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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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Stability Down to its
Molecular Core

Guerbet's research team designed Dotarem® (gadoterate meglumine) with a unique profile, providing the highest molecular stability to minimize the risk of gadolinium release.1

Dotarem’s unmatched profile:

  • The first macrocyclic & ionic GBCA molecule sold in the US2
  • Patented manufacturing process3
  • More than 100 million global doses administered with zero unconfounded cases of NSF2,4,5
  • Following repeated administrations, no visible T1 signal intensity detected on non-contrast images within the brain6-10

Now approved for pediatric patients less than two years of age including term neonates

Many pediatric hospitals have or plan to switch to Dotarem, a stable macrocyclic GBCA11

Sizes that Serve

Dotarem presentation sizes were developed to best serve our customers.

  • Dotarem offers the convenience of standard concentration, unlike Gadavist which is a double-concentrated agent that may require changes to standard dosing protocol2
  • Dotarem offers contrast dosing vial options for younger patients for less waste of unused contrast2
  • Dotarem offers convenient dosing sizes specifically for patients between 44 and 110 lbs.2

Gadolinium by Volume in Vial Offerings2,12

Chart Gadolinium Vial Chart Gadolinium Vial

Gadolinium by Volume in Prefilled Syringe Offerings2,12

Chart Gadolinium PFS Chart Gadolinium PFS

*Clinical substitutions are the responsibility and at the discretion of the physician. Vial size comparisons are for your reference only.

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IMPORTANT SAFETY INFORMATION2

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.

References: 1. Meyer D et al. Gd-DOTA, a potential MRI contrast agent. Current status of physicochemical knowledge. Invest Radiol. 1988 Sep;23 Suppl 1:S232-5. 2. Dotarem [package insert]. Princeton, NJ: Guerbet LLC; Oct 2019. 3. Patent US 9,655,983. 4. Internal data as of Oct 2019. 5. 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. 6. 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):783-91. 7. Radbruch A 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. 8. Eisele P 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. 9. Radbruch A 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. 10. Tibussek D et al. Gadolinium brain deposition after macrocyclic gadolinium administration: a pediatric case-control study. Radiology. 2017 Oct;285(1):223-30. Epub 2017 Jun 21. 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 Mar 10. doi: 10.1007/s00247-017-3810-4. [Epub ahead of print]. 12. Gadavist [package insert]. Whippany, NJ: Bayer HealthCare Pharmaceuticals Inc.; Apr 2016.

* Reimbursement information provided is for illustrative purposes only and does not constitute legal advice. Information provided is gathered from third party sources and is subject to change without notice due to frequently changing laws, rules and regulations. Guerbet makes no guarantee that the use of this information will prevent differences of opinion or disputes with Medicare or other third party payers as to the correct form of billing or the amount that will be paid to providers of service. The provider of service has the responsibility to determine medical necessity and to submit appropriate codes and charges for care provided. Please contact your local payers, reimbursement specialists and/or legal counsel for interpretation of coding, coverage, and payment policies. Guerbet does not promote the use of its products outside FDA-approved labeling.

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

Learn more at guerbet-us.com.
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