CLARISCAN

What it is

CLARISCAN contains gadoteric acid, a complex of the paramagnetic ion gadolinium oxide with tetraxetan (DOTA; 1,4,7,10-tetraazacyclododecane-N,N',N',N'-tetraacetic acid). CLARISCAN is supplied as a solution for injection containing gadoteric acid 0.5 mM/mL. CLARISCAN is a sterile, preservative-free, clear, colourless to yellow solution for injection free of visible particles and packaged in glass vials or bottles for intravenous injection.

Approved indications

CLARISCAN is indicated in adults and children for use with magnetic resonance imaging to provide contrast enhancement for intracranial and spinal lesions with abnormal blood brain barrier or abnormal vascularity, and for whole body imaging.

Dosing overview

The lowest effective dose should be used, calculated based on the patient's body weight and not exceeding the recommended dose per kilogram of body weight. The maximum recommended dose is 0.1 mmol/kg (0.2 mL/kg) for both adults aged 18 years and older and children aged 0 to 18 years. CLARISCAN is intended for intravenous administration only. Due to immature renal function in neonates up to 4 weeks of age and infants up to 1 year of age, CLARISCAN should only be used in these patients after careful consideration, at a dose not exceeding 0.1 mmol/kg body weight.

Key safety warnings

Gadolinium-based contrast agents increase the risk for nephrogenic systemic fibrosis (NSF) in patients with acute or chronic severe renal insufficiency (glomerular filtration rate less than 30 mL/min/1.73 m²) or acute renal insufficiency of any severity due to hepato-renal syndrome or in the perioperative liver transplantation period. CLARISCAN should only be used in these patients after careful risk-benefit assessment and if diagnostic information is essential and not available with non-contrast enhanced MRI. NSF is a debilitating and sometimes fatal disease affecting the skin, muscle, and internal organs. CLARISCAN must not be used intrathecally. Serious, life-threatening and fatal cases, primarily with neurological reactions (such as coma, encephalopathy, seizures), have been reported with intrathecal use. CLARISCAN should be strictly administered via intravenous injection. Current evidence suggests that gadolinium accumulates in the brain after multiple administrations 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 clinical significance of gadolinium accumulation in the brain is presently unknown. To minimise potential risks, it is recommended to use the lowest effective dose and perform a careful benefit-risk assessment before administering repeated doses. Hypersensitivity reactions can occur with CLARISCAN, including life-threatening events. Hypersensitivity reactions may be either allergic (described as anaphylactic reactions when serious) or non-allergic. Anaphylactic reactions occur immediately and can be fatal. They are independent of the dose, can occur after even the first dose and are often unpredictable.

Contraindications

CLARISCAN is contraindicated in patients with hypersensitivity to gadoteric acid, meglumine or any products containing gadolinium. Contraindications related to magnetic resonance imaging include patients with pacemakers, patients with ferromagnetic vascular clips, infusion pumps, nerve stimulators, cochlear implants, or suspected intracorporal metallic foreign bodies, particularly in the eye.

Regulatory history

CLARISCAN was first registered on the ARTG on 11 January 2018, with five variants registered across vials and pre-filled syringes in strengths of 1.397 g/5 mL, 2.793 g/10 mL, 4.190 g/15 mL and 5.586 g/20 mL.