Advancing Neuro MR Imaging with Gadopiclenol

WARNING: RISK ASSOCIATED WITH INTRATHECAL USE and NEPHROGENIC SYSTEMIC FIBROSIS (NSF)

Risk Associated with Intrathecal Use

Intrathecal 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 and internal 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.

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

1. 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
2. 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
3. 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
4. Elucirem Package insert. Guerbet LLC; 2024.

Insert link to the Neuro MRI Video Case Study

ELUCIREM™ (gadopiclenol) injection Important Safety Information

Indications and Usage

ELUCIREM^TM (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 musculoskeletal system).

Contraindications

Contraindicated in patients with history of hypersensitivity reactions to ELUCIREM.

Warnings and Precautions

• Risk Associated with Intrathecal Use: Intrathecal administration of GBCAs can cause serious adverse reactions including death, coma, encephalopathy, and seizures. The safety and effectiveness of ELUCIREM have not been established with intrathecal use. 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 among these patients unless the diagnostic information is essential and not available with non-contrast MRI or other modalities.
• Hypersensitivity Reactions: With GBCAs, serious hypersensitivity reactions have occurred. Before ELUCIREM administration, assess all patients for any history of a reaction to contrast media, bronchial asthma and/or allergic disorders. These patients may have an increased risk for a hypersensitivity reaction to ELUCIREM.
• Gadolinium Retention: Gadolinium is retained for months or years in several organs. The highest concentrations have been identified in the bone, followed by other organs (e.g. brain, skin, kidney, liver, and spleen). While clinical consequences of gadolinium retention have not been established in patients with normal renal function, certain patients might be at higher risk. These include patients requiring multiple lifetime doses, pregnant and pediatric patients, and patients with inflammatory conditions. Minimize repetitive GBCA imaging studies, particularly closely spaced studies when possible.
• Acute Kidney Injury: In patients with chronically reduced renal function, acute kidney injury requiring dialysis has occurred with the use of GBCAs. The risk of acute kidney injury may increase with increasing dose of the contrast agent.
• Extravasation and Injection Site Reactions: Injection site reactions such as injection site pain have been reported in the clinical studies with ELUCIREM. Extravasation during ELUCIREM administration may result in tissue irritation. Ensure catheter and venous patency before the injection of ELUCIREM.
• Interference with Visualization of Lesions Visible with Non-Contrast MRI: As with any GBCA, ELUCIREM may impair the visualization of lesions seen on non-contrast MRI.

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

• Pregnancy: GBCAs cross the human placenta and result in fetal exposure and gadolinium retention. There are no available data on ELUCIREM use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes.
• Lactation: There are no data on the presence of ELUCIREM in human milk, the effects on the breastfed infant, or the effects on milk production. However, published lactation data on other GBCAs indicate that 0.01 to 0.04% of the maternal gadolinium dose is excreted in breast milk.
• Pediatric Use: The safety and effectiveness of ELUCIREM have not been established in pediatric patients younger than 2 years of age.
• Geriatric Use: This drug is known to be substantially excreted by the kidney, and the risk of adverse reactions to this drug may be greater in patients with impaired renal function.
• Renal Impairment: In patients with renal impairment, the exposure of gadopiclenol is increased compared to patients with normal renal function. This may increase the risk of adverse reactions such as NSF. No dose adjustment of ELUCIREM is recommended for patients with renal impairment.

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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