Label Changes for:
Changes have been made to the WARNINGS, PRECAUTIONS and ADVERSE REACTIONS sections of the safety label.
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
WARNINGS AND PRECAUTIONS
- Assess LFTs prior to each administration of YONDELIS and as clinically indicated based on underlying severity of pre-existing hepatic impairment. Manage elevated LFTs with treatment interruption, dose reduction, or permanent discontinuation based on severity and duration of LFT abnormality.
Adverse Reactions in Clinical Trials
- Tables 3 and 4 present selected adverse reactions and laboratory abnormalities, respectively …
USE IN SPECIFIC POPULATIONS
- The mean trabectedin exposure was (97%) higher in patients with moderate (bilirubin levels 1.5 to 3.0 times the upper limit of normal, and AST and ALT less than 8 times the upper limit of normal) hepatic impairment compared to patients with normal (total bilirubin ? the upper limit of normal, and AST and ALT = the upper limit of normal) liver function. Reduce YONDELIS dose in patients with moderate hepatic impairment.
- Do not administer YONDELIS to patients with severe hepatic impairment (bilirubin levels above 3 times to 10 times the upper limit of normal, and any AST and ALT).