updated 2026-03-10
• A Study of Single Fraction Stereotactic Body Radiation Therapy (SBRT) Guided by Magnetic Resonance Imaging (MRI) in People With Liver Metastasis From Colorectal Cancer
  Recruiting · Phase 2 · Interventional · 32 enrolled · Memorial Sloan Kettering Cancer Center
  NCT06130280updated 2026-02-18
• Gadolinium Contrast-enhanced Abbreviated MRI (AMRI) vs. Standard Ultrasound for Hepatocellular Carcinoma (HCC) Surveillance in Patients With Cirrhosis
  Completed · Phase 4 · Interventional · 79 enrolled · University of California, San Diego
  NCT04288323updated 2026-02-12
• REGULUS: MRI-guided Adaptive SABR for Liver Cancers
  Recruiting · Phase 2 · Interventional · 62 enrolled · Stanford University
  NCT07223307updated 2026-02-09
• Effect on Body Movement and Mental Skills in Patients Who Received Gadolinium-based Contrast Media for Magnetic Resonance Examination Multiple Times Within 5 Years
  Recruiting · Phase 4 · Interventional · 2,076 enrolled · Guerbet
  NCT04373564updated 2026-01-22
• Contrast-enhanced MRI in Detecting Benign and Malignant Liver Lesions
  Active not recruiting · Interventional · 100 enrolled · M.D. Anderson Cancer Center
  NCT02156739updated 2025-12-22
• PET/MRI of Primary Sclerosing Cholangitis
  Not yet recruiting · Observational · 10 enrolled · Massachusetts General Hospital
  NCT06252610updated 2025-10-16

Frequently asked questions

How does Gadoxetate work?

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.

What is Gadoxetate used for?

According to FDA labeling, Gadoxetate carries indications including: 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. EOVIST is a gadolinium-based contrast agent 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.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Gadoxetate?

Gadoxetate is classified as Magnetic Resonance Contrast Activity.

What are the contraindications for Gadoxetate?

Gadoxetate labeling lists contraindications including: EOVIST is contraindicated in patients with history of severe hypersensitivity reactions to EOVIST [see Warnings and Precautions (5.3) ] .. Always consult the full prescribing information and a clinician.