Eovist

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Eovist

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Medically reviewed

Marina Burgos

Last updated on 22/12/2025

This page provides general, reference-level information compiled from official medical sources. It is not a substitute for professional medical advice, diagnosis, or treatment. For decisions about your health, please consult a qualified healthcare professional.

Overview of Eovist

What is the Medicine Eovist?

Eovist is a specialized prescription medicine manufactured by Bayer HealthCare Pharmaceuticals Inc., categorized as a Magnetic Resonance Imaging (MRI) Contrast Medium used in diagnostic procedures. The active ingredient is gadoxetate disodium, a synthetic compound supplied as a sterile aqueous solution intended for intravenous injection in adults with known or suspected focal liver disease. This preparation, containing the paramagnetic element gadolinium bound to an organic ligand, possesses dual-functionality in imaging, allowing the agent to be administered directly into the bloodstream to facilitate image enhancement.

Classification as a Hepatobiliary Contrast Agent

Gadoxetate disodium belongs to the broad family of Gadolinium-based Contrast Agents (GBCAs) but is primarily distinguished as a hepatobiliary-specific contrast agent. This classification reflects its biphasic mode of action. Unlike conventional GBCAs that primarily distribute into extracellular fluid, Eovist is actively and selectively taken up by healthy, functioning liver cells, known as hepatocytes. This specific transport process, mediated by the Organic Anion-Transporting Polypeptide (OATP) transporter system, provides a distinct differentiating factor from standard contrast media.

General Purpose and Imaging Benefit

The primary purpose of Eovist is to improve the visual contrast required during T1-weighted magnetic resonance imaging scans of the liver. The compound's paramagnetic properties, when concentrated within the hepatocytes, cause the normal liver tissue to appear distinctly bright on the resulting image. This localized contrast enhancement creates a distinction between functional liver tissue and potentially abnormal tissues, such as those that lack the necessary uptake mechanism. The resulting visual clarity supports the non-invasive detection and characterization of lesions within the liver.

Regulatory References

  1. intravenous injection
  2. hepatocytes

What side effects are possible with Eovist?

Possible Side Effects and Safety Information

Official Safety Profile Overview

The safety profile of gadoxetate disodium (Eovist) is documented through clinical trial data and post-marketing surveillance, classifying possible adverse reactions by frequency and physiological system. The most commonly reported reactions are generally mild to moderate.


Adverse Reactions by Classification

Classification Examples of Reactions
Common (Reported ge 1%) Nausea, headache, and a sensation of feeling hot.
Uncommon (Reported <1%) Dizziness, back pain, vomiting, increased blood pressure, injection site reactions (e.g., pain, burning), and altered taste (dysgeusia).

These effects are grouped by regulatory bodies under categories such as Nervous System Disorders (headache, dizziness) and Gastrointestinal Disorders (nausea, vomiting).


Serious Safety Considerations

Official regulatory labeling includes specific warnings for potentially serious conditions associated with gadolinium-based contrast agents:

  • Nephrogenic Systemic Fibrosis (NSF): There is a documented risk of this rare, severe condition, particularly for patients with pre-existing chronic, severe kidney disease (GFR less than 30 mL/min/1.73m^2) or acute kidney injury.
  • Hypersensitivity Reactions: Anaphylactic and other hypersensitivity reactions, which can range from mild to severe, have been documented. These reactions typically occur within the first half hour after administration, though delayed reactions can appear up to several days later.
  • Gadolinium Retention: Small amounts of the element gadolinium can be retained in body tissues, including the brain, bone, and skin, for months or years after the procedure.

Safety Constraints and Population Notes

The agent is noted to interfere with certain serum iron determinations for up to 24 hours. Pregnancy involves fetal exposure to gadolinium due to placental crossing. For patients with severe renal impairment, the risk of NSF is highest, warranting particular attention according to regulatory guidance.

Overdose and Emergency Response

The official regulatory profile for gadoxetate disodium (Eovist) defines overdose as the administration of a dose that exceeds the maximum recommended level. For any suspected over-administration, it is mandated to seek immediate medical attention and contact a Poison Control Center.

