FDA Grants Cardiac MR Indication for Gadavist Contrast Injection

The FDA has granted expanded indications for use of gadobutrol (Gadavist; Bayer) injection, permitting its use in cardiac MR to assess myocardial perfusion and late gadolinium enhancement in adults with known or suspected coronary artery disease.

Bayer, which announced the approval yesterday, notes that gadobutrol now becomes the first and only contrast agent to be approved for use in cardiac MR.

The expanded indication comes on the heels of the multinational, randomized GadaCAD 1 and GadaCAD 2 trials involving nearly 1,000 adults with known or suspected coronary artery disease.

The test has the advantage of being noninvasive and radiation-free, although use of gadolinium-based contrast agents increases the risk for nephrogenic systemic fibrosis among patients with chronic kidney disease or kidney injury.

Gadobutrol injection for cardiac MR is now approved at a single, 0.1-mL/kg dose given as two separate bolus injections: 0.05 mL/kg (0.05 mmol/kg) body weight at peak pharmacologic stress followed by 0.05 mL/kg (0.05 mmol/kg) body weight at rest.

The contrast agent was previously approved in the United States for use in adults, children, and newborns to detect and visualize areas with disrupted blood-brain barrier and/or abnormal vascularity of the central nervous system; for detecting malignancies in breast cancer; and for known or suspected supra-aortic or renal artery disease.