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U.S. Department of Health and Human Services

Safety

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Gadavist (Gadobutrol) Injection

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)

 

October 2013

Summary View

CONTRAINDICATIONS

  • Gadavist is contraindicated in patients with history of severe hypersensitivity reactions to Gadavist.

WARNINGS AND PRECAUTIONS

Acute Kidney Injury
  • In patients with chronic renal impairment, acute kidney injury sometimes requiring dialysis has been observed with the use of some GBCAs. Do not exceed the recommended dose; the risk of acute kidney injury may increase with higher than recommended doses.