VUEWAY

What it is

VUEWAY contains gadopiclenol 485.1 mg/mL (equivalent to 0.5 mmol/mL of gadopiclenol and to 78.6 mg of gadolinium). It is a solution for injection. VUEWAY is a clear, colourless to pale yellow solution. Gadopiclenol is a new generation macrocyclic gadolinium-based contrast agent that offers high relaxivity, enabling effective imaging at half the dose of conventional agents.

Approved indications

— Contrast-enhanced magnetic resonance imaging (MRI) to detect and visualise lesions with abnormal blood brain barrier or abnormal vascularity in the central nervous system (brain, spine, and associated tissues) in adults and children aged 2 years and older. — Contrast-enhanced magnetic resonance imaging (MRI) to detect and visualise lesions with abnormal blood brain barrier or abnormal vascularity in the body (head and neck, thorax, abdomen, pelvis and musculoskeletal system) in adults and children aged 2 years and older.

Dosing overview

The recommended dose of VUEWAY in adults (≥18 years) is 0.1 mL/kg body weight (equivalent to 0.05 mmol/kg body weight) to provide diagnostically adequate contrast for all indications. In paediatric patients aged 2 years and older, the recommended and maximum dose is 0.1 mL/kg body weight (equivalent to 0.05 mmol/kg body weight) for all indications. The lowest dose that provides sufficient enhancement for diagnostic purposes should be used, and the dose should be calculated based on the patient's body weight and should not exceed the recommended dose per kilogram of body weight. The recommended dose is administered intravenously as a bolus injection at approximately 2 mL/second followed by a flush of sodium chloride 9 mg/mL (0.9%), solution for injection via manual injection or power injector.

Key safety warnings

Gadolinium-based contrast agents increase the risk for nephrogenic systemic fibrosis (NSF) among patients with impaired elimination of the drugs. NSF may result in fatal or debilitating fibrosis affecting the skin, muscle and internal organs. The risk for NSF appears highest among patients with chronic, severe kidney disease (GFR < 30 mL/min/1.73 m²), or acute kidney injury. Gadopiclenol should only be used in patients with severe renal impairment (GFR < 30 mL/min/1.73 m²) and in patients in the perioperative liver transplantation period after careful risk/benefit assessment and if the diagnostic information is essential and not available with non-contrast enhanced MRI. Hypersensitivity reactions can occur, including life-threatening reactions. Hypersensitivity reactions may be either allergic (described as anaphylactic reactions when serious) or non-allergic. They can occur either immediately (less than 60 minutes) after injection or delayed (up to 7 days). Anaphylactic reactions occur immediately and can be fatal. They are independent of the dose, can occur after even the first dose of the product, and are often unpredictable. During the examination, supervision by a physician is necessary. If a hypersensitivity reaction occurs, administration of the contrast agent must be discontinued immediately and – if necessary – a specific therapy must be instituted. A venous access should thus be kept during the entire examination. Intrathecal administration of gadolinium-containing contrast agents can cause serious adverse reactions including death, coma, encephalopathy, and seizures. Do not use by the intrathecal route. Gadolinium may accumulate in the brain after multiple administration of gadolinium-based contrast agents. Increased signal intensity on non-contrast T1-weighted images of the brain has been observed after multiple administrations in patients with normal renal function. Gadolinium has been detected in brain tissue after multiple exposures, particularly in the dentate nucleus and globus pallidus. The evidence suggests that the risk of gadolinium accumulation is higher after repeat administration of linear than after repeat administration of macrocyclic agents. The clinical significance of gadolinium accumulation in the brain is presently unknown; however, gadolinium accumulation may potentially interfere with the interpretation of MRI scans of the brain.

Contraindications

VUEWAY is contraindicated in patients with hypersensitivity to the active ingredient or any of the excipients.

Regulatory history

The TGA approved VUEWAY (gadopiclenol) on 15 April 2025 for use in contrast-enhanced magnetic resonance imaging. VUEWAY gadopiclenol was first listed on the ARTG on 22 April 2025 in seven strengths and formulations. The TGA's evaluation found that gadopiclenol, as a macrocyclic gadolinium-based contrast agent with high relaxivity, offers effective imaging at half the dose of conventional agents. The reduced dose, combined with its macrocyclic structure, suggests a better safety profile with less free gadolinium release, potentially mitigating risks like nephrogenic systemic fibrosis.