which will [1%:1 blister package is dispensed) and to record the date the blister package is opened on the package label. 1 Do not use tablets if package is opened for >60 days. 1 Remove only 1 tablet from blister package at the time of use. 1 Do not place tablets in pill boxes or pill organizers; keep them in original package. 1 If a dose is missed, importance of advising patients to take it as soon as they remember. 1 Do not take the missed dose if it is almost time for the next scheduled dose. 1 Inform patients not to take 2 doses at the same time to make up for a missed dose. 1 Importance of advising patients to add supplemental calcium and/or vitamin D to the diet if daily intake is inadequate. 1 Importance of patients immediately reporting any signs or symptoms related to VTE to a clinician. 1 Importance of women reporting any unusual vaginal bleeding to a clinician as soon as possible. 1 Importance of informing women of possible serious adverse effects of estrogen therapy (e.g., cardiovascular disorders, malignant neoplasms, probable dementia). 1 Importance of informing women of possible less serious, but common adverse effects of bazedoxifene/conjugated estrogens in fixed combination (e.g., muscle spasms, nausea, diarrhea, dyspepsia, upper abdominal pain, throat pain, dizziness, neck pain). 1 Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses. 1 Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed. 1 (See Contraindications under Cautions.) Importance of informing patients of other important precautionary information. 1 (See Cautions.) Preparations Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details. Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations. Bazedoxifene Acetate Combinations Routes Dosage Forms Strengths Brand Names Manufacturer Oral Tablets 20 mg (of bazedoxifene) with Conjugated Estrogens 0.45 mg Duavee Pfizer AHFS DI Essentials. Copyright 2017, Selected Revisions February 19, 2016. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, Maryland 20814. Use is not currently included in the labeling approved by the US Food and Drug Administration. References 1. Pfizer Inc. Duavee (conjugated estrogens/bazedoxifene) tablets prescribing information. Philadelphia, PA; 2013 Oct. 2. US Food and Drug Administration. Center for Drug Evaluation and Research: Application number 022247Orig1s000: Summary review. 2013 Oct 2. From FDA website. Accessed 2015 Oct 1. 3. Lindsay R, Gallagher JC, Kagan R et al. Efficacy of tissue-selective estrogen complex of bazedoxifene/conjugated estrogens for osteoporosis prevention in at-risk postmenopausal women. Fertil Steril . 2009; 92:1045-52. [PubMed 19635616] 4. Pinkerton JV, Harvey JA, Lindsay R et al. Effects of bazedoxifene/conjugated estrogens on the endometrium and bone: a randomized trial. J Clin Endocrinol Metab . 2014; 99:E189-98. [PubMed 24438370] 5. Pinkerton JV, Utian WH, Constantine GD et al. Relief of vasomotor symptoms with the tissue-selective estrogen complex containing bazedoxifene/conjugated estrogens: a randomized, controlled trial. Menopause . 2009 Nov-Dec; 16:1116-24. 6. Lobo RA, Pinkerton JV, Gass ML et al. Evaluation of bazedoxifene/conjugated estrogens for the treatment of menopausal symptoms and effects on metabolic parameters and overall safety profile. Fertil Steril . 2009; 92:1025-38. [PubMed 19635615] 7. US Food and Drug Administration. Center for Drug Evaluation and Research. Application number 022247Orig1s000: Medical review. 2012 Sep 26. From FDA website. Accessed 2015 Oct 1. 8. Yu H, Racketa J, Chines AA et al. Hot flush symptom-free days with bazedoxifene/conjugated estrogens in postmenopausal women. Climacteric . 2013; 16:252-7. [PubMed 23035721] 9. Pickar JH, Yeh IT, Bachmann G et al. Endometrial effects of a tissue selective estrogen complex containing bazedoxifene/conjugated estrogens as a menopausal therapy. Fertil Steril . 2009; 92:1018-24. [PubMed 19635613] 10. Adami S, Palacios S, Rizzoli R et al. The efficacy and safety of bazedoxifene in postmenopausal women by baseline kidney function status. Climacteric . 2014; 17:273-84. [PubMed 23937421] 11. Komm BS, Kharode YP, Bodine PV et al. Bazedoxifene acetate: a selective estrogen receptor modulator with improved selectivity. Endocrinology . 2005; 146:3999-4008. [PubMed 15961563] 12. Ethun KF, Wood CE, Cline JM et al. Endometrial profile of bazedoxifene acetate alone and in combination with conjugated equine estrogens in a primate model. Menopause . 