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Comparison of Dotarem® to Gadavist® for Overall Visualization and Characterization in the MRI Diagnosis of Primary Brain Tumors

Despite the difference in relaxivity between these 2 GBCAs

There Is No Measurable Difference in Clinical Benefit Observed Between Dotarem® and Gadavist®1

as demonstrated by the REMIND Study, a multicenter, double-blind, randomized, controlled intraindividual crossover study.1

Results

For all readers, more than 90% presented with good or excellent overall lesion visualization and characterization with either of the two contrast agents.1

Rate of patients with overall lesion visualization and characterization scored good/excellent or poor/fair

Additionally, in most cases there was no preference of the readers for either contrast agent regarding border delineation, internal morphology, and the qualitative degree of contrast enhancement despite quantitative mean lesion percentage enhancement being higher with gadobutrol.1

Border Delineation

Border Delineation

Internal Morphology

Degree of Contrast Enhancement

Case Studies

The REMIND Study demonstrates non-inferiority in lesion visualization and characterization for both Dotarem and Gadavist.1

A 46-year-old woman with glioblastoma

After injection of Dotarem®

After injection of Gadavist®

A 74-year-old man with a high-grade glioma

After injection of Dotarem®

After injection of Gadavist®

Summary

This study “demonstrates the non-inferiority of gadoterate meglumine [Dotarem] versus gadobutrol [Gadavist] for overall visualization and characterization of primary brain tumors.”1

  • For all readers in the REMIND Study, more than 90% of patient images were scored with good or excellent overall lesion visualization and characterization with either Dotarem® or Gadavist®.1
  • The REMIND Study also confirmed low incidence of immediate reported AEs with Dotarem® and with Gadavist®, as shown in multiple previous studies.1,3,4
  • Dotarem® is an imaging contrast with macrocyclic and ionic structure for high thermodynamic and kinetic stability.5,6
  • Dotarem® is not only trusted for high molecular stability5,6; the REMIND Study demonstrates that it is as effective as Gadavist® for MRI diagnosis of primary brain tumors.1

Stability Down to its
Molecular Core

Guerbet's research team designed Dotarem® (gadoterate meglumine) with a unique profile, providing the highest molecular stability to minimize the risk of gadolinium release.7

Learn more about Dotarem

IMPORTANT SAFETY INFORMATION2

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.

Warnings and Precautions

Adverse Reactions

Use in Specific Populations

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.

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.

1. Maravilla K et al. Comparison of Gadoterate Meglumine and Gadobutrol in the Diagnosis of Primary Brain Tumors: A Double-Blind Randomized Controlled Intraindividual Crossover Study (the REMIND Study). 2017 June 29. doi: 10:3174/ajnr.A5316. [Epub ahead of print]. 2. Dotarem [package insert]. Princeton, NJ: Guerbet LLC; Oct 2019. 3. de Kerviler E et al. Adverse reactions to gadoterate meglumine: review of ov¬oer 25 years of clinical use and more than 50 million doses. Invest Radiol 2016;51:544–51 CrossRef Medline. 4. Endrikat J et al. Safety of gadobutrol: results from 42 clinical phase II to IV studies and postmarketing surveillance after 29 million applications. Invest Radiol 2016;51: 537–43 CrossRef Medline. 5. Port M et al. Efficiency,thermodynamic and kinetic stability of marketed gadolinium chelates and their possible clinical consequences: a critical review. Biometals. 2008;21:469-90. 6. Frenzel T et al. Stability of gadolinium-based magnetic resonance imaging contrast agents in human serum at 37°C. Invest Radiol. 2008;43:817-828. 7. Meyer D et al. Gd-DOTA, a potential MRI contrast agent. Current status of physicochemical knowledge. Invest Radiol. 1988 Sep;23 Suppl 1:S232-5.

* Reimbursement information provided is for illustrative purposes only and does not constitute legal advice. Information provided is gathered from third party sources and is subject to change without notice due to frequently changing laws, rules and regulations. Guerbet makes no guarantee that the use of this information will prevent differences of opinion or disputes with Medicare or other third party payers as to the correct form of billing or the amount that will be paid to providers of service. The provider of service has the responsibility to determine medical necessity and to submit appropriate codes and charges for care provided. Please contact your local payers, reimbursement specialists and/or legal counsel for interpretation of coding, coverage, and payment policies. Guerbet does not promote the use of its products outside FDA-approved labeling.

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

Gadavist® is a registered trademark of the Bayer group of companies, and is available by prescription only.

Learn more at guerbet-us.com.
Legal © 2018 Guerbet Group