DOCSLIB.ORG

Ospemifene, an Oral SERM for Dyspareunia of Menopause: Is It

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text
Ospemifene, an Oral SERM for Dyspareunia of Menopause: Is It SUPPLEMENT TO This activity is supported by an educational grant from Duchesnay. February 2019 CME credit is awarded upon successful completion of the posttest and evaluation. To access posttest and evaluation, visit Ospemifene, an oral www.worldclasscme.com/nonestrogenoraltherapy World Class CME is accredited by the Accreditation Council SERM for dyspareunia for Continuing Medical Education to provide continuing medical education for physicians. of menopause: World Class CME designates this journal-based CME activity for a maximum of 1.0 AMA PRA Category 1 Credit™. Is it being underutilized? Physicians should claim only the credit commensurate with the extent of their participation in the activity. Audience: This activity was planned for obstetricians and Vulvovaginal atrophy: gynecologists and women’s health care providers. an undertreated disorder Faculty Program Director Steven R. Goldstein, MD, CCD, NCMP, FACOG James A. Simon, MD, CCD, NCMP, IF, FACOG Professor of Obstetrics and Gynecology Clinical Professor New York University School of Medicine George Washington University School of Medicine Director of Gynecological Ultrasound President and Medical Director Co-Director of Bone Densitometry and Body Composition IntimMedicine Specialists® Department of Obstetrics and Gynecology Washington, District of Columbia New York University Medical Center New York, New York strogen and androgen deficiency from menopause Author causes vulvovaginal and urogenital changes and a James A. Simon, MD, CCD, NCMP, IF, FACOG E Clinical Professor plethora of symptoms, most prominently dyspareunia. The George Washington University School of Medicine nomenclature recently has been expanded to genitourinary President and Medical Director syndrome of menopause (GSM). IntimMedicine Specialists® Reproductive hormone deficiency leads to vulvar and Washington, District of Columbia vaginal thinning, loss of rugal folds, diminished elastic- Learning Objectives ity, diminished vaginal glycogen, and decreased acidity At the conclusion of this activity, the participant will be (increased pH) of the vaginal secretions, thereby reducing able to: the vagina’s natural defenses.1 1. Understand the pathophysiology of dyspareunia due to Few women with GSM report their symptoms to their vulvovaginal atrophy (VVA) of menopause. health care professionals,2 and conversely most health care 2. Appreciate the underrecognition and undertreatment professionals do not sufficiently query patients or inform of dyspareunia due to VVA. them of their therapeutic options. Furthermore, class label- 3. Discuss efficacy results of randomized placebo controlled trials of ospemifene. ling of most available treatments has emphasized unsub- 3 4. Understand the adverse events associated with stantiated risks (ie, increased endometrial cancer, stroke, ospemifene. myocardial infarction [MI], deep vein thrombosis [DVT], 5. Appreciate the safety data of ospemifine as well as pulmonary embolism [PE], probable dementia, and invasive other oral selective estrogen receptor modulators and breast cancer), thus resulting in only 7% of symptomatic estrogens. women using any pharmacologic agent.4 Date of Original Release: February 1, 2019 CLINICAL DEVELOPMENT AND FDA APPROVAL Date Credits Expire: January 31, 2022 Until recently, all available vulvovaginal atrophy (VVA)/GSM treatments were systemic or local steroid hormones (estradiol, conjugated estrogens, dehydroepiandrosterone AVAILABLE AT WWW.MDEDGE.COM/OBGYN Supplement to OBG MANAGEMENT I February 2019 S1 OSPEMIFENE, AN ORAL SERM FOR DYSPAREUNIA OF MENOPAUSE [DHEA]). Fear of estrogens from the “class labeling” and the nuisance of vaginal administration undermines utilization Conflict of interest disclosure for some