2013; 20:777-84. [PubMed 23793168] 13. Christiansen C, Chesnut CH, Adachi JD et al. Safety of bazedoxifene in a randomized, double-blind, placebo- and active-controlled Phase 3 study of postmenopausal women with osteoporosis. BMC Musculoskelet Disord . 2010; 11:130. [PubMed 20569451] 14. Silverman SL, Christiansen C, Genant HK et al. Efficacy of bazedoxifene in reducing new vertebral fracture risk in postmenopausal women with osteoporosis: results from a 3-year, randomized, placebo-, and active-controlled clinical trial. J Bone Miner Res . 2008; 23:1923-34. [PubMed 18665787] 15. Silverman SL, Chines AA, Kendler DL et al. Sustained efficacy and safety of bazedoxifene in preventing fractures in postmenopausal women with osteoporosis: results of a 5-year, randomized, placebo-controlled study. Osteoporos Int . 2012; 23:351-63. [PubMed 21779819] 16. de Villiers TJ, Chines AA, Palacios S et al. Safety and tolerability of bazedoxifene in postmenopausal women with osteoporosis: results of a 5-year, randomized, placebo-controlled phase 3 trial. Osteoporos Int . 2011; 22:567-76. [PubMed 20535606] 17. Palacios S, de Villiers TJ, Nardone Fde C et al. Assessment of the safety of long-term bazedoxifene treatment on the reproductive tract in postmenopausal women with osteoporosis: results of a 7-year, randomized, placebo-controlled, phase 3 study. Maturitas . 2013; 76:81-7. [PubMed 23871271] 18. Song Y, Santen RJ, Wang JP et al. Inhibitory effects of a bazedoxifene/conjugated equine estrogen combination on human breast cancer cells in vitro. Endocrinology . 2013; 154:656-65. [PubMed 23254198] 19. Pinkerton JV, Harvey JA, Pan K et al. Breast effects of bazedoxifene-conjugated estrogens: a randomized controlled trial. Obstet Gynecol . 2013; 121:959-68. [PubMed 23635731] 20. Lewis-Wambi JS, Kim H, Curpan R et al. The selective estrogen receptor modulator bazedoxifene inhibits hormone-independent breast cancer cell growth and down-regulates estrogen receptor α and cyclin D1. Mol Pharmacol . 2011; 80:610-20. [PubMed 21737572] 21. Mirkin S, Komm BS. Tissue-selective estrogen complexes for postmenopausal women. Maturitas . 2013; 76:213-20. [PubMed 23849704] 22. Romero IL, Lee W, Mitra AK et al. The effects of 17β-estradiol and a selective estrogen receptor modulator, bazedoxifene, on ovarian carcinogenesis. Gynecol Oncol . 2012; 124:134-41. [PubMed 21996264] 24. Gatti D, Rossini M, Sblendorio I et al. Pharmacokinetic evaluation of bazedoxifene for the treatment of osteoporosis. Expert Opin Drug Metab Toxicol . 2013; 9:883-92. [PubMed 23621618] 25. US Food and Drug Administration. Center for Drug Evaluation and Research. Application number 022247Orig1s000: Pharmacology review. 2012 Nov 20. From FDA website. Accessed 2015 Oct 1. 26. Komm BS, Mirkin S, Jenkins SN. Development of conjugated estrogens/bazedoxifene, the first tissue selective estrogen complex (TSEC) for management of menopausal hot flashes and postmenopausal bone loss. Steroids . 2014; 90:71-81. [PubMed 24929044] Next Interactions Print this page Add to My Med List More about bazedoxifene/conjugated estrogens Side Effects During Pregnancy Dosage Information Drug Interactions Support Group En Español 9 Reviews Add your own review/rating Drug class: sex hormone combinations Consumer resources Bazedoxifene and conjugated estrogens Estrogens (Conjugated/Equine) and Bazedoxifene Conjugated estrogens and bazedoxifene (Advanced Reading) Professional resources Bazedoxifene Acetate (AHFS Monograph) Estrogens (Conjugated/Equine) and Bazedoxifene (Wolters Kluwer) Other brands: Duavee Related treatment guides Hot Flashes Prevention of Osteoporosis Osteoporosis Postmenopausal Symptoms]} FEATURED: CAR-T Cell Therapy Overview Mechanism of Action KTE-C19 Studies KTE-C19 Cancer Targets Adverse Events Manufacturing Drug Status Rx Availability Prescription only X Pregnancy Category Not for use in pregnancy N/A CSA Schedule Not a controlled drug Approval History Drug history at FDA Drug Class Sex hormone combinations Related Drugs Postmenopausal Symptoms estradiol , Premarin , Estrace , Prempro , conjugated estrogens topical , More... 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tapering off Duavee (combination) due to
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