Guerbet Partnership with Applied Radiology

Guerbet Partnership with Applied Radiology

Providing webinars, case studies, video interviews and more.

Scroll down for Important Safety Information.

Partnership with Applied Radiology advances physician clinical insights, providing case studies, video interviews, and more

As one of the leading experts in medical diagnostic and interventional imaging worldwide, Guerbet believes in providing clinical insights and highlighting clinical cases that advance the industry. For the past five years Guerbet and Applied Radiology, The Journal of Practical Medical Imaging and Management, have worked together to build a community of clinicians, industry professionals, thought leaders and experts for in-depth conversations and case studies.

Guerbet and Applied Radiology have produced a series of digital articles featuring interviews with leading physicians, imaging professionals and experts on key industry topics. Guerbet’s AR Connect web-portal on Applied Radiology’s website includes articles supporting the clinical use of Guerbet products.

  • In Delivering Stability with Macrocyclic Gadolinium Based Contrast Agents, Donna Roberts, MD and Ari Goldberg, MD, PhD, discuss the importance of Radiologists using a product like Dotarem®, to balance patient safety, agent stability, and diagnostic image quality when choosing a MR contrast agent. This is particularly important within pediatric patients within the neonatal developmental period.
  • In the age of COVID, The Benefits of Prefilled Syringe Utilization in MRI features a discussion between Don Owens, BSRT (R), MS, and Doug Boyd R.T. (R) (MR), on the benefits of using prefilled syringes. Owens and Boyd both note that the closed system of prefilled syringes not only saves time, but also decreases risk of contamination.
  • Tom McLaughlin, Guerbet’s Vice President for North America, discusses the company’s commitment to developing innovative solutions to support radiology in Guerbet: A Dedication to Medical Imaging. Since its release in 1989, Dotarem® has been the world’s leading MR Contrast agent. McLaughlin shares the strides Guerbet is taking with its flagship product in the U.S.
  • In Clinical Evidence Supports Dotarem® Injection for MR Imaging Kohkan Shamsi MD, PhD, Co-founder and Principal, RadMD, discusses the findings of the REMIND Study and shares that “The results of this trial show that Dotarem® was noninferior to Gadavist® for visualization parameters, and the adverse event profile was similar. So, this study supports that there is no difference in clinical benefit between Dotarem® and Gadavist®.”

In addition to AR Connect, Guerbet sponsors the Applied Radiology Pediatric Imaging Digital Community. This pediatric imaging portal shares advances in cutting edge research and advancing technology with the opinions of thought leaders and pediatric radiologists, case studies and clinical reviews, news and more. This is one of six Applied Radiology Communities, including artificial intelligence (also sponsored by Guerbet), Breast Imaging, CT imaging, MR imaging, and Vascular IR imaging.

The community provides clinical case studies across the spectrum of Pediatric Imaging, including several cases specific to Dotarem® utilization.

Coming Soon - New | Video Case Study Reviews with Dr. Aashim Bhatia Assistant Professor of Clinical Radiology, Pediatric Neuroradiologist, Children’s Hospital of Philadelphia, which will deliver a unique learning experience, including the opportunity to hear how Dr. Bhatia approaches dictation with case study teaching points.

Guerbet is committed to promoting education, research, and advances within various imaging fields by bringing together cutting-edge technologies, thought leadership, and industry professionals. Its partnership with Applied Radiology provides a wealth of

information to the radiology community. To learn more about Guerbet, Dotarem ® and Applied Radiology, visit their websites today!

Important Safety Information

WARNING: NEPHROGENIC SYSTEMIC FIBROSIS (NSF)

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. NSF may result in fatal or debilitating fibrosis affecting the skin, muscle and internal organs.

  • 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 (e.g. age > 60 years, hypertension, diabetes), estimate the glomerular filtration rate (GFR) through laboratory testing.
  • For patients at highest risk for NSF, do not exceed the recommended DOTAREM dose and allow a sufficient period of time for elimination of the drug from the body prior to any re-administration.


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.

Warning 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.
DOTAREM® is a registered trademark of Guerbet LLC, and is available by prescription only.

Reimbursement Information**
For U.S. Reimbursement Information, please see attached information for Hospital Outpatient settings and Freestanding/Independent Diagnostic Testing Facility (IDTF) settings.
For further assistance, please contact DOTAREM Reimbursement Support at 1-855-368-2736, Monday–Friday, 7 am–7 pm ET.

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