Duavee

— THERAPEUTIC CATEGORIES —
  • Bone disorders
  • Menopause and HRT

Duavee Generic Name & Formulations

General Description

Conjugated estrogens 0.45mg, bazedoxifene 20mg; tabs.

Pharmacological Class

Conjugated estrogens + estrogen agonist/antagonist.

How Supplied

Blisters—2 x 15

Manufacturer

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

See Literature

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

General Description

Conjugated estrogens 0.45mg, bazedoxifene 20mg; tabs.

Pharmacological Class

Conjugated estrogens + estrogen agonist/antagonist.

How Supplied

Blisters—2 x 15

Manufacturer

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

See Literature

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