INDICATION and IMPORTANT SAFETY INFORMATION
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 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®. 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. The highest concentrations (nanomoles per gram of tissue) have been identified in the bone, followed by other organs (for example, brain, skin, kidney, liver, and spleen). The duration of retention also varies by tissue and is longest in bone. Linear GBCAs cause more retention than macrocyclic GBCAs. At equivalent doses, gadolinium 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. Pathologic and clinical consequences of GBCA administration and retention in skin and other organs have been established in patients with impaired renal function. There are rare reports of pathologic skin changes in patients with normal renal function. Adverse events involving multiple organ systems have been reported in patients with normal renal function without an established causal link to gadolinium retention.
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 when choosing a GBCA for these patients. Minimize repetitive GBCA imaging studies, particularly closely spaced 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 some 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 (for example, ferrocene complexation method) may result in falsely high or low values for up to 24 hours after the examination with Eovist® because of the caloxetate trisodium excipients.
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 was 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 MRI 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.
Please see Medication Guide.
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