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Medically reviewed by Fedorchenko Olga Valeryevna, PharmD. Last updated on 28.04.2022
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Verdye® is indicated:
For Determining Cardiac Output, Hepatic Function and Liver Blood Flow
For ophthalmic angiography
Verdye injection is a medical dye used in tests to help determine cardiac (heart) output, liver function, and blood flow in the liver. It is also used to help certain parts of the eye to become more visible during medical procedures such as angiography.
Verdye is to be given only by or under the supervision of a doctor.
Recommended Dose and Administration for Visualization of Vessels, Blood Flow and Tissue Perfusion
Dosing
Adults:
The recommended dose of Verdye for a single image sequence is 1.25 mg to 5 mg of a 2.5 mg/mL solution.
For visualization of perfusion in extremities through the skin, the recommended dose is 3.75 mg to 10 mg of a 2.5 mg/mL solution.
Immediately flush with a 10 mL bolus of 0.9% Sodium Chloride, USP.
Pediatric patients:
The recommended dose for a single image sequence is 1.25 mg to 5 mg Verdye 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.
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 dosage of Verdye solution into appropriate syringes and prepare a 10 mL syringe of 0.9% Sodium Chloride, USP.
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 Verdye into the line as a tight bolus. Immediately switch the access on the stopcock and inject the prepared flush.
Imaging Instructions for Visualization of Vessels, Blood Flow and Tissue Perfusion
Verdye may be used with either the SPY® Elite or PINPOINT® Fluorescence Imaging Systems or with a FDA cleared or approved imaging device that is specifically intended for fluorescence imaging with Verdye.
A fluorescence response should be visible in blood vessels within 5 to 15 seconds after injection.
Recommended Dose and Administration for Visualization of Extrahepatic Biliary Ducts
Dosing and Administration
The recommended single dose of Verdye for adults and pediatric patients aged 12 to 17 years is 2.5 mg of a 2.5 mg/mL solution administered intravenously as a single dose 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 for Visualization of Extrahepatic Biliary Ducts
Verdye may be used with the PINPOINT® Fluorescence Imaging System or with a FDA cleared or approved imaging device that is specifically intended for fluorescence imaging with Verdye.
Fluorescence is visible in the biliary tree within 45 minutes after injection.
Recommended Dose and Administration for Visualization of Lymph Nodes and Lymphatic Vessels During Lymphatic Mapping for Cervical and Uterine Tumors
Dosing and Administration
The recommended single dose of Verdye is 5 mg of a 1.25 mg/mL solution (four 1 mL injections administered interstitially into the cervix, at the three o’ clock and the nine o’clock positions with a superficial (1 mm to 3 mm) and a deep (1 cm to 2 cm) injection at each position).
Imaging Instructions for Visualization of Lymph Nodes and Lymphatic Vessels During Lymphatic Mapping
Verdye may be used with the PINPOINT® Fluorescence Imaging System or with a FDA cleared or approved imaging device that is specifically intended for fluorescence imaging with Verdye.
Fluorescent lymphatic vessels and lymph nodes should begin to be visible within 1 minute after injection.
Reconstitution Instructions
General
- Prepare Verdye under sterile conditions prior to surgery.
- 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, and Tissue Perfusion and Visualization of Extrahepatic Biliary Ducts
- Dissolve Verdye with 10 mL Sterile Water for Injection, USP to form a concentration of 2.5 mg Verdye/mL.
Visualization of Lymph Nodes and Lymphatic Vessels During Lymphatic Mapping
- Dissolve Verdye with 20 mL Sterile Water for Injection, USP to form a concentration of 1.25 mg Verdye/mL.
Verdye is contraindicated in patients with a history of hypersensitivity to Verdye. Reactions have included anaphylaxis.
