Guerbet to Spotlight the Novel New Drug Elucirem™ (gadopiclenol) injection at the 2022 Radiological Society of North America Scientific Assembly and Annual Meeting

• Join us at Booth #1711
• Opportunity to learn about the recently US FDA-approved novel new drug, Elucirem™
• Announcing Guerbet Research Scholar Grant in Partnership with RSNA
• Displaying a portfolio of digital and artificial intelligence software solutions to enhance patients’ experience

PRINCETON, N.J., Nov. 22, 2022 /PRNewswire/ -- Guerbet LLC, the US affiliate of Guerbet, a global leader in medical imaging offering a comprehensive range of pharmaceutical products, medical devices, and digital and artificial intelligence (AI) solutions for diagnostic and interventional imaging, will present data on Elucirem™ (gadopiclenol) injection, Dotarem® (gadoterate meglumine) injection and AI solutions at the 2022 Radiological Society of North America (RSNA) Scientific Assembly and Annual Meeting.

“It’s very exciting to be back at RSNA, to give the radiology community a first-hand opportunity to experience the clarity of MRI images offered by our new MRI product, Elucirem™,” said David Hale, Chief Executive Officer of the Guerbet Group. “We look forward to sharing insights about gadopiclenol, a novel, highly stable macrocyclic gadolinium-based contrast agent offering the highest relaxivity in its class for magnetic resonance imaging.²"

Elucirem® is indicated for use with MRI in adults and pediatric patients aged two years and older to detect and visualize lesions in the central nervous system (brain, spine and associated tissues) and the body (head and neck, thorax, abdomen, pelvis and musculoskeletal system).¹

For Elucirem®, Guerbet received Priority Review by the US Food and Drug Administration (FDA) on the basis of the unmet medical needs, as there are currently no U.S. approved and marketed MRI contrast agents indicated for musculoskeletal lesion visualization and no macrocyclic GBCAs approved broadly to visualize lesions located throughout the body.³ Guerbet received US FDA’s marketing approval for Elucirem on September 21, 2022.

Elucirem® (gadopiclenol) injection will be available in glass vials, glass pharmacy bulk packages and in plastic pre-filled syringes, which can help to streamline workflow in the imaging suite. All gadopiclenol is manufactured by Guerbet Group Company.

ELUCIREM (gadopiclenol) injection and DOTAREM (gadoterate meglumine) injection Important Safety Information

Opportunities to Learn More at RSNA 2022

RSNA Innovation Theater -- @ 1:00 – 1:15 p.m. CST, Monday November 28, 2022: Aashim Bhatia, MD, MS, Assistant Professor in Radiology and Pediatric Neuroradiologist at the Children’s Hospital of Philadelphia will be presenting Guerbet’s Latest Innovation: Illuminating the Possibilities with a Novel New Drug https://eppro02.ativ.me/web/planner.?id=RSNA22&table=agenda&tid=S1138

Oral and Poster Presentations:

Guerbet’s RSNA Education & Research Award Recipient 2022
As part of its continued partnership with the Radiological Society of North America (RSNA), Guerbet is proud to announce that the RSNA Research & Education (R&E) Foundation Board of Trustees has awarded the Guerbet Research Scholar Grant to Vivek Yedavalli, MD, MS from Johns Hopkins School of Medicine. Dr. Yedavalli was awarded $75,000 per year for two years to support his study, Deep Learning Models Using Baseline Comprehensive CT Stroke Collateral Imaging in Cerebral Angiographic Collateral, Post Procedural Hemorrhagic Transformation, and Clinical Outcomes Predictions for Increasing Thrombectomy Eligibility. The RSNA R&E Foundation invests in the future of radiology by developing investigators and supporting lifelong innovative research and education.

Digital Solutions Featured at Booth #1711
Guerbet will also feature a collection of digital and AI software-based products that help to close the loop with the smart connectivity between monitoring and reporting:

• Dose & Care ^®, a state-of-the-art digital solution for monitoring patient exposure to X-rays that is compatible with all types of ionizing modalities and collects data to provide a record of patient exposure
• Contrast & Care^®, an injection data management solution that enables imaging centers to collect, archive, examine, and share injection data, including data on contrast products, adverse events, injector activity, information on estimated glomerular filtration rate, and other risk factors before a clinical exam
• Icobrain, a cloud-based AI solution designed to quantify disease specific brain structures on MR and CT
• Galileo, an educational web-based case review platform to help train radiology residents.