women. Steven R. Goldstein, MD Ospemifene, a third-generation selective estrogen Consultant: Cook Ob/Gyn, Cooper Surgical, IBSA, Pfizer GYN Advisory Board: AbbVie, Allergan, AMAG, Shionogi, receptor modulator (SERM) originally developed for osteo- TherapeuticsMD porosis, has estrogenic effects on bone, lipids, and vagi- Speakers Bureau: AMAG, Duchesnay, TherapeuticsMD nal tissue while remaining antiestrogenic or neutral in the Equipment Loan: GE Ultrasound breast and endometrium, respectively.5 Multiple phase 3, placebo-controlled, clinical trials6,7 resulted in US Food and James A. Simon, MD Advisory Board/Consultant: AbbVie, Inc. (North Chicago, Drug Administration (FDA) approval for moderate to severe IL), Allergan, Plc (Parsippany, NJ), AMAG Pharmaceuticals, dyspareunia from vulvovaginal atrophy of menopause. Inc. (Waltham, MA), Amgen (Thousand Oaks, CA), The American College of Obstetricians and Gynecologists Ascend Therapeutics (Herndon, VA), Bayer HealthCare (ACOG) endorsed ospemifene (Level A evidence) as first-line Pharmaceuticals Inc. (Whippany, NJ), CEEK Enterprises, LLC. therapy for dyspareunia noting absent endometrial stimu- (Cambridge, MA), Covance Inc., (Princeton, NJ), Millendo 8 Therapeutics, Inc. (Ann Arbor, MI), Mitsubishi Tanabe lation. The most common adverse reactions in these ospe- Pharma Development America, Inc. (Jersey City, NJ), ObsEva mifene trials versus placebo were hot flashes and sweating SA (Geneva, Switzerland), Radius Health, Inc. (Waltham, (9.1% vs 3.2%), and muscle spasms (3.2% vs 0.9%), mostly MA), Sanofi S.A. (Paris, France), Sebela Pharmaceuticals, Inc. leg cramps.6,7 Only 1% of participants discontinued due to (Roswell, GA), Shionogi Inc. (Florham Park, NJ), Symbiotec hot flashes, and there were no differences in rates of bleed- Pharmalab (Indore, India), TherapeuticsMD (Boca Raton, FL), Valeant Pharmaceuticals (Laval, Canada) ing or breast tenderness. Speaker: AMAG Pharmaceuticals, Inc., Duchesnay USA (Rosemont, PA), Novo Nordisk (Bagsvrerd, Denmark), REFERENCES Shionogi Inc., Valeant Pharmaceuticals (Laval, Canada) 1. Wilson JD, Lee RA, Balen AH, Rutherford AJ. Bacterial vaginal flora in rela- Grants/Research: AbbVie, Inc., Allergan, Plc, Agile tion to changing oestrogen levels. Int J STD AIDS. 2007;18(5):308-311. Therapeutics (Princeton, NJ), Bayer Healthcare LLC. 2. Parish SJ, Nappi RE, Krychman ML, et al. Impact of vulvovaginal health (Tarrytown, NY), Dornier MedTech (Munich, Germany), on postmenopausal women: a review of surveys on symptoms of vulvo- Endoceutics, Inc. (Quebec, Canada), GTx, Inc. (Memphis, TN), vaginal atrophy. Int J Womens Health. 2013;5:437-447. Ipsen (Paris, France), Myovant Sciences (Basel, Switzerland), 3. Crandall CJ, Hovey KM, Andrews CA, et al. Breast cancer, endometrial New England Research Institute, Inc. (Watertown, MA), cancer, and cardiovascular events in participants who used vaginal ObsEva SA (Geneva, Switzerland), Palatin Technologies estrogen in the Women’s Health Initiative Observational Study. Meno- (Cranbury, NJ), Symbio Research, Inc. (Port Jefferson, NY), pause. 2018;25(1):11-20. TherapeuticsMD, Tissue Genesis (Honolulu, HI) 4. Kingsberg SA, Krychman M, Graham S, et al. The Women’s EMPOWER Survey: Identifying Women’s Perceptions on Vulvar and Vaginal Atrophy Stock Shareholder: Pharmaceuticals (Columbus, OH) and Its Treatment. J Sex Med. 2017;14(3):413-424. 5. Berga SL. Profile of ospemifene in the breast. Reprod Sci. 2013;20(10):1130- No disclosures to declare 1136. Heidi M. Wilson, Course Director 6. Bachmann GA, Komi JO; Ospemifene Study Group. Ospemifene effec- tively treats vulvovaginal atrophy in postmenopausal women: results from a pivotal phase 3 study. Menopause. 2010;17(3):480-486. 7. Portman DJ, Bachmann GA, Simon JA; Ospemifene Study Group. Ospe- mifene, a novel selective estrogen receptor modulator for treating dys- pareunia associated with postmenopausal vulvar and vaginal atrophy. Menopause. 