Estradiol transdermal
VIVELLE-DOT
What it isER-alpha, ER-beta and GPER agonist delivered through skin; menopausal vasomotor-symptom treatment.
Why this oneCompared with oral estrogen, transdermal delivery has less hepatic effect on clotting and triglycerides and avoids first-pass metabolism.
What limits itWith an intact uterus, add progestogen to prevent endometrial cancer. Breast and thrombotic risks still require screening.
FDA label
Read the full label on DailyMed ↗
BOXED WARNING Endometrial cancer with unopposed estrogen in women with a uterus; cardiovascular disorders (stroke, DVT, and with estrogen+progestin also PE and MI); probable dementia in women ≥65; invasive breast cancer (estrogen+progestin). Do not use for prevention of cardiovascular disease or dementia; use lowest effective dose for shortest duration.
| FDA dosing | Population | Start | Target | Max |
|---|---|---|---|---|
| Moderate to severe vasomotor symptoms due to menopause | Postmenopausal women | 0.025 mg/day, apply once weekly | Adjust to clinical response | |
| Moderate to severe vulvar and vaginal atrophy due to menopause | Postmenopausal women | 0.025 mg/day, apply once weekly | Adjust to clinical response | |
| Hypoestrogenism due to hypogonadism, castration, or primary ovarian failure | Women | 0.025 mg/day, apply once weekly | Adjust to clinical response | |
| Prevention of postmenopausal osteoporosis | Postmenopausal women | 0.025 mg/day, apply once weekly |
Renal Undefined
Hepatic Contraindicated in hepatic impairment or disease
Instructions
- Apply patch to clean, dry lower abdomen (below umbilicus) or upper quadrant of buttock; not on or near the breasts
- Rotate application sites with ≥1 week between applications to the same site; press firmly ~10 seconds
- Wear only one system at a time during the 7-day interval
- In women with a uterus, add a progestogen to reduce endometrial cancer risk
- Use lowest effective dose; attempt to taper/discontinue at 3-6 month intervals
Contraindications
- Undiagnosed abnormal genital bleeding
- Breast cancer or history of breast cancer
- Estrogen-dependent neoplasia
- Active or prior DVT or pulmonary embolism
- Active or prior arterial thromboembolic disease (e.g., stroke, MI)
- Hepatic impairment or disease
- Protein C, protein S, or antithrombin deficiency, or other thrombophilic disorders
Cautions
- Increased risk of gallbladder disease
- Discontinue if severe hypercalcemia, loss of vision (retinal vascular thrombosis), severe hypertriglyceridemia/pancreatitis, or cholestatic jaundice
- May exacerbate hypothyroidism (monitor thyroid function on replacement), fluid retention, hereditary angioedema, asthma, diabetes, epilepsy, migraine, porphyria, SLE
- Add progestogen if uterus intact (endometrial protection)
Adverse reactions
- Breast pain
- Upper respiratory tract infection
- Headache
- Abdominal pain
- Pain
- Edema
- Depression
- Pruritus (application-related)
Pregnancy Not indicated for use in pregnancy
Lactation Estrogens present in human milk and can reduce milk production
NO BOXED WARNINGS
Classes and tags
Clinical profile
Mechanism of action: Estradiol transdermal ballicule
