Estradiol/Progesterone

DEA Class; Rx

Common Brand Names; Bijuva

Indicated for women with a uterus for moderate-to-severe vasomotor symptoms related to menopause

Undiagnosed abnormal genital bleeding

Known, suspected, or history of breast cancer

Known or suspected estrogen-dependent neoplasia

Active DVT, PE, or history of these conditions

Active arterial thromboembolic disease (eg, stroke, MI) or a history of these conditions

Known anaphylactic reaction, angioedema, or hypersensitivity to estradiol, progesterone, or any excipients

Known liver impairment or disease

Known protein C, protein S, or antithrombin deficiency, or other known thrombophilic disorders

Breast tenderness (10.4%)

Headache (3.4%)

Vaginal bleeding (3.4%)

Vaginal discharge (3.4%)

Pelvic pain (3.1%)

Gastrointestinal disorders: Abdominal pain and discomfort, abdominal distention, diarrhea, nausea, vomiting.

General disorders and administration site conditions: Fatigue, feeling abnormal, malaise

Metabolism and nutrition disorders: Fluid retention, weight increased

Musculoskeletal and connective tissue disorders: Muscle spasms, pain in extremity; nervous system disorders dizziness, headache, somnolence, psychiatric disorders

Sleep disorder: Insomnia

Reproductive system and breast disorders: Breast pain, breast tenderness, uterine bleeding. Skin and subcutaneous tissue disorders Night sweats, pruritus

Vascular disorders: Hot flush

Increased risk of PE, DVT, stroke, and MI with estrogen plus progestin hormone replacement therapy (HRT)

Increased risk of breast cancer with estrogen plus progestin HRT

Increased risk of endometrial cancer reported with unopposed estrogen therapy in women with a uterus; endometrial cancer risk among unopposed estrogen users is about 2- to 12-fold greater than in nonusers, and appears dependent on treatment duration and estrogen dose

Nonsignificant increased risk for ovarian cancer reported in the WHI estrogen plus progestin substudy

Risk of probable dementia increased in women aged 65-79 yr taking estrogen plus progestin or estrogen alone

A 2- to 4-fold increase for risk of gallbladder disease requiring surgery reported in postmenopausal women receiving estrogens

Estrogen may lead to severe hypercalcemia in women with breast cancer and bone metastases

Retinal vascular thrombosis reported in women receiving estrogens

Adding progestin for ≥10 days of estrogen administration cycle, or daily with an estrogen continuous regimen, a lowered incidence of endometrial hyperplasia was reported than would be induced by estrogen treatment alone

Several case reports describe substantial increased blood pressure attributed to idiosyncratic reactions to estrogens

In women with preexisting hypertriglyceridemia, estrogen therapy may be associated with elevated plasma triglycerides leading to pancreatitis

Estrogens may be poorly metabolized with impaired liver function; caution with history of cholestatic jaundice associated with past estrogen use or with pregnancy

Estrogen administration leads to increased thyroid-binding globulin levels; women dependent on thyroid hormone replacement therapy who are also receiving estrogens may require an increased thyroid replacement dose

Not indicated for women who are premenopausal, pregnant, or lactating