2013;20(6):623-630. 8. ACOG Practice Bulletin No. 141: management of menopausal symp- toms. Obstet Gynecol. 2014;123(1):202-216. S2 February 2019 I Supplement to OBG MANAGEMENT OSPEMIFENE, AN ORAL SERM FOR DYSPAREUNIA OF MENOPAUSE New important data on ospemifene Steven R. Goldstein, MD, CCD, NCMP, FACOG, FRCOG Professor of Obstetrics and Gynecology New York University School of Medicine Director of Gynecological Ultrasound Co-Director of Bone Densitometry and Body Composition Department of Obstetrics and Gynecology New York University Medical Center New York, New York ENDOMETRIAL SAFETY a SERM, based on class effects, one would expect it to be There is a boxed warning in the ospemifene label that an estrogen antagonist in breast and estrogenic in bone. says, “in the uterus, ospemifene has estrogenic agonis- Additionally, improvement in overactive bladder (OAB) tic effects.”1 Despite the fact that ospemifene is not an symptoms as well as prevention of recurrent lower urinary estrogen (it’s a SERM), it goes on to state, “there is an tract infections have been reported. increased risk of endometrial cancer in a woman with a Previous data have demonstrated that ospemifene uterus who uses unopposed estrogen.” This statement inhibits breast cancer cell growth in in vitro cultures as well actually caused The Medical Letter to initially suggest that as experimental animals6 and inhibits proliferation of human patients receiving ospemifene also should receive a pro- breast tissue epithelial cells,7 with such breast effects similar gestational agent (something they later retracted).2,3 In to tamoxifen and raloxifene. Thus, although one would not trying to understand why the labeling might possibly be choose ospemifene as a primary treatment, or risk-reducing worded in such a way, one has to review the actual data agent, for breast cancer, the direction
Load more

Recommended publications
  • Eraas for Menopause Treatment: Welcome the ‘Designer Estrogens’
    REVIEW CME LEARNING OBJECTIVE: Readers will tailor hormone therapy to the needs of the patient CREDIT HEATHER D. HIRSCH, MD, MS, NCMP ELIM SHIH, MD, NCMP HOLLY L. THACKER, MD, NCMP Assistant Professor, Clinical Internal Medicine, Division Department of Obstetrics and Gynecology, Director of Center for Specialized Women’s Health, of General Internal Medicine, The Ohio State University, Women’s Health Institute, Cleveland Clinic Department of Obstetrics and Gynecology, Women’s Columbus, and Center for Women’s Health, Health Institute, Cleveland Clinic; Professor, Cleveland The Ohio State University Wexner Medical Center, Clinic Lerner College of Medicine of Case Western Upper Arlington, OH Reserve University, Cleveland, OH ERAAs for menopause treatment: Welcome the ‘designer estrogens’ ABSTRACT strogen receptor agonist-antagonists E(ERAAs), previously called selective es- Estrogen receptor agonist-antagonists (ERAAs) selec- trogen receptor modulators (SERMs), have tively inhibit or stimulate estrogen-like action in targeted extended the options for treating the vari- tissues. This review summarizes how ERAAs can be used ous conditions that menopausal women suffer in combination with an estrogen or alone to treat meno- from. These drugs act differently on estrogen pausal symptoms (vasomotor symptoms, genitourinary receptors in different tissues, stimulating re- syndrome of menopause), breast cancer or the risk of ceptors in some tissues but inhibiting them breast cancer, osteopenia, osteoporosis, and other female in others. This allows selective inhibition or midlife concerns. stimulation of estrogen-like action in various target tissues.1 KEY POINTS This article highlights the use of ERAAs Tamoxifen is approved to prevent and treat breast cancer. to treat menopausal vasomotor symptoms It may also have beneficial effects on bone and on car- (eg, hot flashes, night sweats), genitourinary diovascular risk factors, but these are not approved uses.
