ELUCIREM

What it is

ELUCIREM 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 and is presented as a clear, colourless to pale yellow solution. ELUCIREM is for diagnostic use only.

Approved indications

ELUCIREM (gadopiclenol) is indicated in adults and children aged 2 years and older for 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) — the body (head and neck, thorax, abdomen, pelvis and musculoskeletal system)

Dosing overview

The recommended dose of ELUCIREM for adults (18 years and older) is 0.1 mL/kg body weight (equivalent to 0.05 mmol/kg body weight) to provide diagnostically adequate contrast for all indications. The recommended and maximum dose for paediatric patients (2 years and older) is 0.1 mL/kg body weight (equivalent to 0.05 mmol/kg body weight) for all indications. More than one dose should not be used during a scan. The recommended dose is administered intravenously as a bolus injection at approximatively 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. The risk for NSF appears highest among patients with chronic, severe kidney disease (GFR < 30 mL/min/1.73 m²), or acute kidney injury. Patients should be screened for acute kidney injury and other conditions that may reduce renal function, and for patients at risk for chronically reduced renal function (such as age > 60 years, hypertension, diabetes), the glomerular filtration rate (GFR) should be estimated through laboratory testing. Hypersensitivity reactions can occur with ELUCIREM, including life-threatening reactions that may be either allergic (described as anaphylactic reactions when serious) or non-allergic, occurring either immediately (less than 60 minutes) after injection or delayed (up to 7 days), with anaphylactic reactions occurring immediately and potentially being fatal. The risk of hypersensitivity reaction may be higher in patients with a history of previous reaction to gadolinium-containing contrast agents, bronchial asthma or allergy. Intrathecal administration of gadolinium-containing contrast agents can cause serious adverse reactions including death, coma, encephalopathy, and seizures, and ELUCIREM should not be used by the intrathecal route. Gadolinium may accumulate in the brain after multiple administrations of gadolinium-based contrast agents, with increased signal intensity on non-contrast T1-weighted images of the brain observed after multiple administrations in patients with normal renal function and gadolinium detected in brain tissue after multiple exposures, particularly in the dentate nucleus and globus pallidus.

Contraindications

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

Regulatory history

ELUCIREM received ARTG registration on 22 April 2025, with ten strength variants approved across vials and pre-filled syringes. The TGA approved ELUCIREM on 15 April 2025 for use in contrast-enhanced magnetic resonance imaging for detection and visualisation of lesions with abnormal blood brain barrier or abnormal vascularity in the central nervous system and the body in adults and children aged 2 years and older. The TGA's evaluation found that gadopiclenol is a new generation macrocyclic gadolinium-based contrast agent offering high relaxivity, enabling effective imaging at half the dose of conventional agents, with its macrocyclic structure suggesting a better safety profile with less free gadolinium release and potentially mitigating risks like nephrogenic systemic fibrosis.