Usual Adult Dose for Prevention of Osteoporosis

0.75 mg orally once a day for 25 days of a 31-day cycle per month

Comments:

• When estrogen is prescribed for women with a uterus, progestin should also be prescribed to reduce the risk of endometrial cancer.
• Use for the prevention of postmenopausal osteoporosis should only be considered for women at significant risk of osteoporosis and for whom non-estrogen medications are considered inappropriate.
• Mainstays of osteoporosis risk reduction including weight-bearing exercise and adequate calcium and vitamin D supplementation should be part of therapy.

Use: Prevention of postmenopausal osteoporosis.

Usual Adult Dose for Atrophic Vaginitis

0.75 mg to 6 mg orally once a day

Comments:

• When estrogen is prescribed for women with a uterus, progestin should also be prescribed to reduce the risk of endometrial cancer.
• Topical vaginal products should be considered if prescribing solely for the treatment of vulvar and vaginal atrophy.
• The lowest dose to control symptoms should be used; dose discontinuation or tapering should be made at 3 to 6 months intervals.

Uses: Treatment of moderate to severe vasomotor symptoms and vulval and vaginal atrophy associated with the menopause.

Usual Adult Dose for Postmenopausal Symptoms

0.75 mg to 6 mg orally once a day

Comments:

• When estrogen is prescribed for women with a uterus, progestin should also be prescribed to reduce the risk of endometrial cancer.
• Topical vaginal products should be considered if prescribing solely for the treatment of vulvar and vaginal atrophy.
• The lowest dose to control symptoms should be used; dose discontinuation or tapering should be made at 3 to 6 months intervals.

Uses: Treatment of moderate to severe vasomotor symptoms and vulval and vaginal atrophy associated with the menopause.

Usual Adult Dose for Hypoestrogenism

1.5 to 9 mg orally once a day for 21 days followed by a rest period of 8 to 10 days

Comments:

• Adjust dosage upward or downward according to severity of symptoms and response of the patient; maintenance dose should be adjusted to the minimum dose that will achieve the desired clinical effect.
• If bleeding does not occur by the end of the 21-day period, repeat same dose.
• The number of courses of estrogen therapy necessary to produce bleeding may vary depending on the responsiveness of the endometrium; if satisfactory withdrawal bleeding does not occur, an oral progestogen may be given in addition to estrogen during the third week of the cycle.

Use: Treatment of hypoestrogenism due to hypogonadism, castration or primary ovarian failure.

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Contraindicated

Precautions

US BOXED WARNINGS: ENDOMETRIAL CANCER, CARDIOVASCULAR AND OTHER RISKS:

• ENDOMETRIAL CANCER: Estrogens increase the risk of endometrial cancer. Close clinical surveillance of women taking estrogens is important. Adequate diagnostic measures, including endometrial sampling when indicated, should occur to rule out malignancy in all cases of undiagnosed persistent or recurrent abnormal vaginal bleeding. There is no evidence that the use of "natural" estrogens result in a different endometrial risk profile than "synthetic" estrogens at equivalent estrogen doses.
• CARDIOVASCULAR DISORDERS: Estrogen with or without progestins should not be used for prevention of cardiovascular disease. The Women's Health Initiative (WHI) study reported an increased risk of deep vein thrombosis (DVT), pulmonary embolism (PE), stroke, myocardial infarction (MI), and invasive breast cancer in postmenopausal women (50 to 79 years) during 5 years of treatment with oral conjugated estrogens (0.625 mg) relative to placebo.
• PROBABLE DEMENTIA: The WHI Memory Study (WHIMS), a substudy of WHI reported an increased risk of developing probable dementia in postmenopausal women 65 years or older during 4 years of treatment with conjugated estrogens plus medroxyprogesterone acetate relative to placebo. It is unknown whether this finding applies to younger postmenopausal women or women taking estrogen alone.
• Other doses of conjugated estrogens with medroxyprogesterone acetate, and other combinations and dosage forms of estrogens and progestins were not studied in the WHI clinical trials and, in the absence of comparable data, risks should be assumed to be similar; estrogens with or without progestins 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 or suspected pregnancy

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

• Take orally; postmenopausal women with an intact uterus should be prescribed progestin to reduce the risk of endometrial hyperplasia, which may be a precursor to endometrial cancer.

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 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.