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Gadoxetate: Drug information

Gadoxetate: Drug information
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For additional information see "Gadoxetate: Patient drug information"

For abbreviations, symbols, and age group definitions show table
ALERT: US 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. Gadoxetate is not approved for intrathecal use.

Nephrogenic systemic fibrosis:

Gadolinium-based contrast agents increase the risk for nephrogenic systemic fibrosis (NSF) among patients with impaired elimination of the drugs. Avoid use of gadoxetate in these patients unless the diagnostic information is essential and not available with noncontrasted magnetic resonance imaging (MRI) or other modalities. Nephrogenic systemic fibrosis 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 (glomerular filtration rate [GFR] <30 mL/minute/1.73 m2) 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 (eg, >60 years, hypertension, diabetes), estimate the GFR through laboratory testing.

For patients at highest risk of NSF, do not exceed the recommended gadoxetate dose and allow a sufficient period of time for elimination of the drug from the body prior to any readministration.

Brand Names: US
  • Eovist
Pharmacologic Category
  • Diagnostic Agent;
  • Gadolinium-Containing Contrast Agent;
  • Linear Gadolinium-Based Contrast Agent;
  • Radiological/Contrast Media (Ionic, Low Osmolality);
  • Radiological/Contrast Media, Paramagnetic Agent
Dosing: Adult
Liver imaging

Liver imaging: IV: 0.025 mmol/kg (0.1 mL/kg).

Dosing: Kidney Impairment: Adult

There are no dosage adjustments provided in the manufacturer’s labeling; use with caution. Risk for NSF development increases as renal function decreases.

End-stage renal disease: Imaging performance decreases due to elevated serum ferritin levels; if used, complete MR imaging within 60 minutes following administration and use both noncontrast and contrast-enhanced images to aid in diagnosis.

Hemodialysis: If administered to patients already receiving hemodialysis, consider prompt hemodialysis following exposure (eg, within 3 hours) (Ref). Data has shown hemodialysis enhances gadolinium elimination with average gadolinium excretory rates of 78%, 96%, and 99% in the first, second, and third hemodialysis sessions, respectively (Ref).

Peritoneal dialysis: Likely to be less efficient at clearing gadolinium (Ref).

Dosing: Liver Impairment: Adult

No dosage adjustments necessary.

Severe hepatic impairment (including patients with elevated bilirubin >3 mg/dL): Imaging performance decreases; if used, complete imaging no later than 60 minutes after administration and use a paired noncontrast and contrast image for diagnosis.

Dosing: Older Adult

Refer to adult dosing.

Dosing: Pediatric
Liver imaging

Liver imaging: Infants ≥2 months, Children, and Adolescents: Refer to adult dosing.

Dosing: Kidney Impairment: Pediatric

Infants ≥ 2 months, Children, and Adolescents: There are no dosage adjustments provided in the manufacturer’s labeling; use with caution. Risk for nephrogenic systemic fibrosis (NSF) development increases as renal function decreases.

Dialysis: There are no pediatric specific recommendations; based on experience in adult patients, the following has been observed:

Hemodialysis: If administered to patients already receiving hemodialysis, consider prompt hemodialysis following exposure (eg, within 3 hours) (Ref). Data has shown hemodialysis enhances gadolinium elimination with average gadolinium excretory rates of 78%, 96%, and 99% in the first, second, and third hemodialysis sessions, respectively (Ref).

Peritoneal dialysis: Likely to be less efficient at clearing gadolinium (Ref).

Dosing: Liver Impairment: Pediatric

Infants ≥ 2 months, Children, and Adolescents: No dosage adjustments necessary.

Severe hepatic impairment (including patients with elevated bilirubin >3 mg/dL): Imaging performance decreases; if used, complete imaging no later than 60 minutes after administration and use a paired noncontrast and contrast image for diagnosis.

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Adverse reactions reported in adults.