About Gadopiclenol

Gadopiclenol, which was initially invented by Guerbet, with the subsequent contribution of Bracco’s intellectual property, is a new macrocyclic gadolinium-based contrast agent (GBCA) with high relaxivity. The efficacy and safety of gadopiclenol have been evaluated in MRI of the Central Nervous System (brain, spine and associated tissues) and Body (head and neck, thorax, abdomen, pelvis and musculoskeletal system. The details of Phase III clinical trials are available on www.ClinicalTrials.gov:

• Efficacy and Safety of Gadopiclenol for Central Nervous System (CNS) Magnetic Resonance Imaging (MRI) Full Text View - ClinicalTrials.gov
• Efficacy and Safety of Gadopiclenol for Body Magnetic Resonance Imaging (MRI) Full Text View -gov

Forward-looking statements

This press release may contain statements of a forward-looking nature, based on assumptions and predictions made by the management of the Guerbet group. Various known and unknown risks, uncertainties and other factors could lead to marked differences between the future results, financial situation, development and performances of the company, and the estimates made here. These factors include those mentioned in the public reports of Guerbet, available on its website www.guerbet.com. The company assumes no responsibility whatsoever in relation to the updating of these forward-looking statements, or how they correspond to future events or developments.

ELUCIREM^TM (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
History of hypersensitivity reactions to ELUCIREM.

Warnings and Precautions

• Hypersensitivity Reactions: With GBCAs, serious hypersensitivity reactions have occurred. In most cases, initial symptoms occurred within minutes of GBCA administration and resolved with prompt emergency treatment. 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. Linear GBCAs cause more retention than macrocyclic GBCAs. Consequences of gadolinium retention in the brain have not been established. Pathologic and clinical consequences of GBCA administration and retention in skin and other organs have been established in patients with impaired renal function. 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. Consider the retention characteristics of the agent when choosing a GBCA for these patients. 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. Do not exceed the recommended dose.
• 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. Therefore, caution should be exercised when Gadopiclenol MRI scans are interpreted without a companion non-contrast MRI scan.

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. Adverse reactions that occurred with a frequency ≤ 0.2% in patients who received 0.05 mmol/kg BW ELUCIREM included: maculopapular rash, vomiting, worsened renal impairment, feeling hot, pyrexia, oral paresthesia, dysgeusia, diarrhea, pruritus, allergic dermatitis, erythema, injection site paresthesia, Cystatin C increase, and blood creatinine increase.

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 present 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 nephrogenic systemic fibrosis (NSF). Avoid use of GBCAs among these patients unless the diagnostic information is essential and not available with non-contrast MRI or other modalities. No dose adjustment of ELUCIREM is recommended for patients with renal impairment. ELUCIREM can be removed from the body by hemodialysis

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 and Boxed Warning, for additional important safety information.

DOTAREM^® (GADOTERATE MEGLUMINE) INJECTION IMPORTANT SAFETY INFORMATION

INDICATIONS AND USAGE
DOTAREM^® (gadoterate meglumine) injection is a prescription gadolinium-based contrast agent indicated for intravenous use with magnetic resonance imaging (MRI) in brain (intracranial), spine and associated tissues in adult and pediatric patients (including term neonates) to detect and visualize areas with disruption of the blood brain barrier (BBB) and/or abnormal vascularity.

CONTRAINDICATIONS
History of clinically important hypersensitivity reactions to DOTAREM.

WARNINGS AND PRECAUTIONS

• Hypersensitivity Reactions: Anaphylactic and anaphylactoid reactions have been reported with DOTAREM, involving cardiovascular, respiratory, and/or cutaneous manifestations. Some patients experienced circulatory collapse and died. In most cases, initial symptoms occurred within minutes of DOTAREM administration and resolved with prompt emergency treatment.
• Before DOTAREM 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 DOTAREM.
• Administer DOTAREM only in situations where trained personnel and therapies are promptly available for the treatment of hypersensitivity reactions, including personnel trained in resuscitation.
• Gadolinium Retention: Gadolinium is retained for months or years in several organs. The highest concentrations have been identified in the bone, followed by brain, skin, kidney, liver and spleen. The duration of retention also varies by tissue, and is longest in bone. Linear GBCAs cause more retention than macrocyclic GBCAs.
• Consequences of gadolinium retention in the brain have not been established. Adverse events involving multiple organ systems have been reported in patients with normal renal function without an established causal link to gadolinium retention.
• 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; administer the lowest dose necessary for adequate imaging.
• Extravasation and Injection Site Reactions: Ensure catheter and venous patency before the injection of DOTAREM. Extravasation into tissues during DOTAREM administration may result in tissue irritation.

