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The following information is for healthcare professionals licensed in the United States. Countries outside the United States have different practice, legal and regulatory requirements which may require different information. Information may not be appropriate for use outside of the United States.
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Dotarem® Remains an Industry Standard for Contrast Imaging for 30 Years*
Over 100 million global doses administered2

Low Incidence of Immediate
Adverse Events in Clinical Uses3-10

Dotarem® has been tested in more than studies - it has also withstood the test of real-world clinical uses.3-10

  • 4.0% in clinical trials (N=2822)
    • – 0.7% considered serious
  • <1% in postmarketing studies (N>150,000)
  • 0.007% reported spontaneously worldwide
    (>50 million doses)
    • – 0.0023% were considered serious
0.007% reported spontaneously worldwide adverse events (>50 million doses)3
 
 
1 - Dotarem® - The First Macrocyclic and Ionic GBCA Molecule1
 

How Does Dotarem Compare to Other GBCAs Sold in the US?

Differences in reaction rates among GBCAs have been difficult to demonstrate because of the large number of patients needed to show statistically significant differences for such rare events. In a systematic review and meta-analysis of 9 studies, including 716,978 GBCA administrations, rates of immediate allergic-like AEs per 10,000 administrations among macrocyclic agents were lowest for ionic Dotarem® vs nonionic Gadavist® and ProHance®.11

 
 
 
 

A Stable Clinical Profile Established for Children1

The safety and efficacy of Dotarem have been established in pediatric patients from birth (term neonates ≥37 weeks gestational age) to 17 years of age.1 In a pediatric study of 1,568 patients, image quality was rated either good or very good by radiologists in 98.4% of cases when using Dotarem.12

 
 
 
 

Pediatric Radiologists are Switching to Dotarem13

  • 58% (15 of 26) of pediatric radiology departments surveyed switched their GBCA for reasons that included:

    • – Brain gadolinium deposition concerns (73%)
    • – Improved safety profile (47%)
    • – Improved stability (33%)
    • – NSF concerns (20%)
    • – Cost (7%)
  • Of the 58% that recently switched, 53% (8 of 15) switched to DOTAREM

  • Another 23% (6 of 26) were considering switching and of those, 83% (5 of 6) reported that they planned to switch to DOTAREM

 

IMPORTANT SAFETY INFORMATION1

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.

References: 1. Dotarem [package insert]. Princeton, NJ: Guerbet LLC; Oct 2019. 2. Internal data as of Oct 2019. 3. de Kerviler E et al. Adverse reactions to gadoterate meglumine: review of over 25 years of clinical use and more than 50 million doses. Invest Radiol. 2016 Sep;51(9):544-51. 4. Briand et al. Efficacy and safety of the macrocyclic complex Gd-DOTA in Children: Results of a Multi-Centre Study. Proceedings of the 29th Congress of the European Society of Pediatric Radiology. 1992; 128. 5. Briand Y. Daily Paediatric Use of MRI Contrast Agents: Results of a Multi-Centre Survey. Proceedings of the 29th Congress of the European Society of Pediatric Radiology. 1992. 6. Ishiguchi T & Takahashi S. Safety of gadoterate meglumine (Gd-DOTA) as a contrast agent for magnetic resonance imaging: results of a post-marketing surveillance study in Japan. Drugs R D. 2010;10(3):133-45. 7. Emond S & Brunelle F. Gd-DOTA administration at MRI in children younger than 18 months of age: immediate adverse reactions. Pediatr Radiol. 2011 Nov;41(11):1401-6. 8. Maurer M et al. Tolerability and diagnostic value of gadoteric acid in the general population and in patients with risk factors: results in more than 84,000 patients. Eur J Radiol. 2012 May;81(5):885-90. 9. Soyer et al. Observational Study on the Safety Pro le of Gadoterate Megluminein 35,499 Patients: The SECURE Study. J. Magn. Reson. Imag. 2017; 45, 988-997 10. Radbruch A et al. Gadolinium retention in the dentate nucleus and globus pallidus is dependent on the class of contrast agent. Radiology. 2015 Jun;275(3):783-97. 11. Behzadi AH, Zhao Y, Farooq Z, Prince MR. Immediate allergic reactions to gadolinium-based contrast agents: a systematic review and meta-analysis. Radiology. 2018;286(2):471-482. 12. De-Hua, Chang, and Pracros Jean-Pierre. "Safety of Gadoterate Meglumine in over 1600 Children Included in the Prospective Observational SECURE Study." Acta Radiologica, 2019. 13. Mithal LB, Patel PS, Mithal D, Palac HL, Rozenfeld MN. Use of gadolinium-based magnetic resonance imaging contrast agents and awareness of brain gadolinium deposition among pediatric providers in North America. Pediatr Radiol. 2017;47(6):657-664.

*Dotarem was launched globally in 1989 and approved by the FDA for use in the US in 2013.

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

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

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