    [Show full text]
  • Clinical Update on the Use of Ospemifene in the Treatment of Severe Symptomatic Vulvar and Vaginal Atrophy
    Journal name: International Journal of Women’s Health Article Designation: Review Year: 2016 Volume: 8 International Journal of Women’s Health Dovepress Running head verso: Palacios and Cancelo Running head recto: The use of ospemifene in the treatment of severe symptomatic VVA open access to scientific and medical research DOI: http://dx.doi.org/10.2147/IJWH.S110035 Open Access Full Text Article REVIEW Clinical update on the use of ospemifene in the treatment of severe symptomatic vulvar and vaginal atrophy Santiago Palacios1 Abstract: The physiological decrease in vaginal estrogens is accountable for the emergence of María Jesús Cancelo2 vulvar and vaginal atrophy (VVA) and its related symptoms such as vaginal dryness, dyspareunia, vaginal and/or vulvar irritation or itching, and dysuria. The repercussion of these symptoms 1Palacios Institute of Women’s Health, Madrid, Spain; 2Gynecology and on quality of life often makes it necessary to initiate treatment. Up until now, the treatments Obstetrics Department, Guadalajara available included vaginal moisturizers and lubricants, local estrogens, and hormonal therapy. University Hospital, University of Alcalá, Spain However, therapeutic options have now been increased with the approval of 60 mg ospemifene, the first nonhormonal oral treatment with an agonist effect on the vaginal epithelium and an endometrial and breast safety profile which makes it unique. This is the first selective estrogen receptor modulator indicated in women with moderate-to-severe vaginal atrophy not eligible For personal use only. for local estrogen treatment. Considering that “local estrogen noneligible women” are those in whom such treatment cannot be administered either because it is contraindicated or due to skill issues, who are averse to the mode and convenience of vaginal products’ administration or to their use on account of potential systemic absorption, or those who demonstrate dissatisfac- tion in terms of efficacy and safety, it is clear that there is a significant unmet medical need in VVA management.
    [Show full text]
  • Management of Women with Premature Ovarian Insufficiency
    Management of women with premature ovarian insufficiency Guideline of the European Society of Human Reproduction and Embryology POI Guideline Development Group December 2015 1 Disclaimer The European Society of Human Reproduction and Embryology (hereinafter referred to as 'ESHRE') developed the current clinical practice guideline, to provide clinical recommendations to improve the quality of healthcare delivery within the European field of human reproduction and embryology. This guideline represents the views of ESHRE, which were achieved after careful consideration of the scientific evidence available at the time of preparation. In the absence of scientific evidence on certain aspects, a consensus between the relevant ESHRE stakeholders has been obtained. The aim of clinical practice guidelines is to aid healthcare professionals in everyday clinical decisions about appropriate and effective care of their patients. However, adherence to these clinical practice guidelines does not guarantee a successful or specific outcome, nor does it establish a standard of care. Clinical practice guidelines do not override the healthcare professional's clinical judgment in diagnosis and treatment of particular patients. Ultimately, healthcare professionals must make their own clinical decisions on a case-by-case basis, using their clinical judgment, knowledge, and expertise, and taking into account the condition, circumstances, and wishes of the individual patient, in consultation with that patient and/or the guardian or carer. ESHRE makes no warranty, express or implied, regarding the clinical practice guidelines and specifically excludes any warranties of merchantability and fitness for a particular use or purpose. ESHRE shall not be liable for direct, indirect, special, incidental, or consequential damages related to the use of the information contained herein.
