Advancing Neuro MR Imaging with Gadopiclenol
ELUCIREM™ (gadopiclenol) injection Important Safety Information
WARNING: RISK ASSOCIATED WITH INTRATHECAL USE and NEPHROGENIC SYSTEMIC FIBROSIS (NSF)
Risk Associated with Intrathecal Use
lntrathecal administration of gadolinium-based contrast agents (GBCAs) can cause serious adverse reactions including death, coma, encephalopathy, and seizures. ELUCIREM is not approved for intrathecal use. Nephrogenic Systemic Fibrosis
GBCAs increase the risk for NSF among patients with impaired elimination of the drugs. Avoid use of ELUCIREM in these patients unless the diagnostic information is essential and not available with non-contrasted MRI or other modalities. NSF may result in fatal or debilitating fibrosis affecting the skin, muscle andinternal organs. The risk for NSF appears highest among patients with:
Screen patients for acute kidney injury and other conditions that may reduce renal function. For patients at risk for chronically reduced renal function (for example, age >60 years, hypertension or diabetes), estimate the glomerular filtration rate (GFR) through laboratory testing.
For patients at highest risk for NSF, do not exceed the recommended ELUCIREM dose and allow a sufficient period of time for elimination of the drug from the body prior to any re-administration.
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Choosing the appropriate gadolinium-based contrast agent (GBCA) for neuro MR imaging applications is essential to enhancing lesion visualization and maintaining diagnostic accuracy while managing patient exposure to gadolinium.
Elucirem (gadopiclenol) injection is a highly stable macrocyclic GBCA that requires only half the gadolinium dose of conventional, nonspecific GBCAs, addressing practitioners’ concerns about gadolinium exposure.1,2 The administration of a GBCA improves the contrast between lesions and surrounding tissues by accelerating the relaxation of protons through interaction with gadolinium atoms.3 Gadopiclenol delivers twice as much interaction as other GBCAs, resulting in the highest relaxivity among nonspecific GBCAs.3
“The most important characteristics of Elucirem are the improved T1 relaxivity and the improved kinetic stability, which allow its dosage to be 0.05 millimoles per kg, or half the dose of other GBCAs, without impacting image quality,” said Pareen Mehta, MD is Medical Director of Radiology at The Angeles Clinic & Research Institute, a Cedars-Sinai Affiliate in Los Angeles, California.
Practical Considerations in Choosing a GBCA
When administering a GBCA, or any other contrast agent, the first consideration is patient safety. Elucirem (gadopiclenol) injection’s macrocyclic structure contributes to its kinetic stability and safety profile.3,4 “These characteristics indicate that Elucirem is going to be a well-tolerated contrast agent, which was noted in the clinical trials and real-world experience,” said Dr Mehta.
Another important consideration is the agent’s impact on image quality. Unlike other FDA-approved conventional GBCAs, Elucirem enhances areas of interest at a reduced dose, which is “really important for patients who need repeated MR exams over the course of their lifetime,” added Dr Mehta.
The Clinical Utility of Elucirem in Neuro MR Imaging
In a video case study review titled Neuro MRI with Gadopiclenol, Dr Mehta presented several case studies showing how his practice is maintaining high image quality while administering less gadolinium dose to its patients compared to conventional GBCAs.
In one case, he compared the neuro images of a 77-year-old woman with a history of breast cancer who was given 5 mL of Elucirem in one exam, after being administered 10 mL of another GBCA in a previous exam. “The image quality in is comparable, even though you're using only a half dose of the gadolinium with the Elucirem. This is really important because you have full confidence that you’re able to see areas of interest, and if something were to enhance, you would be able to find it,” he said.
In another case, a 61-year-old female with lung cancer was scanned with Elucirem for metastatic disease. The patient received 10 mL of Elucirem, versus 20 mL of another conventional GBCA, which was administered during a previous exam.
The images with Elucirem showed very small intracranial metastases in the right caudate head and the left frontal lobe. This finding led to a more accurate diagnosis and helped streamline the patient’s stereotactic radiosurgery (SRS) treatment plan to treat small tumors of the brain.
“This is where using a high-relaxivity agent is very useful. It ensures that you can find these small intracranial lesions, so when the patient is sent to radiation oncology, all of the lesions are actually radiated,” he said.
Click here to view these Neuro MRI Video Case Studies
Ultimately, Dr Mehta believes Elucirem is the future of MR imaging contrast agents, allowing radiologists to visualize neurological structures and lesions with a reduced dose of gadolinium. “You’re going to use a half dose of gadolinium without sacrificing image quality. I think once others try Elucirem, they're going to prefer this higher relaxivity agent,” he said.
References
- 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;58(5):307-313. doi:10.1097/RLI.0000000000000944
- Kuhl C, Csőszi T, Piskorski W, Miszalski T, Lee JM, Otto PM. Efficacy and Safety of Half-Dose Gadopiclenol versus Full-Dose Gadobutrol for Contrast-enhanced Body MRI. Radiology. 2023;308(1):e222612. doi:10.1148/radiol.222612
- 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;54(8):475-doi:10.1097/RLI.0000000000000563
- Elucirem Package insert. Guerbet LLC; 2024.
ELUCIREM™ (gadopiclenol) injection Important Safety Information
WARNING: RISK ASSOCIATED WITH INTRATHECAL USE and NEPHROGENIC SYSTEMIC FIBROSIS (NSF)
Risk Associated with Intrathecal Use
lntrathecal administration of gadolinium-based contrast agents (GBCAs) can cause serious adverse reactions including death, coma, encephalopathy, and seizures. ELUCIREM is not approved for intrathecal use. Nephrogenic Systemic Fibrosis
GBCAs increase the risk for NSF among patients with impaired elimination of the drugs. Avoid use of ELUCIREM in these patients unless the diagnostic information is essential and not available with non-contrasted MRI or other modalities. NSF may result in fatal or debilitating fibrosis affecting the skin, muscle andinternal organs. The risk for NSF appears highest among patients with:
Screen patients for acute kidney injury and other conditions that may reduce renal function. For patients at risk for chronically reduced renal function (for example, age >60 years, hypertension or diabetes), estimate the glomerular filtration rate (GFR) through laboratory testing.
For patients at highest risk for NSF, do not exceed the recommended ELUCIREM dose and allow a sufficient period of time for elimination of the drug from the body prior to any re-administration.
Indications and Usage
ELUCIREM™ gadopiclenol) injection is indicated in adult and pediatric patients aged 2 years and older for use with magnetic resonance imaging (MRI) to detect and visualize lesions with abnormal vascularity in the central nervous system (brain, spine, and associated tissues), and the body (head and neck, thorax, abdomen, pelvis, and musculoskeletalsystem).
Contraindications
Contraindicated in patients with history of hypersensitivity reactions to ELUCIREM.
Warnings and Precautions
Adverse Reactions:
In clinical trials, the most frequent adverse reactions that occurred in > 0.2% of patients who received ELUCIREM included: injection site pain, headache, nausea, injection site warmth, injection site coldness, dizziness, and localized swelling.
Postmarketing Experience: Acute pancreatitis with onset within 48 hours after GBCA administration. Use in Specific Populations
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
Please see the full Prescribing Information, including the Medication Guide, for additional important safety information.
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