Zyogreen®

GoodRx

Indocyanine Green 2.5 mg/mL · injectable solution

Diagnostic Dye, Injections & Implants

Indication

ZYOGREEN is an optical imaging agent 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; fluorescence imaging of extrahepatic biliary ducts in adults and pediatric patients from birth to less than 1 year of age and 6 years of age and older; fluorescence imaging of lymph nodes and delineation of lymphatic vessels during lymphatic mapping in adults with cervical and uterine cancer for which this procedure is a component of intraoperative management; ophthalmic angiography in adults and pediatric patients.

Contraindications

History of hypersensitivity to indocyanine green (reported reactions have included anaphylaxis)

Available Forms

2.5 mg per mL; 25 mg per 10 mL single-dose ampules, 5 ampules per carton

Mechanism of Action

When bound to proteins in plasma or in 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 the indocyanine green, and the emitted light (fluorescence) is transferred from the field of view to an image on a monitor.

Dosage

Ophthalmic angiography in adults and pediatric patients: doses up to 40 mg by intravenous injection. Visualization of vessels, blood flow and tissue perfusion: pediatric patients less than 1 month of age 0.15 mg/kg; adults and pediatric patients 1 month of age and older 1.25 mg to 5 mg by intravenous injection. Extremity perfusion visualization through the skin: pediatric patients less than 1 month of age 0.15 mg/kg; pediatric patients 1 month of age and older 1.25 mg to 5 mg; adults 3.75 mg to 10 mg by intravenous injection. Visualization of extrahepatic biliary ducts: pediatric patients from birth to less than 1 year of age 0.1 mg/kg (not to exceed 2.5 mg) 12 to 24 hours prior to surgery; adults and pediatric patients 6 years of age and older 2.5 mg by intravenous injection at least 45 minutes prior to surgery. Lymphatic mapping of cervical and uterine cancer in adults: 5 mg interstitially as four 1.25 mg injections. The total dose must not exceed 2 mg/kg for all patients.

Warnings & Precautions

Hypersensitivity Reactions: Hypersensitivity reactions including anaphylaxis, urticaria, and deaths due to anaphylaxis have been reported following intravenous administration of indocyanine green, the active ingredient in ZYOGREEN. ZYOGREEN is contraindicated in patients with a history of hypersensitivity to indocyanine green. Always have cardiopulmonary resuscitation personnel and equipment readily available and monitor all patients for hypersensitivity reactions.
Interference with Thyroid Radioactive Iodine Uptake Studies: Because ZYOGREEN contains sodium iodide, the iodine-binding capacity of thyroid tissue may be reduced for at least one week following administration. Do not perform radioactive iodine uptake studies for at least one week following administration of ZYOGREEN.

Common Side Effects

The most common adverse reactions reported are anaphylaxis and urticaria.

Pregnancy & Lactation

Pregnancy: There are no adequate and well-controlled studies of ZYOGREEN 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. Animal reproduction studies have not been conducted with indocyanine green.

Lactation: Seventeen cases of indocyanine green use in lactating women have been reported in the scientific literature with no adverse events observed in the breastfed infant. However, there are no data on the presence of indocyanine green in human milk or the effects on milk production.

Pediatric Use

Ophthalmic angiography: ZYOGREEN is indicated for ophthalmic angiography in pediatric patients. Vessels, blood flow and tissue perfusion: The safety and effectiveness of ZYOGREEN 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 have been established in pediatric patients. Extrahepatic biliary ducts: The safety and effectiveness of ZYOGREEN for fluorescence imaging of extrahepatic biliary ducts have been established in pediatric patients from birth to less than 1 year of age and in those 6 years of age and older. The safety and effectiveness of ZYOGREEN have not been established for fluorescence imaging of extrahepatic biliary ducts in pediatric patients 1 year to less than 6 years of age. Lymphatic mapping: The safety and effectiveness of ZYOGREEN for fluorescence imaging of lymph nodes and lymphatic vessels during lymphatic mapping for cervical and uterine cancer have not been established in pediatric patients.