    [Show full text]
  • CP.PMN.168 Ospemifene (Osphena)
    Clinical Policy: Ospemifene (Osphena) Reference Number: CP.PMN.168 Effective Date: 08.28.18 Last Review Date: 11.20 Line of Business: Commercial, HIM, Medicaid Revision Log See Important Reminder at the end of this policy for important regulatory and legal information. Description Ospemifene (Osphena®) is a selective estrogen receptor modulator (SERM). FDA Approved Indication(s) Osphena is indicated for the treatment of moderate to severe dyspareunia and vaginal dryness, symptoms of vulvar and vaginal atrophy, due to menopause. Policy/Criteria Provider must submit documentation (such as office chart notes, lab results or other clinical information) supporting that member has met all approval criteria. It is the policy of health plans affiliated with Centene Corporation® that Osphena is medically necessary when the following criteria are met: I. Initial Approval Criteria A. Dyspareunia or Vaginal Dryness (must meet all): 1. Diagnosis of dyspareunia or vaginal dryness due to menopause; 2. Age ≥ 18 years; 3. Failure of two vaginal lubricants or vaginal moisturizers at up to maximally indicated doses, unless contraindicated or clinically significant adverse effects are experienced; 4. Failure of ≥ 4 weeks of one vaginal estrogen at up to maximally indicated doses (e.g., estradiol vaginal cream, Premarin vaginal cream), unless contraindicated or clinically significant adverse effects are experienced; 5. Dose does not exceed 60 mg (1 tablet) per day. Approval duration: Medicaid/HIM – 12 months Commercial – Length of Benefit B. Other diagnoses/indications 1. Refer to the off-label use policy for the relevant line of business if diagnosis is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized): CP.CPA.09 for commercial, HIM.PHAR.21 for health insurance marketplace, and CP.PMN.53 for Medicaid.
    [Show full text]
  • HRT Communications 23.08.20191.Pdf
    DHSC - 23/8/2019 Hormone replacement therapy (HRT) supply issues The Department of Health and Social Care (DHSC) are aware of the ongoing manufacturing issues that have affected the supply of some hormone replacement therapy (HRT) products throughout 2019. Please see Table 1, which provides the latest update on the availability of all HRT products marketed in the UK and the known resupply date for products that are currently experiencing supply issues. This table also provides an update of all HRT preparations that remain available. Clinicians may be required to switch patients to alternative HRT products that contain the same active ingredients for a temporary period. Prescribing information regarding HRT equivalence to support local decision making is available through various sources such as the British National Formulary, Summary of Product Characteristics (SPC), The Monthly Index of Medical Specialities (MIMS), and other sources including local Medicines Information Centres. Clinicians are advised to work closely with community pharmacies to understand local availability of HRT products and use the table below to help make decision about appropriative HRT products for patients who are affected by the supply issues. DHSC will continue to provide updates on HRT availability in the monthly supply report, which is uploaded to the Specialist Pharmacist Services website. All registered user can access this update via this following link: https://www.sps.nhs.uk/articles/department-of-health-and- pharmaceutical-market-strategy-group-pmsg-supply-updates/ Please share this information with relevant networks locally including GP practices and community pharmacies. Table 1. HRT Availability Oestrogen Only Brand Strength Current Availability Anticipated resupply Ingredient (s) Manufacturer Oral preparations date Continued availability 1mg In stock to be confirmed.