Documented manifestations of overdose primarily involve an exacerbation of known adverse drug reactions. These clinical signs may include nausea, vomiting, and headache. Regulatory documents also note that overdose may be associated with transient increases in liver enzymes, specifically serum bilirubin, alanine aminotransferase (ALT), and aspartate aminotransferase (AST).

No specific antidote is known for gadoxetate disodium overdose. Consequently, treatment is strictly symptomatic and supportive. Regulatory authorities note that hemodialysis is an officially described procedure that may be considered to enhance the removal of the agent from the body, and hospital monitoring may be required for observation.

A critical population-specific note highlights that patients with severe renal impairment are at the highest risk for serious complications, particularly Nephrogenic Systemic Fibrosis (NSF) and acute kidney injury, following overexposure due to poor clearance. This dependency on proper kidney function underscores the requirement for prompt medical evaluation.

Therapeutic Uses of Eovist

What Eovist Treats: Main Uses and Benefits

Eovist is utilized to support the diagnostic evaluation of the liver. The agent contributes to diagnostic clarity, which aids in the formulation of an appropriate management plan by providing detailed imaging data.

This agent is applied in scenarios where diagnostic support is required for the liver, particularly to help identify and characterize abnormalities in adults with known or suspected focal liver disease. It is used in situations involving diagnostic uncertainty, focal liver conditions, and when long-term assessment is appropriate, such as for individuals with cirrhosis.

Eovist is relevant for the evaluation of conditions presenting with systemic or localized discomfort where structural findings in the liver may be the source of symptoms. Its use supports the clinical assessment process by providing timely diagnostic information. The data gathered assist the medical team in identifying a management plan, which helps maintain clinical stability when symptoms are present.

Quick Fact: Supports management of Diagnostic Uncertainty

Eligibility and Restrictions for Use

Official Eligibility and Non-Eligibility Rules

Eovist (Gadoxetate Disodium) is indicated for use in adults with known or suspected focal liver disease. Regulatory documents define patient eligibility through specific contraindications and conditional restrictions, ensuring its use is limited to officially approved populations.

Eligibility Scope Regulatory Status
Populations for Whom Use is Allowed Adults (typically 18 years and older).
Absolute Contraindication Patients with a history of severe hypersensitivity reactions to the medicine or its components.
Prohibited Use Intrathecal administration (injection into the spinal canal) is not approved.
Pediatric Population Safety and effectiveness have not been established in patients under 18 years of age.

Condition-Specific Restrictions

Use is restricted and generally to be avoided in patients with chronic, severe kidney disease (GFR < 30 mL/min/1.73 m^2) or acute kidney injury (AKI), due to the increased risk of Nephrogenic Systemic Fibrosis (NSF). Use in these high-risk populations is only permitted if the diagnostic information is essential and unavailable through other methods. For conditions like elevated bilirubin or ferritin levels, the timing of the MR imaging must be adjusted to no later than 60 minutes after administration. Regarding Pregnancy and Lactation, use is conditional; it is recommended only if the potential benefit justifies the potential risk due to a lack of adequate human studies.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Eovist (gadoxetate disodium) is a gadolinium-based contrast agent (GBCA) used for magnetic resonance imaging (MRI). The risk of drug interactions with Eovist is generally considered low, as the medication is typically administered as a single, one-time dose and is primarily eliminated by the liver and kidneys.


Moderate Drug Interactions

Certain medications may moderately interact with Eovist, potentially affecting the clearance of the contrast agent from the body or altering its distribution. A significant number of drugs, including certain statins (e.g., atorvastatin) and some HIV protease inhibitors (e.g., atazanavir), are known to be substrates or inhibitors of the organic anion transporting polypeptide (OATP) liver transporter system. Since Eovist is also transported by OATP, co-administration of these medications may reduce Eovist’s elimination, potentially increasing its plasma concentration or duration of effect. Healthcare professionals should be informed of all medications and supplements being taken.