1% to 10%:

Gastrointestinal: Nausea (1%)

Nervous system: Headache (1%)

<1%:

Cardiovascular: Bundle branch block, chest pain, flushing, increased blood pressure, palpitations

Dermatologic: Hyperhidrosis, maculopapular rash, pruritus, skin rash

Endocrine & metabolic: Increased serum iron

Gastrointestinal: Dysgeusia, oral discomfort, sialorrhea, vomiting, xerostomia

Hepatic: Increased serum bilirubin

Local: Injection-site reaction (including burning sensation at injection site, irritation at injection site, pain at injection site, sensation of cold)

Nervous system: Akathisia, altered sense of smell, chills, dizziness, fatigue, feeling hot, malaise, paresthesia, tremor, vertigo

Neuromuscular & skeletal: Back pain

Ophthalmic: Eye pruritus

Respiratory: Dyspnea, respiratory distress

Frequency not defined: Renal: Nephrogenic systemic fibrosis

Postmarketing:

Cardiovascular: Tachycardia

Dermatologic: Pallor, skin changes (plaques) (Ramalho 2017)

Gastrointestinal: Acute pancreatitis

Hypersensitivity: Hypersensitivity reaction (including anaphylactic shock, anaphylaxis)

Nervous system: Asthenia, pain, restlessness

Respiratory: Acute respiratory distress syndrome, pulmonary edema

Contraindications

Hypersensitivity to gadoxetate or any component of the formulation.

Warnings/Precautions

Concerns related to adverse effects:

• Extravasation: Avoid extravasation; local tissue damage/reactions may occur. Ensure catheter patency prior to administration.

• Gadolinium retention: Gadolinium is retained for months or years in brain, bone, skin, and other organs (kidney, liver, spleen); the highest concentration and longest duration have been found in the bone. Linear gadolinium-based contrast agents (GBCAs) (gadodiamide and gadoversetamide > gadoxetate disodium, gadopentetate dimeglumine, and gadobenate dimeglumine) result in more retention than macrocyclic GBCAs (gadoterate meglumine, gadobutrol, and gadoteridol). Pathologic and clinical consequences of gadolinium retention in skin and other organs have been established in patients with impaired renal function; there also have been rare reports of pathologic skin changes in patients with normal renal function. Consequences of gadolinium retention in the brain or in patients with normal renal function have not been established. Patients with normal renal function that may be at higher risk for gadolinium retention include: patients requiring multiple lifetime doses, pregnant and pediatric patients, and patients with inflammatory conditions; take GBCA retention characteristics into consideration for these patients. Minimize repetitive GBCA imaging studies.

• Hypersensitivity reactions: Anaphylactic and other hypersensitivity reactions with cardiovascular, respiratory, and cutaneous manifestations (ranging from mild to severe), including shock (rare), have occurred; appropriate equipment (eg, ventilator) and emergency medications (eg, epinephrine) should be available during use. Reactions typically occur within 30 minutes of administration; however, delayed reactions may also occur (up to several days following administration). Patients with a history of allergic reactions and/or bronchial asthma may be at an increased risk for developing hypersensitivity reactions; use caution in these patients.

• Nephrogenic systemic fibrosis: The risk for nephrogenic systemic fibrosis appears lower in patients with moderate, chronic renal disease (GFR 30 to 59 mL/minute/1.73 m2) and little, if any, in patients with mild, chronic renal disease (GFR 60 to 89 mL/minute/1.73 m2). NSF, a potentially fatal disease, affects the skin, muscle, and internal organs. All patients should be screened for renal dysfunction prior to administration; estimate GFR in patients at risk for chronic renal disease (diabetes, chronic hypertension, age >60 years). In patients at risk of NSF, do not exceed the recommended dosage and allow sufficient time (ie, several half-lives) for elimination prior to readministration (avoidance of readministration is preferred). In patients receiving hemodialysis, consider prompt initiation of hemodialysis following administration. In patients receiving hemodialysis, consider prompt initiation of hemodialysis following administration.

Disease-related concerns:

• Hepatic impairment: Severe hepatic failure, such as markedly elevated serum bilirubin (>3 mg/dL), may impair imaging performance; if used, complete MR imaging within 60 minutes following administration and use both noncontrast and contrast-enhanced images to aid in diagnosis.

