First of its kind: Introducing the only FDA-approved bio-identical combination hormone therapy1,2

For the treatment of moderate to severe vasomotor symptoms (VMS) due to menopause in women with a uterus

Two Bio-Identical Hormones Precisely Combined1-3

Relieve disruptive vasomotor symptoms while helping reduce the risks to the endometrium with BIJUVA—a once-daily combination of bio‑identical estradiol and bio‑identical progesterone in a single oral capsule1-3

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Offer VMS relief without compromise

Unlike other hormone therapies that include a synthetic progestin or separate oral progesterone, BIJUVA offers the convenience and assurance of 2 bio‑identical* hormones in a single daily oral capsule—studied together for the first time1-3

Well-Studied

The first and only to identify the specific daily combination of estradiol and progesterone needed to effectively treat VMS while helping to reduce the risks to the endometrium1,3,4

1-Capsule Combination

One daily capsule containing a combination of 2 bio‑identical hormones for balanced, sustained VMS relief1-3

Bio-identical Hormones

A single oral capsule containing bio‑identical estradiol and bio‑identical progesterone—structurally identical to the hormones produced within a woman’s body1,2

*Bio-identical hormones are structurally identical to the hormones produced within a woman’s body. The relevance of risks associated with the use of synthetic hormones compared to bio-identical hormones is not known but cannot be excluded.

Efficacy

Just Add Efficacy

VMS Frequency and Severity

In a clinical trial, BIJUVA demonstrated statistically significant improvements in vms frequency and severity1

Mean reduction in number of weekly moderate and severe VMS from week 1 through week 123

Reduction in VMS frequency at Week 12

BIJUVA demonstrated a 76% reduction in VMS frequency at week 12 from baseline5

Mean reduction in severity of weekly moderate and severe VMS from Week 1 through Week 123

Reduction in VMS severity at Week 12

Amenorrhea Rates

BIJUVA delivers a combined regimen of estradiol and progesterone daily with steady improvement in amenorrhea rates (secondary endpoint)1-3

• At cycle 12-13 (~1 year), 90.2% of women did not have any bleeding3*

Rates of cumulative amenorrhea from cycles 1 to 133

Rates of cumulative amenorrhea cycles 1 to 13

*The cumulative amenorrhea† rate in patients receiving BIJUVA was 56.1% with rates increasing over time.1,3

†Cumulative amenorrhea was defined as the absence of bleeding or spotting for a cumulative period, such as first to 13th cycle, second to 13th cycle, and so on to 13th cycle.5

Scroll to See Improvements in Quality of Life with BIJUVA

Help her move beyond the disruptive impacts of hot flashes with BIJUVA, proven to reduce the frequency and severity of moderate to severe VMS1

Quality of life and sleep

As a result of reduction in VMS, BIJUVA demonstrated improvements in quality of life and sleep measures (secondary endpoints)2,6

Menopause Quality of Life

BIJUVA demonstrated statistically significant improvements in Menopause-specific Quality of Life (MENQOL) Total Score6

Sleep

BIJUVA demonstrated statistically significant improvement in sleep score as determined by the Medical Outcomes Study (MOS)2

Study Design

MENQOL Questionnaire6

Menopause-specific quality of life changes in study participants were assessed utilizing the MenQOL (Menopause Quality of Life) questionnaire, which is self-administered and assesses changes in quality of life over a 1-month period.


Medical Outcomes Study (MOS) Sleep Score Questionnaire2

This questionnaire was utilized to assess changes in sleep for study participants. It was self-administered and provided to subjects at visits 1 (randomization), 4 (week 12), 5 (month 6), and 7 (month 12) or early termination.

For the millions of women with moderate to severe VMS, BIJUVA can offer relief from its disruptive impact6,7

Safety

Precisely combined for efficacy and demonstrated safety1,3

Endometrial Safety

First-of-its-kind study

Identified for the first time the specific daily combination of bio‑identical estradiol and bio‑identical progesterone needed to treat VMS while reducing the risks to the endometrium1,3,4

•

Endometrial hyperplasia rate

Reported at a rate of ≤1% in women receiving BIJUVA consistent with the expected incidence rate in a postmenopausal population1,3

•

Amenorrhea rates

At cycle 12-13 (~1 year), 90.2% of women did not report any bleeding3*

*The cumulative amenorrhea† rate in patients receiving BIJUVA was 56.1% with rates increasing over time.1,3

†Cumulative amenorrhea was defined as the absence of bleeding or spotting for a cumulative period, such as first to 13th cycle, second to 13th cycle, and so on to 13th cycle.5

Coagulation Parameters

In a 52-week clinical study with BIJUVA, there were no clinically significant changes in coagulation parameters following treatment3

• Estrogen plus progestin therapy should not be used for the prevention of cardiovascular disease or dementia1

• 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)1

Fibrinogen levels with BIJUVA compared with placebo5

Fibrinogen levels with BIJUVA compared with placebo chart

Activated partial thromboplastin levels with BIJUVA compared with placebo5

Activated partial thromboplastin levels with BIJUVA compared with placebo chart

Prothrombin levels with BIJUVA compared with placebo5

Prothrombin levels with BIJUVA compared with placebo chart

Antithrombin activity5

Antithrombin activity chart

Factor XIV5

Factor XIV chart

Protein S5

Protein S chart

Lipid parameters

In a 52-week clinical study, no clinically important changes to lipid parameters—including total cholesterol, LDL cholesterol, and triglycerides—were seen in women taking BIJUVA5

