FDA Approves IC-GREEN (indocyanine green) for Fluorescence Imaging in Multiple Indications

Indocyanine green is a fluorescent dye that emits fluorescence when excited by near-infrared light. After intravenous or interstitial injection, it binds to plasma proteins and remains intravascular, allowing visualization of vessels, blood flow, and tissue perfusion. It is also taken up by the liver and excreted into bile, enabling imaging of biliary ducts. In lymphatic mapping, it accumulates in lymph nodes and lymphatic vessels.

IC-GREEN is indicated for fluorescence imaging of vessels (micro- and macro-vasculature), blood flow and tissue perfusion before, during and after vascular, gastrointestinal, organ transplant, plastic, micro- and reconstructive surgeries, including general minimally invasive surgical procedures, in adults and pediatric patients aged 1 month and older. It is also indicated for fluorescence imaging of extrahepatic biliary ducts in adults and pediatric patients aged 12 years and older, for fluorescence imaging of lymph nodes and lymphatic vessels during lymphatic mapping in adults with cervical and uterine cancer, and for ophthalmic angiography in adults and pediatric patients.

For visualization of vessels, blood flow and tissue perfusion: adults and pediatric patients aged 1 month and older receive 1.25 mg to 5 mg intravenously (0.5 mL to 2 mL of 2.5 mg/mL solution). For perfusion in extremities through the skin in adults: 3.75 mg to 10 mg intravenously (1.5 mL to 4 mL of 2.5 mg/mL solution). For extrahepatic biliary ducts: adults and pediatric patients aged 12 years and older receive 2.5 mg intravenously (1 mL of 2.5 mg/mL solution) at least 45 minutes prior to surgery. For lymphatic mapping of cervical and uterine cancer: adults receive 5 mg interstitially as four 1 mL injections of 1.25 mg/mL solution. For ophthalmic angiography: doses up to 40 mg in 2 mL of Sterile Water for Injection intravenously. Do not exceed total dose of 2 mg/kg. See full prescribing information for reconstitution and administration details.

Not reported in label.

Not reported in label.

IC-GREEN provides a standardized fluorescent imaging agent for multiple intraoperative and diagnostic applications, allowing real-time visualization of vasculature, perfusion, biliary anatomy, and lymphatic drainage. It may enhance surgical precision and reduce complications in a variety of procedures. The label does not include comparative efficacy data.