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Duavee Generic Name & Formulations
Legal Class
Rx
General Description
Conjugated estrogens 0.45mg, bazedoxifene 20mg; tabs.
Pharmacological Class
Conjugated estrogens + estrogen agonist/antagonist.
How Supplied
Blisters—2 x 15
Manufacturer
Mechanism of Action
Conjugated estrogens and bazedoxifene function by binding to and activating estrogen receptors (ER) α and β, which vary in proportion from tissue to tissue. Conjugated estrogens are composed of multiple estrogens and are agonists of ER- α and β.
Bazedoxifene is an estrogen agonist/antagonist that acts as an agonist in some estrogen-sensitive tissues and an antagonist in others (eg, uterus). The pairing of conjugated estrogens with bazedoxifene produces a composite effect that is specific to each target tissue. The bazedoxifene component reduces the risk of endometrial hyperplasia that can occur with the conjugated estrogens component.
Duavee Indications
Indications
Prevention of postmenopausal osteoporosis.
Duavee Dosage and Administration
Adult
Swallow whole. 1 tab once daily. May supplement diet with calcium and/or Vit. D, if inadequate.
Children
Not applicable.
Duavee Contraindications
Contraindications
Undiagnosed abnormal uterine bleeding. Breast or other estrogen-dependent neoplasms. Thromboembolic disorders (eg, DVT, PE, stroke, MI). Protein C, protein S, or antithrombin deficiency, or other thrombophilias. Hepatic impairment or disease. Pregnancy.
Duavee Boxed Warnings
Boxed Warning
Endometrial cancer. Cardiovascular disorders. Probable dementia.
Duavee Warnings/Precautions
Warnings/Precautions
Increased risk of endometrial carcinoma or hyperplasia in women with intact uterus (adding progestin is essential). Not for prevention of cardiovascular disease or dementia. Increased risk of cardiovascular events (eg, MI, stroke, VTE); discontinue if occurs. Manage risk factors for cardiovascular disease and venous thromboembolism appropriately. Discontinue at least 4–6 weeks before surgery type associated with increased risk of thromboembolism or during prolonged immobilization. Increased risk of breast or ovarian cancer. Risk of probable dementia in women >65yrs of age. Gallbladder disease. Visual abnormalities. History of hypertriglyceridemia. Discontinue if cholestatic jaundice, pancreatitis, or retinal vascular lesions occur. Monitor thyroid function. Conditions aggravated by fluid retention. Hypoparathyroidism. Endometriosis. Hereditary angioedema. Asthma. Diabetes. Epilepsy. Migraine. Porphyria. SLE. Hepatic hemangiomas. Renal impairment: not recommended. Premenopausal women or women >75 years of age: not recommended. Obese women (BMI ≥30). Do initial complete physical and repeat annually (include Pap smear, mammogram, and BP). Reevaluate periodically. Nursing mothers: not applicable.
Duavee Pharmacokinetics
Absorption
Absolute bioavailability: ~6%.
Distribution
Volume of distribution: 14.7 ± 3.9 L/kg. 98–99% serum protein bound (bazedoxifene).
Elimination
Renal (conjugated estrogens), fecal (bazedoxifene). Half-life: ~17 hours (conjugated estrogens); ~30 hour (bazedoxifene).
Duavee Interactions
Interactions
Avoid concomitant progestins, additional estrogens, or estrogen agonist/antagonists. Antagonized by CYP3A4 inducers (eg, phenobarbital, carbamazepine, rifampin, St. John’s Wort). Potentiated by CYP3A4 inhibitors (eg, itraconazole). Concomitant thyroid replacement; may need to increase thyroid dose. Bazedoxifene: may be antagonized by UGT inducers (eg, rifampin, phenobarbital, carbamazepine, phenytoin). May affect or be affected by ibuprofen, atorvastatin, azithromycin, aluminum and magnesium hydroxide. May interfere with lab tests (eg, thyroid, PT, coagulation factors, glucose tolerance, HDL/LDL, triglycerides, hormone concentrations, other binding or plasma proteins).
Duavee Adverse Reactions
Adverse Reactions
Muscle spasms, nausea, diarrhea, dyspepsia, upper abdominal pain, oropharyngeal pain, dizziness, neck pain; thromboembolism, neoplasms.
