VERDYE

What it is

VERDYE is a sterile lyophilised green powder containing 25 mg of indocyanine green as the active ingredient in a 20 mL vial, with no more than 5% sodium iodide. It is presented as a powder for injection. When bound to proteins in plasma or in lymph fluid, indocyanine green absorbs light in the near-infrared region at 805 nm, and emits fluorescence at a slightly longer wavelength, with peak emission at 830 nm.

Approved indications

— Visualisation of vessels, blood flow and tissue perfusion in adults and paediatric patients from one month of age and above. — Visualisation of extrahepatic biliary ducts in adults and children from 12 years of age and above. — Visualisation of lymph nodes and lymphatic vessels in women with cervical or uterine solid tumours for which lymphatic mapping is a component of intraoperative management.

Dosing overview

For visualisation of vessels, blood flow and tissue perfusion in adults, the recommended dose is 1.25 mg to 5 mg of a 2.5 mg/mL solution for a single image sequence, or 3.75 mg to 10 mg for visualisation of perfusion in extremities through the skin. For paediatric patients, the recommended dose for a single image sequence is 1.25 mg to 5 mg of a 2.5 mg/mL solution, with lower doses administered in younger patients and those with lower body weight. The maximum total dose does not exceed 2 mg/kg. For visualisation of extrahepatic biliary ducts in adults and paediatric patients aged 12 years and above, the recommended single dose is 2.5 mg of a 2.5 mg/mL solution administered intravenously at least 45 minutes prior to surgery. For visualisation of lymph nodes and lymphatic vessels during lymphatic mapping for cervical and uterine tumours, the recommended single dose is 5 mg of a 1.25 mg/mL solution administered as four 1 mL interstitial injections into the cervix at the three o'clock and nine o'clock positions with superficial and deep injections at each position.

Key safety warnings

Hypersensitivity reactions including anaphylaxis, urticaria, and deaths due to anaphylaxis have been reported following intravenous administration of indocyanine green. Cardiopulmonary resuscitation personnel and equipment must be readily available and all patients should be monitored for hypersensitivity reactions. Because VERDYE contains iodine, the iodine-binding capacity of thyroid tissue may be reduced for at least one week following administration. Radioactive iodine uptake studies must not be performed for at least one week following administration.

Contraindications

VERDYE is contraindicated in patients with a history of hypersensitivity to indocyanine green or any of the excipients, as reactions have included anaphylaxis.

Regulatory history

VERDYE received its first approval on 28 February 2024. An AusPAR was issued on 2024-02-21 and VERDYE was approved for its proposed diagnostic indications including cardiac, circulatory, and micro-circulatory diagnostics, liver function diagnostics, and ophthalmic angiography diagnostics. This medicinal product is subject to additional monitoring in Australia to allow quick identification of new safety information.