Real World Tested. Real World Proven.

Dotarem® Safety Profile

Real World Tested.
Real World Proven.

The Dotarem® safety profile has been tested and proven in both clinical studies and over 30 years of global clinical use.* 

Dotarem Remains an Industry Standard for Contrast Imaging for Over 30 Years*

Dotarem Safety Profile Stat Image C1

Low Incidence of Immediate Adverse Events in Clinical Uses1-7

Dotarem® has been tested in more than studies - it has also withstood the test of real-world clinical uses.1

  • 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% incidence rate of serious adverse events
Reactions C1chart (2)

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®.9

Pediatricutlization Chart C1

A Stable Clinical Profile Established for Children12

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.12 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.10

Pediatric Radiologists are Switching to Dotarem11

  • 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

References

  1. 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.
  2. 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.
  3. 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.
  4. 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.
  5. 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.
  6. 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.
  7. 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 
  8. 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. 
  9. 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. 
  10. 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. 
  11. 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.
  12. Dotarem [package insert]. Princeton, NJ: Guerbet LLC; Apr 2022

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