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

Gadobutrol Injection

Macrocyclic & High Relaxivity
Gadolinium-Based Contrast Agent3,4

Fresenius Kabi’s FDA-approved generic Gadobutrol Injection provides an option that is chemically equivalent and fully substitutable to Gadavist®.*

Fresenius Kabi’s Gadobutrol Injection is fully substitutable and chemically equivalent to Gadavist®.*

Gadobutrol Injection

• FDA-approved, AP Rated
• High Relaxivity3,4
• Macrocyclic Bond3,4
• High Concentration GBCA3,4

• Preservative Free3,4
• The container closure is not made with natural rubber latex
• Bioequivalent and fully substitutable to Gadavist®*

1. Gadavist Package Insert, April 2022
2. Gadavist Imaging Bulk Package Insert, April 2022
3. Gadobutrol Injection Package Insert, January 2023
4. Gadobutrol Injection Imaging Bulk Package Insert, June 2023

*Gadavist® is a registered trademark of Bayer.


Gadobutrol Injection Brochure

Important Safety Information


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 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 > 60 years, hypertension or diabetes), estimate the glomerular filtration rate (GFR) through laboratory testing.
  • For patients at highest risk for NSF, do not exceed the recommended gadobutrol injection dose and allow a sufficient period of time for elimination of the drug from the body prior to any re-administration.

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