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U.S. Department of Health and Human Services

Safety

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Faslodex (fulvestrant) solution for injection

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

 

July 2012

Summary View

ADVERSE REACTIONS

Post-Marketing Experience
  • elevation of bilirubin, elevation of gamma GT, hepatitis, and liver failure have been reported infrequently (<1%).

 

 

September 2010

Summary View

 

WARNINGS and PRECAUTIONS

Hepatic Impairment
  • A 250 mg dose is recommended in patients with moderate hepatic impairment

     

USE IN SPECIFIC POPULATIONS

Hepatic Impairment
  • A dose of FASLODEX 250 mg is recommended in patients with moderate hepatic impairment (Child-Pugh class B).