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Important Safety Information
Full Prescribing Information
Medication Guide
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An Essential Diagnostic Tool to Support Your Magnetic Resonance (MR) Liver Imaging Practice

Eovist® is the only FDA-approved Hepatobiliary Specific Contrast Agent (HBA) for MR imaging of the liver.1,2 It is a bi-phasic contrast agent combining dynamic phase imaging (similar to extracellular agents) along with functional, hepatobiliary phase information to support your comprehensive evaluation of focal liver disease.2

Eovist® is indicated for intravenous use in magnetic resonance imaging (MRI) of the liver to detect and characterize lesions in patients with known or suspected focal liver disease.

In addition to dynamic-phase imaging, Eovist® specifically targets functioning hepatocytes within the liver providing additional morphological and functional images about lesion cell composition.1,2

How Eovist®, a hepatobiliary agent, works2

  • Following Injection, Eovist® is equally eliminated through the renal and hepatic systems
  • Eovist® is initially distributed in the extracellular space, allowing for arterial, portal venous, and transitional imaging phase1,3
  • Further assessment of lesions through hepatobiliary phase imaging at 20 minutes post injection:
    •  Lesions with little or no hepatobiliary function will generally not accumulate Eovist® 
    • Lesions with normal hepatobiliary function will accumulate Eovist®

References: 1. Eovist® [package insert]. Whippany, NJ: Bayer HealthCare Pharmaceuticals Inc; 2018. 2. Seale MK, Catalano OA, Saini S, Hahn PF, Sahani DV. Hepatobiliary-specific MR contrast agents: role in imaging the liver and biliary tree. Radiographics. 2009;29:1725-1748. doi: 10.1148/rg.296095515. 3. American College of Radiology CT/MRI Li-RADS 2018 CORE.

In clinical trials among 1,989 patients, of whom 1,581 received the recommended dose:

  • Overall, 4% of subjects reported one or more reactions during a follow-up period that for most subjects extended 24 hours after Eovist® administration. The adverse reactions were predominantly of mild to moderate severity.
  • The most frequent (≥0.5%) adverse reactions associated with the use of Eovist® were nausea, headache, feeling hot, dizziness, and back pain.

Eovist_Adverse Reactions_Table 1@2x

Dosing Eovist®

  • Due to high relaxivity in plasma and the liver, the approved dose of Eovist® injection is 0.025 mmol/kg.1

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The Eovist® 15 mL single-dose vial is available to conveniently dose patients weighing 220 lbs to 330 lbs.

  • Quality: Maintain image quality through appropriate weight-based dosing in patients requiring >10 mL
  • Minimization of waste: Use one 15 mL vial instead of two 10 mL vials

Dosing Chart

Dynamic and functional liver imaging in <30 minutes1

Eovist® MRIs don’t have to require extended table time. Imaging protocols with Eovist® allow for the collection of dynamic and functional information in under 30 minutes1, that is important to your department and patient scheduling needs.

Eovist_Optimized_Workflow@2x

 

References: 1. Eovist® [package insert]. Whippany, NJ: Bayer HealthCare Pharmaceuticals Inc; 2018. 2. American College of Radiology CT/MRI Li-RADS 2018 CORE. 3. Jhaveri K, Cleary S, Pascale A. Consensus Statements From a Multidisciplinary Expert Panel on the Utilization and Application of a Liver-Specific MRI Contrast Agent (Gadoxetic Acid). Am J Roentgen AJR. 2015;204:498-509. 4. Yoshioka H, Takahashi N, Yamaguchi M. Double Arterial Phase Dynamic MRI with Sensitivity Encoding (SENSE) for Hypervascular Hepatocellular Carcinomas. J Magn Reson Imaging. 2002;16:259-266.

See Eovist in action with the case studies below. Or go to the Resources section to see all videos.