Other Interactions

  • Interference with Laboratory Tests: Eovist can transiently affect the accuracy of serum iron determination using complexometric methods for up to 24 hours following administration, possibly resulting in falsely high or low values.
  • Other Contrast Agents: The concurrent use of other non-ionic iodinated contrast agents for other procedures (e.g., CT scans) should be carefully managed, especially in patients with impaired kidney function, due to the increased risk of complications such as Nephrogenic Systemic Fibrosis (NSF).
  • Nephrotoxic Medications: The use of other nephrotoxic or diuretic medications may increase the risk of acute kidney injury or other adverse renal effects in patients with pre-existing kidney problems, which can be a risk factor for NSF when receiving a GBCA like Eovist.

Mechanism of Action

The action of Gadoxetate Disodium is fundamentally biophysical, utilizing precise cellular localization. The agent utilizes the liver's natural transport systems to generate a significant contrast differential.

Selective Cellular Targeting via OATP Transporters

The molecule's unique function is dependent on its specific and active transport into healthy liver cells, or hepatocytes, mediated by the Organic Anion-Transporting Polypeptides (OATP) 1B1 and 1B3. This mechanism facilitates the concentration of the paramagnetic substance within functional liver tissue, which initiates the specific hepatobiliary phase of its activity.

Biophysical T1 Relaxivity and Signal Enhancement

Once concentrated within the hepatocytes, the gadolinium component exerts its biophysical effect by significantly accelerating the T1 relaxation rate of nearby water protons. This acceleration directly causes the functional liver parenchyma to appear highly bright (enhanced signal intensity) on T1-weighted magnetic resonance images.

Differential Contrast and Mechanistic Constraints

The mechanism results in differential contrast, where the functioning tissue brightens dramatically, while non-functional areas, lacking the OATP transporters, retain the agent only transiently in the extracellular space and appear relatively dark. The core physiological effect, which generates a distinct signal differential between functional and non-functional tissue on the image, is constrained by hepatocyte function; conditions that impair the number or health of these cells can reduce the effectiveness of the targeted uptake.

Dosage and Administration Information

Administration Overview

Eovist (gadoxetate disodium) is administered as a single, standardized dose during a diagnostic Magnetic Resonance Imaging (MRI) procedure, following defined protocols.


Administration Scope

Feature Instruction Details
Route of administration Intravenous (IV) injection only.
Dosing schedule A fixed, weight-based dose of 0.025 mmol/kg (or 0.1 mL/kg) of actual body weight for adults.
Timing in relation to meals Not applicable; administration is independent of food intake.
Preparation requirements Must be visually inspected for particulate matter or discoloration before use. The dose is drawn from a single-use container (vial or syringe) and must be used immediately.
Age-group administration rules Use is limited to adult patients (age 18 and older).
Missed-dose rules Not applicable; Eovist is a single-use diagnostic agent, not a scheduled therapeutic medication.
Special procedural conditions The injection must be administered as a rapid intravenous bolus (at approximately 2 mL/second) and followed immediately by a sterile 0.9% sodium chloride (saline) flush.

Instruction Classifications (High-Level)

Classification Description
Administration method type Intravenous (IV) injection into a peripheral vein.
Frequency pattern Single event, as needed for a single diagnostic examination.
Use-context constraints Must be administered in a clinical setting under the supervision of a qualified healthcare professional.

Resulting Procedural Structure

The delivery of Eovist involves a precise, sequential administration protocol:

  • Calculate Dose: The exact volume is determined based on the patient's weight to ensure the 0.025 mmol/kg dose is delivered.
  • Administer Bolus: The full, calculated dose is injected rapidly into the vein.
  • Flush Line: The injection is immediately followed by a saline flush to ensure the entire dose is administered and the line is cleared.

The requirements for a fixed, weight-based dose and rapid intravenous bolus ensure the agent is delivered accurately to achieve the necessary contrast enhancement during the time window of the MRI scan.

Recent Clinical Evidence

Eovist (gadoxetate disodium) is a gadolinium-based contrast agent specifically developed for use in Magnetic Resonance Imaging (MRI) of the liver. Its unique clinical utility stems from its biphasic enhancement pattern, combining dynamic blood flow imaging with a subsequent hepatobiliary phase.

