Overview

In this session, we will review VEOZAH™ (fezolinetant), an FDA-approved treatment for moderate to severe vasomotor symptoms due to menopause, including indication, mechanism of action, and clinical safety and efficacy.


Important Safety Information
WARNING: RISKS OF HEPATOTOXICITY
Hepatotoxicity has occurred with the use of VEOZAH in the postmarketing setting.

Perform hepatic laboratory tests prior to initiation of treatment to evaluate for hepatic function and injury. Do not start VEOZAH if either aminotransferase is ≥ 2x the upper limit of normal (ULN) or if the total bilirubin is ≥ 2x ULN for the evaluating laboratory.

Perform follow-up hepatic laboratory testing monthly for the first 3 months, at 6 months, and 9 months of treatment.
Advise patients to discontinue VEOZAH immediately and seek medical attention including hepatic laboratory tests if they experience signs or symptoms that may suggest liver injury (new onset fatigue, decreased appetite, nausea, vomiting, pruritus, jaundice, pale feces, dark urine, or abdominal pain).
Discontinue VEOZAH if transaminase elevations are > 5x ULN, or if transaminase elevations are > 3x ULN and the total bilirubin level is > 2x ULN.
If transaminase elevations > 3x ULN occur, perform more frequent follow-up hepatic laboratory tests until resolution.

Please see additional Important Safety Information, including BOXED WARNING, throughout this presentation.

SPONSORED BY

Astellas Pharma US, Inc.