    [Show full text]
  • OSPHENA) National Drug Monograph October 2015 VA Pharmacy Benefits Management Services, Medical Advisory Panel, and VISN Pharmacist Executives
    Ospemifene Monograph Ospemifene (OSPHENA) National Drug Monograph October 2015 VA Pharmacy Benefits Management Services, Medical Advisory Panel, and VISN Pharmacist Executives The purpose of VA PBM Services drug monographs is to provide a comprehensive drug review for making formulary decisions. Updates will be made when new clinical data warrant additional formulary discussion. Documents will be placed in the Archive section when the information is deemed to be no longer current. FDA Approval Information Description/Mechanism of Ospemifene is a selective estrogen receptor modulator (SERM) with agonist Action actions on vaginal tissue, the endometrium and bone. Antagonist actions suggest antitumor effects in experimental breast cancer models. Ospemifene is not interchangeable with other SERMs such as raloxifene or tamoxifen, nor they with it. Indication(s) Under Review in Ospemifene is an estrogen agonist/antagonist indicated for the treatment this document (may include of moderate to severe dyspareunia, a symptom of vulvar and vaginal off label) atrophy, due to menopause. Dosage Form(s) Under Tablet (oral), 60 mg Review REMS REMS X No REMS Postmarketing Requirements See Other Considerations for additional REMS information Pregnancy Rating X Executive Summary Efficacy After 12 weeks ospemifene reduced the symptom score of dyspareunia significantly more than placebo. Thirty-eight percent of postmenopausal women taking ospemifene reported no pain upon intercourse compared to 28% taking placebo. Ospemifene significantly improved the Maturation Index (composed of percent of vaginal parabasal and superficial cells, and vaginal pH) after 12 and 52 weeks of treatment. Vaginal dryness symptom scores improved significantly more with ospemifene than placebo. Use of vaginal lubricant decreased more in women taking ospemifene than placebo.
    [Show full text]
  • Reference List Abraham L, Pinkerton JV, Messig M, Ryan KA, Komm BS, Mirkin S
    SERM Education Project Reference List Abraham L, Pinkerton JV, Messig M, Ryan KA, Komm BS, Mirkin S. Menopause-specific quality of life across varying menopausal populations with conjugated estrogens/bazedoxifene. Maturitas. 2014;78(3):212-218. Archer DF, Carr BR, Pinkerton JV, Taylor HS, Constantine GD. Effects of ospemifene on the female reproductive and urinary tracts: translation from preclinical models into clinical evidence. Menopause. 2015;22(7):786-796. Archer DF, Lewis V, Carr BR, Olivier S, Pickar JH. Bazedoxifene/conjugated estrogens (BZA/CE): incidence of uterine bleeding in postmenopausal women. Fertil Steril. 2009;92(3):1039-1044. Archer DF. The gynecologic effects of lasofoxifene, an estrogen agonist/antagonist, in postmenopausal women. Menopause. 2011;18(1):6-7. Bachmann G, Bobula J, Mirkin S. Effects of bazedoxifene/conjugated estrogens on quality of life in postmentopausal women with symptoms of vulvar/vaginal atrophy. Climacteric. 2010;13(2):132-140. Bachmann G, Gass M, Kagan R, Moffett A, Barcomb L, Symons J. Lasofoxifene (LASO), a next generation selective estrogen response modulator (SERM) improves dyspareunia in postmenopausal women with vaginal atrophy (VA) [abstract]. Menopause. 2005;12(2):238. Bachmann G, Gass M, Moffett A, Portman D, Symons J. Lasofoxifene improves symptoms associated with vaginal atrophy [abstract]. Menopause. 2004;11(6):669. Abstract P-63. Bachmann GA, Komi JO; Ospemifene Study Group. Ospemifene effectively treats vulvovaginal atrophy in postmenopausal women: results from a pivotal phase 3 study. Menopause. 2010;17(3):480-486. Barrett-Connor E, Grady D, Sashegyi A, et al; MORE Investigators (Multiple Outcomes of Raloxifene Evaluation). Raloxifene and cardiovascular events in osteoporotic postmenopausal women: four-year results from the MORE (Multiple Outcomes of Raloxifene Evaluation) randomized trial.
