Body MR Imaging with Gadopiclenol

By McKenna Bryant

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:

Chronic, severe kidney disease (GFR <30 mVmin/1.73m²), or
Acute kidney injury

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.

The Mount Sinai Health System in New York is comprised of six hospitals and numerous outpatient facilities, where clinicians perform approximately 20,000 body MR exams every year. These studies include scans of the hepatobiliary system, pancreas, gastrointestinal tract, kidneys, prostate, bladder, thorax and the whole body, as well as OB/GYN and fetal scans, pre- and post-treatment exams, and oncology studies.

In October 2023, the health system added Elucirem™ (gadopiclenol) injection to its formulary for use in body MRI applications. Elucirem is a highly stable, macrocyclic gadolinium-based contrast agent (GBCA) that requires only half the gadolinium dose of conventional, nonspecific GBCAs, addressing practitioner concerns about gadolinium exposure.^1,2

“We use gadopiclenol in body MRI¹ due to the half gadolinium dose (0.05 mmol/Kg) you're administering to patients,” said Bachir Taouli, MD, MHA, Director of the Body MRI and Cancer Imaging Program at the Icahn School of Medicine at Mount Sinai in New York City.

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 Elucirem delivers twice as much interaction as other GBCAs, resulting in the highest relaxivity among nonspecific GBCAs.³ The health system selected Elucirem because it delivers high image quality and relaxivity with a good safety profile.^2-4

“Gadopiclenol is a macrocyclic agent that has the highest relaxivity of the currently approved GBCAs; thus, a half dose is good enough for visualization,” said Dr Taouli.

Body MR imaging with Elucirem

In a video case study titled Contrast Enhanced Body MRI, Dr Taouli presented several cases demonstrating the clinical utility of Elucirem in body studies.

In one case, a 60-year-old male with alcoholic cirrhosis and a history of decompensation was referred for a contrast-enhanced MR to screen for hepatocellular carcinoma (HCC). Dr Taouli administered 0.05 mmol/kg of Elucirem, half the typical dose of other GBCAs.

Images obtained approximately one minute after administering Elucirem revealed a 1.9 cm lesion in liver segment 4, with evidence for washout and capsule enhancement on the polar venous phase. Based on LI-RADS® criteria, these characteristics indicated HCC. The patient was recommended for locoregional radioembolization therapy, a minimally invasive procedure that uses radioactive beads to treat liver tumors.

In another case, a 68-year-old female with a history of left parotid cancer underwent follow-up MR and MR cholangiopancreatography (MRCP) after an incidental pancreatic mass was discovered on CT. Dr Taouli administered 0.05 mmol/kg of Elucirem to obtain diagnostic images of her pancreas.

T2 pre-contrast images showed a lobulated, multilocular cystic lesion in the pancreatic head, with no pancreatic duct distension on the MRCP. Images also indicated an additional cystic lesion in the distal pancreas. Post-contrast images showed internal septal enhancement in the lesion, consistent with apatic serous adenoma, a benign pancreatic cyst that's usually asymptomatic and doesn't require treatment.

Previous CTs and MRIs showed this adenoma had remained stable for approximately nine years, confirming its benign nature. Diagnostic image quality with Elucirem was comparable to prior imaging that was completed with a standard contrast dose of another GBCA. In addition, an MRCP obtained a year earlier using 1 mmol/kg of another GBCA showed the same findings, confirming Elucirem’s clinical utility, even at a lower dose.

View these body MRI video case studies.

Based on his experience in more than a year using Elucirem, Dr Taouli has concluded that it can be safely used for body MRI (head and neck, thorax, abdomen, pelvis, and musculoskeletal system) at half the dose of other GBCAs.¹

References

Elucirem Package insert. Guerbet LLC; 2024.
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):475-484. doi:10.1097/RLI.0000000000000563

ELUCIREM™ (gadopiclenol) injection Important Safety Information

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

The risk for NSF appears highest among patients with:

Chronic, severe kidney disease (GFR <30 mVmin/1.73m²), or
Acute kidney injury

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

Risk Associated with Intrathecal Use: lntrathecal 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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