First of its kind: Introducing the only FDA-approved bio-identical combination hormone therapy1,2
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
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.
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
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
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
*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
Help her move beyond the disruptive impacts of hot flashes with BIJUVA, proven to reduce the frequency and severity of moderate to severe VMS1
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
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
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
Activated partial thromboplastin levels with BIJUVA compared with placebo5
Prothrombin levels with BIJUVA compared with placebo5
Antithrombin activity5
Factor XIV5
Protein S5
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
LDL Cholesterol levels with BIJUVA compared with placebo5
Triglyceride levels with BIJUVA compared with placebo5
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
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
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
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
BIJUVA combines 2 bio‑identical hormones into 1 capsule—with just 1 prescription1,2
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
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
Additional medical information about bijuva is within reach
Contact Medical Affairs see links below.
Mayne Pharma provides prescription drug samples to eligible healthcare professionals
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
1. This offer is valid only for eligible patients and is good for use only with a valid prescription for BIJUVA at the time the prescription is filled by the pharmacist and dispensed to the patient.
2. Depending on your insurance coverage, most covered, insured, eligible patients will pay $0 for their prescription. Insured, eligible patients may incur out of pocket costs. Maximum reimbursement limits apply; patient out-of-pocket expenses may vary.
3. This offer is not valid for use by patients enrolled in Medicare, Medicaid, or other federal or state programs (including any state pharmaceutical assistance programs), or private indemnity or HMO Insurance plans that reimburse the patient for the entire cost of the prescription drugs. Patients may not use this offer if they are Medicare-eligible and enrolled in an employer-sponsored health plan or prescription drug benefit program for retirees.
4. This card is valid for up to 12 prescription fills.
5. Mayne Pharma reserves the right to rescind, revoke, or amend this offer without notice.
6. Offer good only in the USA at participating retail pharmacies.
7. Void if prohibited by law, taxed, or restricted.
8. This card is not transferable. Selling, purchasing, trading, or counterfeiting this card is prohibited by law.
9. By redeeming this card, you acknowledge that you are a commercially insured, eligible patient and that you understand and agree to comply with the terms and conditions of this offer.
For questions about this program please call 347-442-7919.For healthcare professionals