Technology | March 15, 2011

FDA Approves Injection for MRI of Central Nervous System

March 15, 2011 – The U.S. Food and Drug Administration (FDA) has approved Gadavist (gadobutrol) injection, a macrocyclic gadolinium-based contrast agent (GBCA), for intravenous use in diagnostic magnetic resonance imaging (MRI) in adults and children. Gadobutrol can help detect and visualize areas with disrupted blood brain barrier (BBB) and/or abnormal vascularity of the central nervous system (CNS).

It is formulated at a higher concentration (1 mmol/mL) compared to certain other GBCAs. Compared to 0.5 molar GBCAs, the higher concentration of gadobutrol results in half the volume of administration and a more compact contrast bolus. It is important to closely examine the dosing table in the full prescribing information to determine the volume to be administered.

GBCAs increase the risk for nephrogenic systemic fibrosis (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 noncontrasted 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 or acute kidney injury.

The most frequent adverse reactions associated with Gadavist in clinical studies were headache, nausea, injection site reaction, dysgeusia and feeling hot.

For more information: www.bayer.com

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