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
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
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 (eg, ≥2x ULN) for the evaluating laboratory. If baseline hepatic transaminase evaluation is <2x ULN and the total bilirubin is normal, VEOZAH can be started.1
Perform follow-up hepatic laboratory tests monthly for the first 3 months, at 6 months, and 9 months after initiation of therapy.1
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.1
ALP=alkaline phosphatase, 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. A case of serious drug-included hepatotoxicity occured in the postmarketing setting. The signs and symptoms of this case gradually resolved after discontinuation of VEOZAH.1 Please see additional Important Safety Information below.
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Since FDA approval, VEOZAH has garnered coverage* for more than 100 million commercial lives.† Approximately 6 out of 10 commercially insured patients have access to VEOZAH.† See if your patients are covered using the Formulary Coverage Lookup Tool.
The average out-of-pocket cost for a VEOZAH prescription for commercially insured patients is $46.‡
With a VEOZAH Savings Card, eligible patients with commercial insurance may pay $0 for their first monthly prescription and as little as $30 for monthly refills thereafter, regardless of income.§
FDA=US Food and Drug Administration, PA=prior authorization.
*Based on an analysis of third-party claims data for 30-day supplies of VEOZAH. Covered with and without restrictions.
†Data are based on current coverage rates of 64% commercial covered lives as of July 2024 and are not inclusive of Health Exchange. Coverage includes unrestricted and coverage subject to PA and/or step edit.
‡Symphony Health, an ICON plc Company, PatientSource®, May 26, 2023 to March 15, 2024.
§Eligibility requirements and terms and conditions apply. This Program is for eligible patients with commercial prescription insurance and a valid prescription for VEOZAH®. The Program is not valid for patients whose prescription claims are reimbursed, in whole or in part, by any state or federal government program. Offer is not valid for cash-paying patients. Offer is not prescription insurance and is void where prohibited by law. Certain rules and restrictions, including an annual copay assistance limit of $4,000, apply. For full terms and conditions, click here.
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 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.
Discontinue VEOZAH if:
- Transaminase elevations are > 5x ULN
- 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.
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 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.