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Eovist (Gadoxetate Disodium) - Summary

 
 



WARNING: NEPHROGENIC SYSTEMIC FIBROSIS

Gadolinium-based contrast agents increase the risk for nephrogenic systemic fibrosis (NSF) in patients with:

  • acute or chronic severe renal insufficiency (glomerular filtration rate <30 mL/min/1.73m2), or
  • acute renal insufficiency of any severity due to the hepato-renal syndrome or in the perioperative liver transplantation period.

In these patients, avoid use of gadolinium-based contrast agents unless the diagnostic information is essential and not available with non-contrast enhanced magnetic resonance imaging (MRI). NSF may result in fatal or debilitating systemic fibrosis affecting the skin, muscle and internal organs. Screen all patients for renal dysfunction by obtaining a history and/or laboratory tests. When administering a gadolinium-based contrast agent, do not exceed the recommended dose and allow a sufficient period of time for elimination of the agent from the body prior to any readministration [ see Warnings and Precautions (5.1) ].

 

EOVIST SUMMARY

EOVIST (gadoxetate disodium) is a paramagnetic contrast agent for MRI. EOVIST is provided as a sterile, clear, colorless to pale yellow aqueous solution for intravenous injection.

EOVIST® Injection is a gadolinium-based contrast agent indicated for intravenous use in T1-weighted magnetic resonance imaging (MRI) of the liver to detect and characterize lesions in adults with known or suspected focal liver disease.


See all Eovist indications & dosage >>

NEWS HIGHLIGHTS

Published Studies Related to Eovist (Gadoxetic Acid)

Evaluation of possible drug-drug interaction between gadoxetic acid and erythromycin as an inhibitor of organic anion transporting peptides (OATP). [2011.02]
PURPOSE: To evaluate if erythromycin compromises liver-specific enhancement of gadoxetic acid; both compounds competing in organic anion transporting peptides (OATP) -mediated hepatocytic uptake... CONCLUSION: Coadministration of erythromycin has no effect on gadoxetic acid enhanced liver MR imaging. Copyright (c) 2011 Wiley-Liss, Inc.

Enhancement of liver parenchyma after injection of hepatocyte-specific MRI contrast media: a comparison of gadoxetic acid and gadobenate dimeglumine. [2010.02]
PURPOSE: To compare enhancement of liver parenchyma in MR imaging after injection of hepatocyte-specific contrast media... CONCLUSION: In the delayed, hepatocyte-specific phase, liver enhancement after injection of gadoxetic acid was superior to that obtained with gadobenate dimeglumine.

Enhancement of liver parenchyma after injection of hepatocyte-specific MRI contrast media: a comparison of gadoxetic acid and gadobenate dimeglumine. [2010]
of hepatocyte-specific contrast media... CONCLUSION: In the delayed, hepatocyte-specific phase, liver enhancement after

Gadoxetic acid disodium-enhanced hepatocyte phase MRI: Can increasing the flip angle improve focal liver lesion detection? [2011.09.29]
PURPOSE: To determine whether hepatocyte phase gadoxetic acid disodium (EOB)-enhanced MRI using a high flip angle (FA) improves focal liver lesion (FLL) detection compared with using a standard low FA... CONCLUSION: Hepatocyte phase EOB-enhanced MRI with increasing FA can significantly increase LLC and improve the detection of FLLs, particularly small malignant lesions. J. Magn. Reson. Imaging 2011;. (c) 2011 Wiley-Liss, Inc. Copyright (c) 2011 Wiley-Liss, Inc.

Detection, classification, and characterization of focal liver lesions: Value of diffusion-weighted MR imaging, gadoxetic acid-enhanced MR imaging and the combination of both methods. [2011.05.20]
Aim: To evaluate diffusion-weighted MR imaging (DWI), gadoxetic acid-enhanced MR imaging and the combination of both methods in the detection, classification, and characterization of focal liver lesions (FLL). Methods: A total of 119 FLL (28 HCCs, 39 metastases, 15 FNHs, 11 adenomas, 13 hemangiomas, 13 cysts) were retrospectively analyzed in 36 patients...

more studies >>

Clinical Trials Related to Eovist (Gadoxetic Acid)

Primovist / Eovist in Renally Impaired Patients [Recruiting]
Patients with moderate to severe renal impairment scheduled for a magnetic resonance imaging (MRI) scan and injection with a contrast agent, Primovist/Eovist, will be asked to participate.

The administration of contrast agents that contain gadolinium such as Primovist/Eovist might increase a potential risk to develop a rare condition called nephrogenic systemic fibrosis (NSF) in patients with renal impairment. This study is to assess the potential risk to develop NSF in patients with renal impairment after the administration of Primovist/Eovist.

Patients who are enrolled in this study will receive a Primovist/Eovist enhanced MRI scan which was prescribed by the referring doctor. After the MRI scan the patient will be included in a two year follow-up period to assess if signs or symptoms suggestive of NSF have appeared.

Liver MRI With Primovist/Eovist in Pediatric Subjects Who Are Suspected or Have Focal Liver Lesions. [Recruiting]
Medical records are reviewed to obtain information about the use of a MRI diagnostic imaging agent (contrast agent) called Primovist/Eovist in children older than 2 months and less than 18 years. Data that has been recorded in the child's medical records relating to the injection of Primovist/Eovist will be collected. Information will be collected from up to 2 weeks before the child received Primovist/Eovist until 12 months after the child received Primovist/Eovist. Copy of the child's MR images that were taken right before and after the child received Primovist/Eovist and all other reports (laboratory reports, other imaging reports, etc) that are part of the child's medical records during that time period will be collected.

The Role of Gadoxetate (Eovist) Enhanced CT in Evaluating Cholangiocarcinoma [Recruiting]
The purpose of this project is to evaluate the role of gadoxetate (EovistŪ) enhanced dual-energy CT in better evaluating perihilar cholangiocarcinoma. This pilot project aims to address a long-term pitfall in the imaging of cholangiocarcinomas, by providing higher resolution delineation of these often infiltrative tumors on single-source, Dual-Energy Spectral Multi Detector CT (MDCT), capitalizing on improved spatial resolution achievable with MDCT compared to MRI and at the same time producing a non-invasive CT cholangiogram to aid in accurate diagnosis and treatment planning of cholangiocarcinoma, particularly, the hilar variety.

Utility Study of Primovist-MRI on HCC Staging [Recruiting]
Gadoxetic acid (Gd-EOB-DTPA, Primovist)-enhanced MRI can affect on BCLC staging during the initial staging workups of definite HCC patients with very early or early stage disease, but with no suspicious intrahepatic HCC lesions by liver dynamic CT.

24hr Imaging Of HCC After EOVIST [Recruiting]
In this research study, the investigators are looking to see if MR imaging with Eovist performed 24 hours after the injection of Eovist helps improve the identification and characterization of focal liver tumors.

more trials >>

Reports of Suspected Eovist (Gadoxetic Acid) Side Effects

Urticaria (4)Chest Discomfort (4)Nausea (4)Throat Irritation (4)Pruritus (2)Injection Site Haematoma (2)Dyskinesia (2)Vomiting (2)Rash Macular (2)Injection Site Pruritus (2)more >>


Page last updated: 2013-02-10

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