IMPORTANT SAFETY INFORMATION FOR BIJUVA® (ESTRADIOL AND PROGESTERONE) CAPSULES 0.5 MG/100 MG AND 1 MG/100 MG
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 deep vein thrombosis (DVT), pulmonary embolism (PE), or history of these conditions; active arterial thromboembolic disease (for example, stroke, myocardial infarction), or a history of these conditions; known anaphylactic reaction, angioedema, or hypersensitivity to BIJUVA; hepatic impairment or disease; known thrombophilic disorders, such as protein C, protein S, or antithrombin deficiency.
WARNING AND PRECAUTIONS
- Cardiovascular Disorders: Increased risks of PE, DVT, stroke, and MI are reported with estrogen plus progestin therapy. Immediately discontinue BIJUVA if a PE, DVT, stroke or MI occurs or is suspected. If feasible, discontinue BIJUVA at least 4 to 6 weeks before surgery of the type associated with an increased risk of thromboembolism, or during periods of prolonged immobilization. The safety and efficacy of BIJUVA for the prevention of cardiovascular disorders has not been established.
- Malignant Neoplasms: BIJUVA is contraindicated in women with breast cancer, a history of breast cancer, or estrogen-dependent neoplasia. Discontinue BIJUVA if a hormone-sensitive malignancy is diagnosed. The use of estrogen plus progestin therapy has been reported to result in an increase in abnormal mammograms requiring further evaluation.
- Gallbladder Disease: A 2- to 4-fold increase in the risk of gallbladder disease requiring surgery in postmenopausal women receiving estrogens has been reported.
- Hypercalcemia: Estrogen administration may lead to severe hypercalcemia in women with breast cancer and bone metastases. Discontinue estrogens, including BIJUVA if hypercalcemia occurs, and take appropriate measures to reduce the serum calcium level.
- Visual Abnormalities: Retinal vascular thrombosis has been reported in women receiving estrogens. Discontinue BIJUVA pending examination if there is a sudden partial or complete loss of vision, or a sudden onset of proptosis, diplopia, or migraine. Permanently discontinue estrogens, including BIJUVA, if examination reveals papilledema or retinal vascular lesions.
- Elevated Blood Pressure: In a small number of case reports, substantial increases in blood pressure have been attributed to idiosyncratic reactions to estrogens.
- Exacerbation of Hypertriglyceridemia: In women with pre-existing hypertriglyceridemia, estrogen therapy may be associated with elevations of plasma triglycerides leading to pancreatitis. Discontinue BIJUVA if pancreatitis occurs.
- Hepatic Impairment and/or Past History of Cholestatic Jaundice: Estrogens may be poorly metabolized in women with hepatic impairment. Exercise caution in any woman with a history of cholestatic jaundice associated with past estrogen use or with pregnancy. In the case of reoccurrence of cholestatic jaundice, discontinue BIJUVA.
- Exacerbation of Hypothyroidism: Estrogen administration leads to increased thyroid-binding globulin. Women dependent on thyroid hormone replacement therapy who are also receiving estrogens may require increased doses of their thyroid replacement therapy. Monitor thyroid function in these women during treatment with BIJUVA to maintain their free thyroid hormone levels.
- Fluid Retention: Estrogens plus progestogens may cause some degree of fluid retention. Monitor any woman with a condition(s) that might predispose her to fluid retention, such as cardiac or renal impairment. Discontinue estrogen plus progestin therapy, including BIJUVA, with evidence of medically concerning fluid retention.
- Hypocalcemia: Estrogen-induced hypocalcemia may occur in women with hypoparathyroidism. Consider whether the benefits of estrogen therapy, including BIJUVA, outweigh the risks in such women.
- Exacerbation of Other Conditions: Estrogen therapy, including BIJUVA, may cause an exacerbation of asthma, diabetes mellitus, epilepsy, migraine, porphyria, systemic lupus erythematosus, and hepatic hemangiomas. Consider whether the benefits of estrogen therapy outweigh the risks in women with such conditions.
SERIOUS REACTIONS
Serious adverse reactions associated with estrogen plus progestin therapy include cardiovascular disorders and malignant neoplasms (see Warnings and Precautions above).
ADVERSE REACTIONS
The most common adverse reactions with BIJUVA capsules (incidence ≥3% of women greater than placebo) are breast tenderness, headache, nausea, vaginal bleeding, vaginal discharge and pelvic pain.
To report SUSPECTED ADVERSE REACTIONS, contact Mayne Pharma at 1-844-825-8500 or FDA at
1-800-FDA-1088 or www.fda.gov/medwatch
Please note that this information is not comprehensive. Please click here for the Full Prescribing 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.
