Moderate to severe Vasomotor Symptoms, also known as VMS or hot flashes and night sweats, are the most bothersome symptoms of menopause. Growing evidence has led to a different treatment pathway that directly targets a source of VMS in the hypothalamus.

Meet VEOZAH^™ (fezolinetant). VEOZAH is not a hormone. It is a first-in-class NK3R antagonist that works differently to directly block a mechanism that triggers VMS.

KNDy neurons in the hypothalamus are inhibited by estrogen and stimulated by the neuropeptide NKB. This balance contributes to body temperature regulation. During the menopause transition, estrogen decline disrupts this balance with NKB. Unopposed, NKB signaling causes heightened KNDy activity and altered activity on the thermoregulatory center, resulting in VMS.

VEOZAH directly targets this source of VMS. By selectively binding to NK3R, VEOZAH blocks NKB, modulating neuronal activity in the thermoregulatory center to reduce heat signaling that triggers hot flashes and night sweats.

It’s time to put the mechanism of VEOZAH to work for your appropriate VMS patients.

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.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

WARNINGS AND PRECAUTIONS

Hepatic Transaminase Elevation and Hepatotoxicity

In 3 clinical trials, 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. No elevations in serum 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.

In the postmarketing setting, a case of acute mixed hepatocellular cholestatic drug-induced liver injury with elevations of ALT, AST, alkaline phosphatase (ALP), and total bilirubin with symptoms of fatigue, nausea, pruritus, jaundice, pale feces, and dark urine occurred in a woman receiving VEOZAH. The individual’s signs and symptoms gradually resolved after discontinuation of the drug.

Perform baseline hepatic laboratory tests to evaluate for hepatic function and injury [including serum ALT, serum AST, serum ALP, and serum bilirubin (total and direct)] prior to VEOZAH initiation. Do not start VEOZAH if the 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 hepatic laboratory tests monthly for the first 3 months, at 6 months, and 9 months after initiation of therapy.

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, nausea, vomiting, pruritus, jaundice, pale feces, dark urine, or upper right quadrant pain.

If transaminase elevations > 3x ULN occur, perform more frequent follow-up hepatic laboratory tests until resolution.

Exclude alternative causes of hepatic laboratory test elevations.

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 see accompanying full Prescribing Information for VEOZAH (fezolinetant).