Eovist® (gadoxetate disodium) injection 0.25 mmol/mL


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Eovist® (gadoxetate disodium) injection

Eovist® is the first and only gadolinium-based MRI-contrast agent approved 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.

Overview and Characteristics

Eovist® Overview and Characteristics

See the value of functional information

In addition to dynamic-phase imaging, Eovist® Injection offers additional morphological and functional information about lesion cell composition. Compared with pre-contrast MRI, MRI with Eovist® increases liver-to-lesion contrast during the hepatocyte phase.1,2

Dynamic phase

Like extracellular GBCA, Eovist® provides morphological and vascular information.

Hepatocyte phase

Eovist® allows for intracellular hepatocyte phase imaging approximately 20 minutes after injection.1,2

Dynamic phase & Hepatocyte phase Chart

Bolus injection of Eovist®

Eovist® distributes rapidly into the extracellular space.

Hepatocyte-specific uptake

50% of the Eovist® dose is selectively taken up by functioning hepatocytes.

Dual elimination

  • Eovist® is equally eliminated via renal and hepatobiliary systems in patients with normal renal and liver function
  • If one of the pathways is impaired, Eovist® can still be eliminated without significant pharmacokinetic or pharmacodynamic changes, except in patients with end-stage renal failure (ESRF)
  • Severe hepatic impairment or ESRF may impair Eovist® imaging performance
Dual Elimination Chart

Eovist® Clinical Pharmacology Video

See how Eovist® is distributed into the extracellular space after bolus injection and selectively taken up by functioning hepatocytes due to its lipophilic (EOB) moiety.

Physiochemcial Properties Chart

Demonstrated safety profile in clinical trials

  • Overall 4.3% 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 predominately of mild to moderate severity.3
  • The most frequent (≥0.5%) adverse reactions associated with the use of Eovist® are nausea, headache, feeling hot, dizziness and back pain.3
Adverse Reactions Chart

References: 1. Bluemke DA, Sahani D, Amendola M, et al. Efficacy and safety of MR imaging with liver-specific contrast agent: U.S. multicenter phase III study. Radiology. 2005;237:(1)89-98. 2. Huppertz A, Balzer T, Blakeborough A, et al. Improved detection of focal liver lesions at MR imaging: multicenter comparison of gadoxetic acid-enhanced MR images with intraoperative findings. Radiology. 2004;230:266-275. 3. Eovist® [package insert]. Whippany, NJ: Bayer HealthCare Pharmaceuticals Inc; 2013.

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Diagnosing Liver Lesions

Lesion Detection

In clinical trials, Eovist®-enhanced MRI demonstrated improved lesion detection, as compared with pre-contrast MRI:

  • Significant improvement in detection of metastases and hepatocellular carcinoma1
  • 12% more small metastases (<1 cm in diameter) detected1*

*Standard of Reference (SOR): surgical specimen and/or intraoperative US (IOUS)

History 41-year-old male chart

Diagnosis: Small liver metastases

Next step: Scheduled hepatectomy cancelled

HolaKere Quote

Lesion characterization

In clinical trials, as compared with pre-contrast MRI, Eovist®-enhanced MRI demonstrated:

  • Improved lesion classification of benign vs malignant1,2*
  • Improved lesion characterization by 12% (96% with Eovist®-enhanced MRI vs. 84% with unenhanced MRI, p=0.0002)4

*SOR: histopathology and/or IOUS and/or long-term imaging follow up.

History 35-year-old female chart

Differential diagnosis:

  • Focal nodular hyperplasia (FNH)
  • Adenoma
  • Hepatocellular carcinoma (HCC)

Diagnosis: FNH and → Adenoma

Next step: Follow-up imaging (6 months later)


Zech Quote

Diagnostic confidence

In clinical trials, as compared with pre-contrast MRI, Eovist®-enhanced MRI improved diagnostic confidence and accuracy:

  • High confidence of lesion characterization: 92% vs 63%2*
  • Improved the accuracy of classification of benign vs malignant lesions from 90.9% to 97.5%2

*SOR: histopathology and/or IOUS and/or long-term imaging follow up.
Gadolinium-based contrast agent.

History 35-year-old female chart

Differential diagnosis:

  • Atypical FNH
  • Adenoma
  • HCC

Next step: Biopsy?

Diagnosis: Fibrolamellar HCC

Next step: Resection (pathology confirmed)

Please see Full Prescribing Information.

