Zyogreen

Zyogreen is an FDA-registered drug product whose active ingredient is INDOCYANINE GREEN. It is labelled by Sagent Pharmaceuticals taken by interstitial and marketed as a human prescription drug product. Identifiers on file: NDC 25021-841, application NDA218579, label effective 20260716. It is one of 3 FDA drug label records sharing the active ingredient INDOCYANINE GREEN. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

Across FDA labelling, products containing INDOCYANINE GREEN are most often described in connection with: fluorescence imaging, pediatric patients, zyogreen indicated, blood flow, tissue perfusion, extrahepatic biliary, lymphatic mapping, uterine cancer. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

1 INDICATIONS AND USAGE 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 ( 1.1 ) 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 ( 1.2 ) Fluorescence imaging of lymph nodes and lymphatic vessels during lymphatic mapping in adults with cervical and uterine cancer ( 1.3 ) Ophthalmic angiography in adults and pediatric patients ( 1.4 ) 1.1 Visualization of Vessels, Blood Flow and Tissue Perfusion ZYOGREEN 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. 1.2 Visualization of Extrahepatic Biliary Ducts ZYOGREEN is indicated for 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. 1.3 Lymphatic Mapping of Cervical and Uterine Cancer ZYOGREEN is indicated for 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. 1.4 Ophthalmic Angiography ZYOGREEN is indicated for use in ophthalmic angiography in adults and pediatric patients.

2 DOSAGE AND ADMINISTRATION 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 ( 2.2 ) 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 ( 2.2 ) 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 ( 2.3 ) Lymphatic mapping of cervical and uterine cancer in adults 5 mg interstitially as four 1.25 mg injections. See Full Prescribing Information for injection techniques. ( 2.4 ) Ophthalmic Angiography in adults and pediatric patients: doses up to 40 mg by intravenous injection. ( 2.5 ) The total dose must not exceed 2 mg/kg for all patients. 2.1 Important Administration Instructions ZYOGREEN is a ready-to-use solution, provided in ampules at a concentration of 2.5 mg per mL. Use immediately after opening ampule. Withdraw the contents of the ampule through a 5 micrometer or smaller straw/filter needle to ensure that the withdrawn solution contains no particulates. Visually inspect the withdrawn solution for particulate matter and discoloration prior to administration. Each ampule of ZYOGREEN is for a single dose. Discard any unused portion. 2.2 Recommended Dose, Administration and Imaging for Visualization of Vessels, Blood Flow and Tissue Perfusion Dosing Administer the recommended initial dose of ZYOGREEN as a single intravenous injection. The recommended initial dose is based on patient age as shown in Table 1 . Additional doses may be administered to obtain imaging sequences during the procedure. The maximum total dose for any patient, including all initial and additional doses combined, must not exceed 2 mg/kg. Table 1. Recommended Dose of ZYOGREEN for Visualization of Vessels, Blood Flow and Tissue Perfusion by Age * Dose based on actual body weight Imaging Patient Age Recommended Dose Visualization of vessels, blood flow and tissue perfusion (single imaging sequence) Pediatric patients from birth to 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 Extremity perfusion visualization through the skin (single imaging sequence) Pediatric patients from birth to 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 Administration Prior to the imaging procedure, draw the desired dose of ZYOGREEN into a syringe. For adults, prepare 10 mL of 0.9% Sodium Chloride Injection in a separate syringe for flushing. For pediatric patients, adjust the amount and type of flush for the individual patient to avoid volume and sodium overload. Administer via a central or peripheral venous line using a three-way stopcock. Inject ZYOGREEN as a tight bolus. Immediately switch the access on the stopcock and inject the prepared flush. Imaging Instructions Use ZYOGREEN 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. 2.3 Recommended Dose, Administration and Imaging for Visualization of Extrahepatic Biliary Ducts Dosing and Administration Administer the recommended dose of ZYOGREEN as a single intravenous injection. The initial dose and timing of administration are based on patient age as shown in Table 2 . Additional doses may be administered to obtain imaging sequences during the procedure. The maximum total dose for any patient, including all initial and additional doses combined, must not exceed 2 mg/kg. Table 2: Recommended Dose of ZYOGREEN for Visualization of Extrahepatic Biliary Ducts by Age * Dose based on actual body weight Patient Age Recommended Dose Timing of Administration Pediatric patients from birth to less than 1 year of age 0.1 mg/kg * (Do not exceed 2.5 mg) Administer 12 hours to 24 hours prior to surgery Pediatric patients from 1 to less than 6 years of age Not indicated Not applicable Pediatric patients 6 years of age and older 2.5 mg Administer at least 45 minutes prior to surgery Adults Imaging Instructions Use ZYOGREEN with an FDA-authorized imaging device that is intended to be used with indocyanine green for fluorescence imaging of extrahepatic biliary ducts. For patients 6 years of age and older, fluorescence is visible in the biliary tree within 45 minutes after injection. For patients less than 1 year of age, fluorescence is visible in the biliary tree between 12 hours and 24 hours after injection. 2.4 Recommended Dose, Administration and Imaging for Lymphatic Mapping of Cervical and Uterine Cancer Dosing and Administration The recommended dose of ZYOGREEN for lymphatic mapping of cervical and uterine cancer in adults is 5 mg. Administer this dose interstitially as four separate 1.25 mg injections into the cervix, with each injection consisting of a 0.5 mL volume of the 2.5 mg/mL solution. The injections should be given at the 3 o'clock and the 9 o'clock positions of the cervix. At each of these two positions, one superficial injection (1 mm to 3 mm depth) and one deep injection (1 cm to 3 cm depth) are required to complete the dosing. Imaging Instructions Use ZYOGREEN 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. 2.5 Recommended Dose and Administration for Ophthalmic Angiography Administer doses up to 40 mg of ZYOGREEN intravenously for ophthalmic angiography in adult and pediatric patients. The specific dose should be determined based on the imaging equipment and technique being used. The total dose must not exceed 2 mg/kg. For adults, administer a 5 mL bolus of 0.9% Sodium Chloride Injection immediately following the injection. For pediatric patients, adjust the amount and type of flush solution for the individual patient to avoid volume and sodium overload. The antecubital vein can be used for ZYOGREEN administration.

