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