PROHANCE

What it is

ProHance is a nonionic paramagnetic contrast medium for magnetic resonance imaging. ProHance contains gadoteridol 279.3 mg per mL (0.5 M). It is supplied as a sterile clear colourless to slightly yellow solution for intravenous injection.

Approved indications

— Enhancement of magnetic resonance images of intracranial and spinal lesions where there is an abnormal blood-brain barrier or abnormal vascularity in adults and children from 2 years of age. — Whole body MRI.

Dosing overview

The recommended dose range of ProHance for imaging most brain and spine pathologies is 0.1 mmol/kg (0.2 mL/kg). Doses of 0.3 mmol/kg (0.6 mL/kg) have been shown to be useful in patients suspected of having cerebral metastases or other poorly enhancing lesions. The recommended dose for whole body MRI is 0.1 mmol/kg (0.2 mL/kg). For children aged 2 years and above, the recommended dose for brain imaging and spine pathologies is 0.1 mmol/kg (0.2 mL/kg). The safety and efficacy of doses higher than 0.1 mmol/kg and sequential or repeat procedures have not been established in children. The lowest effective dose should be used.

Key safety warnings

Gadoteridol must not be used intrathecally, as serious, life-threatening and fatal cases, primarily with neurological reactions such as coma, encephalopathy and seizures, have been reported with intrathecal use. Gadolinium-based contrast agents increase the risk of nephrogenic systemic fibrosis 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. Nephrogenic systemic fibrosis may result in fatal or debilitating fibrosis affecting the skin, muscle and internal organs. Factors that may increase the risk for nephrogenic systemic fibrosis include repeated or higher than recommended doses of gadolinium-based contrast agents and the degree of renal impairment at the time of exposure. Gadolinium accumulates in the brain after multiple administrations of gadolinium-based contrast agents, with increased signal intensity on non-contrast T1 weighted images observed after multiple administrations in patients with normal renal function, and gadolinium detected in brain tissue particularly in the dentate nucleus and globus pallidus. The clinical significance of gadolinium accumulation in the brain is presently unknown. Anaphylactic, anaphylactoid or allergic reactions have been reported with gadolinium-chelates, manifesting in varying degrees of severity up to anaphylactic shock and involving one or more body systems, mostly respiratory, cardiovascular and/or mucocutaneous systems.

Contraindications

ProHance is contraindicated in patients with a history of previous hypersensitivity to ProHance, its constituents or other gadolinium based contrast media. ProHance is contraindicated in children under 6 months of age.

Regulatory history

ProHance was first registered on the ARTG on 1 September 2000 with multiple presentations including gadoteridol 4189.5 mg/15 mL injection syringe and gadoteridol 4189.5 mg/15 mL injection vial, followed by gadoteridol 2793 mg/10 mL injection syringe and gadoteridol 5586 mg/20 mL injection vial on 6 September 2000. An additional gadoteridol 2793 mg/10 mL injection vial presentation was registered on 26 April 2016. The product information was revised on 20 August 2024.