Eovist® (gadoxetate disodium) injection 0.25 mmol/mL pi

IMPORTANT SAFETY INFORMATION AND INDICATIONS

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.

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%).

INDICATIONS AND USAGE

Please see Full Prescribing Information for Eovist^®.

Consulte la información de prescripción completa para Eovist^®.

Medication Guide

Guía del Medicamento