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Label Changes for:

Yondelis (trabectedin)

July 2016

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)

July 2016

WARNINGS AND PRECAUTIONS

Hepatotoxicity
  • 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

Adverse Reactions in Clinical Trials
  • Tables 3 and 4 present selected adverse reactions and laboratory abnormalities, respectively …

USE IN SPECIFIC POPULATIONS

Hepatic Impairment
  • 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).
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