Bijuva (estradiol and progesterone)

The following drug information is obtained from various newswires, published medical journal articles, and medical conference presentations.

Company:

Approval Status:

Approved October 2018

Specific Treatments:

moderate to severe vasomotor symptoms due to menopause

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General Information

Bijuva is a bio-identical hormone therapy combination of an estrogen and progesterone. 

Bijuva is specifically indicated for use in women with a uterus for the treatment of moderate to severe vasomotor symptoms due to menopause.

Bijuva is supplied as a capsule for oral administration. The recommended dose is a single capsule, 1 mg/100 mg, orally each evening with food.

Clinical Results

FDA Approval

The FDA approval of Bijuva was based on the phase III Replenish Trial which evaluated four doses of Bijuva and placebo in 1,835 post-menopausal women between 40 and 65 years old. The Replenish Trial results demonstrated: Two Bijuva doses (estradiol 1 mg/progesterone 100 mg) and (estradiol 0.5 mg/progesterone 100 mg) achieved all of the co-primary efficacy endpoints and the primary safety endpoint. Both doses demonstrated a statistically significant and clinically meaningful reduction from baseline in both the frequency and severity of hot flashes compared to placebo, and the primary safety endpoint: the incidence of consensus endometrial hyperplasia or malignancy was 0 percent. In addition, both doses met the secondary endpoints using well-validated patient reported outcome tools, including the Menopause-Specific Quality of Life (MENQOL), the Clinical Global Impression scale (CGI), and the responder analysis rate. 

Side Effects

Adverse effects associated with the use of Bijuva may include, but are not limited to, the following:

breast tenderness

headache

vaginal bleeding

vaginal discharge

pelvic pain

The Bijuva drug label comes with the following Black Box Warning: 

Estrogen plus progestin therapy may increase the risk of the following: cardiovascular disorders (including stroke, deep vein thrombosis, pulmonary embolism and myocardial infarction; invasive breast cancer and probable dementia in postmenopausal women 65 years of age of older. Estrogen-Alone Therapy may increase the risk of the following: endometrial cancer in a woman with a uterus who uses unopposed estrogens, stroke and DVT and probable dementia in postmenopausal women 65 years of age or older. 

 

Mechanism of Action

Bijuva is a bio-identical hormone therapy combination of an estrogen and progesterone. Bio-identical refers to estradiol and progesterone that are molecularly identical to the hormones circulating naturally in the woman’s body. As the ovaries stop producing hormones, levels of circulating estrogen and progesterone decrease, often causing vasomotor symptoms (VMS) such as night sweats, hot flashes, and sleep disturbances.

Additional Information

For additional information regarding Bijuva or moderate to severe vasomotor symptoms due to menopause, please visit https://bijuva.com/