Effects on the Laboratory Results: Administration of Verdye has been reported to cause and increase in serum inorganic iodide concentrations and decrease in radioactive iodide uptake in several patients due to sodium iodide in the product. Therefore, examinations using Verdye should be conducted with at least 1 week interval before the thyroid radioactive iodide uptake test, which may be influenced by the use of the drug. Heparin preparations containing sodium bisulfate should not be used as the anticoagulant for the collection of samples for analysis as these solutions reduce the peak absorption of Verdye in blood.
Precaution Concerning Diagnosis: There may be some errors in estimated values of liver function test in following cases: Effect of the Following Physical Condition: Chylous serum or extremely turbid or hemolytic serum; edema, emaciation, obesity or massive blood loss. (In this case, the plasma elimination rate method should be used for measurement)
Effect of Concomitant Therapy: Biliary contrast agents (eg, iotroxate meglumine), choleretic agents, rifampicin and antigout agents. (Concomitant use of these drugs with Verdye may inhibit uptake of Verdye into hepatocytes).
Phenobarbital: It can decrease the t½ of Verdye, presumably because of an increase in hepatic dye transport induced by phenobarbital. Simultaneous administration of Verdye and sulfobromophthalein sodium (BSP) may result in an impairment of hepatic excretion of BSP, particularly in patients with hepatic impairment. The presence of BSP in blood may cause changes in the maximum absorption spectrum of Verdye, and simultaneous use of these agents should be avoided.
Effect of Substances Other Than Drug: Effect of Food: Hepatic blood flow may be increased. Intake of dietary fat may increase the blood lipid level and the serum may become clouded.
Incompatibilities: Verdye should not be dissolved by normal saline solution (NSS).
See also:
What are the possible side effects of Verdye?
Clinical Studies: Liver Function Test and Circulatory Function Test (Including Adverse Reactions Information From Circulatory Function Tests Which is Approved Indication in Japan): Adverse reactions associated with the use of Verdye have been reported in 0.17% (36 patients) of 21,278 patients who received the drug based on the Japanese literature (The reporting of adverse reactions is not included in the reexamination). Common adverse reactions included shock 0.02% (5 reactions), nausea 0.08% (16 reactions), vascular pain 0.04% (8 reactions) and pyrexia/hot feeling 0.02% (4 reactions).
Chorioretinal Angiography Diagnostic: In Japanese clinical study of chorioretinal angiography diagnostics, queasy was observed in 1 (1.8%) of 57 patients who received Verdye.
In Japanese post-marketing study of chorioretinal angiography diagnostics, adverse reactions were observed in 6 (0.62%) of 967 patients who received Verdye.
Undesirable Effects from Post-Marketing Studies and Adverse Drug Reactions Reports: The following undesirable effects are recognized for Verdye. The frequency are not defined:
Immune System Disorder: Anaphylactoid symptoms, Quincke’s oedema.
Vascular Disorders: Shock.
Gastrointestinal Disorders: Nausea, queasy, vomiting, feces discoloration (green).
Skin and Subcutaneous Tissue Disorder: Urticaria, pruritus, diaphoresis, hot flush, rash.
General Disorders and Administration Site Condition: Pyrexia.
Central Nervous System: Headache, dizziness.
Other Reactions: Transient elevation in serum unconjugated bilirubin.
Verdye is 2-[7-1,1-Dimethyl-3-(4-sulfobutyl) benz[e] indolin-2-ylidene]-1, 3, 5-heptatrienyl]-1, 1- (dimethyl-3-(4-sulfobutyl)-1H-benz[e]indolium hydroxide, inner salt, sodium salt. Its empirical formula is C43H47N2NaO6S2 and molecular weight is 774.96. Verdye is a dark, green-blue, odorless, lump, soluble in water or methanol and practically insoluble in acetone.
Verdye is unstable in aqueous solution but is stable in the solutions containing protein or in the dry form. Its melting point is 230°C (decomposition). It has a pH of 5-7 and an osmotic pressure ratio to physiological saline of about 0.01 when 1 vial of Verdye is dissolved in 5 mL water for injection (0.5% aqueous solution).