The FDA has approved gadobutrol (Gadavist®, Bayer) injection for use in cardiac magnetic resonance imaging (MRI) to assess myocardial perfusion and late gadolinium enhancement in adult patients with known or suspected coronary artery disease (CAD). This is the first and only contrast agent approved for use in cardiac MRI.
Gadobutrol’s approval was based on two multinational, non-randomized, blinded-read phase 3 studies involving almost 1,000 adults with suspected/known CAD. Approximately 800 patients were evaluated for efficacy.
Gadobutrol was first approved in 2011; cardiac MRI is now its fourth FDA approved indication. The drug’s safety profile has been established in clinical trials with 7,713 patients (including 184 pediatric patients ages 0–17). Gadobutrol injection is a gadolinium-based contrast agent indicated for use with MRI:
The use of gadobutrol carries a risk of nephrogenic systemic fibrosis (NSF). Gadolinium-based contrast agents (GBCAs) increase this risk in patients with impaired elimination of the drugs.
Gadobutrol is contraindicated in patients with a history of severe hypersensitivity reactions to the drug. Anaphylactic and other hypersensitivity reactions with cardiovascular, respiratory, or cutaneous manifestations have uncommonly occurred following administration.
The most frequent adverse reactions associated with gadobutrol in clinical studies were headache, nausea, and dizziness.
Source: BioSpace, July 15, 2109