"Cooler Moments" educates and empowers women in midlife to speak up for themselves and celebrate this natural change in their lives.
NORTHBROOK, Ill., Dec. 5, 2024 /PRNewswire/ -- Astellas Pharma US, Inc. (TSE: 4503, Head of US Commercial: Michael Petroutsas, "Astellas") today announced the launch of Cooler Moments in partnership with Dr. Jen Ashton, a leading women's health medical expert, Founder and President of Ajenda, and former network news Chief Medical Correspondent who is board-certified in OBGYN and Obesity Medicine. Cooler Moments is an effort to inform and empower women to speak up about their moderate to severe menopausal hot flashes and night sweats, also known as vasomotor symptoms (VMS), and talk to their doctor about potential treatment options.1
This effort shines light on the millions of women in the U.S. experiencing moderate to severe hot flashes and night sweats due to menopause, which can be very disruptive to daily life, with effects on sleep, mood, concentration, work productivity and relationships, among other things.1,2Cooler Moments aims to inspire women to feel educated, empowered and confident to talk about this phase of life and advocate for themselves so that their symptoms can be addressed.
As part of Cooler Moments, Dr. Ashton will host a video series and speak to women live to debunk myths about menopause, break down the science, and encourage them to advocate for themselves when it comes to hot flashes and night sweats due to menopause. She will also speak with Kris, a woman with moderate to severe hot flashes and night sweats, about her personal experience and how she was able to manage her symptoms with VEOZAH™.3 VEOZAH is a first-of-its-kind, FDA-approved, 100% hormone-free treatment used to reduce moderate to severe hot flashes and night sweats due to menopause.3,4
Do not use VEOZAH if you have cirrhosis, have severe kidney problems or kidney failure, or are taking certain medicines called CYP1A2 inhibitors.3Please see additional Important Safety Information below.
Dr. Jen Ashton, Board-Certified OBGYN, Former Chief Medical Correspondent "I'm honored to partner with Astellas to help inspire conversation about hot flashes and night sweats due to menopause and treatment options. Managing these symptoms is not one-size-fits-all, and women should feel comfortable having an open dialogue with their healthcare providers to create a plan that's right for them. As a doctor, I've seen how hot flashes due to menopause can significantly impact women, and I know how important it is women are counseled about all of their options, both hormonal and nonhormonal.2 Many women and doctors alike may not know that there are nonhormonal treatment options such as VEOZAH available, especially for women who cannot or choose not to take hormones.3 We are at a pivotal time to elevate cultural and medical conversations around hot flashes, night sweats, and menopause in a way that is backed in science and informed by the latest data, and to do so without judgment, fear or stigma."
Ben Ormsbee, U.S. Head of Commercial, Women's Health, Astellas "Astellas is committed to elevating the conversation around hot flashes and night sweats due to menopause to help ensure women are informed and empowered to seek the support they need to make the best decision for their menopause journey. We're thrilled to launch Cooler Moments with Dr. Ashton, a leading women's health expert, to encourage women to not settle and to advocate for their own health."
Cooler Moments builds on the work that Astellas launched earlier this year with Emmy- and Golden Globe-nominated actress Gloria Reuben, who has experienced moderate to severe VMS due to menopause first-hand and has had fewer and less severe hot flashes and night sweats thanks to VEOZAH.3 Individual results may vary. Women should talk to their doctor about what it could mean to them.
Visit VEOZAH.com for more information about moderate to severe VMS due to menopause, including Gloria Reuben's personal journey with VMS due to menopause, tips for how to have an informed conversation with your healthcare provider, and all there is to know about VEOZAH.
About VEOZAH (fezolinetant) VEOZAH (fezolinetant) is a neurokinin 3 (NK3) receptor antagonist approved in the U.S. for the treatment of moderate to severe vasomotor symptoms (VMS) due to menopause.3 VEOZAH is not a hormone.3 VMS are the feelings of warmth in the face, neck, and chest, or sudden intense feelings of heat and sweating ("hot flashes" or "hot flushes").1 VEOZAH works by blocking neurokinin B (NKB) binding on the kisspeptin/neurokinin B/dynorphin (KNDy) neuron to modulate neuronal activity in the thermoregulatory center of the brain (the hypothalamus) to reduce the frequency and severity of moderate to severe VMS due to menopause.3
About Vasomotor Symptoms due to Menopause VMS, characterized by hot flashes (also called hot flushes) and/or night sweats, are common symptoms of menopause.1 In the U.S., nearly half of women going through menopause may experience moderate to severe VMS.5 VMS can have a disruptive impact on women's daily activities and overall quality of life.2
U.S. Important Safety Information
Do not use VEOZAH if you:
have cirrhosis.
have severe kidney problems or kidney failure.
are taking certain medicines called CYP1A2 inhibitors. Ask your healthcare provider if you are not sure.
