Iopromide-300 and -370 (Ultravist), an iodine-based contrast agent, has been approved by the U.S. Food and Drug Administration (FDA) for contrast-enhanced mammography—making it the only contrast agent approved for this indication. The product can be used to visualize known or suspected lesions of the breast in adults as an adjunct to mammography and/or ultrasound. The approval was announced by the manufacturer of this agent, Bayer, on June 23.
Contrast-enhanced mammography is an emerging modality that combines digital mammography with the administration of a contrast agent 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 can 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 women at higher risk for breast cancer, which may include the 40% to 50% of U.S. women older than age 40 with dense breasts.
About Iopromide-300 and -370
Iopromide-300 and -370 is also indicated for the following uses:
Intra‐arterial procedures: Cerebral arteriography and peripheral arteriography in adults; coronary arteriography and left ventriculography, visceral angiography, and aortography in adults; and radiographic evaluation of cardiac chambers and related arteries in pediatric patients aged 2 years and older.
Intravenous procedures: Excretory urography in adults and pediatric patients aged 2 years and older; contrast computed tomography of the head and body (intrathoracic, intra-abdominal, and retroperitoneal regions) for the evaluation of neoplastic and non-neoplastic lesions in adults and pediatric patients aged 2 years and older; and, now, contrast mammography to visualize known or suspected lesions of the breast in adults, as an adjunct following mammography and/or ultrasound.
For important safety information, visit bayer.com.
