Usual Adult Dose for Postmenopausal Symptoms

Conjugated estrogens 0.45 mg/bazedoxifene 20 mg orally once a day

Comments:

• The duration of therapy should be for the shortest duration consistent with treatment goals and risks for the individual patient. Patients should be re-evaluated periodically as clinically appropriate to determine if treatment is still needed.
• When prescribing solely for the prevention of postmenopausal osteoporosis, therapy should only be considered in women at significant risk of osteoporosis; non-estrogen therapy should be carefully considered.
• When use is for the prevention of postmenopausal osteoporosis, women whose calcium and/or vitamin D intake is inadequate should add calcium and vitamin D supplementation to their diet.

Uses: Treatment of moderate to severe vasomotor symptoms associated with menopause and prevention of postmenopausal osteoporosis.

Usual Adult Dose for Prevention of Osteoporosis

Conjugated estrogens 0.45 mg/bazedoxifene 20 mg orally once a day

Comments:

• The duration of therapy should be for the shortest duration consistent with treatment goals and risks for the individual patient. Patients should be re-evaluated periodically as clinically appropriate to determine if treatment is still needed.
• When prescribing solely for the prevention of postmenopausal osteoporosis, therapy should only be considered in women at significant risk of osteoporosis; non-estrogen therapy should be carefully considered.
• When use is for the prevention of postmenopausal osteoporosis, women whose calcium and/or vitamin D intake is inadequate should add calcium and vitamin D supplementation to their diet.

Uses: Treatment of moderate to severe vasomotor symptoms associated with menopause and prevention of postmenopausal osteoporosis.

Usual Geriatric Dose for Postmenopausal Symptoms

65 to less than 75 years:
Conjugated estrogens 0.45 mg/bazedoxifene 20 mg orally once a day

75 years or older: Not Recommended

Comments:

• The duration of therapy should be for the shortest duration consistent with treatment goals and risks for the individual patient. Patients should be re-evaluated periodically as clinically appropriate to determine if treatment is still needed.
• When prescribing solely for the prevention of postmenopausal osteoporosis, therapy should only be considered in women at significant risk of osteoporosis; non-estrogen therapy should be carefully considered.
• When use is for the prevention of postmenopausal osteoporosis, women whose calcium and/or vitamin D intake is inadequate should add calcium and vitamin D supplementation to their diet.

Uses: Treatment of moderate to severe vasomotor symptoms associated with menopause and prevention of postmenopausal osteoporosis.

Usual Geriatric Dose for Prevention of Osteoporosis

65 to less than 75 years:
Conjugated estrogens 0.45 mg/bazedoxifene 20 mg orally once a day

75 years or older: Not Recommended

Comments:

• The duration of therapy should be for the shortest duration consistent with treatment goals and risks for the individual patient. Patients should be re-evaluated periodically as clinically appropriate to determine if treatment is still needed.
• When prescribing solely for the prevention of postmenopausal osteoporosis, therapy should only be considered in women at significant risk of osteoporosis; non-estrogen therapy should be carefully considered.
• When use is for the prevention of postmenopausal osteoporosis, women whose calcium and/or vitamin D intake is inadequate should add calcium and vitamin D supplementation to their diet.

Uses: Treatment of moderate to severe vasomotor symptoms associated with menopause and prevention of postmenopausal osteoporosis.

Renal Dose Adjustments

Not recommended

Liver Dose Adjustments

Contraindicated

Precautions

US BOXED WARNINGS: ENDOMETRIAL CANCER, CARDIOVASCULAR DISORDERS, AND PROBABLE DEMENTIA:

• Women taking this combination drug should not take additional estrogen.
• ENDOMETRIAL CANCER: There is an increased risk of endometrial cancer in a woman with a uterus who uses unopposed estrogens. This drug has been shown to reduce the risk of endometrial hyperplasia, which may be a precursor to endometrial cancer. Adequate diagnostic measures, including directed or random endometrial sampling when indicated, should be undertaken to rule out malignancy in postmenopausal women with undiagnosed persistent or recurring abnormal genital bleeding.
• CARDIOVASCULAR DISORDERS: 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; Estrogen therapy should not be used for prevention of cardiovascular disease.
• PROBABLE DEMENTIA: The WHI Memory Study (WHIMS) estrogen-alone ancillary study of WHI reported an increased risk of probable dementia in postmenopausal women 65 years of age 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. Estrogen therapy should not be used for prevention of dementia.
• 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.

CONTRAINDICATIONS:

• Undiagnosed abnormal uterine bleeding
• Known, suspected or history of breast cancer
• Known or suspected estrogen-dependent neoplasia
• Active deep vein thrombosis, pulmonary embolism, or history of these conditions
• Active arterial thromboembolic disease (e.g., stroke, myocardial infarction) or a history of these conditions
• Hypersensitivity (e.g., anaphylactic reaction or angioedema) to estrogens, bazedoxifene or any product ingredients
• Known liver impairment or disease
• Known protein C, protein S or antithrombin deficiency or other known thrombophilic disorders
• Known or suspected pregnancy
• Nursing mothers

Safety and efficacy have not been established in premenopausal women or women greater than 75 years.

Consult WARNINGS section for dosing related precautions.

Dialysis

Data not available

Other Comments

Administration advice:

• May take without regard to meals
• Swallow tablets whole

Missed Dose: If a dose is missed, it should be taken as soon as remembered, but two doses should not be taken at the same time

Storage requirements:

• Tablets should not be removed from blisters
• After opening foil pouch, product must be used within 60 days

General:

• When prescribed for the prevention of postmenopausal osteoporosis, therapy should only be considered for women at significant risk of osteoporosis and non-estrogen medication should be considered.
• When prescribed for the prevention of postmenopausal osteoporosis, supplemental calcium and/or vitamin D should be added if daily intake is inadequate.

Monitoring: Thyroid function in women on thyroid replacement

Patient advice:

• Patients should be instructed to read US FDA-approved patient labeling (Patient Information).
• Patients should understand that they should not take additional estrogen products while taking this drug.
• Patients should be instructed not to place tablets in pill boxes or pill organizers; they should record date that the blister package is opened in the space provided on the package and use within 2 months.
• Patients should be instructed to report any unusual vaginal bleeding or signs or symptoms related to venous thrombosis or thromboembolic events to their health care provider promptly.
• Patients should be instructed to get their daily recommended amount of calcium and vitamin D.