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IC Green
Classes
Other Imaging Agents
Administration
Visually inspect parenteral products for particulate matter and discoloration prior to administration whenever solution and container permit.
Reconstitution
Under sterile conditions, dissolve the indocyanine green powder with Sterile Water for Injection. The amount of Sterile Water for Injection to be used is determined by the procedure to be performed.
For hepatic function studies, dilute 25 mg indocyanine green with 5 mL of Sterile Water for Injection to yield 5 mg/mL.
For lymphatic mapping of breast cancer, dilute 25 mg indocyanine green with 10 mL of Sterile Water for Injection to yield 2.5 mg/mL.
For lymphatic mapping of cervical and uterine cancer, dilute 25 mg indocyanine green with 20 mL of Sterile Water for Injection to yield 1.25 mg/mL.
For ophthalmic angiograms, dilute up to 40 mg indocyanine green with 2 mL of Sterile Water for Injection to yield 20 mg/mL.
For visualization of vessels, blood flow, tissue perfusion, and extrahepatic biliary ducts, dilute 25 mg indocyanine green with 10 mL of Sterile Water for Injection to yield 2.5 mg/mL.
Discard the solution if the product precipitates.
Storage: Indocyanine green is unstable in aqueous solution and must be used within 6 hours. The dye is stable in whole blood and plasma, so samples obtained during testing may be read hours later.[48809] [63781]
Intravenous Bolus Injection
Indocyanine green is administered as a rapid IV bolus.
For hepatic function studies, administer into the lumen of an arm vein as rapidly as possible, without allowing the dye to escape outside the vein. Study the patient in a fasting, basal state. Changing concentrations of indocyanine green can be monitored by ear densitometry or by obtaining blood specimens at timed intervals (i.e., photometric method). The normal percentage disappearance rate in healthy subjects is 18% to 24% per minute.
For visualization of vessels, blood flow, and tissue perfusion, administer via a central or peripheral venous line using a 3-way stopcock attached to an injection port on the infusion line. Immediately after indocyanine green injection, switch the access on the stopcock and flush the line with 10 mL of 0.9% Sodium Chloride Injection. Adjust the amount and type of flush to avoid volume and/or sodium overload in pediatric patients.
For cardiac output studies, administer via the cardiac catheter. Rinse the syringe that will be used for the injection with the Sterile Water for Injection provided. Use isotonic saline to flush the residual dye from the cardiac catheter to avoid hemolysis.
For ophthalmic angiography studies, administer into the antecubital vein. Inject a 5 mL IV bolus of 0.9% Sodium Chloride Injection immediately after the indocyanine green.[48809] [63781]
Interstitial Cervical Injection
For lymphatic mapping, administer as 4 interstitial injections into the cervix at the 3 and 9 o'clock positions with a superficial (1 to 3 mm) and a deep (1 to 3 cm) injection at each position.[63781]
Intradermal Breast Injection
For lymphatic mapping, administer as 2 intradermal injections into the peri-areolar area of the breast at the 12 and 9 o'clock positions for the right breast or at the 12 and 3 o'clock positions for the left breast. If a peri-tumoral dose is necessary, administer as 3 intradermal injections at the 12 o'clock, 3 o'clock, and 9 o'clock positions.
Adverse Reactions
anaphylactic shock / Rapid / Incidence not known
anaphylactoid reactions / Rapid / Incidence not known
respiratory arrest / Rapid / Incidence not known
cyanosis / Early / Incidence not known
cardiac arrest / Early / Incidence not known
laryngospasm / Rapid / Incidence not known
bronchospasm / Rapid / Incidence not known
visual impairment / Early / Incidence not known
edema / Delayed / Incidence not known
hypotension / Rapid / Incidence not known
peripheral vasodilation / Rapid / Incidence not known
erythema / Early / Incidence not known
wheezing / Rapid / Incidence not known
sinus tachycardia / Rapid / Incidence not known
palpitations / Early / Incidence not known
confusion / Early / Incidence not known
dyspnea / Early / Incidence not known
flushing / Rapid / Incidence not known
syncope / Early / Incidence not known
weakness / Early / Incidence not known
agitation / Early / Incidence not known
headache / Early / Incidence not known
pharyngitis / Delayed / Incidence not known
nausea / Early / Incidence not known
pruritus / Rapid / Incidence not known
anxiety / Delayed / Incidence not known
vomiting / Early / Incidence not known
urticaria / Rapid / Incidence not known
diaphoresis / Early / Incidence not known
cough / Delayed / Incidence not known
skin discoloration / Delayed / Incidence not known
Common Brand Names
IC Green
Dea Class
Rx
Description
Parenteral tricarbocyanine dye and optical imaging agent
Used for determining cardiac output, hepatic function and liver blood flow, ophthalmic angiography, and visualization of extrahepatic biliary ducts, lymph nodes and lymphatic vessels in setting of breast, cervical, and uterine cancers, and vessels, blood flow, and tissue perfusion around several surgical procedures
Associated with severe hypersensitivity reactions
Dosage And Indications
NOTE: See FDA-approved labeling for calibrating dye curves to quantitate the patient-specific dilution curves.
