Label Changes for:
Faslodex (fulvestrant) Injection
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)
- elevation of bilirubin, elevation of gamma GT, hepatitis, and liver failure have been reported infrequently (<1%).
WARNINGS and PRECAUTIONS
A 250 mg dose is recommended in patients with moderate hepatic impairment
USE IN SPECIFIC POPULATIONS
A dose of FASLODEX 250 mg is recommended in patients with moderate hepatic impairment (Child-Pugh class B).