About Gadavist
Gadavist® (gadobutrol) injection was first approved in the U.S. in 2011 for intravenous use in magnetic resonance (MR) imaging in adults and children (2 years of age and older) to detect and visualize areas with disrupted blood brain barrier and/or abnormal vascularity of the central nervous system. Gadavist was further approved in the U.S. in 2014 for MR of the breast in adult patients to assess the presence and extent of malignant breast disease and for pediatric patients less than 2 years of age, including term neonates, to detect and visualize areas with disrupted blood brain barrier and/or abnormal vascularity of the central nervous system. In 2016, it was approved in the U.S. for use with magnetic resonance angiography (MRA) to evaluate known or suspected supra-aortic or renal artery disease in adult and pediatric patients including term neonates.
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Gadavist, also known as Gadovist® and Gadovist® 1.0 in other regions, is the U.S. brand name of the aqueous 1.0M solution of gadobutrol, a gadolinium (Gd)-based extracellular contrast agent for MRI with a macrocyclic structure. The safety profile of Gadavist has been established in clinical trials involving 7,713 patients (including 184 pediatric patients ages 0-17). The safety and effectiveness of Gadavist have not been established in preterm neonates for any indication or in pediatric patients of any age for use with MR to assess the presence and extent of malignant breast disease, or for use in cardiac MR to assess myocardial perfusion (stress, rest) and late gadolinium enhancement in patients with known or suspected coronary artery disease (CAD). Please see Important Safety Information, including Boxed Warning below.
INDICATIONS and IMPORTANT SAFETY INFORMATION
INDICATIONS
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 (BBB) 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.
