Usual Adult Dose for Postmenopausal Symptoms

1 capsule (estradiol 1 mg/progesterone 100 mg) orally once a day in the evening with food

Comments:

• Hormone replacement therapy should be limited to the shortest duration consistent with treatment goals and risks for the individual women.
• Reevaluate periodically to determine if treatment is still necessary.

Renal Dose Adjustments

No adjustment recommended

Liver Dose Adjustments

Hepatic impairment or disease: Use is Contraindicated

Precautions

US BOXED WARNINGS: CARDIOVASCULAR DISORDERS, PROBABLE DEMENTIA, BREAST CANCER, and ENDOMETRIAL CANCER:
Estrogen Plus Progestin Therapy:

• Cardiovascular Disorders and Probable Dementia: The Women's Health Initiative (WHI) estrogen plus progestin substudy reported increased risks of deep vein thrombosis (DVT), pulmonary embolism (PE), stroke, and myocardial infarction (MI) in postmenopausal women (50 to 79 years of age) during 5.6 years of treatment with daily oral conjugated estrogens 0.625 mg combined with medroxyprogesterone acetate 2.5 mg, relative to placebo. The WHI Memory Study (WHIMS) estrogen plus progestin ancillary study of WHI reported an increased risk of developing probable dementia in postmenopausal women 65 years of age or older during 4 years of treatment with daily conjugated estrogens 0.625 mg combined with medroxyprogesterone acetate 2.5 mg, relative to placebo. It is unknown whether this finding applies to younger postmenopausal women. Do not use estrogen plus progestin therapy for the prevention of cardiovascular disease or dementia.
• Breast Cancer: The WHI estrogen plus progestin substudy demonstrated an increased risk of invasive breast cancer.
• Only daily oral 0.625 mg conjugated estrogen and 2.5 mg medroxyprogesterone were studied in the estrogen plus progestin substudy of the WHI. Therefore, the relevance of the WHI findings regarding adverse cardiovascular events, dementia, and breast cancer to lower doses, other routes of administration, or other estrogen plus progestogen products is not known. Without such data, it is not possible to definitively exclude these risks or determine the extent of these risks for other products. The benefits and risks of estrogen plus progestogen therapy should be discussed, considering the individual risk profile.

• Endometrial Cancer There is an increased risk of endometrial cancer in a woman with a uterus who use unopposed estrogens. Adding a progestin to estrogen therapy has been shown to reduce the risk of endometrial hyperplasia, which may be a precursor to endometrial cancer. Perform adequate diagnostic measures, including directed or random endometrial sampling when indicated, to rule out malignancy in postmenopausal women with undiagnosed persistent or recurring abnormal genital bleeding.
• Cardiovascular Disorders and Probable Dementia: The WHI estrogen-alone substudy reported increased risks of stroke and DVT in postmenopausal women (50 to 79 years of age) during 7.1 years of treatment with daily oral conjugated estrogen 0.625 mg alone, relative to placebo. The WHIMS estrogen-alone ancillary study of WHI reported an increased risk of developing probable dementia in postmenopausal women 65 years of age or older during 5.2 years of treatment with daily conjugated estrogen alone, relative to placebo. It is unknown whether this finding applies to younger postmenopausal women. Do not use estrogen-alone therapy for the prevention of cardiovascular disease or dementia.
• Only daily oral 0.625 mg conjugated estrogen was studied in the estrogen-alone substudy of the WHI. Therefore, the relevance of the WHI findings regarding adverse cardiovascular events and dementia to lower doses, other routes of administration, or other estrogen-alone products is not known. Without such data, it is not possible to definitively exclude these risks or determine the extent of these risks for other products. Without such data, it is not possible to definitively exclude these risks or determine the extent of these risks for other products. The benefits and risks of estrogen plus progestogen therapy should be discussed, considering the individual risk profile.
• Prescribe estrogens with or without progestogens at the lowest effective doses and for the shortest duration consistent with treatment goals and risks for the individual woman.

• Undiagnosed abnormal genital bleeding
• Breast cancer, or a history of breast cancer
• Estrogen-dependent neoplasia
• Active DVT, PE, or a history of DVT or PE
• Active arterial thromboembolic disease (e.g., stroke, MI) or a history of these conditions
• Known anaphylactic reaction, angioedema, or hypersensitivity to active substance or any product ingredients
• Hepatic impairment or disease
• Protein C, protein S, or antithrombin deficiency, or other known thrombophilic disorders

Dialysis

Data not available

Other Comments

Administration advice:

• Take orally once a day in the evening with food

• Due to risks of cardiovascular disorders, breast cancer, endometrial cancer, and probable dementia, estrogens with or without progestins should be prescribed at the lowest effective dose and for the shortest duration consistent with treatment goals and risks for the individual woman.
• The WHI and WHIM studies used daily oral doses of conjugated estrogen 0.625 mg and medroxyprogesterone 2.5 mg; the relevance of these studies regarding adverse cardiovascular events, dementia and breast cancer to lower conjugated estrogen plus other medroxyprogesterone doses, other routes of administration, or other estrogen plus progestogen products is not known.

• Monitor thyroid function in women on thyroid hormone replacement therapy
• Monitor for fluid retention, especially in women with a condition that might predispose her to fluid retention, such as cardiac or renal impairment

• Advice patients to read the US FDA-approved patient labeling (Patient Information).
• Women should be instructed to report abnormal vaginal bleeding to their healthcare provider as soon as possible.
• Women should understand the serious risks of therapy including cardiovascular disorders, malignant neoplasms, and dementia.

Frequently asked questions

• Does Bijuva contain bio-identical hormones?