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Dotarem (GADOTERATE MEGLUMINE)
Gadoterate enhances MRI image brightness by shortening T1 and T2 relaxation times in tissues.
Gadoterate meglumine (Dotarem), marketed by Guerbet, is an MRI contrast agent used for detecting and visualizing blood-brain barrier disruption and abnormal vascularity. Its key strength lies in enhancing MRI image brightness through the shortening of T1 and T2 relaxation times, providing clear visualization critical for diagnostic accuracy. The primary risk is the key composition patent expiry in 2028, which could lead to increased competition from generics.
At a glance
| Generic name | GADOTERATE MEGLUMINE |
|---|---|
| Sponsor | Guerbet |
| Drug class | gadoterate meglumine |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | FDA-approved |
| First approval | 2013 |
Mechanism of action
Gadoterate is a paramagnetic molecule that, when placed in a magnetic field, develops a magnetic moment. This moment increases the relaxation rates of nearby water protons, making tissues appear brighter in MRI images, especially in T1-weighted sequences.
Approved indications
- Detection and visualization of BBB disruption/abnormal vascularity
Boxed warnings
- WARNING: RISK ASSOCIATED WITH INTRATHECAL USE and NEPHROGENIC SYSTEMIC FIBROSIS WARNING: RISK ASSOCIATED WITH INTRATHECAL USE and NEPHROGENIC SYSTEMIC FIBROSIS See full prescribing information for complete boxed warning Intrathecal administration of gadolinium-based contrast agents (GBCAs) can cause serious adverse reactions including death, coma, encephalopathy, and seizures. Clariscan is not approved for intrathecal use. ( 5.1 ) GBCAs increase the risk for nephrogenic systemic fibrosis (NSF) among patients with impaired elimination of the drugs. Avoid use of Clariscan in these patients unless the diagnostic information is essential and not available with non-contrasted MRI or other modalities. The risk for NSF appears highest among patients with: Chronic, severe kidney disease (GFR < 30 mL/min/1.73 m 2 ), 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 (for example, age > 60 years, hypertension or diabetes), estimate the glomerular filtration rate (GFR) through laboratory testing ( 5.2 ). Risk Associated with Intrathecal Use Intrathecal administration of gadolinium-based contrast agents (GBCAs) can cause serious adverse reactions including death, coma, encephalopathy, and seizures. Clariscan is not approved for intrathecal use [see Warnings and Precautions (5.1) ]. Nephrogenic Systemic Fibrosis GBCAs increase the risk for nephrogenic systemic fibrosis (NSF) among patients with impaired elimination of the drugs. Avoid use of Clariscan 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/1.73 m 2 ), 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 ( 5.2 ). For patients at highest risk for NSF, do not exceed the recommended Clariscan dose and allow a sufficient period of time for elimination of the drug from the body prior to any re-administration [see Warnings and Precautions (5.2) ].
Common side effects
- Nausea
- Headache
- Injection Site Pain
- Injection Site Coldness
- Rash
Key clinical trials
- Dotarem vs Gadobutrol Contrast for Breast MRI (PHASE4)
- Value of PET/MR Enterography in the Assessment of Crohn's Disease Using a Collagen-binding Radiotracer.
- Performance of Elucirem in DSC-MRI Perfusion of Brain Gliomas (PHASE3)
- Effect on Body Movement and Mental Skills in Patients Who Received Gadolinium-based Contrast Media for Magnetic Resonance Examination Multiple Times Within 5 Years (PHASE4)
- Evaluation of the Efficacy and Safety of Magnetic Resonance Angiography (MRA) Using Gadopiclenol Compared to Gadoterate Meglumine in the Assessment of Steno-occlusive Disease in Adult Patients With Suspected Vascular Disease (PHASE3)
- Diffusion MRI in Heart Failure (EARLY_PHASE1)
- A Study to Compare How Well Gadoquatrane Works and Its Safety With an Already Available Contrast Agent for MRI in People With Any Known or Suspected Problems of the Body (Except Brain or Spinal Cord-related Problems) (PHASE3)
- Developing a New Metabolic Imaging Approach (aMRI) for Evaluating Neurological Disease in Patients With Gliomas
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Dotarem CI brief — competitive landscape report
- Dotarem updates RSS · CI watch RSS
- Guerbet portfolio CI