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1 Osphena (ospemifene) ® Osphena (ospemifene)
OSPHENA® (OSPEMIFENE) ® OSPHENA (OSPEMIFENE) 1 Patient Information OSPHENA® (os fee’ nah) (ospemifene) tablets Read this Patient Information before you …


2 Ospemifene (osphena) - Pharmacy Benefit Management
Ospemifene Monograph October 2015 Updated version may be found at www.pbm.va.gov or PBM INTRAnet 1 Ospemifene (OSPHENA) National Drug Monograph October 2015 VA Pharmacy Benefits Management Services, Medical Advisory Panel, and VISN Pharmacist Executives


3 Ospemifene (osphena®) - Eocco.com
II. Ospemifene (Osphena) is classified as an impotence drug according to First Databank. This is considered a categorical exclusion in the prescription benefit structure; however, coverage is allowed in the setting of moderate to severe vaginal dryness outside of the dyspareunia setting. III. Dyspareunia is defined as difficult or painful ...


4 Patient Information Osphena (os Fee’ Nah) (ospemifene ...
OSPHENA for a condition for which it was not prescribed. Do not give OSPHENA to other people, even if they have the same symptoms you have. It may harm them. This Patient Information leaflet summarizes the most important information about OSPHENA. If you would like more information, talk with your healthcare provider or pharmacist. You can ask ...


5 Osphena (ospemifene) Basics - Iodine
Osphena (Ospemifene) basics Powered by Helps make sex less painful for postmenopausal women. Osphena (Ospemifene) helps make sex less painful in postmenopausal women, but has more side -effects than topical medications applied directly to the vagina.


6 Osphena (ospemifene) – New Indication
Osphena ® (ospemifene) – New indication • On January 29, 2019, Duchesnay announcedthe FDA approval of Osphena (ospemifene), for the treatment of moderate to severe vaginal dryness, a symptom of vulvar and vaginal atrophy (VVA), due to menopause. — Osphena is also approved for the treatment of moderate to severe dyspareunia, a symptom


7 Dosage Forms And Strengths-----------------­ Osphena.
See full prescribing information for OSPHENA. OSPHENA ® (ospemifene) tablets, for oral use Initial U.S. Approval: 2013 . WARNING: ENDOMETRIAL CANCER and CARDIOVASCULAR DISORDERS . See full prescribing information for complete boxed warning. OSPHENA is an estrogen agonist/antagonist with tissue selective effects. In the endometrium , OSPHENA has estrogen agonistic effects. There is an ...


8 Osphena (ospemifene)
Osphena (ospemifene) May be subject to quantity limit APPROVAL CRITERIA Requests for Osphena (ospemifene) may be approved for individuals who meet the following criteria: I. Individual is using to treat moderate-to-severe dyspareunia , a symptom of vulvar and ...


9 Dosage Forms And Strengths------------------ Osphena.
OSPHENA. OSPHENA® (ospemifene) tablets, for oral use . Initial U.S. Approval: •2013 . WARNING: ENDOMETRIAL CANCERand CARDIOVASCULAR DISORDERS See full prescribing information for complete boxed warning. OSPHENA is an estrogen agonist/antagonist with tissue selective effects. In the endometrium , OSPHENA has estrogen agonistic effects. There ...


10 Reference Id: 3267292
OSPHENA tablets are white to off-white, oval, biconvex, film coated tablets containing 60 mg of ospemifene and engraved with “60” on one side. 4. CONTRAINDICATIONS . OSPHENA is contraindicated in women with any of the following conditions: Undiagnosed abnormal genital bleeding . Reference ID: 3267292 . 2


11 Clinical Policy: Ospemifene (osphena) - Pa Health & Wellness
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


12 To Receive Your Samples Of Osphena (ospemifene) Tablets 60mg
SAMPLE REQUEST FAX FORM Fax to 973-644-2386. To receive your samples of Osphena (ospemifene) tablets 60mg. Reference# Practitioner’s Last Name (required)


13 Clinical Policy: Ospemifene (osphena)
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,


14 Osphena® (ospemifene) Oral Tablet - Azblue
Osphena (ospemifene) has agonistic effects on the endometrium, when a product with estrogenic agonistic effects on the endometrium is used, a progestin should be considered to reduce the risk of endometrial cancer. A woman without a uterus does not need a progestin. The use of Osphena (ospemifene) with a progestin was not evaluated in clinical trials. Menopausal symptoms include hot …


15 Safety Data Sheet Page: 1 Of 5 Ospemifene Revision
06/01/2018 · Revision: 01/06/2018 Page: 1 of 5 Ospemifene SAFETY DATA SHEET according to Regulation (EC) No. 1907/2006 as amended by (EC) No. 1272/2008 1.1 Product Code: 23755 Section 1.


