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William J. Gradishar, MD, FACP, FASCO


FDA Brief: Iopromide Injection Approved for Contrast-Enhanced Mammography

By: JNCCN 360 Staff
Posted: Wednesday, June 28, 2023

On June 23, Bayer announced that its iodine-based contrast agent—iopromide-300 and -370 (Ultravist)—has been approved by the U.S. Food and Drug Administration (FDA). It is reportedly the only contrast agent approved for this indication. The contrast agent can be used to visualize known or suspected lesions of the breast in adults as an adjunct to mammography and/or ultrasound. Iopromide-300 and -370 is also indicated for cardiac use in intra-arterial as well as in other intravenous procedures.

Briefly, mammography with the administration of a contrast agent is used to help identify breast lesions. It is a relatively low-cost breast imaging examination; is easy to perform in everyday clinical practice and can be used in various clinical settings (such as when routine imaging produces inconclusive findings); and may also be a helpful tool when breast magnetic resonance imaging is unavailable or contraindicated.

The new FDA-approved indication for iopromide-300 and -370 aligns with the recent increased focus on supplemental imaging needs for individuals at higher risk for breast cancer. These people may include the 40% to 50% of U.S. women older than age 40 with dense breasts.

A safety warning is included regarding the risk associated with intrathecal use of iopromide-300 and -370. This agent is not approved for intrathecal use.

Common adverse reactions (> 1%) associated with this contrast agent include headache, nausea, injection-site and infusion-site reactions, vasodilatation, vomiting, back pain, urinary urgency, chest pain, pain, dysgeusia, and abnormal vision.

For more detailed information, visit prescribing information.

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