• Renal impairment: Use with caution in patients with renal impairment. Dose-dependent worsening of renal function or acute renal failure has occurred in patients with renal insufficiency following use of other gadolinium agents, generally within 48 hours following administration; risk may be lower with gadoxetate due to its combined renal and hepatic elimination pathways. Evaluate renal function in patients with renal impairment prior to use; consider follow-up monitoring. End-stage renal disease may impair imaging performance due to elevated serum ferritin levels; if used, complete MR imaging within 60 minutes following administration and use both noncontrast and contrast-enhanced images to aid in diagnosis.

Other warnings/precautions:

• Appropriate use: Lesions with minimal or no hepatocyte function (eg, cysts, metastases, certain hepatocellular carcinomas) will generally not accumulate gadoxetate resulting in decreased visualization.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution, Intravenous, as disodium:

Eovist: 0.25 mmol/mL (10 mL, 15 mL)

Generic Equivalent Available: US

No

Pricing: US

Solution (Eovist Intravenous)

0.25 mmol/mL (per mL): $17.04

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Administration: Adult

IV: Administer undiluted as rapid IV bolus injection at a rate of 1 to 2 mL/second. Flush line with NS to ensure complete injection of medium. May begin imaging immediately after administration and may be performed up to 120 minutes post-injection. In patients with elevated ferritin or bilirubin (>3 mg/dL) levels, complete MR imaging within 60 minutes following administration.

Administration: Pediatric

IV: Administer undiluted as rapid IV bolus injection at a rate of ~2 mL/second. Flush line with NS to ensure complete injection of medium. May begin imaging immediately after administration and may be performed up to 120 minutes post-injection. In patients with elevated ferritin or bilirubin (>3 mg/dL) levels, complete MR imaging within 60 minutes following administration.

Medication Guide and/or Vaccine Information Statement (VIS)

An FDA-approved patient medication guide, which is available with the product information and as follows, must be dispensed with this medication;

Eovist: https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/022090s027lbl.pdf#page=15

Use: Labeled Indications

Liver imaging: For use with magnetic resonance imaging (MRI) to detect and characterize lesions in patients with known or suspected focal liver disease.

Use: Off-Label: Adult

Magnetic resonance angiography (MRA)

Medication Safety Issues
Sound-alike/look-alike issues:

Eovist may be confused with Evista

Metabolism/Transport Effects

None known.

Drug Interactions

There are no known significant interactions.

Reproductive Considerations

Evaluate pregnancy status prior to the use of gadolinium-based contrast agents in patients who may become pregnant (ACR 2023).

Pregnancy Considerations

Gadolinium-based contrast agents may cross the placenta (ACOG 723 2017; ACR 2023).

Evaluate pregnancy status prior to the use of gadolinium-based contrast agents in patients who may become pregnant (ACR 2023).

Pregnant patients may be at increased risk for gadolinium retention. Use of gadolinium-based contrast agents in pregnancy is controversial and should be limited. A gadolinium-based contrast agent with MRI may be considered for use in pregnancy if it will significantly improve diagnostic performance and is expected to improve fetal or maternal outcome (ACOG 723 2017). In addition, use should only be considered if information needed from the MRI study cannot be acquired without using a contrast agent and cannot be deferred until after delivery. Agents with a low risk for development of nephrogenic systemic fibrosis should be used at the lowest effective dose (ACR 2023).

Breastfeeding Considerations

Gadolinium-based contrast agents may be present in breast milk (ACOG 723 2017; ACR 2023).

Because of the low expected excretion into breast milk and the low absorption from an infant's GI tract, breastfeeding may be continued without interruption after use (ACOG 723 2017; ACR 2023). Theoretically, the taste of milk could be altered if it contains contrast media. Patients who prefer to temporarily withhold breastfeeding may express and discard milk from both breasts during a period of 10 to 24 hours after the administration of contrast media. They can pump and store milk prior to the procedure then bottle feed using the stored milk during this time (ACR 2023).

