Dosage & Administration
One capsule orally each evening with food. ( 2.1)
By using PrescriberAI, you agree to the AI Terms of Use.
Bijuva Prescribing Information
Estrogen Plus Progestin Therapy
Cardiovascular Disorders and Probable Dementia
The Women's Health Initiative (WHI) estrogen plus progestin substudy reported increased risks of pulmonary embolism (PE), deep vein thrombosis (DVT), 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 (CE) [0.625 mg] combined with medroxyprogesterone acetate (MPA) [2.5 mg], relative to placebo[see Warnings and Precautions ( 5.1), and Clinical Studies ( 14.4)] .
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 and older during 4 years of treatment with daily CE (0.625 mg) combined with MPA (2.5 mg), relative to placebo. It is unknown whether this finding applies to younger postmenopausal women[see Warnings and Precautions ( 5.3), Use in Specific Populations ( 8.5), and Clinical Studies ( 14.5)] .
Do not use estrogen plus progestogen therapy for the prevention of cardiovascular disease or dementia [see Warnings and Precautions ( 5.1, 5.3), and Clinical Studies ( 14.4, 14.5)].
Breast Cancer
The WHI estrogen plus progestin substudy demonstrated an increased risk of invasive breast cancer[see Warnings and Precautions ( 5.2), and Clinical Studies ( 14.4)] .
Only daily oral 0.625 mg CE and 2.5 mg MPA 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 CE plus other MPA 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. Discuss with your patient the benefits and risks of estrogen plus progestogen therapy, taking into account her 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.
Estrogen-Alone Therapy
Endometrial Cancer
There is an increased risk of endometrial cancer in a woman with a uterus who uses unopposed estrogens. Adding a progestogen 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[see Warnings and Precautions ( 5.2)].
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 CE (0.625 mg)-alone, relative to placebo[see Warnings and Precautions ( 5.1), and Clinical Studies ( 14.4)] .
The WHIMS estrogen-alone ancillary study of WHI reported an increased risk of developing probable dementia in postmenopausal women 65 years of age and older during 5.2 years of treatment with daily CE (0.625 mg)-alone, relative to placebo. It is unknown whether this finding applies to younger postmenopausal women [seeWarnings and Precautions ( 5.3), Use in Specific Populations ( 8.5), and Clinical Studies ( 14.5) ].
Do not use estrogen-alone therapy for the prevention of cardiovascular disease or dementia [see Warnings and Precautions ( 5.1, 5.3), and Clinical Studies ( 14.4, 14.5)] .
Only daily oral 0.625 mg CE 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 CE 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. Discuss with your patient the benefits and risks of estrogen-alone therapy, taking into account her 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.
Treatment of Moderate to Severe Vasomotor Symptoms Due to Menopause
Use estrogen, alone or in combination with a progestogen, at the lowest effective dose and the shortest duration consistent with treatment goals and risks for the individual woman. Re-evaluate postmenopausal women periodically as clinically appropriate to determine whether treatment is still necessary.
Treatment of Moderate to Severe Vasomotor Symptoms Due to Menopause
Take a single BIJUVA capsule orally each evening with food. Generally, start therapy with BIJUVA 0.5 mg estradiol/100 mg progesterone dosage strength. Make dosage adjustment based on the clinical response. Attempt to taper or discontinue BIJUVA at 3 to 6 month intervals.
BIJUVA capsules, 0.5 mg/100 mg, are oval shaped, opaque, light pink on one side, dark pink on the other side, and printed with "5C1" in white ink.
BIJUVA capsules, 1 mg/100 mg, are oval shaped, opaque, light pink on one side, dark pink on the other side, and printed with "1C1" in white ink.
Pregnancy
Risk Summary
BIJUVA is not indicated for use in pregnancy. There are no data with the use of BIJUVA in pregnant women, however, epidemiologic studies and meta-analyses have not found an increased risk of genital or non-genital birth defects (including cardiac anomalies and limb-reduction defects) following exposure to combined hormonal contraceptives (estrogens and progestins) before conception or during early pregnancy.
In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.
Lactation
Risk Summary
Estrogens plus progestogens are present in human milk and can reduce milk production in breast-feeding females. This reduction can occur at any time but is less likely to occur once breast-feeding is well-established. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for BIJUVA and any potential adverse effects on the breastfed child from BIJUVA or from the underlying maternal condition.
Pediatric Use
BIJUVA is not indicated for use in pediatric patients. Clinical studies have not been conducted in the pediatric population.
Geriatric Use
There have not been sufficient numbers of geriatric women involved in clinical studies utilizing BIJUVA to determine whether those over 65 years of age differ from younger women in their response to BIJUVA.
The Women's Health Initiative Studies
In the WHI estrogen plus progestin substudy (daily CE [0.625 mg] plus MPA [2.5 mg] versus placebo), there was a higher relative risk of nonfatal stroke and invasive breast cancer in women greater than 65 years of age [see Clinical Studies ( 14.4)] .
In the WHI estrogen-alone substudy (daily CE [0.625 mg]-alone versus placebo), there was a higher relative risk of stroke in women greater than 65 years of age [see Clinical Studies ( 14.4)] .
The Women's Health Initiative Memory Study
In the WHIMS 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 or estrogen-alone when compared to placebo [see Warnings and Precautions ( 5.3), and Clinical Studies ( 14.5)] .
Since both ancillary studies were conducted in women 65 to 79 years of age, it is unknown whether these findings apply to younger postmenopausal women 8[see Warnings and Precautions ( 5.3), and Clinical Studies ( 14.5)] .
BIJUVA is contraindicated in women with any of the following conditions:
- Undiagnosed abnormal genital bleeding [see Warnings and Precautions ( 5.2)] .
- Breast cancer or a history of breast cancer [see Warnings and Precautions ( 5.2)] .
- Estrogen-dependent neoplasia [see Warnings and Precautions ( 5.2)] .
- Active DVT, PE, or history of these conditions [see Warnings and Precautions ( 5.1)] .
- Active arterial thromboembolic disease (for example, stroke, MI), or a history of these conditions [see Warnings and Precautions ( 5.1)] .
- Known anaphylactic reaction, angioedema, or hypersensitivity to BIJUVA.
- Hepatic impairment or disease.
- Protein C, protein S, or antithrombin deficiency, or other known thrombophilic disorders.