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.
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
Like extracellular GBCA, Eovist® provides morphological and vascular information.
Eovist® allows for intracellular hepatocyte phase imaging approximately 20 minutes after injection.1,2
Bolus injection of Eovist®
Eovist® distributes rapidly into the extracellular space.
50% of the Eovist® dose is selectively taken up by functioning hepatocytes.
- 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
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.
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
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.Back to top
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)
Diagnosis: Small liver metastases
Next step: Scheduled hepatectomy cancelled
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.
- Focal nodular hyperplasia (FNH)
- Hepatocellular carcinoma (HCC)
Diagnosis: FNH and → Adenoma
Next step: Follow-up imaging (6 months later)
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.
- Atypical FNH
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.Back to top
- Due to high relaxivity in plasma and the liver, the approved dose of Eovist® injection is 0.025 mmol/kg.1-3
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
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.Back to top
- 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
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.
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
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.Back to top
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