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 ALT or AST is ≥2x the ULN or if the total bilirubin is ≥2x the ULN for the evaluating laboratory.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 (new onset fatigue, decreased appetite, nausea, vomiting, pruritus, jaundice, pale feces, dark urine, or abdominal pain).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. Cases of serious drug-induced hepatotoxicity occurred in the postmarketing setting; signs and symptoms gradually resolved after discontinuation.1 Please see additional Important Safety Information, including BOXED WARNING, 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 monthly 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. Offer is not health insurance and is void where prohibited by law. A patient must have a valid prescription for VEOZAH, meet the eligibility requirements, and present the VEOZAH Savings Card to their preferred pharmacy. The card has an annual maximum copay assistance limit of $4,000 per calendar year. There are no income requirements. The card is not valid for cash-pay patients or patients whose prescription claims are reimbursed, in whole or in part, by any state or federal government program. See full terms and conditions here.
IMPORTANT SAFETY INFORMATION
INDICATIONS AND USAGE
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IMPORTANT SAFETY INFORMATION
INDICATIONS AND USAGE
WARNING: RISKS OF HEPATOTOXICITY
Hepatotoxicity has occurred with the use of VEOZAH in the postmarketing setting.
- Perform hepatic laboratory tests prior to initiation of treatment to evaluate for hepatic function and injury. Do not start VEOZAH if either aminotransferase is ≥ 2x the upper limit of normal (ULN) or if the total bilirubin is ≥ 2x ULN for the evaluating laboratory.
- Perform follow-up hepatic laboratory testing monthly for the first 3 months, at 6 months, and 9 months of treatment.
- 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, decreased appetite, nausea, vomiting, pruritus, jaundice, pale feces, dark urine, or abdominal pain).
- Discontinue VEOZAH if transaminase elevations are > 5x ULN, or if 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.
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
WARNING: RISKS OF HEPATOTOXICITY
Hepatotoxicity has occurred with the use of VEOZAH in the postmarketing setting.
- Perform hepatic laboratory tests prior to initiation of treatment to evaluate for hepatic function and injury. Do not start VEOZAH if either aminotransferase is ≥ 2x the upper limit of normal (ULN) or if the total bilirubin is ≥ 2x ULN for the evaluating laboratory.
- Perform follow-up hepatic laboratory testing monthly for the first 3 months, at 6 months, and 9 months of treatment.
- 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, decreased appetite, nausea, vomiting, pruritus, jaundice, pale feces, dark urine, or abdominal pain).
- Discontinue VEOZAH if transaminase elevations are > 5x ULN, or if 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.
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
WARNINGS AND PRECAUTIONS
Hepatotoxicity
In 3 clinical trials, elevations in serum transaminase [alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST)] levels > 3x 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, cases of drug-induced liver injury with elevations of ALT, AST, alkaline phosphatase (ALP), and total bilirubin occurred within 40 days of starting VEOZAH. Patients reported a general sense of feeling unwell and symptoms of fatigue, nausea, pruritus, jaundice, pale feces, and dark urine. The patients’ signs and symptoms gradually resolved after discontinuation of VEOZAH.
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 ALT or AST is ≥ 2x ULN or if the total bilirubin is ≥ 2x ULN for the evaluating laboratory.
Perform follow-up hepatic laboratory tests monthly for the first 3 months, at 6 months, and 9 months after initiation of therapy.
See BOXED WARNING for full hepatic laboratory testing protocol and discontinuation criteria. 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%).
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.