Bazedoxifene
Class: Estrogen Agonists-Antagonists
Chemical Name: 1-[[4-[2-(Hexahydro-1H-azepin-1-yl)ethoxy]phenyl]methyl]-2-(4-hydroxyphenyl)-3-methyl-1H-indol-5-ol monoacetate (salt)
Molecular Formula: C30H34N2O3 • C2H4O2
CAS Number: 198481-33-3
Brands: Duavee (combination)
Warning
Do not use bazedoxifene/conjugated estrogens in fixed combination with additional estrogens.
Increased risk of endometrial cancer in postmenopausal women with an intact uterus who use estrogens alone. Bazedoxifene/conjugated estrogens in fixed combination shown to reduce risk of endometrial hyperplasia. (See GU Effects under Cautions.)
Increased risk of stroke and DVT observed in postmenopausal women receiving daily dosages of oral conjugated estrogens alone as part of Women's Health Initiative (WHI). (See Contraindications and Cardiovascular Effects under Cautions.)
Increased risk of probable dementia observed in postmenopausal women ≥65 years of age receiving daily dosages of oral conjugated estrogens alone as part of WHI Memory Study.
Do not use estrogens for prevention of cardiovascular disease or dementia.
Prescribe for shortest duration consistent with treatment goals and risks for the individual woman.
Introduction
Tissue-selective, estrogen agonist-antagonist.
Uses for Bazedoxifene
Osteoporosis
Bazedoxifene/conjugated estrogens in fixed combination: Prevention of osteoporosis in postmenopausal women with an intact uterus.
Not FDA-labeled for treatment† of osteoporosis in postmenopausal women in the US. Bazedoxifene commercially available in other countries for this use.
Not recommended for prevention of osteoporosis in premenopausal women†; safety and efficacy not established.
Vasomotor Symptoms
Bazedoxifene/conjugated estrogens in fixed combination: Management of moderate to severe vasomotor symptoms associated with menopause in women with an intact uterus.
Bazedoxifene Dosage and Administration
General
Use for shortest duration consistent with treatment goals and risks for the individual woman. Reevaluate patients periodically to determine if continued treatment is necessary.
When used for prevention of osteoporosis, use supplemental calcium and/or vitamin D concomitantly if daily dietary intake is considered inadequate.
Administration
Oral Administration
Administer orally without regard to meals.
Swallow tablets whole.
Dosage
Available as bazedoxifene acetate; dosage expressed in terms of bazedoxifene.
Each tablet of bazedoxifene/conjugated estrogens in fixed combination contains bazedoxifene 20 mg and conjugated estrogens 0.45 mg.
Adults
Osteoporosis
Prevention in Postmenopausal Women
OralBazedoxifene 20 mg in fixed combination with conjug.