57-year-old male with suspected liver metastasis from renal cell carcinoma 

59‐year‐old female with history of Hepatitis C 

52-year-old male with suspected liver metastasis from colorectal cancer

Eovist® Packaging

  •  Eovist® injection is supplied in single-dose, rubber-stoppered vials containing 181.43 mg/mL of gadoxetate disodium, equivalent to 0.25 mmol/mL
  • The recommended dose of Eovist® injection is 0.025 mmol/kg body weight

eov_table4

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Note: The Bayer in Radiology contrast and device products should be used in accordance with the Prescribing Information and Instructions For Use, respectively.

 

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IMPORTANT SAFETY INFORMATION and INDICATIONS
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WARNING: NEPHROGENIC SYSTEMIC FIBROSIS (NSF)
 

Gadolinium-based contrast agents (GBCAs) increase the risk for NSF among patients with impaired elimination of the drugs. Avoid use of GBCAs in these patients unless the diagnostic information is essential and not available with non-contrasted MRI or other modalities. NSF may result in fatal or debilitating fibrosis affecting the skin, muscle and internal organs.

  • The risk of NSF appears highest among patients with:
    • Chronic, severe kidney disease (GFR <30 mL/min/1.73m2), 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 (for example, age >60 years, hypertension or diabetes), estimate the glomerular filtration rate (GFR) through laboratory testing.
  • For patients at highest risk for NSF, do not exceed the recommended EOVIST dose and allow a sufficient period of time for elimination of the drug from the body prior to any re-administration.

Contraindication and Important Information about Hypersensitivity Reactions: Eovist® is contraindicated in patients with history of severe hypersensitivity reactions to Eovist®. Anaphylactic and other hypersensitivity reactions with cardiovascular, respiratory and cutaneous manifestations, ranging from mild to severe, including shock have uncommonly occurred following Eovist® administration. Before Eovist® administration, assess all patients for any history of a reaction to contrast media, bronchial asthma and allergic disorders. These patients may have an increased risk for a hypersensitivity reaction to Eovist®.

 

Gadolinium Retention: Gadolinium is retained for months or years in several organs. Linear GBCAs cause more retention than macrocyclic GBCAs. At equivalent doses, retention varies among the linear agents. Retention is lowest and similar among the macrocyclic GBCAs. Consequences of gadolinium retention in the brain have not been established, but they have been established in the skin and other organs in patients with impaired renal function. While clinical consequences of gadolinium retention have not been established in patients with normal renal function, certain patients might be at higher risk. These include patients requiring multiple lifetime doses, pregnant and pediatric patients, and patients with inflammatory conditions. Consider the retention characteristics of the agent and minimize repetitive GBCA studies, when possible.

 

Acute Kidney Injury: In patients with chronic renal impairment, acute kidney injury sometimes requiring dialysis has been observed with the use of GBCAs. Do not exceed the recommended dose; the risk of acute kidney injury may increase with higher than recommended doses.

 

Extravasation and Injection Site Reactions: Ensure catheter and venous patency before the injection of Eovist®. Extravasation into tissues during Eovist® administration may result in local tissue reactions. Strictly avoid intramuscular administration of Eovist® because it may cause myocyte necrosis and inflammation.

 

Interference with Laboratory Tests: Serum iron determination using complexometric methods may result in falsely high or low values for up to 24 hours after the examination with Eovist®.

 

Interference with Visualization of Liver Lesions: End-stage renal failure or hepatic failure may impair Eovist® imaging performance. In patients with elevated serum ferritin or serum bilirubin >3 mg/dL, reduced hepatic contrast was observed.

 

Adverse Reactions: The most frequent (≥0.5%) adverse reactions associated with Eovist® are nausea (1.1%), headache (1.1%), feeling hot (0.8%), dizziness (0.6%), and back pain (0.6%).

 

INDICATIONS AND USAGE

Eovist® (gadoxetate disodium) injection is indicated for intravenous use in magnetic resonance imaging (MRI) of the liver to detect and characterize lesions in patients with known or suspected focal liver disease.

Please see Full Prescribing Information for Eovist®.

Consulte la información de prescripción completa para Eovist®.

Medication Guide

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