Indocyanine Green

Indications and Usage, For determining Cardiac Output, Hepatic Function, and Liver Blood Flow (1.1) Removed                                                                                          12/2024

Indications and Usage (

Dosage and Administration, Indicator-Dilution Studies and Hepatic Function Studies (2.1, 2.2) Removed                                                                                                            12/2024

Dosage and Administration (

Indocyanine Green for injection is indicated:

• •Visualization of vessels, blood flow and tissue perfusion (2.5 mg/mL solution)
  • o1.25 mg to 5 mg by intravenous injection is recommended for a surgical procedure in adults and pediatric patients aged 1 month and older.
  • o3.75 mg to 10 mg by intravenous injection is recommended for visualization of perfusion in extremities through the skin for plastic, micro- and reconstructive surgeries in adults.
  • oAdditional doses may be administered. Do not exceed a total dose of 2 mg/kg. (
    2.1 Indicator-Dilution Studies

    Dosing

    Adults:

    The recommended dose of Indocyanine Green for a single image sequence for visualization of vessels, blood flow and tissue perfusion in adults is 1.25 mg to 5 mg administered intravenously as 0.5 mL to 2 mL of a 2.5 mg/mL solution.

    For visualization of perfusion in extremities through the skin in adults, the recommended dose is 3.75 mg to 10 mg administered intravenously as 1.5 mL to 4 mL of a 2.5 mg/mL solution.

    Immediately flush with a 10 mL bolus of 0.9% Sodium Chloride Injection.

    Pediatric patients aged 1 month and older:

    The recommended dose of Indocyanine Green for a single image sequence for visualization of vessels, blood flow and tissue perfusion in pediatric patients aged 1 month and older is 1.25 mg to 5 mg administered intravenously as 0.5 mL to 2 mL of a 2.5 mg/mL solution. Lower doses may be administered in younger patients and in those with lower body weight. Adjust the amount and type of flush to avoid volume and/or sodium overload.

    In both adults and pediatric patients aged 1 month and older, additional doses may be administered to obtain imaging sequences during the procedure. Do not exceed the maximum total dose of 2 mg/kg.

    Administration

    Prior to the imaging procedure, draw up the desired dose of Indocyanine Green solution into appropriate syringes and prepare a 10 mL syringe of 0.9% Sodium Chloride Injection.

    Administer via a central or peripheral venous line using a three-way stopcock attached to an injection port on the infusion line. Inject the prepared Indocyanine Green into the line as a tight bolus. Immediately switch the access on the stopcock and inject the prepared flush.

    Imaging Instructions

    Indocyanine Green may be used with an FDA-authorized imaging device that is intended to be used with indocyanine green for fluorescence imaging of vessels, blood flow and tissue perfusion.

    A fluorescence response should be visible in blood vessels within 5 seconds to 15 seconds after injection.
    )
• •Visualization of extrahepatic biliary ducts in adults and pediatric patients aged 12 years and older (2.5 mg/mL solution)
  • o2.5 mg by intravenous injection at least 45 minutes prior to surgery.
  • oAdditional doses may be administered. Do not exceed a total dose of 2 mg/kg. (
    2.2 Recommended Dose, Administration and Imaging for Visualization of Extrahepatic Biliary Ducts

    Dosing and Administration

    The recommended dose of Indocyanine Green for visualization of extrahepatic biliary ducts in adults and pediatric patients aged 12 years and older is 2.5 mg administered intravenously as 1 mL of a 2.5 mg/mL solution at least 45 minutes prior to surgery.

    Additional doses may be administered to obtain imaging sequences during the procedure.

    Do not exceed a total dose of 2 mg/kg.

    Imaging Instructions

    Indocyanine Green may be used with an FDA-authorized imaging device that is intended to be used with indocyanine green for fluorescence imaging of extrahepatic biliary ducts.

    Fluorescence is visible in the biliary tree within 45 minutes after injection.
    )
• •Lymphatic mapping of cervical and uterine cancer in adults (1.25 mg/mL solution)
  • o5 mg interstitially as four 1 mL injections.
  • oSee Full Prescribing Information for injection techniques. (
    2.3 Recommended Dose, Administration and Imaging for Lymphatic Mapping of Cervical and Uterine Cancer

    Dosing and Administration

    The recommended dose of Indocyanine Green for lymphatic mapping of cervical and uterine cancer in adults is 5 mg administered interstitially as four 1 mL injections of a 1.25 mg/mL solution into the cervix, at the 3 o’ clock and the 9 o’clock positions with a superficial (1 mm to 3 mm) and a deep (1 cm to 3 cm) injection at each position.

    Imaging Instructions

    Indocyanine Green may be used with an FDA-authorized imaging device that is intended to be used with indocyanine green for fluorescence imaging of lymph nodes and delineation of lymphatic vessels during lymphatic mapping of cervical and uterine cancer.

    Fluorescent lymphatic vessels and lymph nodes should begin to be visible within 1 minute after injection.
    )
• •Ophthalmic Angiography
  • oDoses up to 40 mg in 2 ml of Sterile Water for Injection by intravenous injection. (
    2.4 Recommended Dose and Administration for Ophthalmic Angiography

    Dosing and Administration

    Doses up to 40 mg Indocyanine Green in 2 mL of Sterile Water for Injection depending on the imaging equipment and technique used should be administered intravenously and immediately followed by a 5 mL bolus of 0.9% Sodium Chloride Injection. The antecubital vein can be used for Indocyanine Green administration.
    )
• •See Full Prescribing Information for reconstitution instructions. (
  2.5 Reconstitution Instructions

  General

  • •Prepare Indocyanine Green for injection using aseptic techniques prior to procedure.
  • •Inspect the reconstituted solution for particulate matter. The reconstituted solution should be a clear, green solution.
  • •Use the prepared solution within 6 hours.
  • •Discard any unused product.

  Visualization of Vessels, Blood Flow, Tissue Perfusion and Extrahepatic Biliary Ducts

  Dissolve 25 mg of Indocyanine Green with 10 mL Sterile Water for Injection to form a concentration of 2.5 mg/mL indocyanine green.

  Lymphatic Mapping of Cervical and Uterine Cancer

  Dissolve 25 mg of Indocyanine Green with 20 mL Sterile Water for Injection to form a concentration of 1.25 mg/mL indocyanine green.

  Ophthalmic Angiography

  Dissolve doses up to 40 mg of Indocyanine Green with 2 mL Sterile Water for Injection.
  ).

For injection: 25 mg of indocyanine green as a sterile, lyophilized, green powder for reconstitution provided in a 25 mL single-patient-use vial.

There are no adequate and well-controlled studies of Indocyanine Green in pregnant women. Available data from a very small number of scientific literature studies with indocyanine green use in pregnant women over several decades have not reported any drug associated risks for major birth defects, miscarriage, or adverse maternal or fetal outcomes. Data from one small study in which indocyanine green was administered intravenously to pregnant women during labor suggest there is no placental transfer of the drug. Animal reproduction studies have not been conducted with indocyanine green.

All pregnancies have a background risk of birth defects, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.