Dotarem® (Gadoteric acid - Gadoterate meglumine)

Contrast Agent for MRI

Dotarem® (Gadoteric acid - Gadoterate meglumine)

Launched in 1989 in France, Dotarem® is currently available in over 70 countries.

Dotarem® is BOTH Ionic & Macrocyclic. It has a high Thermodynamic Stability and High Kinetic Stability (Dissociation ½ Life)19.

Dotarem® is licensed for patients of ALL ages for enhancement of contrast for Encephalic and spinal MRI, whole body MRI (including cardiac, breast, uterine, ovarian, abdominal, renal, and osteo-articular pathology) and for adults (18 year and above) in angiography16.

Nephrogenic Systemic Fibrosis (NSF) is a well-documented concern in MRI. Dotarem has no confirmed unconfounded cases of NSF17. According to the FDA and EMA, Dotarem has a low-level risk for NSF18.

 

Download the product related SMPCs

SPC Dotarem PFS_2020

SPC Dotarem Vials_Dec 2017

References

  1. Data on file
  2. USA PI as of August 2018. https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204781 s000lbl.pdf
  3. de Kerviler E, Maravilla K, Meder JF, Naggara O 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 doi: 10.1097/RLI.0000000000000276
  4. Radbruch A, Weberling LD, Kieslich PJ, Eidel O, 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
  5. Radbruch A, Weberling LD, Kieslich PJ, Hepp J, et al. Intraindividual Analysis of Signal Intensity Changes in the Dentate Nucleus After Consecutive Serial Applications of Linear and Macrocyclic Gadolinium-Based Contrast Agents. Invest Radiol. 2016 Nov;51(11):683-690
  6. Eisele P, Alonso A, Szabo K, Ebert A, et al. Lack of increased signal intensity in the dentate nucleus after repeated administration of a macrocyclic contrast agent in multiple sclerosis: An observational study. Medicine (Baltimore). 2016 Sep;95(39):e4624. doi: 10.1097/MD.0000000000004624
  7. Radbruch A, Haase R, Kieslich PJ, Weberling LD, et al. No Signal Intensity Increase in the Dentate Nucleus on Unenhanced T1-weighted MR Images after More than 20 Serial Injections of Macrocyclic Gadolinium-based Contrast Agents. Radiology. 2017 Mar;282(3):699- 707. doi: 10.1148/radiol.2016162241. Epub 2016 Dec 7
  8. Radbruch A, Haase R, Kickingereder P, Bäumer P, et al. Pediatric Brain: No Increased Signal Intensity in the Dentate Nucleus on Unenhanced T1-weighted MR Images after Consecutive Exposure to a Macrocyclic Gadolinium-based Contrast Agent. Radiology. 2017 Jun;283(3):828-836. doi: 10.1148/radiol.2017162980. Epub 2017 Mar 8.
  9. Dotarem: Summary of product specifications
  10. 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
  11. 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. doi: 10.1007/s00247-011-2167-3. Epub 2011 Jul 24
  12. Maurer M, Heine O, Wolf M, Durmus T, 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. doi: 10.1016/j.ejrad.2011.04.022. Epub 2011 May 8
  13. Soyer P, Dohan A, Patkar D, Gottschalk A. Observational Study on the Safety Profile of Gadoterate Meglumine in 35,499 Patients: The SECURE Study. J Magn Reson Imaging. 2017 Apr;45(4):988-997. doi: 10.1002/jmri.25486. Epub 2016 Oct 11
  14. de Kerviler E, Maravilla K, Meder JF, Naggara O, 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. doi: 10.1097/RLI.0000000000000276
  15. Balassy C, Roberts D, Miller SF. Safety and efficacy of gadoteric acid in pediatric magnetic resonance imaging: overview of clinical trials and post-marketing studies. Pediatr Radiol. 2015 Nov;45(12):1831-41. doi: 10.1007/s00247-015-3394-9. Epub 2015 Jun 5
  16. SPC Dotarem
  17. De Kerviler E et al. Invest    .    .   Radiol. 2016 Sep;51(9):544-5 no
  18. Gadolinium Article-31 referral – EMA’s final opinion confirms restrictions on use of linear gadolinium agents in body scans. 21/07/2017, http://www.ema.europa.eu/ 
    ESUR guidelines v.10 ESUR_Guidelines_10.0_Final_Version.pdf
  19. J.-M. Id´ee et al., Toxicology, 248, 77–88, 2008