-BIJUVA is the only
-Company to Hold Investor Day in
Bio-identical refers to the estradiol and progesterone that are
structurally identical to the hormones naturally circulating in a
woman’s body.* The commercial availability of BIJUVA fills an unmet need
by offering an
“We are excited to offer women, healthcare providers and pharmacists an
answer to their desire for bio-identical hormone therapy,” said Dr.
As of
“The momentum we have seen early on with the payer community is
encouraging and indicates recognition of the need for an
*The relevance of risks associated with the use of synthetic hormones compared to bio-identical hormones is not known, but cannot be excluded.
About Menopause and Vasomotor Symptoms (VMS)
Menopause is a natural life-stage transition for women that usually
occurs at an average onset of 51 years of age.1 According to
the
As the ovaries stop producing hormones, levels of circulating estrogen decrease, often causing vasomotor symptoms (VMS) (commonly known as hot flashes or flushes), as well as sleep and mood disturbances and genitourinary problems. Hot flashes (including night sweats) are the most common symptoms, occurring in up to 80 percent of women, and can be debilitating and last years after menopause.3 Despite living with these troublesome symptoms, many women do not seek treatment.
About BIJUVA
BIJUVA is the first and only
BIJUVA IMPORTANT SAFETY INFORMATION
BIJUVA 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.
WARNING: CARDIOVASCULAR DISORDERS, BREAST CANCER, ENDOMETRIAL CANCER, AND PROBABLE DEMENTIA |
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See full prescribing information for complete boxed warning. |
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Estrogen Plus Progestin Therapy |
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Estrogen plus progestin therapy should not be used for the prevention of cardiovascular disease or dementia |
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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) |
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The WHI estrogen plus progestin substudy reported increased risks of invasive breast cancer |
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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 or older |
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Estrogen-Alone Therapy |
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There is an increased risk of endometrial cancer in a woman with a uterus who uses unopposed estrogens |
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Estrogen-alone therapy should not be used for the prevention of cardiovascular disease or dementia |
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The WHI estrogen-alone substudy reported increased risks of stroke and DVT |
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The WHIMS estrogen-alone ancillary study of WHI reported an increased risk of probable dementia in postmenopausal women 65 years of age or older |
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Contraindications
- BIJUVA is contraindicated in women with any of the following conditions: Undiagnosed abnormal genital bleeding; Known, suspected, or history of cancer of the breast; Known or suspected 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 or any of its ingredients; Known liver impairment or disease; Known protein C, protein S, or antithrombin deficiency, or other known thrombophilic disorders.
Warnings & Precautions
- An increased risk of PE, DVT, stroke, and MI has been reported with estrogen plus progestin therapy. Should these occur or be suspected, therapy should be discontinued immediately. Risk factors for arterial vascular disease and/or venous thromboembolism (VTE) should be managed appropriately.
- 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 for 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 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 less than one percent with BIJUVA. Clinical surveillance of all women using estrogen plus progestin therapy is important. Adequate diagnostic measures should be undertaken to rule out malignancy in postmenopausal women with undiagnosed persistent or recurring abnormal genital bleeding.
- 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 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 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%) for BIJUVA are breast tenderness (10.4%), headache (3.4%), vaginal bleeding (3.4%), vaginal discharge (3.4%), and pelvic pain (3.1%).
Please note that this information is not comprehensive. Please see the Full Prescribing Information, including BOXED WARNING, for BIJUVA at https://www.bijuva.com/pi.pdf.
Forward-Looking Statements
This press release by
References
1 | NAMS “Overview of Menopause” 2010. | |
2 | US Census Bureau. Age and Sex Composition: 2010. 2011 May. Report No.: C2010BR-03. | |
3 | Woods NF, Mitchell ES. Symptoms during the perimenopause: prevalence, severity, trajectory, and signi-ficance in women’s lives. Am J Med. 2005;118(suppl 12B):14–24. | |
4 | Symphony Health Solutions PHAST Data powered by IDV; 12 months as of December 31, 2018 and Composite of Fisher, J. QuintilesIMS, White Paper: A Profile of the US Compounding Pharmacy Market, internal surveying of compounding pharmacies. | |
View source version on businesswire.com: https://www.businesswire.com/news/home/20190417005218/en/
Source:
Investor Contact
Nichol Ochsner
Vice
President, Investor Relations
561-961-1900, ext. 2088
Nochsner@TherapeuticsMD.com