Bayer - Eovist Liver MRI Case Study_Characterization of Focal Liver Lesions PP-EOV-US-0121_v3

Case Study in Magnetic Resonance Imaging (MRI) Characterization of Focal Liver Lesions

Indication 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.

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 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.

Please see additional Important Safety Information throughout this brochure.

Please also see the enclosed Full Prescribing Information.

Case courtesy of Dr. Elmar M. Merkle, Center for Advanced MR Development, Duke University Medical Center, Durham, NC. Participating physicians were compensated for their time in submitting these cases.

Case Study in MRI of the Liver: Characterization of Focal Liver Lesions History ° A 39-year-old female presented with vague abdominal pain and a focal liver lesion was seen on ultrasound ° Bilirubin levels were normal and estimated glomerular filtration rate (eGFR) was over 60 mL/min/1.73m2 ° It was determined that the patient was not pregnant.

Eovist-enhanced MRI was performed to further evaluate the lesion A: Pre-contrast Axial pre-contrast gradient recalled echo (GRE) T1 demonstrates an isointense mass with central low intensity in the left lobe of the liver.

A

Important Safety Information (continued) 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.

Please see additional Important Safety Information throughout this brochure.

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A Focus On Liver Imaging

15 seconds

B

25 seconds

C

35 seconds

D

B–D: Arterial Phase Triple arterial phase imaging demonstrates a hyperenhancing mass with a slightly darker region in the center suggestive of a scar.

E

E: Portal Venous Phase During the portal venous phase, the lesion is isointense to the surrounding liver parenchyma.

G

F

F: Transitional Phase In the transitional phase, the lesion starts to become slightly hyperintense relative to the surrounding liver.

H

G–H: Hepatobiliary Phase In the hepatobiliary phase images (G: 10 minutes post-Eovist injection and H: 20 minutes postEovist injection), the lesion became increasingly hyperintense indicating uptake of Eovist by functioning hepatocytes. The central region remained unenhanced, consistent with the presence of a central scar typical of focal nodular hyperplasia (FNH).

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I: T1-weighted The coronal T1-weighted hepatobiliary phase maximum intensity projection (MIP) image post-Eovist injection shows a hyperenhancing mass typical of FNH. Also, note the biliary excretion into the common bile duct and duodenum.

Conclusion Due to the uptake of Eovist seen during hepatobiliary phase imaging, the lesion was characterized as an FNH, a benign lesion. No follow-up was needed.

Please see clinical study data on reverse side of this page.

I

Important Safety Information (continued) 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%).

Please see Full Prescribing Information.

Please see additional Important Safety Information throughout this brochure.

4

A Focus On Liver Imaging

Results for Eovist® (gadoxetate disodium) Injection Clinical Studies The combination of non-contrasted and Eovist-contrasted magnetic resonance (MR) images had improved sensitivity for the detection and characterization of liver lesions, compared to pre-contrasted MR images (Tables 1 and 2). The improved sensitivity in detection of lesions was predominantly related to the detection of additional lesions among patients with multiple lesions on the pre-contrast MR images. The false positive rates for detection of lesions were similar for non-contrasted MR images and Eovist-contrasted MR images (32% versus 34% respectively). Liver lesion detection and characterization results were similar between computed tomography (CT) and the combination of pre-contrasted and Eovist-contrasted MR images.

Table 1: Sensitivity in Liver Lesion Detection (%) Diagnostic Procedure Pre-contrast MRI

Combined pre- and Eovist-contrast MRI Difference: Combined pre- + Eovistcontrast MRI minus pre-contrast MRI (95% confidence interval)

Table 2: Proportion of Correctly Characterized Lesions (%)†

Reader

Study 1 n = 129

Study 2 n = 126

Study 3 n = 182

Study 4 n = 177

Reader 1

76

77

51

60

Reader 2

76

73

59

64

Reader 3

71

72

53

48

Reader 1

81

82

67

61

Reader 2

78

76

76

76

Reader 3

74

78

58

67

Reader 1

5 (1, 9)*

5 (1, 9)*

16 (7, 25)*

1 (-7, 10)

Reader 2

2 (-1, 5)

3 (-1, 7)

17 (9, 25)*

11 (5, 18)*

Reader 3

3 (0, 6)*

6 (0, 10)*

5 (-2, 12)

19 (11, 27)*

* Statistically significant improvement † Proportion of correctly characterized lesions with respect to the reference

Important Safety Information (continued) 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%).

Please see additional Important Safety Information throughout this brochure.

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Prescribing Information

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.

Bayer, the Bayer Cross, and Eovist are trademarks owned by and/or registered to Bayer in the U.S. and/or other countries. Other trademarks and company names mentioned herein are properties of their respective owners and are used herein solely for informational purposes. No relationship or endorsement should be inferred or implied.

Bayer HealthCare LLC 100 Bayer Boulevard P.O. Box 915 Whippany, NJ 07981 U.S.A. Phone: +1-412-767-2400 +1-800-633-7231 Fax: +1-412-767-4120 More information on radiologysolutions.bayer.com

PP-EOV-US-0121-1â&#x20AC;&#x192; July 2020

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