5 mg IV. An average of 5 dilution curves is recommended for diagnostic cardiac catheterization. Do not exceed the maximum total dose of 2 mg/kg.[48809]
2.5 mg IV. An average of 5 dilution curves is recommended for diagnostic cardiac catheterization. Do not exceed the maximum total dose of 2 mg/kg.
1.25 mg IV. An average of 5 dilution curves is recommended for diagnostic cardiac catheterization. Do not exceed the maximum total dose of 2 mg/kg.[48809]
1.25 to 5 mg IV for a single image sequence or 3.75 to 10 mg IV for visualization of perfusion in extremities through the skin. Additional doses may be administered to obtain imaging sequences during the procedure. Do not exceed the maximum total dose of 2 mg/kg.
1.25 to 5 mg IV for a single image sequence. Lower doses may be administered in younger patients and in those with lower body weight. Additional doses may be administered to obtain imaging sequences during the procedure. Do not exceed the maximum total dose of 2 mg/kg.
0.5 mg/kg IV.
2.5 mg IV as a single dose at least 45 minute prior to surgery. Additional doses may be administered to obtain imaging sequences during the procedure. Do not exceed the maximum total dose of 2 mg/kg.
2.5 mg IV as a single dose at least 45 minute prior to surgery. Additional doses may be administered to obtain imaging sequences during the procedure. Do not exceed the maximum total dose of 2 mg/kg.
NOTE: Because excessive dye extravasation does not occur in the highly fenestrated choroidal vasculature, indocyanine green is useful in both absorption and fluorescence infrared angiography of the choroidal vasculature when using appropriate filters and film in a fundus camera.
Up to 40 mg IV via the antecubital vein depending on the imaging equipment and technique used.
5 mg interstitially into the cervix as four 1 mL injections at the 3 o'clock and 9 o'clock positions with a superficial (1 to 3 mm) and a deep (1 to 3 cm) injection at each position.[63781]
0.25 mg intradermally into the peri-areolar area of the breast as two 0.05 mL injections at the 12 o'clock and the 9 o'clock positions for the right breast or at the 12 o'clock or 3 o'clock positions for the left breast. If lymphatic flow towards the axillary lymph nodes is not visualized, a subsequent peri-tumoral dose of 0.375 mg intradermally as three 0.05 mL injections at the 12 o'clock, 3 o'clock, and 9 o'clock positions is recommended.
Dosing Considerations
Specific dosing recommendations in patients with hepatic impairment are not available; it appears no dosage adjustment is needed.
Specific dosing recommendations in patients with renal impairment are not available; it appears no dosage adjustment is needed.
Drug Interactions
Haloperidol: (Moderate) Haloperidol may increase the clearance of indocyanine green. The half-life of indocyanine green was lower in patients taking the drugs concomitantly compared to patients with normal and abnormal liver function taking no concomitant medications. The mechanism of interaction is unclear; those proposed in the medical literature include increased indocyanine green uptake by the liver cell, enhanced binding by specific hepatic carrier proteins, or more rapid excretion into bile.
Heparin: (Moderate) Heparin products that contain sodium bisulfite may reduce the absorption peak of indocyanine green. Collection of blood samples for analysis should be performed with anticoagulants that do not contain sodium bisulfite.
Nifedipine: (Moderate) In a study of 9 healthy adults given 0.5 mg/kg of indocyanine green, nifedipine increased indocyanine green clearance by 14%.
Nitrofurantoin: (Moderate) Nitrofurantoin may increase the clearance of indocyanine green. The half-life of indocyanine green was lower in patients taking the drugs concomitantly compared to patients with normal and abnormal liver function taking no concomitant medications. The mechanism of interaction is unclear; those proposed in the medical literature include increased indocyanine green uptake by the liver cell, enhanced binding by specific hepatic carrier proteins, or more rapid excretion into bile.
Phenobarbital: (Moderate) Phenobarbital may increase the clearance indocyanine green. The half-life of indocyanine green was lower in patients taking the drugs concomitantly compared to patients with normal and abnormal liver function taking no concomitant medications. The mechanism of interaction is unclear; those proposed in the medical literature include increased indocyanine green uptake by the liver cell, enhanced binding by specific hepatic carrier proteins, or more rapid excretion into bile.
