Clinical Applications & Imaging Considerations of Gadopiclenol Injection

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Claiming CE Credits

To receive CE credits, participants must review the program materials in their entirety and complete the online post examination and evaluation with a score of 80% or better.

Program Summary

In September 2022, Gadopiclenol injection, which is both macrocyclic (stable) and has high relaxivity properties received FDA marketing approval and may provide dosing options that can decrease gadolinium exposure, particularly in vulnerable patients.

In this accredited Expert Forum webinar, the assessment of Gadopiclenol injection in neuro, body, and pediatric MR imaging will be presented by a panel of MR imaging experts and will include commentary from Lawrence N. Tanenbaum, MD. To encourage audience participation, a live Q & A session will follow the discussion.

CE Effective Date: May 10, 2023
CE Expiration Date: May 31, 2026

Format: Self Instructional - Audio Visual with Slides
Educational Credits:
One (1) ARRT Category A CE Credit.
One (1) AHRA CRA Credit
Estimated Completion Time: 1 hour

This webinar is an educational activity sponsored by Guerbet, LLC.

Target Audience & Cost

This program is intended for: Radiologic Technologists, Radiology Administrators and related Imaging Professionals.

There is no cost to participate in this program.

Educational Objectives

Upon completion of this CE activity the healthcare provider should be able to:

  • Explain the properties that distinguish Gadopiclenol injection from the other high-relaxivity and conventional gadolinium-based contrast agents.
  • Describe the clinical use of Gadopiclenol injection in neuro, body, and pediatric MRI applications.
  • Describe the clinical development program of Gadopiclenol injection for neuro and body MRI applications.
  • Apply clinical considerations and dosing options when selecting a macrocyclic, high relaxivity, MRI contrast in vulnerable patient populations.

Presented by

 Lawrence N. Tanenbaum, MD Lawrence N. Tanenbaum, MD
VP & Chief Technology Officer
RadNet, Inc.

Lawrence N Tanenbaum MD, FACR is currently Vice President & Chief Technology Officer at RadNet, Inc., a leading provider of freestanding, fixed-site diagnostic imaging services in the United States, where he also serves as Medical Director for the Eastern Region. Prior to this role, Dr. Tanenbaum served as Associate Professor of Radiology and Director of MRI/CT & Outpatient / Advanced Imaging Development at the Icahn School of Medicine at Mount Sinai in New York.

Dr. Tanenbaum has authored approximately 100 scholarly and peer reviewed articles, continues to chair educational and academic meetings, and has delivered over 1500 invited lectures around the world.

Accreditation

Radiologic Technologists:
This course meets all criteria and has been approved by the AHRA, The Association for Medical Imaging Management for One (1) ARRT Category A CE Credit.

Radiology Administrators:
This course meets all CRA renewal credit criteria and has been approved for One (1) continuing education credit in the following CRA domains: Operations Management (OM), and Asset Management (AM)

.

For information on applicability and acceptance of continuing education credit for this activity, please consult your professional licensing board or other credentialing organization.

Method of Participation/Criteria for Success

CE Credits
To receive CE credits for participating in this CE activity you must successfully complete the online post examination with a passing score of 80% or higher.

Online examinations return an immediate grade report. Upon receiving a passing score click Continue and complete the evaluation form. To view and print your Statement of Credit click the Print/View Certificate button displayed from within your MyAR Archives page.

Disclaimer

Participants have an implied responsibility to use the newly acquired information to enhance patient outcomes and their own professional development. The information presented in this activity is not meant to serve as a guideline for patient management. Any procedures, medications, or other courses of diagnosis or treatment discussed or suggested in this activity should not be used by clinicians without evaluation of their patient’s conditions and possible contraindications on dangers in use, review of any applicable manufacturer’s product information, and comparison with recommendations of other authorities.

ELUCIREM™ (gadopiclenol) injection Important Safety Information

WARNING: NEPHROGENIC SYSTEMIC FIBROSIS (NSF)
See full prescribing information for complete boxed warning

Gadolinium-based contrast agents (GBCAs) increase the risk for NSF among patients with impaired elimination of the drugs. Avoid use of GBCAs in these patients unless the diagnostic information is essential and not available with non-contrasted MRI or other modalities.

  • The risk for NSF appears highest among patients with:
    • Chronic, severe kidney disease (GFR <30 mL/min/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. .

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 musculoskeletal system).

Contraindications

History of hypersensitivity reactions to ELUCIREM

Warnings and Precautions

  • Nephrogenic Systemic Fibrosis: GBCAs increase the risk for NSF among patients with impaired elimination of the drugs. Avoid use of GBCAs among these patients unless the diagnostic information is essential and not available with non-contrast MRI or other modalities. The GBCA-associated NSF risk appears highest for patients with chronic, severe kidney disease as well as patients with acute kidney injury.
  • 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.

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 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 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, for additional important safety information.