Detection and Characterization of Liver Lesions

Clinical trials and observational studies have consistently evaluated Eovist’s effectiveness in detecting and characterizing focal liver lesions (FLLs) in patients with known or suspected liver disease. Key findings indicate:

  • Improved Sensitivity: The combination of non-contrast and Eovist-enhanced MRI images has been associated with improved sensitivity for detecting FLLs, particularly for smaller lesions (less than 1 cm), compared to non-specific extracellular contrast agents or CT scans.
  • Diagnostic Characterization: The delayed hepatobiliary phase (HBP), which occurs approximately 10 to 20 minutes after injection, allows for the differentiation of lesions based on whether they contain functioning hepatocytes. This information is considered valuable for characterizing various lesion types, including hepatocellular carcinoma (HCC) and metastases.

Safety and Tolerability

Safety data collected from clinical trials and post-marketing surveillance involving millions of administered doses indicate a favorable safety profile. Adverse reactions are typically reported as mild to moderate in severity. The most frequently reported adverse reactions (occurring in ge 0.5% of subjects in trials) include:

Adverse Reaction Incidence (ge 0.5%)
Nausea approx 1.1%
Headache approx 1.1%
Feeling Hot approx 0.8%
Dizziness approx 0.6%
Back Pain approx 0.6%

Authorities classify gadoxetate disodium as a contrast agent with a low risk of Nephrogenic Systemic Fibrosis (NSF), even in patients with severe renal impairment, though appropriate precautions are still advised.

Frequently Asked Questions (FAQ)

Common questions about Eovist (FAQ)


Q: Why does Eovist require a special type of MRI sequence after injection?

A: Eovist requires a specific sequence called the hepatocyte imaging phase, which is performed approximately 20 minutes post-injection. This timing is necessary because regulatory documents outline that the medicine needs this time to be actively taken up by the healthy liver cells, which supports the detection and characterization of liver lesions during the procedure.


Q: What is the 'hepatobiliary phase' and why is it important for Eovist?

A: The hepatobiliary phase is the period of the MRI scan where the contrast agent is highly concentrated inside the functioning liver cells (hepatocytes). According to official product information, this phase is important because it assists healthcare professionals to better differentiate liver lesions based on whether the lesion is functional (takes up the agent) or non-functional (does not take up the agent).


Q: Can gadolinium from Eovist stay in the body after the scan is finished?

A: Official warnings note that small amounts of the metal gadolinium from Eovist can be retained in body tissues, including the brain, bone, and skin, for a long time (several months to years) after the procedure. This finding is documented in FDA labeling for all gadolinium-based contrast agents.


Q: Is there a link between Eovist and the condition Nephrogenic Systemic Fibrosis (NSF)?

A: There is a documented risk of Nephrogenic Systemic Fibrosis (NSF), a rare, severe condition, associated with all gadolinium-based contrast agents. The risk is highest for patients with severe kidney problems, specifically those with chronic, severe kidney disease or acute kidney injury.


Q: Does Eovist interact with any commonly used medications?

A: Regulatory documents state that certain medications, including some statins and some HIV protease inhibitors, may moderately interact with Eovist by sharing the same liver uptake system. This could potentially affect the contrast agent’s distribution or elimination from the body.


Q: Is it safe to get an Eovist-enhanced MRI while breastfeeding?

A: Official information indicates that gadolinium-based contrast agents are excreted in human milk. The use of Eovist while breastfeeding is a conditional decision based on a review of the potential benefits and risks. Management strategies may be discussed with a healthcare professional, as the decision is conditional.


Q: Should Eovist be avoided in pregnancy?

A: In pregnancy, Eovist is recommended only if the potential benefit justifies the potential risk to the fetus. This conditional recommendation is due to the lack of adequate human studies on the fetal effects of gadolinium exposure.


Q: Is the Eovist injection painful?

A: According to official reports on adverse reactions, the most frequent sensations reported during or after injection include a feeling of being hot. Less commonly, reactions at the injection site such as pain or burning have been reported.


Q: What is the purpose of the saline flush given with the Eovist injection?

A: The administration protocol in official documents states that the injection of Eovist is followed immediately by a sterile saline flush (a simple salt water solution). The purpose of the flush is to facilitate the complete administration of the calculated dose of the contrast agent into the vein.


