Gadolinium-based contrast agent: PROHANCE (gadoteridol)
Reason for request
High clinical benefit in angiography and magnetic resonance imaging, along with minor clinical added value in the diagnostic strategy.
Gadolinium-based contrast agents are used in various indications in both adults and children depending on the medicines: angiography, magnetic resonance imaging (MRI) of the cranial and spinal regions, kidneys, liver and whole body. MULTIHANCE is indicated only in liver MRI. It should only be used when diagnosis is necessary and when this diagnosis cannot be reached by MRI without contrast enhancement.
Considering the structure of MULTIHANCE, gadolinium accumulates in larger amounts and over a longer period than with DOTAREM, GADOVIST or PROHANCE, whose structures are different.
In liver MRI, during the dynamic early phase, no difference in efficacy between the 4 contrast agents was demonstrated. MULTIHANCE is the only contrast agent with a role in late phase liver MRI with hepatocyte capture. MULTIHANCE has not been granted a marketing authorisation in the other indications and the studies have not shown any significant difference between DOTAREM, GADOVIST and PROHANCE.
Very few cases of systemic nephrogenic fibrosis have been reported, and no new data concerning gadolinium accumulation in the brain are available.
Improvement in actual benefit