Phenobarbital; Hyoscyamine; Atropine; Scopolamine: (Moderate) Phenobarbital may increase the clearance indocyanine green. The half-life of indocyanine green was lower in patients taking the drugs concomitantly compared to patients with normal and abnormal liver function taking no concomitant medications. The mechanism of interaction is unclear; those proposed in the medical literature include increased indocyanine green uptake by the liver cell, enhanced binding by specific hepatic carrier proteins, or more rapid excretion into bile.
Primidone: (Moderate) Primidone may increase the clearance indocyanine green. The half-life of indocyanine green was lower in patients taking the drugs concomitantly compared to patients with normal and abnormal liver function taking no concomitant medications. The mechanism of interaction is unclear; those proposed in the medical literature include increased indocyanine green uptake by the liver cell, enhanced binding by specific hepatic carrier proteins, or more rapid excretion into bile.
Propranolol: (Minor) In a study of 9 healthy adults given 0.5 mg/kg of indocyanine green, propranolol decreased clearance by 21%.
Propranolol; Hydrochlorothiazide, HCTZ: (Minor) In a study of 9 healthy adults given 0.5 mg/kg of indocyanine green, propranolol decreased clearance by 21%.
How Supplied
IC Green/Indocyanine Green Intravenous Inj Pwd F/Sol: 25mg
Maximum Dosage
2 mg/kg IV; 5 mg interstitially into the cervix.
2 mg/kg IV; 5 mg interstitially into the cervix.
2 mg/kg IV.
2 mg/kg IV.
2 mg/kg IV.
Safety and efficacy have not been established.
Mechanism Of Action
Indocyanine green enables intravascular imaging through fluorescence. When bound to proteins in plasma or lymph fluid, indocyanine green absorbs light in the near-infrared region with peak absorption at 805 nm, and emits fluorescence (light) at a slightly longer wavelength, with peak emission at 830 nm. Fluorescence imaging devices provide external energy as near-infrared light for indocyanine green to absorb, resulting in excitation of indocyanine green; emitted fluorescence is transferred from the field of view to an image on a monitor. Its visual color is created from microbubbles produced from shaking during product reconstitution, rather than the chemical composition of the dye itself. Approximately 0.01 mL of air is injected with each 1 mL of prepared indocyanine green dye.[48809] [48816]
Pharmacokinetics
Indocyanine green is administered parenterally as intravenous or interstitial cervical injections. Once in systemic circulation, indocyanine green binds to plasma (98%) or lymphatic proteins (including albumin and alpha-1 lipoproteins), which confines the drug to the intravascular compartment. No extrahepatic or enterohepatic circulation occurs, and there is negligible renal, peripheral, lung, or cerebrospinal uptake. Indocyanine green is not metabolized. The drug is removed from plasma almost exclusively by hepatic parenchymal cells and is subsequently excreted unchanged in bile. The peak absorption and emission of indocyanine green lie in a region of 800 to 850 nm where transmission of energy by the pigment epithelium is more efficient than in the region of visible light energy.
Affected cytochrome P450 isoenzymes and drug transporters: none
Fluorescence is visible in the blood vessels within 5 to 15 seconds postinjection. The time from injection to appearance of indocyanine green in bile ranges from 8 to 15 minutes. Peak concentrations in bile occur at 120 minutes.
Interstitial Route
After interstitial injection, indocyanine green is taken up by the lymphatic vessels and lymph nodes. Fluorescence is visible in the lymphatic vessels and lymph nodes within 1 minute postinjection.[63781]
Pregnancy And Lactation
There are no adequate, well-controlled studies with indocyanine green during pregnancy. Available data from a small number of scientific literature studies with indocyanine green use in pregnant women have not reported any drug-associated risks for major birth defects, miscarriage, or adverse maternal or fetal outcomes. Data from a single small study suggest there is no placental transfer of indocyanine green. Maternal doses of indocyanine green ranging from 0.5 to 5 mg/kg were administered during stage 1 or 2 of labor in 9 pregnant women. Blood samples were obtained from the mother and the fetal scalp at baseline, 2 to 4 minutes, and 6 to 8 minutes after dye injection. No indocyanine green was found in the fetal blood of all 9 infants or the umbilical vein blood of 4 infants. Animal reproduction studies have not been conducted with indocyanine green.[48809] [49707]
No adverse events have been observed in the breast-fed infant in 17 cases of indocyanine green use in breast-feeding women reported in the literature. However, there are no data on the presence of indocyanine green in human milk or the effects on milk production. Consider the developmental and health benefits of breast-feeding along with the mother's clinical need for indocyanine green and any potential adverse effects on the breast-fed infant from indocyanine green or the underlying maternal condition.