Safety

Faslodex (fulvestrant) solution for injection

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

March 2016

Summary View

WARNINGS AND PRECAUTIONS

Embryo-Fetal Toxicity
  • Based on findings from animal studies and its mechanism of action, FASLODEX can cause fetal harm when administered to a pregnant woman. In animal reproduction studies, administration of fulvestrant to pregnant rats and rabbits during organogenesis resulted in embryo-fetal toxicity at daily doses that are significantly less than the maximum recommended human dose. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with FASLODEX and for one year after the last dose.

 

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). 

 

Page Last Updated: 04/15/2016
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.