Metrorrhagia

DEERFIELD, Ill.--(BUSINESS WIRE)-- TerSera Therapeutics LLC announced today that The National Comprehensive Cancer Network® (NCCN) Breast Cancer Panel included both goserelin 3.6 mg every 4 weeks and goserelin 10.8 mg every 12 weeks, as methods for ovarian function suppression in Version 1.2024 of the Breast Guidelines revised as of January 25, 2024.1 "In addition to the 3.6 mg monthly dose, I am pleased to see that NCCN recognizes the role of goserelin 10.8 mg every 12 weeks as an option for premenopausal women with hormone receptor positive (HR+) breast cancer, ” said Virginia Kaklamani, MD, Professor of Medicine in the Division of Hematology and Medical Oncology at the University of Texas Health Sciences Center San Antonio and leader of the breast cancer program at the Mays Cancer Center, home to UT Health San Antonio MD Anderson. The inclusion of goserelin 10.8 mg every 12 weeks in the breast cancer guidelines as a method for ovarian function suppression is a category 2A recommendation. Multiple international studies have evaluated the safety and efficacy of goserelin 10.8 mg every 12 weeks for ovarian function suppression in premenopausal patients with HR+ breast cancer.2-5 In the United States, ZOLADEX® (goserelin implant) 3.6 mg is the only dosage form approved for use in breast cancer. ZOLADEX 10.8 mg is not approved by FDA for breast cancer. Please see the full Prescribing Information for ZOLADEX 3.6 mg and ZOLADEX 10.8 mg and additional Important Safety Information below. Worldwide, ZOLADEX 3.6 mg is approved for use in breast cancer in 125 countries. Additionally, ZOLADEX 10.8 mg is approved for use in breast cancer in over 60 countries, with multiple additional regulatory reviews underway. This is the third update to NCCN guidelines regarding goserelin over the past few months related to head and neck cancers (V1.2024), ovarian cancer (V1.2024), and breast cancer (V1.2024). About ZOLADEX® (goserelin implant) ZOLADEX is an injectable luteinizing hormone-releasing hormone agonist (LHRHa) used to treat prostate cancer, breast cancer, and certain benign gynecological disorders. First approved in the U.S. in 1989, ZOLADEX is available as a 3.6 mg implant dosed every 28 days or as a 10.8 mg implant dosed every 12 weeks.6,7 U.S. INDICATIONS ZOLADEX 3.6 mg and ZOLADEX 10.8 mg are indicated for: Management of locally confined Stage T2b-T4 (Stage B2-C) carcinoma of the prostate in combination with flutamide. Treatment with ZOLADEX and flutamide should start 8 weeks prior to initiating radiation therapy and continue during radiation therapy. Palliative treatment of advanced carcinoma of the prostate. ZOLADEX 3.6 mg is also indicated for: Management of endometriosis, including pain relief and reduction of endometriotic lesions for the duration of therapy. Experience with ZOLADEX for the management of endometriosis has been limited to women 18 years of age and older treated for 6 months. Use as an endometrial-thinning agent prior to endometrial ablation for dysfunctional uterine bleeding. Palliative treatment of advanced breast cancer in pre- and perimenopausal women. IMPORTANT SAFETY INFORMATION Anaphylactic reactions to ZOLADEX have been reported in the medical literature. ZOLADEX is contraindicated in patients with a known hypersensitivity to GnRH, GnRH agonist analogues, or any of the components in ZOLADEX. ZOLADEX is contraindicated during pregnancy unless used for palliative treatment of advanced breast cancer. ZOLADEX can cause fetal harm when administered to a pregnant woman. If used during pregnancy, the patient should be apprised of the potential hazard to the fetus. There is an increased risk for pregnancy loss due to expected hormonal changes that occur with ZOLADEX treatment. ZOLADEX should not be given to women with undiagnosed abnormal vaginal bleeding. Pregnancy must be excluded for use in benign gynecological conditions. Women should be advised against becoming pregnant while taking ZOLADEX. Effective nonhormonal contraception must be used by all premenopausal women during ZOLADEX therapy and for 12 weeks following discontinuation of therapy. Transient worsening of tumor symptoms, or the occurrence of additional signs and symptoms of breast cancer, may occasionally develop during the first few weeks of treatment. Some patients may experience a temporary increase in bone pain. Monitor patients at risk for complications of tumor flare. Hyperglycemia and an increased risk of developing diabetes or worsening of