Bijuva Dosing for Menopausal Hormone Therapy and Hot Flashes
Bijuva (estradiol 1 mg/progesterone 100 mg) is administered as one oral capsule daily for the treatment of moderate to severe vasomotor symptoms in postmenopausal women with an intact uterus. 1, 2
Standard Dosing Regimen
- The FDA-approved dose is estradiol 1 mg combined with progesterone 100 mg taken once daily 1, 2
- This represents the only commercially available bioidentical combination product approved for moderate to severe menopausal vasomotor symptoms 2
- The formulation is provided as a single oral softgel capsule 1
Clinical Efficacy Data
Women treated with Bijuva experienced 3.0 additional vasomotor symptom-free days per week compared to 1.3 days with placebo at 12 weeks 1
- At week 12,43-56% of women treated with estradiol/progesterone had no severe hot flashes versus only 26% with placebo 1
- Moderate to severe hot flashes were reduced by approximately 80% with active treatment compared to 41% with placebo 1
- Responder rates (≥50% reduction in moderate to severe VMS) were significantly higher at weeks 4 and 12 compared to placebo 1
Duration and Monitoring
Use the lowest effective dose for the shortest duration consistent with treatment goals, with reassessment every 3-6 months 3
- Attempts to discontinue or taper should be made at 3-6 month intervals 3
- The REPLENISH trial demonstrated sustained efficacy over 52 weeks with no cases of endometrial hyperplasia 2
- Review efficacy and side effects at 2-6 weeks after initiation 4
Critical Prescribing Requirements
Women with an intact uterus require progesterone in combination with estrogen to prevent endometrial hyperplasia and cancer 3, 5
- Bijuva's combination formulation eliminates the need for separate progestin therapy 2
- Women who have undergone hysterectomy do not need progesterone and should receive estrogen-only therapy 4, 3
- Adequate diagnostic measures, including endometrial sampling when indicated, should be undertaken to rule out malignancy in cases of undiagnosed persistent or recurring abnormal vaginal bleeding before initiating therapy 3
Absolute Contraindications to Screen For
Do not prescribe Bijuva to women with: 4
- History of breast cancer or other hormone-sensitive cancers
- Active or recent thromboembolic events (stroke, DVT, pulmonary embolism)
- Unexplained vaginal bleeding
- Active liver disease
- Pregnancy
Common Prescribing Pitfalls to Avoid
Do not prescribe vaginal estrogen for systemic vasomotor symptoms—it lacks adequate systemic absorption to treat hot flashes 4
- Vaginal estrogen is designed only for local genitourinary symptoms, not hot flashes 4
- Do not use custom compounded bioidentical hormones, as they lack data supporting claims of greater safety or efficacy 4
- Do not recommend complementary therapies (soy, multibotanicals) as first-line treatment—published data do not support their efficacy, and some may actually worsen symptoms 4
Alternative Formulations if Bijuva Not Tolerated
If oral combination therapy is not appropriate, consider: 3
- Transdermal estradiol formulations have lower rates of venous thromboembolism and stroke compared to oral estrogen 4, 6
- Transdermal estradiol 50 μg with micronized progesterone 200 mg for 12 days each month reduced moderate to severe hot flashes from 44% at baseline to 7.4% at 6 months 6
- Lower-than-conventional doses (oral conjugated estrogens 0.45 mg or transdermal estradiol 50 μg) provide substantial and sustained reductions in vasomotor symptoms over 4 years 6
Risk-Benefit Considerations
For every 10,000 women taking estrogen-only therapy for 1 year, there is no increased risk of invasive breast cancer 4
- Combined estrogen/progestogen therapy increases breast cancer risk only when used for more than 3-5 years 5
- Small increased risks of stroke and venous thromboembolism exist, though absolute risk remains low 4
- The benefit-risk balance is most favorable for women ≤60 years old or within 10 years of menopause onset 7