Elucirem | European Medicines Agency (EMA)

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Overview

Elucirem is a ‘contrast agent’, a medicine used to improve the contrast of images obtained during magnetic resonance imaging (MRI) examinations. This helps doctors find certain pathologies in patients in whom this would not be possible otherwise. Elucirem is used in adults and children from 2 years of age.

Elucirem contains the active substance gadopiclenol.

Elucirem is given as an injection into a vein by a specialised healthcare professional, just before the MRI scan. It can only be obtained with a prescription. For more information about using Elucirem, see the package leaflet or contact your doctor or pharmacist.

The active substance in Elucirem, gadopiclenol, contains gadolinium, a ‘rare-earth’ metal element used in contrast agents to help obtain better MRI images. MRI is an imaging method that relies on the tiny magnetic fields produced by water molecules in the body. Once injected, gadolinium interacts with the water molecules. As a result of this interaction, the water molecules give a stronger signal in the locations reached by the contrast agent, and this helps to obtain a brighter picture.

Two main studies were carried out to investigate whether MRI images made with Elucirem were comparable to those made with another contrast agent, and better than those made without a contrast agent. One study involved 256 adults who had, or were highly suspected to have, a tumour in their brain or spinal cord, based on the outcome of a previous imaging procedure (such as an MRI or CT scan). The second study involved 304 adults with a tumour or other pathological tissue (such as a cyst) in another part of their body.

Study participants had MRI scans in combination with Elucirem, in combination with another gadolinium-based contrast agent and without a contrast agent. Doctors experienced in analysing MRI images then compared how clearly the tumours or pathologies were visible in the different scans. All doctors considered that MRI images with Elucirem were clearer than those made without a contrast agent, and comparable with those made with the other contrast agent.

For the full list of side effects and restrictions with Elucirem, see the package leaflet.

The most common side effects with Elucirem (which may affect up to 1 in 10 people) include headache and injection site reactions. Other common side effects (which may affect up to 1 in 100 people) include nausea, fatigue and diarrhoea.

Using Elucirem as a contrast agent improved the quality of the resulting MRI scan compared to an unenhanced scan. The safety profile of Elucirem is in line with that of other gadolinium-based contrast agents. Importantly, Elucirem contains gadolinium in a specific complex. This means that it can be given at half the dose of gadolinium compared with other, non-specific gadolinium-containing contrast agents while providing the same contrast enhancement. The European Medicines Agency therefore decided that Elucirem’s benefits are greater than its risks and it can be authorised for use in the EU.

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Elucirem have been included in the summary of product characteristics and the package leaflet.

As for all medicines, data on the use of Elucirem are continuously monitored. Suspected side effects reported with Elucirem are carefully evaluated and any necessary action taken to protect patients.

Elucirem received a marketing authorisation valid throughout the EU on 07 December 2023.

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First published: 08/02/2024

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First published: 08/02/2024

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Product information

English (EN)
(421.72 KB – PDF)

First published: 08/02/2024Last updated: 04/02/2025

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Latest procedure affecting product information:
PSUSA/00000232/202403

13/01/2025

This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.

Product information documents contain:

summary of product characteristics (annex I);
manufacturing authorisation holder responsible for batch release (annex IIA);
conditions of the marketing authorisation (annex IIB);
labelling (annex IIIA);
package leaflet (annex IIIB).

English (EN)
(127.66 KB – PDF)

First published: 08/02/2024

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Product details

Name of medicine: Elucirem
Active substance: Gadopiclenol
International non-proprietary name (INN) or common name: Gadopiclenol
Therapeutic area (MeSH): Magnetic Resonance Imaging
Anatomical therapeutic chemical (ATC) code: V08CA12

Pharmacotherapeutic group

Paramagnetic contrast media

Therapeutic indication

This medicinal product is for diagnostic use only.

Elucirem is indicated in adults and children aged 2 years and older for contrast-enhanced magnetic resonance imaging (MRI) to improve detection and visualization of pathologies with disruption of the blood-brain-barrier (BBB) and/or abnormal vascularity of:

– the brain, spine, and associated tissues of the central nervous system (CNS);

– the liver, kidney, pancreas, breast, lung, prostate, and musculoskeletal system.

It should be used only when diagnostic information is essential and not available with unenhanced MRI.

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