Duavee Clinical Trials
See Literature
Duavee Note
Not Applicable
Duavee Patient Counseling
See Literature
Duavee Generic Name & Formulations
Legal Class
Rx
General Description
Conjugated estrogens 0.45mg, bazedoxifene 20mg; tabs.
Pharmacological Class
Conjugated estrogens + estrogen agonist/antagonist.
How Supplied
Blisters—2 x 15
Manufacturer
Mechanism of Action
Conjugated estrogens and bazedoxifene function by binding to and activating estrogen receptors (ER) α and β, which vary in proportion from tissue to tissue. Conjugated estrogens are composed of multiple estrogens and are agonists of ER- α and β.
Bazedoxifene is an estrogen agonist/antagonist that acts as an agonist in some estrogen-sensitive tissues and an antagonist in others (eg, uterus). The pairing of conjugated estrogens with bazedoxifene produces a composite effect that is specific to each target tissue. The bazedoxifene component reduces the risk of endometrial hyperplasia that can occur with the conjugated estrogens component.
Duavee Indications
Indications
Moderate to severe vasomotor symptoms of menopause. Limitation of use: use for shortest duration consistent with treatment goals and risks.
Duavee Dosage and Administration
Adult
Swallow whole. 1 tab once daily.
Children
Not applicable.
Duavee Contraindications
Contraindications
Undiagnosed abnormal uterine bleeding. Breast or other estrogen-dependent neoplasms. Thromboembolic disorders (eg, DVT, PE, stroke, MI). Protein C, protein S, or antithrombin deficiency, or other thrombophilias. Hepatic impairment or disease. Pregnancy.
Duavee Boxed Warnings
Boxed Warning
Endometrial cancer. Cardiovascular disorders. Probable dementia.
Duavee Warnings/Precautions
Warnings/Precautions
Increased risk of endometrial carcinoma or hyperplasia in women with intact uterus (adding progestin is essential). Not for prevention of cardiovascular disease or dementia. Increased risk of cardiovascular events (eg, MI, stroke, VTE); discontinue if occurs. Manage risk factors for cardiovascular disease and venous thromboembolism appropriately. Discontinue at least 4–6 weeks before surgery type associated with increased risk of thromboembolism or during prolonged immobilization. Increased risk of breast or ovarian cancer. Risk of probable dementia in women >65yrs of age. Gallbladder disease. Visual abnormalities. History of hypertriglyceridemia. Discontinue if cholestatic jaundice, pancreatitis, or retinal vascular lesions occur. Monitor thyroid function. Conditions aggravated by fluid retention. Hypoparathyroidism. Endometriosis. Hereditary angioedema. Asthma. Diabetes. Epilepsy. Migraine. Porphyria. SLE. Hepatic hemangiomas. Renal impairment: not recommended. Premenopausal women or women >75 years of age: not recommended. Obese women (BMI ≥30). Do initial complete physical and repeat annually (include Pap smear, mammogram, and BP). Reevaluate periodically. Nursing mothers: not applicable.
Duavee Pharmacokinetics
Absorption
Absolute bioavailability: ~6%.
Distribution
Volume of distribution: 14.7 ± 3.9 L/kg. 98–99% serum protein bound (bazedoxifene).
Elimination
Renal (conjugated estrogens), fecal (bazedoxifene). Half-life: ~17 hours (conjugated estrogens); ~30 hour (bazedoxifene).
Duavee Interactions
Interactions
Avoid concomitant progestins, additional estrogens, or estrogen agonist/antagonists. Antagonized by CYP3A4 inducers (eg, phenobarbital, carbamazepine, rifampin, St. John’s Wort). Potentiated by CYP3A4 inhibitors (eg, itraconazole). Concomitant thyroid replacement; may need to increase thyroid dose. Bazedoxifene: may be antagonized by UGT inducers (eg, rifampin, phenobarbital, carbamazepine, phenytoin). May affect or be affected by ibuprofen, atorvastatin, azithromycin, aluminum and magnesium hydroxide. May interfere with lab tests (eg, thyroid, PT, coagulation factors, glucose tolerance, HDL/LDL, triglycerides, hormone concentrations, other binding or plasma proteins).
Duavee Adverse Reactions
Adverse Reactions
Muscle spasms, nausea, diarrhea, dyspepsia, upper abdominal pain, oropharyngeal pain, dizziness, neck pain; thromboembolism, neoplasms.
Duavee Clinical Trials
See Literature
Duavee Note
Not Applicable
Duavee Patient Counseling
See Literature
