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Pioneers in magnetic resonance imaging (MRI), Bayer continually pushes to develop technologies that enhance the quality of scans and streamline the workflow for technicians.
MEDRAD® MRXperion MR Injection System
Provide your practice with improved efficiencies, personalized care, and reproducible quality.
Gadavist®
(gadobutrol) injection
1 mmol/mL
Please see Full Prescribing Information, including Boxed Warning, for Gadavist® (gadobutrol) injection.
Please see Important Safety Information for Gadavist®.
Eovist®
(gadoxetate disodium) injection
0.25 mmol/mL
Please see Full Prescribing Information, including Boxed Warning, for Eovist® (gadoxetate disodium) injection.
Please see Important Safety Information for Eovist®.
Note: The Bayer in Radiology contrast and device products should be used in accordance with the Prescribing
Information and Instructions For Use, respectively.
INDICATIONS and IMPORTANT SAFETY INFORMATION
GADAVIST® (gadobutrol) Injection
INDICATIONS AND USAGE
Gadavist® (gadobutrol) injection is a gadolinium-based contrast agent indicated for use with magnetic resonance imaging (MRI):
- To detect and visualize areas with disrupted blood brain barrier and/or abnormal vascularity of the central nervous system in adult and pediatric patients including term neonates.
- To assess the presence and extent of malignant breast disease in adult patients.
- To assess myocardial perfusion (stress, rest) and late gadolinium enhancement in adult patients with known or suspected coronary artery disease (CAD).
Gadavist® is indicated for use in magnetic resonance angiography (MRA):
- To evaluate known or suspected supra-aortic or renal artery disease in adult and pediatric patients including term neonates.
IMPORTANT SAFETY INFORMATION
WARNING: RISK ASSOCIATED WITH INTRATHECAL USE and NEPHROGENIC SYSTEMIC FIBROSIS Risk Associated with Intrathecal Use Intrathecal administration of gadolinium-based contrast agents (GBCAs) can cause serious adverse reactions including death, coma, encephalopathy, and seizures. Gadavist is not approved for intrathecal use. Nephrogenic Systemic Fibrosis GBCAs increase the risk for NSF among patients with impaired elimination of the drugs. Avoid use of Gadavist 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:
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 Gadavist 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: Gadavist® is contraindicated in patients with history of severe hypersensitivity reactions to Gadavist®. Anaphylactic and other hypersensitivity reactions with cardiovascular, respiratory, or cutaneous manifestations, ranging from mild to severe, including death, have uncommonly occurred following Gadavist® administration. Before Gadavist® administration, assess all patients for any history of a reaction to contrast media, bronchial asthma and/or allergic disorders. These patients may have an increased risk for a hypersensitivity reaction to Gadavist®.
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 Gadavist®. Extravasation into tissues during Gadavist® administration may result in moderate irritation.
Overestimation of Extent of Malignant Disease in MRI of the Breast: Gadavist® MRI of the breast overestimated the histologically confirmed extent of malignancy in the diseased breast in up to 50% of the patients.
Low Sensitivity for Significant Arterial Stenosis: The performance of Gadavist® MRA for detecting arterial segments with significant stenosis (>50% renal, >70% supra-aortic) has not been shown to exceed 55%. Therefore, a negative MRA study alone should not be used to rule out significant stenosis.
Adverse Reactions: The most frequent (≥0.5%) adverse reactions associated with Gadavist® in clinical studies were headache (1.7%), nausea (1.2%) and dizziness (0.5%).
Please see Full Prescribing Information for Gadavist® (Vials and Syringes).
Please see Full Prescribing Information for Gadavist® (Imaging Bulk Package).
EOVIST® (gadoxetate disodium) injection
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.
IMPORTANT SAFETY INFORMATION
WARNING: RISK ASSOCIATED WITH INTRATHECAL USE and NEPHROGENIC SYSTEMIC FIBROSIS Risk Associated with Intrathecal Use Intrathecal administration of gadolinium-based contrast agents (GBCAs) can cause serious adverse reactions including death, coma, encephalopathy, and seizures. Eovist is not approved for intrathecal use. Nephrogenic Systemic Fibrosis GBCAs increase the risk for NSF among patients with impaired elimination of the drugs. Avoid use of Eovist 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:
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%).
Please see Full Prescribing Information for Eovist®.
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Patient Information listed on the Graphical User Interfaces are fictitious examples only and do not contain any actual patient data.
MRI images throughout this website are actual patient cases but all personal identifiers have been removed or otherwise anonymized. No personally identifiable information is shown.
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.
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Last update: November 2024