References: 1. Bluemke DA, Sahani D, Amendola M, et al. Efficacy and safety of MR imaging with liver-specific contrast agent: U.S. multicenter Phase III study. Radiology. 2005;237:(1)89-98. 2. Raman S, Leary C, Bluemke DA, et al. Improved characterization of focal liver lesions with liver-specific Gd-EOB-DTPA-enhanced magnetic resonance imaging: a phase III clinical trial. Comput Assist Tomogr. In press. 3. Holalkere NS, Sahani DV, Blake MA, et al. Characterization of small liver lessions: added role of MR after MDCT. J Comput Assist Tomogr. 2006;30:591-596 4. Data on file. Bayer Healthcare Pharmaceuticals. 5. Zech CJ, Herrmann KA, Reiser MF, et al. MR imaging in patients with suspected liver metastases: value of liver-specific contrast agent Gd-EOB-DTPA. Magn Reson Med Sci. 2007;6:43-52.

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Dosing

Dosing

  • Due to high relaxivity in plasma and the liver, the approved dose of Eovist® injection is 0.025 mmol/kg.1-3
The dose of Eovist

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
Dosage Informatin Chart

References: 1. Zech CJ, Herrmann KA, Reiser MF, et al. MR imaging in patients with suspected liver metastases: value of liver-specific contrast agent Gd-EOB-DTPA. Magn Reson Med Sci. 2007;6:43-52. 2. Data on file. Bayer HealthCare Pharmaceuticals. 3. Eovist® [package insert]. Whippany, NJ: Bayer HealthCare Pharmaceuticals Inc; 2013.

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Packaging

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
Single Dose Vials Chart
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Reimbursement

Reimbursement

The Bayer Imaging Reimbursement Helpline is available to all institutions to provide further information. The Helpline can be reached at 1-800-423-7539. The HCPCS code A9581 should be used for all claims with dates of service beginning January 1, 2010.

Hospital Outpatient

Hospital Outpatient Chart

When billing for Eovist® for hospital outpatient services on or after January 1, 2010:

  • Enter the A9581 code in record locator 44 on the CMS 1450 Form
  • If appropriate, bill for a quantity of 10 units in record locator 46 to reflect the total mL dosage

Freestanding Outpatient

Freestanding Outpatient Chart

When billing for Eovist® for freestanding outpatient services on, or after, January 1, 2010:

  • Enter the A9581 code in Field 254D on the CMS 1500 Form
  • If appropriate, bill for a quantity of 10 units in Field 24G to reflect the total mL dosage

To avoid billing confusion, the use of Eovist® should be noted on the patient's report dictated by the radiologist.

Note: These codes are provided for your information only. It is the responsibility of the provider to determine the most appropriate code to use in billing for services rendered. The use of these codes does not guarantee payment.

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Purchasing

Purchasing Resources

In today's cost-conscious healthcare environment, Bayer HealthCare LLC offers a comprehensive line of quality imaging products at competitive prices combined with highly regarded service and support. Knowing that purchasers have unique requirements, we do our best to provide creative yet competitive contracts that go beyond just meeting product needs. Additional purchasing resources are described below.

Bayer HealthCare LLC's partnership with McKesson Specialty Care Solutions combines Bayer's commitment to our customers with the drug distribution of McKesson, focused on delivering the right product to the right place at the right time. McKesson's reputation for reliable service makes them an ideal solution through which to source your Bayer HealthCare LLC imaging products.

Suppliers are listed below in alphabetical order.

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INDICATION and IMPORTANT SAFETY INFORMATION

INDICATION AND USAGE

Eovist® (gadoxetate disodium) 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.

IMPORTANT SAFETY INFORMATION

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 for 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®. Anaphylactoid and anaphylactic reactions with cardiovascular, respiratory and cutaneous manifestations, ranging from mild to severe reactions, including shock have uncommonly occurred following Eovist® administration. Patients with any history of a reaction to contrast media, bronchial asthma, and/or allergic disorders may have an increased risk for a hypersensitivity reaction to Eovist®.

Acute Kidney Injury: In patients with chronic renal impairment, acute kidney injury sometimes requiring dialysis has been observed with the use of some GBCAs. The risk of acute kidney injury might be lower with Eovist® due to its dual excretory pathways. Do not exceed the recommended dose.

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 method (for example, Ferrocine complexation method) may result in falsely high or low values for up to 24 hours after Eovist® administration.

Interference with Visualization of Liver Lesions: Severe renal or hepatic failure may impair Eovist® imaging performance. In patients with end-stage renal failure, hepatic contrast was markedly reduced and attributed to elevated serum ferritin levels. In patients with abnormally high (>3 mg/dL) serum bilirubin, reduced hepatic contrast was observed. If Eovist® is used in these patients, complete MR imaging no later than 60 minutes after Eovist® administration and use a paired non-contrast and contrast MRI set for diagnosis.

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%).

Please see Full Prescribing Information.

You are encouraged to report negative side effects or quality complaints of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.