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For the treatment of moderate to severe Vasomotor Symptoms (VMS)—commonly referred to as hot flashes and night sweats—due to menopause1,2

VEOZAH™ (fezolinetant) logo fire extinguisher spraying VMS fire

COOL VEOZAH TOOLS
forYOUR PRACTICE

Simplify the VMS conversation with easy-to-use VEOZAH resources

Download or share resources below

 

Simplify the VMS conversation with easy-to-use VEOZAH resources

Download or share resources below

 

Mechanism of action (MOA) flashcard

Mechanism of action (MOA) flashcard

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Quickly reference VEOZAH in your practice.

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Mechanism of action (MOA) video
Mechanism of action (MOA) video

Mechanism of action (MOA) video

Duration: 6 mins 30 secs

Watch the mechanism of action of VEOZAH.

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Mechanism of action

TRANSCRIPT

Mechanism of action

MOA video transcript

6 mins 30 secs

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

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.

CONTRAINDICATIONS

VEOZAH is contraindicated in women with any of the following:

  1. Known cirrhosis
  2. Severe renal impairment or end-stage renal disease
  3. 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%).

Please see accompanying full Prescribing Information, including BOXED WARNING, for VEOZAH (fezolinetant).

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Sampling card

Sampling card

Size: 764 KB

A quick overview on how to request samples for your practice.

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VEOZAH Support Solutions℠ flashcard

VEOZAH Support SolutionsSM prior authorization materials

 

Access prior authorization information, including a list of ICD-10-CM codes, a checklist, and a sample letter of medical necessity, all in one place.

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Doctor discussion guide

Doctor discussion guide

Size: 5.7 MB

Offer this guide to your patients to help them reflect on how they want to discuss VMS with you.

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Digital Downloadable Copay Card

Digital downloadable savings card

Size: 343 KB

Prescription savings may be right at your patients’ fingertips.

For commercially insured patients. Eligibility criteria, terms, and conditions apply. The program is not valid for patients whose prescription claims are reimbursed by any state or federal government program.

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VEOZAH Free Trial Voucher

Utilize the VEOZAH Voucher Program to provide your patients with a 10-day free trial offer*

VEOZAH™ (fezolinetant) free trial voucher
  1. Order vouchers to be shipped directly to your practice within 10 business days
  2. Offer these one-time-use vouchers to your eligible patients to initiate treatment
  3. Instruct patients to fulfill vouchers at their local pharmacy to start free trial*
OPEN ORDER FORM
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VEOZAH® (fezolinetant) Savings Card

*Requires a 10-day VEOZAH prescription. Only new patients may use this voucher. Patients who have previously used or are currently using VEOZAH are not eligible for this voucher offer. See below for full Terms & Conditions.

Terms & Conditions

To the healthcare practitioner: By providing this voucher to an appropriate patient, you certify that you understand and agree to comply with the Terms and Conditions below and that you or your office site staff have reviewed the Terms and Conditions with the patient.

Voucher Terms and Conditions: This voucher may be redeemed for a 10-day supply of VEOZAH. Prescription is for the FDA-approved indication. Only new patients may use this voucher. Patients who have previously used or are currently using VEOZAH are not eligible for this voucher offer. A Member ID and a valid prescription from a US-licensed healthcare practitioner must be provided to the pharmacy. Product dispensed pursuant to this voucher cannot be resold or further distributed to any other third party. No claim for reimbursement for product dispensed pursuant to this voucher may be submitted to any third-party payor, including Medicare, Medicaid, or any other federal or state healthcare program. The value of the free product received through this voucher cannot be counted toward any insurance benefit out-of-pocket spending calculations, such as Medicare Part D True Out-of-Pocket (TrOOP) costs. The patient must be 18 years of age or older to use this voucher. This voucher is not valid where prohibited by law. This voucher has no cash value. The selling, purchasing, or counterfeiting of this voucher is strictly prohibited. This voucher is limited to one per patient and is non-transferable. The voucher cannot be combined with any other savings, free trial, or similar offer for VEOZAH. This voucher should not be combined with samples for VEOZAH. This voucher is not health insurance. This voucher is not intended to address delays or gaps in health insurance coverage for the specified prescription. Offer good only in the US. No purchase of VEOZAH or any other Astellas product is necessary. No membership fees. Patients have no obligation to use VEOZAH or any other Astellas product in the future. Astellas reserves the right to rescind, revoke, or amend this offer without notice. For questions, please call 1-800-657-7613.

IMPORTANT SAFETY INFORMATION

INDICATIONS AND USAGE

EXPAND COLLAPSE

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:

  1. Known cirrhosis
  2. Severe renal impairment or end-stage renal disease
  3. 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:

  1. Known cirrhosis
  2. Severe renal impairment or end-stage renal disease
  3. 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%).

Please click here for full Prescribing Information, including BOXED WARNING, 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.