• Estrogen plus progestin therapy should not be used for the prevention of cardiovascular disease or dementia1

Total cholesterol levels with BIJUVA compared with placebo5

Total cholesterol levels with BIJUVA compared with placebo chart

LDL Cholesterol levels with BIJUVA compared with placebo5

LDL Cholesterol levels with BIJUVA compared with placebo chart

Triglyceride levels with BIJUVA compared with placebo5

Triglyceride levels with BIJUVA compared with placebo chart

Sustained levels of estradiol

The pharmacokinetics of BIJUVA show a steady state of bio-identical estradiol that is sustained over 24 hours. A steady state is achieved at 7 days.1

Mean steady-state serum estradiol concentrations with BIJUVA at day 71

Mean steady state serum estradiol concentrations with BIJUVA at Day 7

The BIJUVA tolerability profile

Most Common Adverse Reactions

The safety of BIJUVA was assessed in a 52-week study1

Treatment-emergent adverse reactions occurring in ≥3% of women receiving BIJUVA vs placebo1

Treatment-emergent adverse reactions occurring in ≥3% of women receiving BIJUVA vs placebo

Study Design

Efficacy and Safety Study Design1,3

The efficacy and safety of BIJUVA were examined in a phase 3, multicenter, 12-week randomized, double-blind, placebo-controlled substudy of a single 52-week safety study. Participants (N=726) in the study were:

• Randomized to multiple dose combinations of estradiol and progesterone, and placebo

• 40 to 65 years of age (mean 54.6 years) with at least 50 moderate to severe VMS/week at baseline

• Mean of 5.9 years since last menstrual period

• White (67%), black/African American (31%), and other (2.1%)


In the efficacy substudy, 141 women received BIJUVA and 135 women received placebo. The evaluated co-primary efficacy endpoints included mean weekly reduction in:

• Frequency of moderate to severe VMS with BIJUVA compared to placebo at weeks 4 and 12

• Severity of moderate to severe VMS with BIJUVA compared to placebo at weeks 4 and 12


Safety of BIJUVA was assessed in a 1-year, phase 3 trial that included 1835 postmenopausal women (1684 received multiple dose combinations of estradiol/progesterone. 415 received BIJUVA and 151 received placebo).

The bio-identical progesterone in BIJUVA has been shown to reduce the risks of stimulating the endometrium associated with unopposed estrogen1,2,4

Experience

Offer her the convenience of “one”

One BIJUVA capsule each evening with food1

BIJUVA is a combination of bio‑identical estradiol and bio‑identical progesterone—a single oral capsule that fits easily into her daily routine and may improve compliance1-3

One prescription

BIJUVA combines 2 bio‑identical hormones into 1 capsule—with just 1 prescription1,2

One affordable treatment

BIJUVA Patient Savings Program* to help patients get on and stay on therapy

 

*Please see program terms, conditions, and eligibility requirements.

It’s affordable and easy for patients to get on and stay on BIJUVA treatment

Support

Helping women get the care they need

Assistance with prescriptions and savings simplifies the experience for you and your patients

BIJUVA requires just 1 prescription1

A team of pharmacists is available with answers to patients' questions about therapy and support programs

BIJUVA Patient Savings Program* to help patients get on and stay on therapy

Download Savings Card

Additional medical information about bijuva is within reach

Contact Medical Affairs see links below.

Contact Medical Affairs Request a Representative

Request Samples

Request Bijuva Samples For Your Patients

Mayne Pharma provides prescription drug samples to eligible healthcare professionals

Package of BIJUVA and BIJUVA capsule


Request Samples

References:

1. BIJUVA [package insert]. Raleigh , NC: Mayne Pharma, Inc; 2022. 2. Kagan R, Constantine G, Kaunitz AM, Bernick B, Mirkin S. Improvement in sleep outcomes with a 17β-estradiol-progesterone oral capsule (TX-001HR) for postmenopausal women. Menopause. 2018;25(6). doi:10.1097/GME.0000000000001278 3. Lobo RA, Archer DF, Kagan R, et al. A 17β-estradiol-progesterone oral capsule for vasomotor symptoms in postmenopausal women. Obstet Gynecol. 2018;132(1):161-170. 4. Mirkin S. Evidence on the use of progesterone in menopausal hormone therapy. Climacteric. 2018;21(4):346-354. 5. Data on file. Clinical study report TXC12-05. 6. Simon JA, Kaunitz AM, Kroll R, Graham S, Bernick B, Mirkin S. Oral 17β-estradiol/progesterone (TX-001HR) and quality of life in postmenopausal women with vasomotor symptoms. Menopause. 2019;26(5). doi:10.1097/GME.0000000000001271 7. Sussman M, Trocio J, Best C, et al. Prevalence of menopausal symptoms among mid-life women: findings from electronic medical records. BMC Womens Health. 2015;15:58. doi:10.1186/s12905-015-0217-y

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 pulmonary embolism (PE), deep vein thrombosis (DVT), stroke, 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

The WHI estrogen-alone and estrogen plus progestin substudies evaluated only daily oral conjugated estrogens (CE) [0.625 mg] and medroxyprogesterone acetate (MPA) [2.5 mg]. Therefore, the relevance of the WHI findings regarding adverse cardiovascular events, dementia, and breast cancer to lower CE and MPA doses, other routes of administration, or other estrogen-alone or estrogen plus progestogen products is not known, and cannot be definitively excluded or determined.

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%), nausea (2.2%), 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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