Important Safety Information

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.


Important Safety Information

WARNING: CARDIOVASCULAR DISORDERS, PROBABLE DEMENTIA, BREAST CANCER, and ENDOMETRIAL CANCER

See full prescribing information for complete boxed warning.


Estrogen Plus Progestin Therapy

  • The Women’s Health Initiative (WHI) estrogen plus progestin substudy reported increased risks of stroke, deep vein thrombosis (DVT), pulmonary embolism (PE), and myocardial infarction (MI)
  • The WHI estrogen plus progestin substudy reported increased risks of invasive breast cancer
  • The WHI Memory Study (WHIMS) estrogen plus progestin ancillary study of WHI reported an increased risk of probable dementia in postmenopausal women 65 years of age and older
  • Do not use estrogen plus progestogen therapy for the prevention of cardiovascular disease or dementia

Estrogen-Alone Therapy

  • There is an increased risk of endometrial cancer in a woman with a uterus who uses unopposed estrogens
  • The WHI estrogen-alone substudy reported increased risks of stroke and DVT
  • The WHIMS estrogen-alone ancillary study of WHI reported an increased risk of probable dementia in postmenopausal women 65 years of age and older
  • Do not use estrogen-alone therapy for the prevention of cardiovascular disease or dementia

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. Observational studies have also reported an increased risk of breast cancer with estrogen plus progestin therapy after several years of use. The risk increased with duration of use and appeared to return to baseline over about 5 years after stopping treatment (only the observational studies have substantial data on risk after stopping). 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. A meta-analysis of 17 prospective and 35 retrospective epidemiology studies found that women who used hormonal therapy for menopausal symptoms had an increased risk for ovarian cancer. The exact duration of hormone therapy use associated with an increased risk of ovarian cancer, however, is unknown.
  • 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 are breast tenderness (10.4%), headache (3.4%), vaginal bleeding (3.4%), vaginal discharge (3.4%) and pelvic pain (3.1%).



Please note that this information is not comprehensive. Please click here for the Full Prescribing Information, including BOXED WARNING.

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