glycemic control in patients with diabetes have been reported in men receiving GnRH agonists like ZOLADEX. Monitor blood glucose levels and glycosylated hemoglobin (HbA1c) periodically and manage according to current clinical practice. Increased risk of developing myocardial infarction, sudden cardiac death and stroke has been reported in association with use of GnRH agonists like ZOLADEX in men. Patients receiving a GnRH agonist should be monitored for symptoms and signs suggestive of development of cardiovascular disease and be managed according to current clinical practice. Hypercalcemia has been reported in some breast cancer patients with bone metastases after starting treatment with ZOLADEX. If hypercalcemia does occur, appropriate treatment measures should be initiated. Hypersensitivity, antibody formation and acute anaphylactic reactions have been reported with GnRH agonist analogues. ZOLADEX may cause an increase in cervical resistance. Therefore, caution is recommended when dilating the cervix for endometrial ablation. GnRH agonists may prolong the QT/QTc interval. Providers should consider whether the benefits of androgen deprivation therapy outweigh the potential risks in patients with congenital long QT syndrome, congestive heart failure, frequent electrolyte abnormalities, and in patients taking drugs known to prolong the QT interval. Electrolyte abnormalities should be corrected. Consider periodic monitoring of electrocardiograms and electrolytes. Injection site injury and vascular injury including pain, hematoma, hemorrhage and hemorrhagic shock, requiring blood transfusions and surgical intervention, have been reported with ZOLADEX. Extra care should be taken when administering ZOLADEX to patients with low BMI and/or to patients receiving full dose anticoagulation. Depression may occur or worsen in women receiving GnRH agonists. Treatment with ZOLADEX may be associated with a reduction in bone mineral density over the course of treatment. Data suggest a possibility of partial reversibility. In women, current available data suggest that recovery of bone loss occurs on cessation of therapy in the majority of patients. In women, the most frequently reported adverse reactions were related to hypoestrogenism. The adverse reaction pro similar for women treated for breast cancer, dysfunctional uterine bleeding, and endometriosis. The most commonly reported adverse reactions with ZOLADEX in clinical trials for endometriosis were: hot flashes (96%), vaginitis (75%), headache (75%), decreased libido (61%), emotional lability (60%), depression (54%), sweating (45%), acne (42%), breast atrophy (33%), seborrhea (26%), and peripheral edema (21%). The most commonly reported adverse reactions with ZOLADEX in clinical trials for endometrial thinning were: vasodilation/hot flashes (57%), headache (32%), sweating (16%), and abdominal pain (11%). The most commonly reported adverse reactions with ZOLADEX in breast cancer clinical trials were hot flashes (70%), decreased libido (47.7%), tumor flare (23%), nausea (11%), edema (5%), and malaise/fatigue/lethargy (5%). Injection site reactions were reported in less than 1% of patients. For ZOLADEX 3.6 mg: Hot flashes (62%), sexual dysfunction (21%), decreased erections (18%), lower urinary tract symptoms (13%), lethargy (8%), pain (worsened in the first 30 days) (8%), edema (7%), upper respiratory infection (7%), rash (6%), and sweating (6%). For ZOLADEX 10.8 mg: Hot flashes (64%), pain (general) (14%), gynecomastia (8%), pelvic pain (6%), and bone pain (6%). In the locally advanced carcinoma of the prostate clinical trial, additional adverse event data were collected for the combination therapy with radiation group during both the hormonal treatment and hormonal treatment plus radiation phases of this study. Adverse experiences (incidence >5%) in both phases of this study were hot flashes (46%), diarrhea (40%), nausea (9%), and skin rash (8%). Treatment with ZOLADEX and flutamide did not add substantially to the toxicity of radiation treatment alone. Please see Full Prescribing Information for ZOLADEX 3.6 mg and ZOLADEX 10.8 mg. