Delestrogen® (Estradiol Valerate)

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Delestrogen® (estradiol valerate) – Drug Shortage • The drug shortage of Par’s Delestrogen (estradiol valerate) and Perrigo’s generic estradiol valerate injection products are ongoing. Both products have been unavailable for at least 90 days. — Estimated availability of Delestrogen is the first quarter of 2017. — Estimated availability of generic estradiol valerate 20 mg/mL injection is early November 2016. Estimated availability of estradiol valerate 40 mg/mL injection is mid-November 2016. • Delestrogen is indicated for the following: — Treatment of moderate to severe vasomotor symptoms associated with the menopause. — Treatment of moderate to severe symptoms of vulvar and vaginal atrophy associated with the menopause. When prescribing solely for the treatment of symptoms of vulvar and vaginal atrophy, topical vaginal products should be considered. — Treatment of hypoestrogenism due to hypogonadism, castration or primary ovarian failure. — Treatment of advanced androgen-dependent carcinoma of the prostate (for palliation only). Manufacturer Product Description Strength NDC# 10 mg/mL (5 mL); 42023-110-01; Delestrogen (estradiol valerate) 20 mg/mL (5 mL); Par 42023-111-01; injection 40 mg/mL (5 mL) 42023-112-01 multiple dose vials 20 mg/mL (5 mL); 0574-0870-05; Perrigo Estradiol valerate injection 40 mg/mL (5 mL) 0574-0872-05 multiple dose vials Action Plan • Information about the long-term drug shortage of Delestrogen and estradiol valerate injection will be communicated with clients. Formulary changes may be made, as appropriate. • Information regarding Delestrogen and estradiol valerate injection will be posted on the optumrx.com portals. optumrx.com OptumRx® specializes in the delivery, clinical management and affordability of prescription medications and consumer health products. We are an Optum® company — a leading provider of integrated health services. Learn more at optum.com. All Optum® trademarks and logos are owned by Optum, Inc. All other brand or product names are trademarks or registered marks of their respective owners. This document contains information that is considered proprietary to OptumRx and should not be reproduced without the express written consent of OptumRx. Rx News® is published by the OptumRx Clinical Services Department. ©2016 Optum, Inc. All rights reserved. .

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Europäisches Patentamt *EP001522306A1* (19) European Patent Office Office européen des brevets (11) EP 1 522 306 A1 (12) EUROPEAN PATENT APPLICATION (43) Date of publication: (51) Int Cl.7: A61K 31/567, A61K 31/565, 13.04.2005 Bulletin 2005/15 A61P 15/12 (21) Application number: 03103726.0 (22) Date of filing: 08.10.2003 (84) Designated Contracting States: • Perez, Francisco AT BE BG CH CY CZ DE DK EE ES FI FR GB GR 08970 Sant Joan Despi (Barcelona) (ES) HU IE IT LI LU MC NL PT RO SE SI SK TR • Banado M., Carlos Designated Extension States: 28033 Madrid (ES) AL LT LV MK (74) Representative: Markvardsen, Peter et al (71) Applicant: Liconsa, Liberacion Controlada de Markvardsen Patents, Sustancias Activas, S.A. Patent Department, 08028 Barcelona (ES) P.O. Box 114, Favrholmvaenget 40 (72) Inventors: 3400 Hilleroed (DK) • Palacios, Santiago 28001 Madrid (ES) (54) A pharmaceutical product for hormone replacement therapy comprising tibolone or a derivative thereof and estradiol or a derivative thereof (57) A pharmaceutical product comprising an effec- arate or sequential use in a method for hormone re- tive amount of tibolone or derivative thereof, an effective placement therapy or prevention of hypoestrogenism amount of estradiol or derivative thereof and a pharma- associated clinical symptoms in a human person, in par- ceutically acceptable carrier, wherein the product is pro- ticular wherein the human is a postmenopausal woman. vided as a combined preparation for simultaneous, sep- EP 1 522 306 A1 Printed by Jouve, 75001 PARIS (FR) 1 EP 1 522 306 A1 2 Description [0008] The review article of Journal of Steroid Bio- chemistry and Molecular Biology (2001), 76(1-5), FIELD OF THE INVENTION: 231-238 provides a review of some of these compara- tive studies.
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Original Article Obstet Gynecol Sci 2016;59(1):32-38 http://dx.doi.org/10.5468/ogs.2016.59.1.32 pISSN 2287-8572 · eISSN 2287-8580 Effects of different add-back regimens on hypoestrogenic problems by postoperative gonadotropin-releasing hormone agonist treatment in endometriosis Dong-Yun Lee, Hyang Gi Park, Byung-Koo Yoon, DooSeok Choi Department of Obstetrics and Gynecology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea Objective To compare the efficacy of different add-back regimens on hypoestrogenic symptoms during postoperative gonadotropin-releasing hormone (GnRH) agonist treatment in endometriosis patients. Methods This prospective cohort study included reproductive-aged women who underwent conservative laparoscopic surgery for ovarian endometriosis and received add-back therapy during a 6-month course of GnRH agonist therapy after surgery. Participants received one of four different add-back regimens: 1 mg of estradiol valerate, 2.5 mg of tibolone, or a combination of 1 mg of estradiol and 2 mg of drospirenone or 0.5 mg of norethisterone acetate. Changes in quality of life, hypoestrogenic symptoms, and bone mineral density were compared according to add-back regimens. Results A total of 57 participants completed a 6-month course of GnRH agonist and add-back therapy. All components of quality of life did not differ across groups. However, within the same treatment group, social relationship factors decreased significantly with estradiol valerate and tibolone alone, and environmental factors decreased significantly with estradiol valerate alone. Menopausal Rating Scale score did not change significantly, but the incidence of hot flushes significantly decreased with a combination of estradiol and norethisterone acetate.
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