Q: Is Eovist different from other contrast agents used for MRI?

A: Eovist is primarily distinguished from most other gadolinium-based contrast agents as a hepatobiliary-specific agent. This means it is designed to be actively and selectively taken up by the functioning liver cells, providing a unique imaging phase compared to standard extracellular contrast agents.


Q: Can people with high bilirubin levels use Eovist?

A: Patients with elevated levels of bilirubin (a liver waste product) may experience a reduced and delayed contrast effect during the scan. Official guidelines address this by recommending the MRI be performed no later than 60 minutes following Eovist administration in these cases.


Q: Is Eovist used for any MRI scans besides the liver?

A: According to its regulatory labeling, Eovist is officially indicated for use only in Magnetic Resonance Imaging (MRI) of the liver to detect and characterize lesions in this organ for adult patients.


Q: What is the difference between Eovist and Primovist?

A: Eovist and Primovist refer to the same active ingredient, which is gadoxetate disodium. Eovist is the trade name used in the United States, while Primovist is the trade name used in various other global regions, including Europe.


Q: Are there any known interactions between Eovist and birth control pills?

A: The official product information does not list specific interactions with birth control pills. However, it advises that healthcare professionals should be informed of all medications being taken because many drugs can be affected by the same liver transport system used by Eovist.


Q: What is the half-life of Eovist, or how quickly is it cleared from the body?

A: According to regulatory pharmacokinetics data, the elimination half-life of Eovist is approximately 55 to 57 minutes in adult patients with normal kidney function. This measure describes the time it takes for half of the substance to be cleared from the body.


Q: Are there any special risks with Eovist for children or elderly patients?

A: Eovist is officially indicated for use only in adult patients (age 18 and older), as safety and effectiveness have not been established in children. In elderly patients, the overall safety profile is similar to younger adults, but age-related medical conditions may be a factor in the risk assessment prior to use.


Q: Do other medical conditions like diabetes or high blood pressure affect the use of Eovist?

A: While the medicine's use is not strictly dependent on these conditions, for patients with pre-existing issues that affect the kidneys, such as diabetes or high blood pressure, regulatory guidelines suggest an assessment of kidney function for these patients. This is due to the need to mitigate the potential risk of Nephrogenic Systemic Fibrosis (NSF).


Q: Why is Eovist sometimes recommended for patients with a history of cancer?

A: Eovist is officially indicated for use to detect and characterize lesions in patients with known or suspected focal liver disease. This includes the clinical need to distinguish between various types of masses, such as benign tumors, metastases from other cancers, or hepatocellular carcinoma (HCC).


Q: Can Eovist affect the results of other medical tests?

A: Yes, Eovist can transiently affect the accuracy of serum iron determination (a blood test for iron levels) using complexometric methods for up to 24 hours following administration. This effect could potentially result in falsely high or low values if the specific testing method is used.


Q: Is Eovist considered a linear or macrocyclic contrast agent?

A: Regulatory bodies classify Eovist (gadoxetate disodium) based on its chemical structure. It is considered a linear gadolinium-based contrast agent. This classification is often mentioned in discussions concerning the potential for gadolinium retention.


Q: Is Eovist used in patients who have already had a liver transplant?

A: Regulatory warnings indicate that patients around the time of liver transplantation are among those at the highest risk for Nephrogenic Systemic Fibrosis (NSF). This information is used by healthcare professionals when assessing risk for this population.


Q: How does Eovist compare to an MRI without any contrast agent at all?

A: The medicine's official purpose is to enhance the visualization of liver lesions. This means that when Eovist is used, the image detail and contrast between healthy liver tissue and potential lesions are improved compared to a scan performed without a contrast agent.


Q: Can Eovist cause anxiety or a change in mood after the scan?

A: Official adverse reaction reports include very rare instances (occurring in less than 0.1%) of effects such as tremor, akathisia, and general discomfort or malaise. These are not among the commonly reported side effects.


Q: Are there delayed side effects from Eovist that can happen days or weeks later?

