The U.S. Food and Drug Administration
approved Gadavist (gadobutrol), a gadolinium-based contrast agent, for use in
patients undergoing magnetic resonance imaging (MRI) of the central nervous
system.
Gadavist was approved by the FDA on
March 14. It provides contrast-enhanced imaging of the central nervous system,
helping to detect and visualize lesions that disrupt the cell barrier that
normally separates the brain from the blood stream. It also helps to detect and
visualize abnormal blood supply and circulation of the central nervous system.
Gadavist is the sixth gadolinium-based
contrast agent (GBCA) approved by the FDA for use in patients undergoing
magnetic resonance imaging of the central nervous system. It is indicated for
adults and children ages 2 years and older. Gadavist is more concentrated than
the other GBCAs and should be administered at half the volume. Two clinical
studies involving 657 patients and other trial data established the safety and
efficacy of Gadavist.
All GBCAs, including Gadavist, carry a
boxed warning about the risk of nephrogenic systemic fibrosis (NSF), a rare,
but serious, condition associated with the use of GBCAs in certain patients
with kidney dysfunction. NSF is characterized by pain and thickening of
the skin, and can cause fibrosis of internal organs. There is no known
treatment for NSF. Gadavist is currently considered to be one the GBCAs with a
lower risk of NSF, and is not one of the GBCAs that is contraindicated in
patients with acute kidney injury or chronic, severe kidney
disease.
Those receiving Gadavist during the
studies reported headache and nausea as the most common adverse reactions.
Other adverse events associated with Gadavist included hypersensitivity
reactions, involving cardiovascular, respiratory, or skin effects ranging from
mild to severe.
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