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Important Safety Information | Medication Guide | Full Prescribing Information: Single Dose Vials / Pharmacy Bulk Package

Gadoterate Meglumine Injection, USP

Macrocyclic & Ionic Gadolinium-Based Contrast Agent2,3

Fresenius Kabi’s FDA-approved generic Gadoterate Meglumine Injection, USP provides an option that is bioequivalent and fully substitutable to Dotarem®.*

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Fresenius Kabi’s Gadoterate Meglumine Injection, USP is fully substitutable and chemically equivalent to Dotarem®.*

Gadoterate Meglumine Injection, USP

• FDA-approved, AP Rated
• Macrocyclic2,3
• Ionic2,3

• Preservative Free2,3
• The container closure is not made with natural rubber latex
• Bioequivalent and fully substitutable to Dotarem®*

1: Dotarem Package Insert, April 2019
2: Gadoterate Meglumine Injection Package Insert, April 2022
3: Gadoterate Meglumine Injection Pharmacy Bulk Package Insert, April 2022

*Dotarem® is a registered trademark of Guerbet.

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Gadoterate Meglumine Injection, USP Brochure
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Gadoterate Meglumine Injection, USP Clinical Brochure
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Important Safety Information


WARNING: NEPHROGENIC SYSTEMIC FIBROSIS (NSF)
See full prescribing information for complete boxed warning

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.
  • The risk for NSF appears highest among patients with:
    • Chronic, severe kidney disease (GFR less than 30 mL/min/1.73 m2), 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 more than 60 years, hypertension, or diabetes), estimate the glomerular filtration rate (GFR) through laboratory testing.

INDICATIONS AND USAGE

Gadoterate Meglumine Injection is a 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.

Gadoterate Meglumine Injection is contraindicated in clinically important hypersensitivity reactions to Gadoterate Meglumine Injection.

Nephrogenic Systemic Fibrosis has occurred in patients with impaired elimination of GBCAs. Higher than recommended dosing or repeat dosing appear to increase the risk.

Hypersensitivity: Anaphylactoid/anaphylactic reactions with cardiovascular, respiratory, or cutaneous manifestations, ranging from mild to severe, including death, have uncommonly occurred. Monitor patients closely for need of emergency cardiorespiratory support.

Gadolinium is retained for months or years in brain, bone, and other organs.

Adverse Events: The most frequent (≥ 0.2%) adverse reactions in clinical studies were nausea, headache, injection site pain, injection site coldness, and rash.

To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800-551-7176, option 5, or FDA at 1-800- FDA-1088 or www.fda.gov/medwatch.

Pregnancy: Use only if imaging is essential during pregnancy and cannot be delayed.

This Important Safety Information does not include all the information needed to use Gadoterate Meglumine Injection, USP safely and effectively. Please see full prescribing information, including BOXED WARNING, for Gadoterate Meglumine Injection, USP single dose vials and pharmacy bulk package at www.fresenius-kabi.com/us.
For more information or to place an order, contact your Sales Representative or call Customer Service at (888) 386-1300
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