Menopause and HRT:

Indications for BIJUVA:

Moderate to severe vasomotor symptoms due to menopause in women with a uterus.

Adult:

Use lowest effective dose and for the shortest duration. Take with food. 1 cap daily in the evening.

Children:

Not indicated.

Contraindications:

Undiagnosed abnormal genital bleeding. Breast or other estrogen-dependent neoplasms. Active DVT, PE, or history of. Active arterial thromboembolic disease, or history of. Known hepatic impairment or disease. Known protein C, protein S, or antithrombin deficiency, or other known thrombophilic disorders.

Boxed Warning:

Cardiovascular disorders. Breast cancer. Endometrial cancer. Probable dementia.

Warnings/Precautions:

Not for prevention of cardiovascular disease or dementia. Increased risk of cardiovascular events (eg, MI, stroke, VTE); discontinue if occurs or suspected. Manage risk factors for cardiovascular disease and/or 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 endometrial cancer in women with intact uterus (adding progestins has been shown to reduce endometrial hyperplasia risk). Breast or ovarian cancer. Risk of probable dementia in women ≥65yrs of age. Gallbladder disease. Severe hypercalcemia in breast cancer or bone metastases. Visual abnormalities. History of hypertriglyceridemia. Discontinue if cholestatic jaundice, pancreatitis, hypercalcemia, papilledema, 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. Perform yearly breast exams (including mammography). Reevaluate periodically. Elderly.

Pharmacologic Class:

Estrogen + progestin.

Interactions:

May be potentiated by CYP3A4 inhibitors (eg, erythromycin, clarithromycin, ketoconazole, itraconazole, ritonavir, grapefruit juice). May be antagonized by CYP3A4 inducers (eg, phenobarbital, carbamazepine, rifampin, St. John's wort). Concomitant thyroid replacement; may need to increase thyroid dose. May interfere with lab tests (eg, thyroid, PT, coagulation factors, glucose tolerance, HDL/LDL, triglycerides, hormone concentrations, other binding or plasma proteins).

Adverse Reactions:

Breast tenderness, headache, vaginal bleeding, vaginal discharge, pelvic pain; thromboembolism, neoplasms.

Generic Availability:

NO

How Supplied:

Caps—30

Pricing for BIJUVA

30 capsules of 1mg/100mg package (Qty: 1)
Appx. price $228
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