Indication(s):

Treatment of moderate-to-severe vasomotor symptoms associated with menopause. Prevention of postmenopausal osteoporosis. Limitation of use: use for shortest duration consistent with treatment goals and risks.

Pharmacology:

Conjugated estrogens agonize estrogen α/β receptors. Bazedoxifene agonizes some estrogen-sensitive tissues and antagonizes others (eg, uterus). Bazedoxifene reduces the risk of endometrial hyperplasia that can occur with conjugated estrogens.

Clinical Trials:

The safety and efficacy of Duavee for moderate-to-severe vasomotor symptoms associated with menopause and the prevention of postmenopausal osteoporosis was eva luated in several Phase 3 clinical trials. Results from one trial demonstrated that Duavee significantly reduced the number of moderate-to-severe hot flashes by 74% at 12 weeks, as compared with placebo (47%). In addition, significant decreases in mean hot flash severity were seen at 12 weeks (39%), as compared with placebo (13%).

In other clinical trials, at years one and two, ­Duavee significantly increased bone mineral density in the total hip and lumbar spine from baseline vs. decreases seen with placebo.

For more clinical trial data, see full labeling.

Legal Classification:

Rx

Adults:

Swallow whole. 1 tablet daily. Postmenopausal osteoporosis: may supplement diet with calcium and/or Vitamin D, if inadequate.

Children:

Not applicable.

Contraindication(s):

Undiagnosed abnormal uterine bleeding. Known, suspected or history of breast cancer. Known or suspected estrogen-dependent neoplasia. Active DVT, PE or history of. Active arterial thromboembolic disease or history of. Hepatic impairment. Known protein C, protein S, or antithrombin deficiency, or other known thrombophilic disorders. Pregnancy (Category X). Women who may become pregnant. Nursing mothers.

Warnings/Precautions:

Not for prevention of cardiovascular disease. Increased risk of cardiovascular disorders (eg, stroke, DVT, VTE); discontinue if occurs or suspected. Discontinue at least 4–6 weeks before surgery type associated with increased risk of thromboembolism or during prolonged immobilization. Endometrial, breast, or ovarian cancer. Gallbladder disease. Visual abnormalities. Hypertriglyceridemia. Discontinue if cholestatic jaundice, pancreatitis, or retinal vascular lesions occur. Monitor thyroid function. Conditions aggravated by fluid retention. Renal impairment: not recommended. Hypoparathyroidism. Hereditary angioedema. ­Caution in asthma, diabetes, epilepsy, migraine, porphyria, SLE, and hepatic hemangiomas. Do initial complete physical and repeat yearly (include Pap smear, mammogram, BP). Premenopausal women or women >75 years of age: not recommended. Risk of probable dementia in women >65 years of age. Women with BMI >27kg/m²: increased risk of endometrial hyperplasia. Reeva luate ­periodically.

Interaction(s)

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, erythromycin, clarithromycin, ketoconazole, itraconazole, ritonavir, grapefruit juice). 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. Duavee may interfere with lab tests (eg, thyroid, PT, glucose tolerance, HDL/LDL, triglycerides, hormone concentrations, other binding proteins).

Adverse Reaction(s)

Muscle spasms, nausea, diarrhea, dyspepsia, upper abdominal pain, oropharyngeal pain, dizziness, neck pain.

How Supplied:

Blisters—2 × 15

LAST UPDATED:

3/10/2014