Estrogen Derivative; Selective Estrogen Receptor Modulator (SERM); Tissue-Selective Estrogen Complex (TSEC)
“ALERT: US Boxed Warning
There is an increased risk of endometrial cancer in a woman with a uterus who uses unopposed estrogens. Conjugated estrogens/bazedoxifene has been shown to reduce the risk of endometrial hyperplasia, which may be a precursor to endometrial cancer. Perform adequate diagnostic measures, including directed or random endometrial sampling when indicated, to rule out malignancy in postmenopausal women with undiagnosed persistent or recurring abnormal genital bleeding.
Do not use estrogen therapy for the prevention of cardiovascular disease.
The Women’s Health Initiative (WHI) estrogen-alone substudy reported increased risks of stroke and deep vein thrombosis (DVT) in postmenopausal women (50 to 79 years of age) during 7.1 years of treatment with daily oral conjugated estrogens (0.625 mg) alone, relative to placebo.
Do not use estrogen therapy for the prevention of dementia. The WHI Memory Study (WHIMS) estrogen-alone ancillary study of WHI reported an increased risk of probable dementia in postmenopausal women 65 years and older during 5.2 years of treatment with daily conjugated estrogens (0.625 mg) alone, relative to placebo. It is unknown whether this finding applies to younger postmenopausal women.
Risk vs benefit:
Women taking conjugated estrogens/bazedoxifene should not take additional estrogens. In the absence of comparable data, these risks should be assumed to be similar for other doses of conjugated estrogens and other dosage forms of estrogens. Estrogens should be prescribed at the lowest effective doses and for the shortest duration consistent with treatment goals and risks for the individual woman.”
CSA NA – FDA Approved – REMS (N) – Can Ship
How Does It Work
Conjugated estrogens contain a mixture of estrogens and as a group act as an estrogen agonists. Estrogen is a steroid hormone that supports the development and function of the female reproductive system, secondary sex characteristics and urogenital structures. Estradiol is the principal female estrogen and inhibits the pituitary release of follicle-stimulating hormone (FSH) and luteinizing hormone (LH) thereby inhibiting ovulation through a negative feedback system.
Bazedoxifene is a selective estrogen receptor modulator (SERM) that acts as a partial estrogen receptor agonist and helps maintain bone mineral density while at the same time acting as an estrogen receptor antagonist in breast tissue and the uterus.
Indications For Use
Bazedoxifene+Conjugated Equine Estrogens, Duavive/Duavee is officially indicated for vasomotor symptoms associated with menopause and osteoporosis prevention in women with a uterus.
Do not use in women with an increased risk of invasive breast cancer
Do not use in women to prevent or treat dementia
Do not use unopposed estrogen in women with a uterus
Do not use in women with endometriosis
Use with caution in women with pre-existing hypertriglyceridemia
Use with caution in women with ovarian cancer
Use with caution in women with retinal vascular thrombosis
Use with caution in asthma, carbohydrate intolerance, cardiovascular disease, fluid retention, hepatic dysfunction, hypoparathyroidism, migraines, porphyria, and system lupus erythematosus
Vasomotor symptoms: Take one tablet daily.
Osteoporosis prevention: Take one tablet daily.
Pharmacist Tips On Using
How to Take: You can take tablets with food or after a meal to reduce nausea. Take the medication exactly as prescribed by your doctor at the same time each day. If you miss a dose, make sure to take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and continue with your regular schedule. Bleeding may occur if you miss several doses in a row.
Contact Your Doctor if You Ever Experience: If you experience a sudden, intense, severe headache or chest pain; sudden loss of coordination; sudden loss of vision or speech disturbances; chest or calf pain; weakness in the extremities; sudden shortness of breath of pain with breathing (may indicate thromboembolic disorder); persistent or recurrent vaginal bleeding (may indicate endometrial cancer); edema; abdominal pain or jaundice (may indicate hepatitis or gallbladder disease).
The frequency of side effects is not well defined and some of the adverse reactions are dependent on the dosage form and combination therapy used:
1 to 10%
Central Nervous System: Dizziness (5%)
Gastrointestinal: Diarrhea (8%), nausea (8%), dyspepsia (7%), upper abdominal pain (7%)
Neuromuscular and Skeletal: Muscle spasm (9%), neck pain (5%)
Respiratory: Oropharyngeal pain (7%)