A: Yes, official warnings indicate that delayed hypersensitivity reactions (allergic reactions) can occur up to several days after Eovist administration. For the rare condition Nephrogenic Systemic Fibrosis (NSF), symptoms such as skin hardening can also be observed later.


Q: Does Eovist affect the body's liver function tests?

A: Temporary elevations of serum bilirubin laboratory values have been reported as an uncommon side effect (less than 1%) after administration. These values typically return to baseline within 1 to 4 days.


Q: Is Eovist only used for distinguishing benign liver lesions from malignant ones?

A: The official indication for Eovist is to detect and characterize lesions in the liver. This characterization helps to distinguish between various types of liver abnormalities, including those that are benign and those that are malignant (cancerous).


Q: Is there a maximum number of times Eovist can be used in a patient's lifetime?

A: Official regulatory warnings advise that for patients at highest risk for Nephrogenic Systemic Fibrosis (NSF), the recommended dose must not be exceeded. Additionally, a sufficient time must be allowed for the medicine to be eliminated prior to any re-administration of Eovist.


Q: Why is Eovist described as having a 'dual excretion pathway'?

A: Eovist has a dual excretion pathway because it uses two different ways to leave the body. Pharmacokinetic data shows that approximately 50% of the dose is eliminated via the liver and bile duct, and the remaining 50% is eliminated via the kidneys.


Q: Does the time between the injection and the scan affect the quality of the Eovist MRI?

A: Yes, the quality of the scan is highly dependent on timing. Official labeling specifies different imaging periods, including the dynamic phases (immediately after injection) and the hepatocyte imaging phase (approximately 20 minutes later), for optimal diagnostic results.


Q: Is Eovist related to a metallic or strange taste in the mouth?

A: Official adverse reaction data includes reports of altered taste, medically known as dysgeusia, as an uncommon side effect following the injection.


Q: What are the signs of a non-severe hypersensitivity reaction to Eovist?

A: Hypersensitivity reactions can range from mild to severe. Possible signs documented in regulatory information include cutaneous manifestations (skin rash, itching) as well as milder cardiovascular or respiratory symptoms.


Q: Does Eovist interact with any herbal supplements?

A: The official product information advises that healthcare professionals should be informed of all medications and supplements being taken before administration. Specific interactions with herbal supplements are not detailed in the drug label.


Q: Is Eovist used in patients with known liver disease, such as cirrhosis?

A: Eovist is indicated for use in patients with known or suspected focal liver disease. It is important to note that conditions that impair the function of liver cells may reduce the effectiveness of the contrast enhancement.


Q: What types of liver lesions is Eovist specifically designed to help characterize?

A: Eovist is used to help detect and characterize various types of focal liver lesions (FLLs). This includes helping to distinguish between specific lesion types like metastases and hepatocellular carcinoma (HCC).


Q: Does Eovist have any effect on blood pressure during the MRI procedure?

A: Official adverse reaction data includes reports of increased blood pressure as an uncommon side effect following the administration of Eovist.


Q: Is Eovist approved in all major global regions (US, Europe, Japan)?

A: Yes, the medicine is approved across major global regulatory regions. It is used under the trade name Eovist in the United States and Primovist in Europe, Japan, and other regions.


Q: Can Eovist cause temporary back or joint pain after the procedure?

A: Official adverse reaction data indicates that back pain is a commonly reported side effect. Joint-related issues are noted in official warnings, where joint stiffness is listed as a rare symptom associated with a serious safety consideration (NSF).

How should Eovist be stored and disposed of?

Eovist (Gadoxetate Disodium) vials must be stored under specific environmental constraints to maintain product integrity. The mandatory storage condition is room temperature, defined as 25 C (77 F), with permitted short excursions between 15 C and 30 C. It is critical to protect the product from freezing at all times.

Eovist is supplied in a single-dose vial and must be used immediately after opening; the rubber stopper should not be pierced more than once. Prior to use, the solution must be visually inspected for any discoloration or particulate matter. Any unused portion of the vial must be discarded. Disposal of all unused drug and waste materials must strictly follow established local procedures for pharmaceutical waste, and the product should be kept out of the sight and reach of children.

Attention! Always consult to a doctor or pharmacist before using pills or medicines.

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