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 (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.
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. 
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...
Clinical Trials Related to Eovist (Gadoxetic Acid)
Evaluation of Remnant Liver Function Using Primovist-enhanced MRI Before Resection/Ablation of Hepatocellular Carcinoma [Active, not recruiting]
The purpose of this study is to determine whether the global and segmental hepatic uptake
and excretion of Gd-EOB-DTPA on Gd-EOB-DTPA-enhanced liver MRI correlates with standard
liver function test results in the patients with Hepatocellular Carcinoma (HCC) before major
hepatic resection or radiofrequency ablation (RFA).
Primovist / Eovist in Renally Impaired Patients [Completed]
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
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
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.
Primovist Post-marketing Surveillance in Japan [Completed]
This study is a regulatory post marketing surveillance in Japan, and it is a local
prospective and observational study of patients who have received Primovist for contrast
enhancement in MRI of liver. The objective of this study is to assess safety, especially in
relation to renal dysfunction, and efficacy of using Primovist in clinical practice. A total
2,000 patients for diagnosis on detection and identify hepatic tumor will be recruited and
followed 7 days after the injection.
Liver Lesions in Contrast-Enhanced Magnetic Resonance Imaging (MRI) [Recruiting]
The goal of this clinical research study is to learn if using 2 different kinds of contrast
agents (Eovist [gadoxetate] and Gadovist [gadobutrol]) given at the same time is better than
using 1 contrast agent alone in learning which liver lesions may be cancerous.
Contrast agents are used by doctors in order to see MRI images more clearly.
Reports of Suspected Eovist (Gadoxetic Acid) Side Effects
Chest Discomfort (4),
Throat Irritation (4),
Injection Site Haematoma (2),
Rash Macular (2),
Injection Site Pruritus (2), more >>
Page last updated: 2013-02-10