Eovist® (gadoxetate disodium) injection 0.25mmol/mL

The Only FDA-Approved Hepatobiliary Specific Contrast Agent (HBA) for MRI Liver Imaging^1,2

Eovist is the only FDA-approved Hepatobiliary Specific Contrast Agent (HBA) for MR liver imaging.^1,2 It is a contrast agent combining dynamic phase imaging (similar to extracellular agents) along with functional, hepatobiliary phase information³ to support your comprehensive evaluation of focal liver disease.

Eovist is indicated for intravenous use in magnetic resonance imaging (MRI) of the liver to detect and characterize lesions in adult and pediatric patients, including term neonates, 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 lesions cell composition^2,4

Review Eovist Mechanism of Action (MOA)

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Eovist Indication

Eovist is indicated for use in magnetic resonance imaging (MRI) of the liver to detect and characterize lesions in adult and pediatric patients, including term neonates, with known or suspected focal liver disease.

How Eovist, a hepatobiliary agent,¹ works

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 phase^2,3
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

Metastasis

Focal Nodular Hyperplasia

References: 1. Melanie K. Seale. Hepatobiliary-specific MR Contrast Agents: Role in Imaging the Liver and Biliary Tree. Radiographics.rsna.org; 2009. 2. Eovist [package insert]. Whippany, NJ: Bayer HealthCare Pharmaceuticals; 2008. 3. American College of Radiology CT/MRI Li-RADS 2018 CORE. 4. Zech CJ, Herrmann KA, Reiser MF, Schoenberg SO. 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.

Safety in Clinical Trials

The safety of Eovist was evaluated in 1,989 adult subjects who received Eovist in clinical trials.

ADVERSE REACTIONS >0.1% IN 1581 PATIENTS AT RECOMMENDED DOSE
Reaction	Rate (%)
Nausea	1.1
Headache	1.1
Feeling hot	0.8
Dizziness	0.6
Back pain	0.6
Vomiting	0.4
Blood pressure increased	0.4
Injection site reactions (Pain, Burning, Coldness, Extravasation, Irritation)	0.4
Dysgeusia	0.4
Paresthesia	0.3
Flushing	0.3
Parosmia	0.3
Pruritus (generalized, eye)	0.3
Rash	0.3
Respiratory disorders (Dyspnea, Respiratory distress)	0.2
Fatigue	0.2
Chest pain	0.1
Vertigo	0.1
Dry Mouth	0.1
Chills	0.1
Feeling abnormal	0.1

Protocol

Allows for dynamic and functional, hepatobiliary liver imaging in <30 minutes¹

Eovist MRIs don't have to require extended table time.

Eovist imaging protocols allow for image acquisition of dynamic and functional, hepatobiliary information in under 30 minutes, which can be important to your department and patient scheduling needs.

Optimized Workflow^2,3

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

Important considerations for high quality Arterial Imaging with Eovist

Consider using a fixed timing dual arterial phase beginning at approximately 25 sec post-injection as noted above^4,5
Patient performs an 18 sec breathhold, while acquiring two back-to-back acquisitions, each taking approximately 9 seconds^4,5
Using high temporal resolution imaging such as DISCO, breathhold can be reduced⁶

References: 1. Eovist [package insert]. Whippany, NJ: Bayer HealthCare Pharmaceuticals Inc; 2008. 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 Im. 2002;16:259-266. REF-US-28431. 5. Pietryga JA, Burk LMB, Marin D. Respiratory Motion Artifact Affecting Hepatic Arterial Phase imaging with Gadoxetate Disodium. Radiology. 2014;271(2):426-34. REF-US-28430. 6. Manojkumar Saranathan, Dan W. Rettmann. Differential Subsampling with Cartesian (DISCO). J Magn Reson Im 35:1484-1492 (2012).

Dosing

Uses less Gadolinium Per Dose Than Extracellular MRI Agents

52 YEAR-OLD MALE WITH SUSPECTED HEPATOCELLULAR CARCINOMA

Image shown is not an actual patient

Imaging Procedure - Abdominal/Liver MRI
Weight - 176 lbs
The recommended dose is 8 mL
The recommended dose of Eovist is 0.1mL/kg body weight (0.025 mmol/kg body weight).

Case Studies

See Eovist in action with the case studies below or additional cases linked here.
For The Detection and Characterization of Focal Liver Disease.

Detecting Focal Liver Lesions: MRI with Eovist
53-YEAR-OLD MALE WITH ABDOMINAL PAIN

20-minute hepatobiliary phase images reveal presence of additional metastatic deposits (example highlighted with red arrow) confirmed at surgical resection.

Case courtesy of Rajan T. Gupta, M.D., Associate Professor of Radiology, Duke University Medical Center, Duke
University, Durham, North Carolina

The patient data that appears in this document is actual health information but all personal identifiers have been removed or otherwise anonymized.
No personally identifiable information is shown.

41-YEAR-OLD MALE WITH KNOWN SEGMENT III METASTASIS FROM CT

20-minute hepatobiliary phase identified three additional lesions (highlighted with pink arrows) not seen on previous images.

Case courtesy of Dr. Claude Sirlin, University of California San Diego Liver Imaging Group.

Characterizing Lesions with Eovist
64-YEAR-OLD MALE WITH WEIGHT LOSS

CT (A and B) and MRI (C and D) dynamic imaging revealed a large capsulated mass in right lobe (white arrow) and
questionable area in left lobe (white circle). Right hepatectomy and biopsy of left lobe lesion was planned.

Eovist MRI hepatobiliary phase confirmed the presence of the two lesions seen previously, and also showed numerous additional lesions (red arrows) in both lobes that were not seen on other imaging. Right hepatectomy was subsequently canceled and the patient was managed medically.
Case courtesy of Dushyant V. Sahani M.D., Director of Computed Tomography, Massachusetts General Hospital and Associate Professor of Radiology. Harvard. Boston, Massachusetts.

Packaging Information

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

SINGLE-DOSE VIALS (mL)	Vial Size (mL)	NDC Code	McKesson Material Number
In Boxes of 5	10	(NDC 50419-320-05)	3278959
	15	(NDC 50419-320-15)	2018554

Ordering Information

Eovist can be ordered through all the same suppliers as for other Bayer imaging products. Purchasing from McKesson Specialty 3rd Party Logistics (3PL), Bayer Radiology's primary distributor, allows you to avoid additional shipping charges and receive a 2% quick-pay discount when invoices are paid within 30 days.

Call 1-877-259-4624 (option #1) or
Contact your local distributor

For more information on reimbursement and purchasing options, click here.

If you have a question about reimbursement, please contact Bayer's Reimbursement Hotline Managed by Pinnacle at 1-800-423-7539 or BayerImaging@thepinnaclehealthgroup.com.

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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.