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Effective URL: https://www.veozahhcp.com/
Submission: On October 04 via manual from US — Scanned from DE
Effective URL: https://www.veozahhcp.com/
Submission: On October 04 via manual from US — Scanned from DE
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* Full Prescribing Information * Important Safety Information * Women’s Health Resources * Medical Inquiry * Patient Site * Request a Rep * Mechanism of Action * Efficacy & Safety * Study Design * Efficacy * Safety * Dosing * Get Patients Started * VEOZAH Support SolutionsSM * Resources * Samples Full Prescribing Information Important Safety Information CLOSE HOME * HOME * MECHANISM OF ACTION * EFFICACY & SAFETY MAIN MENU * STUDY DESIGN * EFFICACY * SAFETY * DOSING * GET PATIENTS STARTED MAIN MENU * VEOZAH Support SolutionsSM * RESOURCES * SAMPLES * REQUEST A REP * WOMEN’S HEALTH RESOURCES * MEDICAL INQUIRY * PATIENT SITE × YOU ARE ABOUT TO LEAVE THIS WEBSITE. By clicking “Continue”, you will leave this site and enter VEOZAHsamples.com. Cancel Continue NOTE: The website you are linking to is neither owned nor controlled by Astellas. You should review the applicable terms and polices, including privacy and data-gathering policies, of any website to which you navigate. × YOU ARE ABOUT TO LEAVE THIS WEBSITE. By clicking “Continue”, you will open AstellasAnswers.com. Cancel Continue This website is funded and developed by Astellas Pharma US, Inc. THIS WEBSITE IS INTENDED FOR US HEALTHCARE PROFESSIONALS ONLY. I certify that I am a healthcare professional in the US. NO YES STAY UP TO DATE * * * * * For the treatment of moderate to severe Vasomotor Symptoms (VMS) due to menopause, commonly referred to as hot flashes and night sweats1,2 FighttheFire WITH NONHORMONAL VEOZAH New VEOZAH directly targets a source of VMS—specific neurons in the hypothalamus. Give your patients another way to treat the heat day and night.1 EXPLORE THE MOA WATCH THE MECHANISM OF ACTION (MOA) VEOZAH is the first and only neurokinin 3 (NK3) receptor antagonist that blocks NKB from binding on KNDy neurons to help reduce heat signals that trigger VMS.1,3 SEE VIDEO KNDy=kisspeptin/neurokinin B/dynorphin, NKB=neurokinin B. TRANSCRIPT KNDy=kisspeptin/neurokinin B/dynorphin, NKB=neurokinin B. MECHANISM OF ACTION * Off * English 04:43 TRANSCRIPT MECHANISM OF ACTION MOA VIDEO TRANSCRIPT 4 mins 43 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 CONTRAINDICATIONS 1. VEOZAH is contraindicated in women with any of the following: 2. Known cirrhosis 3. Severe renal impairment or end-stage renal disease 4. Concomitant use with CYP1A2 inhibitors 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 see accompanying full Prescribing Information for VEOZAH™ (fezolinetant). BACK TO VIDEO OFFER YOUR PATIENTS A DIFFERENT OPTION TO MANAGE VMS WITH VEOZAH.1,3 EFFICACY AND SAFETY VMS RELIEF DAY AND NIGHT 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* SEE THE DATA 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 SAVINGS AND SUPPORT VEOZAH SUPPORT SOLUTIONSSM Help your patients access VEOZAH and save on prescriptions.† GET STARTED †Subject to eligibility. Restrictions may apply. Sign up for exclusive VEOZAH updates and product information Survey × What is your primary medical specialty? [Select one] * General practice/ family practice/ internal medicine * Nurse practitioner * Physician assistant or associates * Obstetrics and gynecology/ urogynecology * Other specialty physician * Healthcare office staff not prescribing drugs * None of these Crafted with Pulse Insights IMPORTANT SAFETY INFORMATION INDICATIONS AND USAGE 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 VEOZAH™ (fezolinetant) is a neurokinin 3 (NK3) receptor antagonist indicated for the treatment of moderate to severe vasomotor symptoms due to menopause. 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 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. Depypere H, Lademacher C, Siddiqui E, Fraser GL. Fezolinetant in the treatment of vasomotor symptoms associated with menopause. Expert Opin Investig Drugs 2021;30(7):681-94. IMPORTANT SAFETY INFORMATION INDICATIONS AND USAGE 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 VEOZAH™ (fezolinetant) is a neurokinin 3 (NK3) receptor antagonist indicated for the treatment of moderate to severe vasomotor symptoms due to menopause. 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 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. Depypere H, Lademacher C, Siddiqui E, Fraser GL. Fezolinetant in the treatment of vasomotor symptoms associated with menopause. Expert Opin Investig Drugs 2021;30(7):681-94. * Stay Up to Date * Request a Rep * Medical Information * Privacy Policy * Legal Disclaimer * Sitemap * Contact Us * Accessibility Astellas and the flying star logo are registered trademarks of Astellas Pharma Inc. VEOZAH and the Wave logo are trademarks of Astellas US LLC. VEOZAH Support Solutions℠, a component of Astellas Pharma Support Solutions℠, is a service mark of Astellas US LLC. This website is intended for US Healthcare Professionals only. ©2023 Astellas Pharma US, Inc. All rights reserved. 054-0017-PM 06/23