SPY AGENT GREEN KIT
Clinical safety rating: caution
Comprehensive clinical and safety monograph for SPY AGENT GREEN KIT (SPY AGENT GREEN KIT).
SPY AGENT GREEN KIT contains indocyanine green (ICG), a tricarbocyanine dye that binds to plasma proteins, primarily albumin, and remains intravascular. It is used for fluorescence imaging to visualize blood vessels, lymphatic structures, and tissues during surgery. ICG fluoresces near-infrared light (NIR) upon excitation, allowing real-time visualization of perfusion and drainage patterns.
| Metabolism | ICG is rapidly taken up by the liver and excreted unchanged into bile via the hepatobiliary system without significant metabolism. It is not metabolized by hepatic microsomal enzymes. |
| Excretion | Primarily renal excretion of the intact indocyanine green (ICG) molecule; >90% of the administered dose is cleared unchanged into bile and eliminated in feces, with negligible renal excretion (<5%). |
| Half-life | Terminal elimination half-life is approximately 2.5-3.0 minutes in patients with normal hepatic function; clinically, the rapid clearance allows for repeated assessments of hepatic function and cardiac output. |
| Protein binding | Highly bound to plasma proteins, primarily albumin and alpha-1-lipoproteins; approximately 95-98% bound. |
| Volume of Distribution | Initial volume of distribution is approximately 20-30 mL/kg, reflecting confinement to the vascular space; Vd is small (0.02-0.03 L/kg), consistent with limited extravascular distribution. |
| Bioavailability | Only administered intravenously; bioavailability is 100% by the IV route. |
| Onset of Action | Intravenous administration: Immediate onset of fluorescence (within seconds) due to rapid mixing in the blood pool. |
| Duration of Action | Duration of detectable fluorescence is approximately 10-15 minutes following IV injection; clinically limited by rapid hepatic clearance, enabling repeated measurements within 30 minutes. |
Indocyanine Green 0.25-0.5 mg/kg intravenous bolus as a single dose for cardiac output determination or hepatic function assessment. Repeat dosing after 30-60 minutes if needed.
| Dosage form | POWDER |
| Renal impairment | No dose adjustment required for renal impairment as ICG is primarily excreted by the liver into bile. GFR does not affect pharmacokinetics. |
| Liver impairment | In Child-Pugh Class A and B: standard dose. In Child-Pugh Class C: reduce dose to 0.125-0.25 mg/kg due to reduced clearance and risk of prolonged retention. Monitor for adverse effects. |
| Pediatric use | Neonates: 0.5 mg/kg IV bolus. Infants and children: 0.25-0.5 mg/kg IV bolus. Maximum single dose: 25 mg. Use with caution in neonates due to limited data. |
| Geriatric use | No specific dose adjustment required; consider reduced hepatic blood flow in elderly and use lower end of dosing range (0.25 mg/kg). Monitor closely for adverse effects. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for SPY AGENT GREEN KIT (SPY AGENT GREEN KIT).
| Breastfeeding | Contraindicated during breastfeeding. Indocyanine green is excreted into breast milk but M/P ratio not established. May cause severe adverse reactions in nursing infants. |
| Teratogenic Risk | FDA Pregnancy Category D. First trimester: High risk of neural tube defects, cardiovascular malformations, and cleft palate. Second and third trimesters: Increased risk of intrauterine growth restriction, oligohydramnios, and fetal renal dysplasia. |
| Fetal Monitoring |
■ FDA Black Box Warning
None
| Serious Effects |
["Hypersensitivity to indocyanine green or iodine","Patients with known iodine allergy or anaphylaxis to iodinated contrast media","Pregnancy (category C) - use only if potential benefit justifies risk","Lactation - discontinue nursing or drug due to potential excretion in breast milk"]
| Precautions | ["Contains iodine; may cause allergic reactions in patients with iodine sensitivity","Anaphylactic reactions have been reported, especially in patients with a history of allergy to iodinated compounds","Use with caution in patients with hyperthyroidism, thyroid nodules, or thyroid autoimmune disease due to iodine content","Extravasation may cause tissue irritation or necrosis; ensure proper intravenous administration","Do not administer intra-arterially; may cause severe adverse reactions","Hepatic dysfunction may alter ICG clearance; dose adjustment may be necessary"] |
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| Serial fetal ultrasound for structural anomalies and growth. Amniotic fluid index monitoring. Nonstress test and biophysical profile in third trimester. Monitor maternal thyroid function due to iodine content. |
| Fertility Effects | Reproductive toxicity observed in animal studies including impaired fertility and decreased implantation rates. May cause ovarian or testicular dysfunction in humans with high cumulative exposure. |