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NOIMPORTANT SAFETY INFORMATION
INDICATIONS AND USAGE
IMPORTANT SAFETY INFORMATION
INDICATIONS AND USAGE
VEOZAH is contraindicated in women with any of the following:
VEOZAH® (fezolinetant) is a neurokinin 3 (NK3) receptor antagonist indicated for the treatment of moderate to severe vasomotor symptoms due to menopause.
VEOZAH is contraindicated in women with any of the following:
VEOZAH® (fezolinetant) is a neurokinin 3 (NK3) receptor antagonist indicated for the treatment of moderate to severe vasomotor symptoms due to menopause.
Hepatic Transaminase Elevation
Elevations in serum transaminase [alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST)] levels > 3x the upper limit of normal (ULN) occurred in 2.3% of women receiving VEOZAH and 0.9% of women receiving placebo in three clinical trials. No serum elevations in total bilirubin (> 2x ULN) occurred. Women with ALT or AST elevations were generally asymptomatic. Transaminase levels returned to pretreatment levels (or close to these) without sequelae with dose continuation, and upon dose interruption, or discontinuation. Women with cirrhosis were not studied.
Perform baseline bloodwork to evaluate for hepatic function and injury prior to VEOZAH initiation. Do not start VEOZAH if concentration of ALT or AST is ≥ 2x ULN or if the total bilirubin is elevated (e.g., ≥ 2x ULN) for the evaluating laboratory. If baseline hepatic transaminase evaluation is < 2x ULN and the total bilirubin is normal, VEOZAH can be started. Perform follow-up evaluations of hepatic transaminase concentration at 3 months, 6 months, and 9 months after initiation of therapy and when symptoms (such as nausea, vomiting, or yellowing of the skin or eyes) suggest liver injury.
The most common adverse reactions with VEOZAH ≥ 2% and > placebo (VEOZAH % vs. placebo %) are: abdominal pain (4.3% vs. 2.1%), diarrhea (3.9% vs. 2.6%), insomnia (3.9% vs. 1.8%), back pain (3.0% vs. 2.1%), hot flush (2.5% vs. 1.6%), and hepatic transaminase elevation (2.3% vs. 0.8%).
Please click here for full Prescribing Information for VEOZAH® (fezolinetant).
REFERENCES: 1. VEOZAH [package insert]. Northbrook, IL: Astellas Pharma US, Inc. 2. Thurston RC. Vasomotor symptoms. In: Crandall CJ, Bachman GA, Faubion SS, et al., eds. Menopause Practice: A Clinician’s Guide. 6th ed. Pepper Pike, OH: The North American Menopause Society, 2019:43-55.