16 Policy: Osphena (ospemifene) Annual Review Date: 03/21/2019
Policy: Osphena (ospemifene) Annual Review Date: 03/21/2019 Last Revised Date: 03/21/2019 OVERVIEW Osphena is an estrogen agonist/antagonist with tissue selective effects, commonly referred to as a selective estrogen receptor modulator (SERM) indicated for the treatment of moderate to severe dyspareunia and moderate to severe vaginal dryness, symptoms of vulvar and vaginal atrophy, due to ...


17 Osphena® (ospemifene) Oral Tablet - Azblue
OSPHENA® (ospemifene) oral tablet Page 1 of 6 Coverage for services, procedures, medical devices and drugs are dependent upon benefit eligibility as outlined in the member's specific benefit plan. This Pharmacy Coverage Guideline must be read in its entirety to determine coverage eligibility, if any.


18 Pharmacy Medical Necessity Guidelines: Osphena™ (ospemifene)
2439315 2 Pharmacy Medical Necessity Guidelines: Osphena (ospemifene) 9. Portman DJ, Bachmann GA, Simon JA, et al. Ospemifene, a novel selective estrogen receptor


19 Shionogi Receives Fda Approval For Osphenatm …
Click here for Full Prescribing Information for OsphenaTM (ospemifene) tablets, including Boxed WARNING and Patient Information. For more information, please visit www.Osphena.com. Indications and Usage for OsphenaTM (ospemifene) tablets OsphenaTM (ospemifene) is indicated for the treatment of moderate to severe dyspareunia, a symptom of


20 Prior Authorization Approval Criteria - Fallon Health
Fallon Community Health Plan Department of Pharmacy Services Page 1 of 2 Prior Authorization Approval Criteria Osphena (ospemifene) Generic name: Ospemifene


21 Clinical Pharmacy Program Guidelines For Osphena
Clinical Pharmacy Program Guidelines for Osphena Program Prior Authorization Medication Osphena (ospemifene) Markets in Scope Arizona, California, Florida-CHIP, Hawaii, Maryland, Nevada, New Jersey, New York Chip, New York EPP, Ohio, Pennsylvania, Rhode Island Issue Date 3/2019 Pharmacy and Therapeutics Approval Date 3/2019


22 Shionogi Inc. Osphena- Ospemifene Tablet, Film Coated
OSPHENA- ospemifene tablet, film coated Shionogi Inc.-----HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to …


23 Clinical Pharmacy Program Guidelines For Osphena
Clinical Pharmacy Program Guidelines for Osphena . Program Prior Authorization Medication Osphena (ospemifene) Markets in Scope Arizona, California, Florida-CHIP, Hawaii, Maryland, Nevada, New Jersey, New York Chip, New York EPP, Ohio, Pennsylvania, Rhode Island Issue Date 3/2019 Pharmacy and Therapeutics Approval Date 3/2019


24 Vaginal Dryness - North American Menopause Society
Ospemifene (Osphena) is an oral tablet for the treatment of painful intercourse secondary to vaginal atrophy. Ospemifene is an estrogen agonist/antagonist, which means it works like estrogen in some tissues and opposes estrogen’s actions in others. Note: Not all vaginal symptoms are related to menopause. For instance, yeast infections, allergic


25 Osphena (ospemifene) Prior Approval Criteria December 2015 I.
Osphena (ospemifene) Prior Approval Criteria . December 2015 . Definition: Osphena is an estrogen agonist/antagonist indicated for the treatment of moderate to severe dyspareunia, a symptom of vulvar and vaginal atrophy, due to menopause . I. Moderate to severe dyspareunia. The Company considers ospemifene medically


26 Ospemifene, A Non-oestrogen Selective Oestrogen Receptor ...
Ospemifene, a non-oestrogen selective oestrogen receptor modulator for the treatment of vaginal dryness associated with postmenopausal vulvar and vaginal atrophy: A randomised, placebo-controlled, phase III trial D. Portmana,∗, S. Palaciosb, R.E. Nappic, A.O. Mueckd a Columbus Center for Women’s Health Research, Columbus, OH 43213, USA b ...