    [Show full text]
  • OSPHENA Safely and Effectively
    HIGHLIGHTS OF PRESCRIBING INFORMATION Active DVT, pulmonary embolism (PE), or a history of these conditions These highlights do not include all the information needed to use (4, 5.1) OSPHENA safely and effectively. See full prescribing information for Active arterial thromboembolic disease (for example, stroke and OSPHENA. myocardial infarction [MI]), or a history of these conditions (4, 5.1) Known or suspected pregnancy (4, 8.1) OSPHENATM (ospemifene) tablets, for oral use Initial U.S. Approval: 2013 ---------------WARNINGS AND PRECAUTIONS------------ WARNING: ENDOMETRIAL CANCER AND CARDIOVASCULAR Venous Thromboembolism: Risk of DVT and pulmonary embolism DISORDERS (5.1) See full prescribing information for complete boxed warning. Known, suspected, or history of breast cancer (5.2) OSPHENA is an estrogen agonist/antagonist with tissue selective effects. In the endometrium, OSPHENA has estrogen agonistic effects. Severe Hepatic Impairment (5.3, 8.7, 12.3) There is an increased risk of endometrial cancer in a woman with a uterus who uses unopposed estrogens. Adding a progestin to estrogen -------------------ADVERSE REACTIONS---------------------- therapy reduces the risk of endometrial hyperplasia, which may be a precursor to endometrial cancer [see Warnings and Precautions (5.2)]. Adverse reactions (≥1 percent) include: hot flush, vaginal discharge, muscle spasms, genital discharge, hyperhidrosis. (6.1) Estrogen-alone therapy has an increased risk of stroke and deep vein thrombosis (DVT). OSPHENA 60 mg had cerebral thromboembolic To report SUSPECTED ADVERSE REACTIONS, contact Shionogi Inc. and hemorrhagic stroke incidence rates of 0.72 and 1.45 per thousand at 1-855-OSPHENA (1-855-677-4362) or FDA at 1-800-FDA-1088 or women, respectively vs.
    [Show full text]
  • MSAN(2020)67 – Hormone Replacement Therapy
    NHS Circular: MSAN (2020) 67 Chief Medical Officer Directorate Pharmacy and Medicines Division 23 July 2020 Medicine Supply Alert Notice Hormone Replacement Therapy (all formulations) Priority: Level 3* - update to MSAN (2020)3 Valid until: See table at Annex A Issue 1. The Chief Pharmaceutical Officer previously wrote in circular PCA(P)(2019)18 to community pharmacy contractors and NHS Boards regarding information on the availability of all Hormone Replacement Therapy (HRT) products marketed in the UK. This was updated in January 2020 by MSAN (2020)3. 2. This MSAN gives an update on the information provided in MSAN (2020)3, as issued by the UK Department of Health and Social Care Medicine Supply Team in July 2020. Advice and Actions 4. The table 1 attached at Annex A provides the latest update on the availability of all HRT products marketed in the UK and the known resupply date for products that are currently experiencing supply issues. The table also provides an update of all HRT preparations that remain available. 5. Clinicians may be required to switch patients to alternative HRT products that contain the same active ingredients for a temporary period. Prescribing information regarding HRT equivalence to support local decision making is available through various sources such as the British National Formulary, Summary of Product Characteristics (SPC), The Monthly Index of Medical Specialities (MIMS), and other sources including local Medicines Information Centres. Additional Information 6. Clinicians are advised to work closely with community pharmacies to understand local availability of HRT products and use the table below to help make decision about appropriative HRT products for patients who are affected by the supply issues.