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit fda.gov/medwatch or call 1-800-FDA-1088. You can also contact TerSera Therapeutics at 1-844-334-4035 or medicalInformation@tersera.com. About TerSera Therapeutics TerSera Therapeutics is a biopharmaceutical company with a focus in oncology, acute care, and non-opioid pain management. Founded in 2016, TerSera is building new cornerstones of care through its portfolio of unique therapeutics, amplifying their ability to deliver meaningful outcomes for patients. For more information about TerSera Therapeutics, please visit tersera.com. References NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Breast Cancer Version 1.2024. © National Comprehensive Cancer Network, Inc 2024. All rights reserved. [Accessed January 29, 2024]. To view the most recent and complete version of the guideline, go online to NCCN.org. NATIONAL COMPREHENSIVE CANCER NETWORK®, NCCN®, NCCN GUIDELINES®, and all other NCCN Content are trademarks owned by the National Comprehensive Cancer Network, Inc. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way. Noguchi S, Kim HJ, Jesena A, et al. Phase 3, open-label, randomized study comparing 3-monthly with monthly goserelin in pre-menopausal women with estrogen receptor-positive advanced breast cancer. Breast Cancer. 2016; 23:771-779. Masuda N, Iwata H. Rai Y, et al. Monthly versus 3-monthly goserelin acetate treatment in pre-menopausal patients with estrogen receptor-positive early breast cancer. Breast Cancer Res Treat. 2011; 126:443-451. El Zawawy SF, Khedr G. 209P Efficacy and feasibility of long acting every three months goserelin for premenopausal breast cancer patients during COVID pandemic. Annals of Oncology. 2022;33: S631. Wu H, Bian L, Xie J, et al. 111P Goserelin 3 monthly depot is noninferior to goserelin monthly depot in the treatment of breast cancer: A real-world evidence study. ESMO Open. 2023;8(1):101335. ZOLADEX (goserelin implant) 3.6 mg prescribing information. TerSera Therapeutics LLC. ZOLADEX (goserelin implant) 10.8 mg prescribing information. TerSera Therapeutics LLC. ZOLADEX® is a registered trademark of AstraZeneca or its affiliates and is used herein under license. ©2024 TerSera Therapeutics LLC. All rights reserved.

Hologic's new website for the campaign wants women to visit their doctors for abnormal uterine bleeding symptoms. Women’s health tech company Hologic is launching "Better is Possible," a new health education and awareness campaign aimed at getting women to talk to their doctors about their disruptive period symptoms. Hologic said the initiative is set up to boost awareness around what it calls “quality-of-life challenges” in uterine health, including heavy and disruptive periods, pelvic pain and fibroids. The company, which sells surgical and imaging technologies for these conditions, said in a release it also wants to “educate women about available treatment options.” Heavy and disruptive periods, also known as abnormal uterine bleeding (AUB), are estimated by Hologic to impact around 10 million U.S. women each year. This can cause life-disrupting issues such as pain and tiredness and the need to more frequently change tampons/pads, with a common cause being uterine fibroids. Hologic says that while these uterine health issues are common, “many women aren’t aware of available treatment options,” and have to live with a stigma about these conditions. "Roughly two-thirds of women say that their period has impacted their day-to-day life, but until now, there’s been a glaring absence of discussion around solutions," said Mary Byerly, Vice President of Marketing for Hologic’s Gynecological Surgical Solutions division. “Through this campaign, we want to show women who experience painful periods, uncontrolled bleeding or other uterine health issues, that they don’t have to suffer in silence.” The new campaign is geared up to get women into their doctor’s offices, shed the stigma and seek treatment, which could include Hologic’s products. The campaign comes with a dedicated website of the same name that has educational themes about AUB and asks women to “advocate for yourself” and offers a quiz to see if you have symptoms that require a trip to the doctor. There is also a video that plays on the theme that “women are strong,” which shows women lifting weights in the gym; giving birth; rock climbing, and more. “When the going gets tough, we get tougher” the narrator intones, but then turns this positive into a negative. “We’ll put on a smile, even when we’re in pain … or know something is just wrong,” the narrator goes on to say, but that you’re told it’s “just part of being a woman.” “You need a healthcare partner that is as strong as you, and your uterus.” That’s where you need care from Hologic, the video says. The campaign is being launched first in New York, Los Angeles, Atlanta and Detroit this month.

