Elucirem™ (gadopiclenol) has a high kinetic stability with a comparable safety profile to gadobutrol2-4
Elucirem™ has at least 4 x the kinetic stability of approved GBCAs1
The macrocyclic structure of Elucirem™ is associated with higher kinetic stability and a longer dissociation half-life1
Elucirem™ (gadopiclenol) has been shown to have a comparable safety profile to gadobutrol in clinical trials2-4
• In the PICTURE trial, treatment emergent adverse event (TEAE) incidence was 14.6% after MRI with gadopiclenol and 17.6% after MRI with gadobutrol.3,4
• In the PROMISE trial, TEAE incidence was 18.1% after MRI with gadopiclenol and 20.0% after MRI with gadobutrol.3,4
At least one TEAE related to contrast agent in phase III clinical trial3,4
Elucirem™ (gadopiclenol)
Rate (%)
Gadovist® (gadobutrol)
Rate (%)
CNS MRI (PICTURE trial)
4.9% 15 reported in 12 patients
6.9% 19 reported in 17 patients
Body MRI (PROMISE trial)
4.2% 14 reported in 12 patients
5.5% 19 reported in 16 patients
|
Elucirem™ (gadopiclenol) |
Gadovist® (gadobutrol) |
|
| CNS MRI (PICTURE trial) | 4.9% 15 reported in 12 patients | 6.9% 19 reported in 17 patients |
| Body MRI (PROMISE trial) | 4.2% 14 reported in 12 patients | 5.5% 19 reported in 16 patients |
Adverse reactions reported in 0.2% of patients (2 years to 88 years old) who received the recommended dose of Elucirem™ (0.05 mmol/kg) in clinical trials3,4
Reaction
Rate (%)
Injection site pain
0,7
Headache
0,7
Nausea
0,4
Injection site warmth
0,4
Injection site coldness
0,3
Dizziness
0,3
Localised swelling
0,3
| Reaction |
Rate (%) |
| Injection site pain | 0,7 |
| Headache | 0,7 |
| Nausea | 0,4 |
| Injection site warmth | 0,4 |
| Injection site coldness | 0,3 |
| Dizziness | 0,3 |
| Localised swelling | 0,3 |
The table lists adverse reactions that occurred in >0.2% of patients who received 0.05 mmol/kg Elucirem™
No cases of nephrogenic systemic fibrosis have been reported in clinical trials with Elucirem™1
Discover the simple dosing and administration of Elucirem™
Trademarks are the property of their respective owners.
CNS: Central Nervous System
GBCA: Gadolinium-Based Contrast Agent
MRI: Magnetic Resonance Imaging NSF: Nephrogenic Systemic Fibrosis
TEAE: Treatment Emergent Adverse Events
References
1. Robic C, Port M, Rousseaux O, et al. Physicochemical and Pharmacokinetic Profiles of Gadopiclenol: A New Macrocyclic Gadolinium Chelate With High T1 Relaxivity. Invest Radiol. 2019 Aug;54(8):475-484.
2. Elucirem Summary of Product Characteristics. 2023.
3. Loevner LA, Kolumban B, Hutóczki G, et al. Efficacy and Safety of Gadopiclenol for Contrast-Enhanced MRI of the Central Nervous System: The PICTURE Randomized Clinical Trial. Invest Radiol. 2023 May 1;58(5):307-313.
4. Kuhl C, Csőszi T, Piskorski W, et al. Efficacy and safety of half-dose gadopiclenol versus full-dose gadobutrol for contrast-enhanced body MRI. Radiology. 2023 Jul;308(1):e222612.
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