4 CONTRAINDICATIONS ZYOGREEN is contraindicated in patients with a history of hypersensitivity to indocyanine green. Reactions have included anaphylaxis [see Warnings and Precautions ( 5.1 )] . Hypersensitivity to indocyanine green ( 4 )

6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Hypersensitivity Reactions [see Warnings and Precautions ( 5.1 )] . The following adverse reactions have been identified during post-approval use of indocyanine green, the active ingredient in ZYOGREEN. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Immune System Disorders : Anaphylaxis, urticaria The most common adverse reactions reported are anaphylaxis and urticaria. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Sagent Pharmaceuticals at 1–800-625-1618 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

FDA lists 3 drug label records with INDOCYANINE GREEN as the active ingredient. The most common dosage forms and the manufacturers with the most records are summarised below; strengths, pack sizes and inactive ingredients can still differ between apparently similar products.

5 FDA recall record(s) match this product name or manufacturer. A match means the firm or product name appears in the enforcement report; confirm lot numbers and dates against the official FDA notice before acting.

What is Zyogreen used for?
1 INDICATIONS AND USAGE 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 ( 1.1 ) …

Who makes Zyogreen?
Sagent Pharmaceuticals is the labeler of record for Zyogreen. 3 FDA label records share the active ingredient INDOCYANINE GREEN, so generic and branded versions may come from different companies; the manufacturer named on your pack is the one that matters for any enquiry.

What form does Zyogreen come in?
administered by interstitial. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is Zyogreen prescription or over-the-counter?
The FDA label for this product is recorded as human prescription drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Are there other products containing INDOCYANINE GREEN?
Yes. 3 FDA drug label records list INDOCYANINE GREEN as the active ingredient. Products with the same active ingredient can usually be substituted only when a prescriber or pharmacist confirms it is appropriate.

Has Zyogreen been recalled?
5 FDA recall record(s) match this product name or manufacturer. Review the recall and safety notices section on this page and confirm lot numbers against the official FDA enforcement report.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.