MARLBOROUGH, Mass.--( BUSINESS WIRE )--Hologic, Inc. (Nasdaq: HOLX), a global leader in women’s health, today announced its new uterine health education and awareness campaign Better is Possible ™. Launching in New York, Los Angeles, Atlanta and Detroit, the campaign seeks to increase awareness about daily quality-of-life challenges such as heavy and disruptive periods, pelvic pain and fibroids, while also educating women about available treatment options. Heavy and disruptive periods, also known as abnormal uterine bleeding (AUB), affect more than 10 million U.S. women each year, causing persistent symptoms like pain, tiredness, lack of energy and long menstrual cycles with frequent changing of tampons and pads. 1 A common cause of AUB symptoms is uterine fibroids, which 77% of women will develop during their childbearing years. 2 While these uterine health issues are quite common, many women aren’t aware of available treatment options. “Roughly two-thirds of women say that their period has impacted their day-to-day life, but until now, there’s been a glaring absence of discussion around solutions. 3 Through this campaign, we want to show women who experience painful periods, uncontrolled bleeding or other uterine health issues, that they don’t have to suffer in silence,” said Mary Byerly, Vice President of Marketing for Hologic’s Gynecological Surgical Solutions division. “When it comes to periods, it can be so difficult to differentiate between what is normal and what isn’t. We’re proud to equip women with the resources they need to start the conversation and feel empowered when talking to their doctor about their periods and play an active role in their treatment plan.” The Better Is Possible campaign includes a video highlighting the experiences of women living with uterine health issues and encourages those dealing with similar symptoms to talk to their doctor. The campaign hub, BetterIsPossible.com , offers downloadable materials such as a period symptom quiz, discussion guides and information about potential treatment options. “I’ve heard from patients who search online for information about their symptoms and feel discouraged to discuss them with me when they see hysterectomy listed as the only treatment option,” said Danny Younes, MD, an obstetrician-gynecologist in San Diego. “Minimally invasive options are game-changing for my patients who seek relief from their painful fibroid symptoms but don’t want to remove their uterus.” In addition to educating patients, Hologic is also empowering physicians to create tailored care plans for their patients by providing cutting-edge, uterine-care technology with both surgical and surgery-free solutions. For more information about how Hologic is supporting physicians to discuss hysterectomy-alternative treatment options, visit gynsurgicalsolutions.com/hcp/for-medical-professionals/ For more information about the Better is Possible campaign and to access educational resources, visit BetterIsPossible.com . About Hologic, Inc. Hologic, Inc. is a global medical technology innovator focused on improving the health and well-being of women, their families and communities through early detection and treatment. Its advancements include invention of the world’s first commercial 3D mammography system to find breast cancer earlier; leadership in testing for cervical cancer, sexually transmitted infections and respiratory illnesses; and minimally invasive surgical technologies for uterine fibroids and abnormal uterine bleeding. Hologic, The Science of Sure, Better is Possible and associated logos are trademarks and/or registered trademarks of Hologic, Inc. and/or its subsidiaries in the United States and/or other countries. SOURCE: Hologic, Inc. References 1 Centers for Disease Control and Prevention. Heavy menstrual bleeding. https://www.cdc.gov/ncbddd/blooddisorders/women/menorrhagia.html . Accessed January 3, 2024. 2 Johns Hopkins. Fibroids. https://www.hopkinsmedicine.org/health/conditions-and-diseases/uterine-fibroids . Accessed January 3, 2024. 3 This survey was conducted online within the United States by The Harris Poll on behalf of Hologic between May 10-12, 2022, among 997 female adults ages 18+.