Elestrin (estradiol gel 0.06%) features Advanced Transdermal Delivery (ATD™), a delivery system designed to increase the rate of estradiol absorption. ATD permeation enhancers reversibly loosen dermal lipid packing, enhancing the absorption of estradiol into the bloodstream.1,2
Consider the pharmacokinetic profile of Elestrina:
In a study population with a mean baseline of 13.1 to 13.5 hot flushes per day and a 2.4 out of 3 severity rating, Elestrin demonstrated a reduction in the frequency and severity of hot flushes.3
Elestrin also contains 17ß-estradiol, the same hormone occurring naturally in a womans body.4 It was originally derived from a plant5 and synthesized in a lab. It is a once-daily estrogen therapy that is applied to the upper arm and shoulder area—a clear topical gel that dries in approximately five minutes.6
a All PK parameters except half-life are unadjusted for baseline concentrations and were measured after 14 days of dosing. Half-life is adjusted for baseline concentrations after multiple doses to upper arm and was measured after the last daily application.
b Shown as median.
Elestrin features ATD, a delivery system designed to increase the rate of estradiol absorption.
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ELE-13-0009
Elestrin (estradiol gel) is indicated for the treatment of moderate-to-severe vasomotor symptoms due to menopause. Please expand this section to read Important Risk Information.
WARNING: ENDOMETRIAL CANCER, CARDIOVASCULAR DISORDERS, BREAST CANCER and PROBABLE DEMENTIA
Estrogen-Alone Therapy
Endometrial Cancer
There is an increased risk of endometrial cancer in a woman with a uterus who uses unopposed estrogens. Adding a progestin to estrogen therapy has been shown to reduce the risk of endometrial hyperplasia, which may be a precursor to endometrial cancer. Adequate diagnostic measures, including directed or random endometrial sampling when indicated, should be undertaken to rule out malignancy in postmenopausal women with undiagnosed, persistent or recurring abnormal genital bleeding [see Warnings and Precautions (5.2)].
Cardiovascular Disorders and Probable Dementia
Estrogen-alone therapy should not be used for the prevention of cardiovascular disease or dementia [see Warnings and Precautions (5.1, 5.3), and Clinical Studies (14.2, 14.3)].
The Women's Health Initiative (WHI) estrogen-alone substudy reported increased risks of stroke and deep vein thrombosis (DVT) in postmenopausal women (50 to 79 years of age) during 7.1 years of treatment with daily oral conjugated estrogens (CE) [0.625 mg]-alone, relative to placebo.
The WHI Memory Study (WHIMS) estrogen-alone ancillary study of the WHI reported an increased risk of developing probable dementia in postmenopausal women 65 years of age or older during 5.2 years of treatment with daily CE (0.625 mg)-alone, relative to placebo. It is unknown whether this finding applies to younger postmenopausal women.
In the absence of comparable data, these risks should be assumed to be similar for other doses of CE and other dosage forms of estrogens.
Estrogens with or without progestins should be prescribed at the lowest effective doses and for the shortest duration consistent with treatment goals and risks for the individual woman.
Estrogen Plus Progestin Therapy
Cardiovascular Disorders and Probable Dementia
Estrogen plus progestin therapy should not be used for the prevention of cardiovascular disease or dementia.
The WHI estrogen plus progestin substudy reported increased risks of DVT, pulmonary embolism (PE), stroke and myocardial infarction (MI) in postmenopausal women (50 to 79 years of age) during 5.6 years of treatment with daily oral CE (0.625 mg) combined with medroxyprogesterone acetate (MPA) [2.5 mg], relative to placebo.
The WHIMS estrogen plus progestin ancillary study of the WHI reported an increased risk of developing probable dementia in postmenopausal women 65 years of age or older during 4 years of treatment with daily CE (0.625 mg) combined with MPA (2.5 mg), relative to placebo. It is unknown whether this finding applies to younger postmenopausal women.
Breast Cancer
The WHI estrogen plus progestin substudy also demonstrated an increased risk of invasive breast cancer. In the absence of comparable data, these risks should be assumed to be similar for other doses of CE and MPA, and other combinations and dosage forms of estrogens and progestins.
Estrogens with or without progestins should be prescribed at the lowest effective doses and for the shortest duration consistent with treatment goals and risks for the individual woman.
Elestrin should not be used in women with any of the following conditions:
The most frequently reported adverse events in ≥ 5% of subjects were nasopharyngitis, breast tenderness, upper respiratory tract infection, and metrorrhagia.
Please see full Prescribing Information, including Boxed Warning and Patient Information Sheet.
You are encouraged to report negative side effects of prescription drugs to the FDA at 1-800-FDA-1088 or to Meda Pharmaceuticals Inc. at 1-877-999-8401