Before you use VEOZAH, tell your healthcare provider about all of your medical conditions, including if you:
have liver disease or problems.
have kidney problems.
have any medical conditions that may become worse while you are using VEOZAH.
Tell your healthcare provider about all the medicines you take, including prescription and over-the- counter medicines, vitamins, and herbal supplements. VEOZAH may affect the way other medicines work, and other medicines may affect how VEOZAH works.
VEOZAH can cause serious side effects, including:
increased liver blood test values and liver problems. Your healthcare provider will do a blood test to check your liver before you start taking VEOZAH. Your healthcare provider will also do this blood test monthly for the first 3 months, at month 6, and month 9 after you start taking VEOZAH or if you have signs or symptoms that suggest liver problems. If your liver blood test values are elevated, your healthcare provider may advise you to stop treatment or request additional liver blood tests.
Stop VEOZAH and call your healthcare provider right away if you have the following signs or symptoms of liver problems:
feeling more tired than you do usually
nausea
vomiting
itching
yellowing of the eyes or skin (jaundice)
pale feces
dark urine
pain in the right upper stomach (abdomen)
The most common side effects of VEOZAH include:
stomach (abdominal) pain
diarrhea
difficulty sleeping (insomnia)
back pain
hot flashes or hot flushes
These are not all the possible side effects of VEOZAH. Tell your healthcare provider if you have any side effect that bothers you or does not go away.
Call your healthcare provider for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800- FDA-1088.
About Astellas Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are promoting the Focus Area Approach that is designed to identify opportunities for the continuous creation of new drugs to address diseases with high unmet medical needs by focusing on Biology and Modality. Furthermore, we are also looking beyond our foundational Rx focus to create Rx+® healthcare solutions that combine our expertise and knowledge with cutting-edge technology in different fields of external partners. Through these efforts, Astellas stands on the forefront of healthcare change to turn innovative science into VALUE for patients. For more information, please visit our website at https://www.astellas.com/en.
Cautionary Notes In this press release, statements made with respect to current plans, estimates, strategies and beliefs and other statements that are not historical facts are forward-looking statements about the future performance of Astellas. These statements are based on management's current assumptions and beliefs in light of the information currently available to it and involve known and unknown risks and uncertainties. A number of factors could cause actual results to differ materially from those discussed in the forward-looking statements. Such factors include, but are not limited to: (i) changes in general economic conditions and in laws and regulations, relating to pharmaceutical markets, (ii) currency exchange rate fluctuations, (iii) delays in new product launches, (iv) the inability of Astellas to market existing and new products effectively, (v) the inability of Astellas to continue to effectively research and develop products accepted by customers in highly competitive markets, and (vi) infringements of Astellas' intellectual property rights by third parties. Information about pharmaceutical products (including products currently in development) which is included in this press release is not intended to constitute an advertisement or medical advice.
References:
1 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. 2 English M, Stoykova B, Slota C, et al. Qualitative study: burden of menopause-associated vasomotor symptoms (VMS) and validation of PROMIS sleep disturbance and sleep-related impairment measures for assessment of VMS impact on sleep. J Patient Rep Outcomes 2021;5(37):1-13. Erratum in: J Patient Rep Outcomes 2021;5:42 3 Veozah [package insert]. Northbrook, IL: Astellas Pharma US, Inc. 4 The North American Menopause Society. The 2023 nonhormone therapy position statement of the North American Menopause Society. Menopause. 2023;30(6):573-590. 5 FFreeman EW, Sammel MD, Sanders RJ. Risk of long-term hot flashes after natural menopause: evidence from the Penn Ovarian Aging Study cohort. Menopause. 2014;21(9):924-932.
