
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
References
- Data on file
- USA PI as of August 2018. https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204781 s000lbl.pdf
- 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
- 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
- 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
- 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
- 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
- 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.
- Dotarem: Summary of product specifications
- 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
- 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
- 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
- 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
- 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
- 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
- SPC Dotarem
- De Kerviler E et al. Invest . . Radiol. 2016 Sep;51(9):544-5 no
- 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 - J.-M. Id´ee et al., Toxicology, 248, 77–88, 2008