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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® (GADOTERATE MEGLUMINE) INJECTION IMPORTANT SAFETY INFORMATION

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.

Reimbursement Information*

For U.S. Reimbursement Information, please see attached information for Hospital Outpatient settings and Freestanding/Independent Diagnostic Testing Facility (IDTF) settings.

For further assistance, please contact DOTAREM Reimbursement Support at 1-855-368-2736, Monday–Friday, 7 am–7 pm ET.

1. Maravilla K et al. Comparison of Gadoterate Meglumine and Gadobutrol in the Diagnosis of Primary Brain Tumors: A Double-Blind Randomized Controlled Intraindividual Crossover Study (the REMIND Study). 2017 June 29. doi: 10:3174/ajnr.A5316. [Epub ahead of print]. 2. Dotarem [package insert]. Princeton, NJ: Guerbet LLC; Oct 2019. 3. de Kerviler E et al. Adverse reactions to gadoterate meglumine: review of ov¬oer 25 years of clinical use and more than 50 million doses. Invest Radiol 2016;51:544–51 CrossRef Medline. 4. Endrikat J et al. Safety of gadobutrol: results from 42 clinical phase II to IV studies and postmarketing surveillance after 29 million applications. Invest Radiol 2016;51: 537–43 CrossRef Medline. 5. Port M et al. Efficiency,thermodynamic and kinetic stability of marketed gadolinium chelates and their possible clinical consequences: a critical review. Biometals. 2008;21:469-90. 6. Frenzel T et al. Stability of gadolinium-based magnetic resonance imaging contrast agents in human serum at 37°C. Invest Radiol. 2008;43:817-828.

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

Gadavist® is a registered trademark of the Bayer group of companies, and is available by prescription only.

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