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Now approved
VEOZAHTM

A NOVEL TREATMENT FOR moderate to severe Vasomotor Symptoms (VMS) due to menopause

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VEOZAH is the first and only neurokinin 3 (NK3) receptor antagonist that treats VMS, commonly referred to as hot flashes and night sweats.1-3

Prescribing Information

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VMS, VEOZAH

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Important Safety Information

INDICATIONS AND USAGE

INDICATIONS AND USAGE

VEOZAH™ (fezolinetant) is a neurokinin 3 (NK3) receptor antagonist indicated for the treatment of moderate to severe vasomotor symptoms due to menopause.

CONTRAINDICATIONS

VEOZAH is contraindicated in women with any of the following:

Known cirrhosis Severe renal impairment or end-stage renal disease Concomitant use with CYP1A2 inhibitors

CONTRAINDICATIONS

VEOZAH is contraindicated in women with any of the following:

Known cirrhosis Severe renal impairment or end-stage renal disease Concomitant use with CYP1A2 inhibitors

VEOZAH™ (fezolinetant) is a neurokinin 3 (NK3) receptor antagonist indicated for the treatment of moderate to severe vasomotor symptoms due to menopause.

WARNINGS AND PRECAUTIONS

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.

ADVERSE REACTIONS

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).