Label Changes for:

Faslodex (fulvestrant) Injection

July 2012

Changes have been made to the ADVERSE REACTIONS sections of the safety label.

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

 

July 2012

ADVERSE REACTIONS

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

 

 

September 2010

 

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).

 

Hide
(web2)