VEOZAH is a neurokinin 3 (NK3) receptor antagonist for the treatment of moderate to severe Vasomotor Symptoms (VMS) —commonly referred to as hot flashes and night sweats—due to menopause.1,2
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NOVEOZAH is not a hormone. It is a VMS treatment that works differently to directly block NKB, a known trigger of VMS due to menopause.1,3
It is a selective NK3R antagonist that blocks NKB binding on the KNDy neuron to modulate neuronal activity in the thermoregulatory center. This action helps to reduce the number and intensity of hot flashes and night sweats.1
VEOZAH directly targets NK3R with a high affinity, more than 450-fold higher than NK1 or NK2 receptors.1
KNDy=kisspeptin/neurokinin B/dynorphin, NK1=neurokinin 1, NK2=neurokinin 2, NKB=neurokinin B.
VEOZAH demonstrated statistically significant reductions from baseline in the frequency and severity of moderate to severe VMS over 24 hours compared to placebo, at weeks 4 and 12.1*
*The efficacy of VEOZAH was studied in 1022 women who received 1 of 2 doses of VEOZAH (including 45 mg) in two 12-week, randomized, placebo-controlled, double-blind Phase 3 studies. In each of these 2 trials, after the first 12 weeks, women on placebo were rerandomized to VEOZAH for a 40-week extension to evaluate safety for up to 52 weeks total exposure.1
Perform baseline bloodwork to evaluate for hepatic function and injury (ALT, AST, and serum bilirubin [total and direct]) before initiating VEOZAH. Do not start VEOZAH if ALT or AST is ≥2x the ULN or total bilirubin is elevated (eg, ≥2x the ULN) for the evaluating laboratory. VEOZAH can be started if baseline hepatic transaminase evaluation is <2x the ULN and total bilirubin is normal.1
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.1
VEOZAH 45 mg should be taken orally once daily with liquids, with or without food. VEOZAH should be swallowed whole. Do not cut, crush, or chew tablets. Patients can choose what time to take it, but should adhere to the same time each day.1
ALT=alanine aminotransferase, AST=aspartate aminotransferase, ULN=upper limit of normal.
The most common adverse reactions with VEOZAH (≥2% and > placebo) are: abdominal pain, diarrhea, insomnia, back pain, hot flush, and hepatic transaminase elevation.1 Please see additional Important Safety Information below.
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IMPORTANT SAFETY INFORMATION
INDICATIONS AND USAGE
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IMPORTANT SAFETY INFORMATION
INDICATIONS AND USAGE
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.
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
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.
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).
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. 3. Jayasena CN, Comninos AN, Stefanopoulou E, et al. Neurokinin B administration induces hot flushes in women. Sci Rep (Epub) 02-16-2015.