CONTRAINDICATIONS
BIJUVA is contraindicated in women with any of the following conditions: undiagnosed abnormal genital bleeding; breast cancer or a history of breast cancer; estrogen-dependent neoplasia; active DVT, PE, or history of these conditions; active arterial thromboembolic disease (for example, stroke, MI), or a history of these conditions; known anaphylactic reaction, angioedema, or hypersensitivity to BIJUVA; hepatic impairment or disease; protein C, protein S, or antithrombin deficiency, or other known thrombophilic disorders.
WARNING AND PRECAUTIONS
- Increased risks of PE, DVT, stroke, and MI are reported with estrogen plus progestin therapy. Should these occur or be suspected, therapy should be discontinued immediately. Manage appropriately any risk factors for arterial vascular disease and/or venous thromboembolism (VTE).
- The WHI substudy of daily estrogen plus progestin after a mean follow‑up of 5.6 years reported an increased risk of invasive breast cancer. One large meta-analysis of prospective cohort studies reported increased risks that were dependent upon duration of use and could last up to >10 years after discontinuation of estrogen plus progestin therapy and estrogen-alone therapy. Extension of the WHI trials also demonstrated increased breast cancer risk associated with estrogen plus progestin therapy.
- The use of estrogen-alone and estrogen plus progestin therapy has been reported to result in an increase in abnormal mammograms requiring further evaluation.
- Endometrial hyperplasia (a possible precursor to endometrial cancer) has been reported to occur at a rate of approximately
1 percent or less with BIJUVA. Clinical surveillance of all women using estrogen-alone or estrogen plus progestogen therapy is important. Adequate diagnostic measures should be undertaken to rule out malignancy in postmenopausal women with undiagnosed persistent or recurring abnormal genital bleeding with unknown etiology.
- The WHI estrogen plus progestin substudy reported a statistically non-significant increased risk of ovarian cancer.
- In the WHI Memory Study (WHIMS) estrogen plus progestin ancillary studies of postmenopausal women 65 to 79 years of age, there was an increased risk of developing probable dementia in women receiving estrogen plus progestin when compared to placebo. It is unknown whether these findings apply to younger postmenopausal women.
- Estrogens increase the risk of gallbladder disease.
- Discontinue estrogen if severe hypercalcemia, loss of vision, severe hypertriglyceridemia, or cholestatic jaundice occurs.
- Monitor thyroid function in women on thyroid replacement hormone therapy.
ADVERSE REACTIONS
The most common adverse reactions (≥3%) with BIJUVA capsules, 0.5 mg/100 mg and 1 mg/100 mg, respectively are breast tenderness (4.0%/10.4%), headache (4.0%/3.4%), nausea (3.5%/2.2%), vaginal bleeding (2.4%/3.4%), vaginal discharge (1.9%/3.4%) and pelvic pain (2.8%/3.1%).
INDICATION
BIJUVA (estradiol and progesterone) is a combination of an estrogen and progesterone indicated in a woman with a uterus for the treatment of moderate to severe vasomotor symptoms due to menopause.
Please note that this information is not comprehensive. Please click here for the Full Prescribing Information, including BOXED WARNING.