ADVERSE REACTIONS

• The most common adverse reactions associated with DOTAREM in clinical trials were nausea, headache, injection site pain, injection site coldness and rash.
• Serious adverse reactions in the Postmarketing experience have been reported with DOTAREM. These serious adverse reactions include but are not limited to: arrhythmia, cardiac arrest, respiratory arrest, pharyngeal edema, laryngospasm, bronchospasm, coma and convulsion.

USE IN SPECIFIC POPULATIONS

• Pregnancy: GBCAs cross the human placenta and result in fetal exposure and gadolinium retention. Use only if imaging is essential during pregnancy and cannot be delayed.
• Lactation: There are no data on the presence of gadoterate 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 present in breast milk.
• Pediatric Use: The safety and efficacy of DOTAREM at a single dose of 0.1 mmol/kg has been established in pediatric patients from birth (term neonates ≥ 37 weeks gestational age) to 17 years of age based on clinical data. The safety of DOTAREM has not been established in preterm neonates. No cases of NSF associated with DOTAREM or any other GBCA have been identified in pediatric patients age 6 years and younger.

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 patient Medication Guide, for additional important safety information.

Dose&Care ® Indications for Use

Dose&Care® allows the user to store and monitor the patient’s dosimetric information. It collects dose reports created by modalities (scanner, conventional and interventional radiology, mammography, etc.)

Dose&Care® enables real-time monitoring of patient’s dose and includes a user management system. It also provides tools to associate procedure descriptions to regions, to edit alert rules for each region and to manage groups of procedure descriptions.

For complete information about precautions and optimal usage conditions, we recommend consulting the instructions for use supplied with the software or by your local Guerbet representative(s).

Manufacturer: MPTronic

Contrast&Care ® Indications for Use

Contrast&Care® is a medical device intended for use by healthcare professionals only. It allows imaging centers to collect, archive, view and share patients’ injection data, including data concerning contrast products, adverse events, injector activity, data on the estimated eGFR and other pre-exam alerts, such as previously reported allergies.

Contrast&Care® also provides options to visualize analytics data and trends relating to injection activity and contrast product usage.

For complete information about precautions and optimal usage conditions, we consult the instructions for use supplied with the device or by your local Guerbet representative(s).

Manufacturer: Medex

icobrain Indications for Use

icobrain is a 510(k) cleared medical device intended for automatic labeling, visualization and volumetric quantification of segmentable brain structures from a set of MR or NCCT images. This software is intended to automate the current manual process of identifying, labeling and quantifying the volume of segmentable brain structures identified on MR or NCCT images.

icobrain consists of two distinct image processing pipelines: icobrain cross and icobrain long. icobrain cross is intended to provide volumes from MT or NCCT images acquired in a single timepoint.

icobrain long is intended to provide changes in volumes between two MR images that were acquired on the same scanner, with the same image acquisition protocol and with same contrast at two different time points.

The results of icobrain cross cannot be compared with the results of icobrain long.

Manufacturer: icometrix

References:

1. Elucirem [package insert]. Princeton, NJ: Guerbet LLC; 2022
2. Robic, C., Port, M., Rousseaux, O., Louguet, S., Fretellier, N., Catoen, S., Factor, C., Le Greneur, S., Medina, C., Bourrinet, P., Raynal, I., Idée, J. M., & Corot, C. (2019). Physicochemical and Pharmacokinetic Profiles of Gadopiclenol: A New Macrocyclic Gadolinium Chelate With High T1 Relaxivity. Investigative radiology, 54(8), 475–484. https://doi.org/10.1097/RLI.0000000000000563
3. FDA’s Multi-Discipline Review https://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/216986Orig1s000MultidisciplineR.pdf

Note: The person clicking on the link must be a registered attendee and be logged in to add the session to their agenda. Otherwise, the person will be stopped to register and/or login, as the direct link will not take them to our session page after login.

Contacts:

Guerbet
Claire Lauvernier, Group Communication Director +33.6.79.52.11.88 / claire.lauvernier@guerbet.com

Actifin
Mathias Jordan, Media Relations +33.1.56.88.11.26 / mjordan@actifin.fr

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SOURCE Guerbet