27 State Of West Virginia Department Of Health And …
STATE OF WEST VIRGINIA DEPARTMENT OF HEALTH AND HUMAN RESOURCES BUREAU FOR MEDICAL SERVICES Office of Pharmacy Service Prior Authorization Criteria Osphena ® (ospemifene) Prior Authorization Request Form Prior authorization requests for Osphena will be approved if the following criteria are met:


28 Speaker Program In Your Area The Role Of Osphena ...
Osphena® (ospemifene) is indicated for the treatment of moderate to severe dyspareunia, a symptom of vulvar and vaginal atrophy, due to menopause. Important Safety Information for Osphena WARNING: Endometrial Cancer and Cardiovascular Disorders Osphena is an estrogen agonist/antagonist with tissue selective eff ects. In the endometrium Osphena ...


29 Approved Prior Authorization Criteria Initial Approval ...
APPROVED Prior Authorization Criteria Page 1 of 1 Initial Approval: October 9, 2013 CRITERIA FOR PRIOR AUTHORIZATION Osphena® (ospemifene) PROVIDER GROUP Pharmacy MANUAL GUIDELINES The following drug requires prior authorization: Ospemifene (Osphena) CRITERIA FOR OSPHENA Must meet all of the following: Patient must have dyspareunia


30 Shionogi Enters Into License Agreement With Pharmbio …
Osphena® (ospemifene, 60 mg tablets) is the only oral selective estrogen receptor modulator (”SERM”) approved by FDA for the treatment of moderate to severe dyspareunia (painful intercourse), a symptom of VVA due to menopause and has been on the US market since June 2013.


31 Duchesnay Inc. Announces Submission Of Supplemental New ...
osphena.com. About Osphena® (ospemifene) Osphena® is the only FDA-approved oral pill for the treatment of moderate to severe dyspareunia (painful sex), a symptom of vulvar and vaginal atrophy (VVA), due to menopause. It is not an estrogen, but helps improve specific vaginal tissues* and relieves moderate to severe painful sex due to menopause ...


32 Duchesnay Expands Its Women’s Health Product Portfolio ...
Press Release . For Immediate Release . Duchesnay Expands its Women’s Health Product Portfolio with Acquisition of Osphena® from Shionogi Inc. . BLAINVILLE, QC (Canada) and OSAKA, Japan – March10th, 2017 – Duchesnay, a specialty pharma company with a long-standing commitment to women’s health, has acquired exclusive U.S. and Canadian


33 Contains Confidential Patient Information Osphena ...
Osphena NTL PAB Fax Form 02.01.14.doc CONTAINS CONFIDENTIAL PATIENT INFORMATION Osphena (ospemifene) Prior Authorization of Benefits (PAB) Form . Complete form in its entirety and fax to: Prior Authorization of Benefits Center at (800) 601- 4829 . 1. PATIENT INFORMATION 2. PHYSICIAN INFORMATION Patient Name: _____


34 Speaker Program In Your Area Speaker Program In Your …
Indication Osphena® (ospemifene) is indicated for the treatment of moderate to severe dyspareunia, a symptom of vulvar and vaginal atrophy, due to menopause. Important Safety Information for Osphena WARNING: Endometrial Cancer and Cardiovascular Disorders


35 Ospemifene May Not Treat Vulvar Atrophy: A Report Of Two Cases
CASE REPORTS Ospemifene May Not Treat Vulvar Atrophy: A Report of Two Cases Andrew T. Goldstein, MD, and Michelle A. King, MSC ABSTRACT Introduction: Ospemifene (Osphena, Shionogi Inc, Florham, NJ ...