Monitoring Parameters

Signs of hypersensitivity (during and for several hours after procedure); injection site for extravasation; renal function (prior to administration); short- and long-term monitoring of signs and symptoms of NSF (eg, burning, itching, swelling, hardening and/or tightening of skin, joint stiffness, deep hip or rib bone pain, muscle weakness, limited range of motion, and/or yellowed/raised spots on whites of eye). Evaluate pregnancy status prior to use in patients who may become pregnant (ACR 2023).

Mechanism of Action

Gadoxetate is a gadolinium-containing paramagnetic agent. Exposure to an external magnetic field induces a large local magnetic field in exposed tissues. This local magnetism disrupts water protons in the vicinity, resulting in a change in proton density and spin characteristics, which can be detected by the imaging device.

Pharmacokinetics (Adult Data Unless Noted)

Distribution: Vd: 0.21 L/kg; initial distribution in extracellular space, followed by selective uptake by hepatocytes; does not cross intact blood-brain barrier

Protein binding: <10%

Half-life elimination: Healthy volunteers: 0.91 to 0.95 hours; prolonged with hepatic or renal impairment

Excretion: Urine; feces

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (AT) Austria: Primovist;
  • (CH) Switzerland: Primovist;
  • (HU) Hungary: Primovist;
  • (PT) Portugal: Primovist;
  • (QA) Qatar: Eovist | Primovist
  1. American College of Obstetricians and Gynecologists (ACOG) Committee on Obstetric Practice. Committee Opinion No. 723: guidelines for diagnostic imaging during pregnancy and lactation. Obstet Gynecol. 2017;130(4):e210-e216. Erratum in: Obstet Gynecol. 2018;132(3):786. [PubMed 28937575]
  2. American iCollege of Radiology (ACR), North American Society for Cardiovascular Imagining (NASCI), Society for Pediatric Radiology (SPR). ACR-NASCI-SPR practice guideline for the performance of pediatric and adult body magnetic resonance angiography (MRA). http://medi-guide.meditool.cn/ymtpdf/D19C3AAB-9209-C443-4B21-50B44A05A9A7.pdf. Updated 2010.
  3. American College of Radiology (ACR) Committee on Drugs and Contrast Media. ACR manual on contrast media. https://www.acr.org. Published 2023. Accessed February 12, 2024.
  4. Centers for Disease Control and Prevention (CDC). Nephrogenic fibrosing dermopathy associated with exposure to gadolinium-containing contrast agents -- St. Louis, Missouri, 2002-2006. MMWR Weekly Rep. 2007; 56(7):137-141. [PubMed 17318112]
  5. Eovist (gadoxetate disodium) [prescribing information]. Whippany, NJ: Bayer HealthCare Pharmaceuticals Inc; December 2021.
  6. Eovist (gadoxetate disodium) [prescribing information]. Whippany, NJ: Bayer HealthCare Pharmaceuticals Inc; March 2025.
  7. Joffe P, Thomsen HS, and Meusel M. Pharmacokinetics of gadodiamide Injection in Patients with Severe Renal Insufficiency and Patients undergoing hemodialysis or continuous ambulatory peritoneal dialysis. Acad Radiol. 1998; 5(7):491-502. [PubMed 9653466]
  8. Kuo PH, Kanal E, Abu-Alfa AK, et al. Gadolinium-based MR contrast agents and nephrogenic systemic fibrosis. Radiology. 2007;242(3):647-649. [PubMed 17213364]
  9. Okada S, Katagiri K, Kumazaki T, et al. Safety of gadolinium contrast agent in hemodialysis patients. Acta Radiol. 2001;42(3):339-341. [PubMed 11350296]
  10. Ramalho M, Ramalho J, Burke LM, Semelka RC. Gadolinium retention and toxicity-an update. Adv Chronic Kidney Dis. 2017;24(3):138-146. doi:10.1053/j.ackd.2017.03.004. [PubMed 28501075]
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