    [Show full text]
  • Ospemifene for the Treatment of Dyspareunia Associated with Vulvar and Vaginal Atrophy: Potential Benefits in Bone and Breast
    International Journal of Women’s Health Dovepress open access to scientific and medical research Open Access Full Text Article REVIEW Ospemifene for the treatment of dyspareunia associated with vulvar and vaginal atrophy: potential benefits in bone and breast Lin H Soe Abstract: Ospemifene is a selective estrogen receptor modulator (SERM), or estrogen receptor Gregory T Wurz agonist/antagonist, that was recently approved by the US Food and Drug Administration for the Chiao-Jung Kao treatment of dyspareunia associated with vulvar and vaginal atrophy, a chronic condition that Michael W DeGregorio affects up to 60% of postmenopausal women. Ospemifene is the first and only nonestrogen com- pound approved for this indication. Compared with other approved SERMs, such as tamoxifen, Department of Internal Medicine, Division of Hematology and Oncology, toremifene, bazedoxifene, and raloxifene, the estrogen-like effects of ospemifene in the vaginal School of Medicine, University of epithelium are unique. This review first discusses the rationale for developing ospemifene, includ- California, Davis, Sacramento, CA, ing its mechanism of action, and then focuses on the clinical development of ospemifene for the USA treatment of dyspareunia associated with vulvar and vaginal atrophy. Included are discussions For personal use only. of the effects of ospemifene on the endometrium, serum lipids, coagulation markers, bone, and breast cancer. In conclusion, ospemifene is a SERM with a unique estrogen agonist/antagonist Video abstract tissue profile that was recently approved in the US for the treatment of dyspareunia associated with vulvar and vaginal atrophy in postmenopausal women. Ospemifene warrants further clinical investigation for the treatment and prevention of osteoporosis and breast cancer.
    [Show full text]
  • 2017 Hormone Therapy Position Statement of the North American Menopause Society
    Menopause: The Journal of The North American Menopause Society Vol. 24, No. 7, pp. 728-753 DOI: 10.1097/GME.0000000000000921 ß 2017 by The North American Menopause Society POSITION STATEMENT The 2017 hormone therapy position statement of The North American Menopause Society Abstract The 2017 Hormone Therapy Position Statement of The North American Menopause Society (NAMS) updates the 2012 Hormone Therapy Position Statement of The North American Menopause Society and identifies future research needs. An Advisory Panel of clinicians and researchers expert in the field of women’s health and menopause was recruited by NAMS to review the 2012 Position Statement, evaluate new literature, assess the evidence, and reach consensus on recommendations, using the level of evidence to identify the strength of recommendations and the quality of the evidence. The Panel’s recommendations were reviewed and approved by the NAMS Board of Trustees. Hormone therapy (HT) remains the most effective treatment for vasomotor symptoms (VMS) and the genito- urinary syndrome of menopause (GSM) and has been shown to prevent bone loss and fracture. The risks of HT differ depending on type, dose, duration of use, route of administration, timing of initiation, and whether a progestogen is used. Treatment should be individualized to identify the most appropriate HT type, dose, formulation, route of administration, and duration of use, using the best available evidence to maximize benefits and minimize risks, with periodic reevaluation of the benefits and risks of continuing or discontinuing HT. For women aged younger than 60 years or who are within 10 years of menopause onset and have no contraindications, the benefit-risk ratio is most favorable for treatment of bothersome VMS and for those at elevated risk for bone loss or fracture.
    [Show full text]
  • Senshio, INN-Ospemifene
    ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 1 This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions. 1. NAME OF THE MEDICINAL PRODUCT Senshio 60 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 60 mg ospemifene. Excipient with known effect Each film-coated tablet contains 1.82 mg lactose as monohydrate. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet (tablet). Oval biconvex, white to off-white, film-coated tablets of dimensions 12 mm x 6.45 mm, debossed with “60” on one side. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications Senshio is indicated for the treatment of moderate to severe symptomatic vulvar and vaginal atrophy (VVA) in post-menopausal women who are not candidates for local vaginal oestrogen therapy. 4.2 Posology and method of administration Posology The recommended dose is one 60 mg tablet once daily with food taken at the same time each day. If a dose is missed it should be taken with food as soon as the patient remembers. A double dose should not be taken in the same day. Special populations Elderly (>65 years old) No dose adjustment is necessary in patients above the age of 65 years (see section 5.2). Renal impairment No dose adjustment is necessary for patients with mild, moderate or severe renal impairment (see section 5.2). 2 Hepatic impairment No dose adjustment is necessary for patients with mild to moderate hepatic impairment.
    [Show full text]