Active Ingredient: Pegulicianine
Pegulicianine is indicated for fluorescence imaging in adults with breast cancer as an adjunct for the intraoperative detection of cancerous tissue within the resection cavity following removal of the primary specimen during lumpectomy surgery.
For this indication, competent medicine agencies globally authorize below treatments:
For:
Intravenous, 1 milligrams pegulicianine per kilogram of body weight, one dose.
The recommended dose of pegulicianine is 1 mg/kg actual body weight by intravenous injection over 3 minutes administered 2 hours to 6 hours prior to imaging.
Pegulicianine is used with a fluorescence imaging device that is FDA-approved for specific use with pegulicianine in the indicated population. The device provides illumination to excite the fluorescent components of pegulicianine and collects images showing pegulicianine’s fluorescence emission. Regions suspected to contain cancerous tissue are highlighted as positive signals on the display.
Training on the use of the device is essential prior to employing the system in a lumpectomy procedure. Please refer to the device labeling for details on how to use the device and for training information.
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