36 Shionogi Inc. Announces Co-promotion Agreement …
Osphena (ospemifene) is a non-estrogen oral pill for the treatment of moderate to severe dyspareunia (painful intercourse), a symptom of vulvar and vaginal atrophy (VVA), due to menopause. Osphena, as an estrogen agonist/antagonist with tissue selective effects, is the first


37 Research And Development At Shionogi
Ospemifene (OsphenaTM) S-297995/S-555739/ S-888711 . Basic strategy 1 Steady growth mainly through enriched pipeline Back to growth era Basic Strategy 3 Therapeutic areas to be focused on Peptide vaccines/ S-117957/S-649266 etc. Drug candidate selections Crestor cliff . Basic strategy 2 Investments in the new growth drivers 2


38 Duchesnay Expands Its Women’s Health Product …
DUCHESNAY EXPANDS ITS WOMEN’S HEALTH PRODUCT PORTFOLIO WITH ACQUISITION OF OSPHENA ® FROM SHIONOGI INC. BLAINVILLE, QC (Canada) and OSAKA, Japan, Mar. 10, 2017 – Duchesnay, a specialty pharma company with a long-standing commitment to women’s health, has acquired exclusive U.S. and Canadian rights to market and distribute Osphena ®


39 1 Patientswithriskfactorsforcardiovasculardisease,arterial ...
Name /bks_53161_deglins_md_disk/ospemifene 02/17/2014 08:29AM Plate # 0-Composite pg 1 # 1 PDF Page #1 Canadian drug name. Genetic Implication.


40 Duchesnay Inc. Is Seeking Health Canada's Approval For ...
with Health Canada on this new drug submission to ensure that Osphena® (ospemifene) will be available in Canada," said Michael Gallo, Vice-President of Regulatory and Medical Affairs at Duchesnay Inc. Duchesnay acquired the exclusive marketing and distribution rights for Osphena® in the United


41 10.19080/jgwh.2018.09.555762 Safety Of Ospemifene During ...
Safety of Ospemifene during Real-Life Use. J Gynecol Women’s Health 2018; 9(3): 555762. DOI: 10.19080/JGWH.2018.09.555762. 002 Journal of Gynecology and Women s Health name Osphena® [6]. On 15th January 2015, ospemifene 60 mg once daily was granted marketing authorisation by the European Commission for the use in the European Economic Area (EEA)


42 Acog Releases Clinical Guidelines On Management Of ...
Studies indicate that ospemifene (Osphena), which is FDA-approved for treating moderate to severe dyspareu-nia in postmenopausal women, improves vaginal atrophy without stimulating the endometrium ...


43 L’histoire D’osphena Et De La Dyspareunie
l’Osphena, la FDA fait état de trois essais contre placebo ; les deux premiers de douze semaines chacun, le troisième de cinquante-deux semaines (426 femmes de 49 à 79 ans – 363 sous Osphena, 63 sous placebo). Résultats satisfai-sants sur les symptômes de la dyspareunie. Pas d’événements indésirables de nature à ne pas


44 Shionogi Inc. Initiates Phase 3 Clinical Study Of Osphena ...
SHIONOGI INC. INITIATES PHASE 3 CLINICAL STUDY OF OSPHENA® FOR THE TREATMENT OF POSTMENOPAUSAL VAGINAL DRYNESS . Florham Park, N.J., (December 2, 2015) – Shionogi Inc. announced today the company has initiated a Phase 3 clinical trial to evaluate the safety and efficacy of Osphena® (ospemifene) for the treatment of moderate to severe vaginal dryness, a symptom of …


45 Postmenopausal Vaginal Atrophy - Global Drug …
Postmenopausal Vaginal Atrophy – Global Drug Forecast and Market Analysis to 2022 POSTMENOPAUSAL VAGINAL ATROPHY - GLOBAL DRUG FORECAST AND MARKET ANALYSIS


46 Shionogi Inc. Divests And Exclusively Licenses Its ...
pipeline.” Shionogi Inc. received FDA approval in February for Osphena™ (ospemifene), a first in class drug indicated for the treatment of moderate to severe dyspareunia (painful intercourse), a symptom of vulvar and vaginal atrophy (VVA), due to menopause. About Shionogi Inc.


47 Fda Approves Osphena For Postmenopausal Women Experiencing ...
Krankenpflege-Journal.com FDA approves Osphena for postmenopausal women experiencing pain during sex Silver Spring, MD, USA (February 26, 2013) - The U.S. Food and Drug Administration today approved Osphena (ospemifene) to treat women experiencing moderate to severe dyspareunia (pain during sexual intercourse), a symptom of vulvar and vaginal atrophy due to menopause.


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