About
Elestrin

Elestrin Dosage and Administration

Convenient, Flexible Dose Titration

When estrogen is prescribed for postmenopausal women with a uterus, a progestin should also be initiated to reduce the risk of endometrial cancer.1 A woman without a uterus does not need progestin.1 Use of estrogen, alone or in combination with a progestin, should be prescribed at the lowest effective dose and for the shortest duration, consistent with your treatment goals and the potential risks in women.1

Elestrin (estradiol gel 0.06%) is a colorless and quick-drying gel formulation of topical estradiol applied once daily to a small area of the upper arm/shoulder.1 It is dispensed via metered dose pump and available in two dosing options: one or two pumps.1

  • One pump of Elestrin (dose of 0.87 g/day) = 0.0125 mg of estradiol daily1
  • Two pumps of Elestrin (dose of 1.7 g/day) = 0.0375 mg of estradiol daily1

Based upon the individual patient response, you may want to reassess the dose periodically. Subsequent dosage adjustment may be necessary.1

Discreet, Easy Application for Patients

Elestrin is discreet, cosmetically elegant and easy to use.1 Elestrin is a clear gel that dries quickly.1 Your patients simply apply Elestrin to clean, dry skin and let the gel dry for five minutes. After applying Elestrin, the patient should wash her hands with soap and water.1

Estradiol Transfer

As part of the FDA approval process, a study was conducted with Elestrin to evaluate estradiol skin-to-skin transfer from a female to a male.2 The study showed that the risk of estradiol transfer between a treated female and untreated male partner was negligible, based on the observation of no detectable absorption of estradiol in the male partners after 5 minutes of skin contact with a treated female subject, at either 2 or 8 hours after gel application to the upper arm.2 This study evaluated the transfer from female to male; no transfer studies to children or pets were conducted.2

  • During the pivotal Phase 3, there were no adverse events (AE) related to unintended transfer of product with Elestrin2
  • Since FDA approval of Elestrin, there have been no spontaneous AE reports of unintended transfer events2

Systemic Estradiol Dose

aThis chart is for educational purposes only and no clinical implications are meant to be extrapolated.
There are no head-to-head studies comparing safety, efficacy and pharmacokinetic parameters

ball data was collected on day 14

ctime frame for data collection unknown with exception of Cave (0.05 mg) measured over 80 hours

Estrogen therapy is available in various formulations—each with specific pharmacokinetic parameters and systemic estradiol dose.

Your patients will pay no more than $25 with each Elestrin prescription.

Download and Print the Elestrin Coupon for Your Patients

Indication

Elestrin is indicated for the treatment of moderate-to-severe vasomotor symptoms associated with menopause.

Important Safety Information

Estrogens, with or without progestins, should not be used for the prevention of cardiovascular disease or dementia. The use of estrogens and progestins has shown an increased risk of breast cancer, myocardial infarction, and pulmonary embolism. The use of estrogen, with or without progestins, has shown an increased risk of stroke, dementia, and DVT while estrogen alone therapy increases the risk of endometrial cancer. The most frequently reported adverse events in clinical trials were nasopharyngitis, breast tenderness, upper respiratory tract infection, and metrorrhagia.

Estrogen products should not be used in women with undiagnosed abnormal genital bleeding; known, suspected, or history of breast cancer; known or suspected estrogen-dependent neoplasia; active or history of deep vein thrombosis or pulmonary embolism; active or recent (within the past year) arterial thromboembolic disease (e.g., stroke, myocardial infarction); liver dysfunction or disease; known or suspected pregnancy.

ESTROGENS INCREASE THE RISK OF ENDOMETRIAL CANCER Close clinical surveillance of all women taking estrogens is important. Adequate diagnostic measures, including endometrial sampling when indicated, should be undertaken to rule out malignancy in all cases of undiagnosed persistent or recurring abnormal vaginal bleeding. There is no evidence that the use of "natural" estrogens results in a different endometrial risk profile than synthetic estrogens at equivalent estrogen doses.

CARDIOVASCULAR AND OTHER RISKS Estrogens, with or without progestins, should not be used for the prevention of cardiovascular disease or dementia.

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 6.8 years and 7.1 years, respectively, of treatment with oral conjugated estrogens (CE 0.625 mg) per day relative to placebo.

The estrogen plus progestin WHI substudy reported increased risk of myocardial infarction, stroke, invasive breast cancer, pulmonary emboli, and deep vein thrombosis in postmenopausal women (50 to 79 years of age) during 5.6 years of treatment with oral conjugated estrogens (CE 0.625 mg) combined with medroxyprogesterone acetate (MPA 2.5 mg) per day relative to placebo.

The Women's Health Initiative Memory Study (WHIMS), a substudy of the WHI study, reported increased risk of developing probable dementia in postmenopausal women 65 years of age or older during 5.2 years of treatment with CE 0.625 mg alone and during 4 years of treatment with CE 0.625 mg combined with MPA 2.5 mg relative to placebo. It is unknown whether this finding applies to younger postmenopausal women.

Other doses of conjugated equine estrogens with medroxyprogesterone acetate and other combinations and dosage forms of estrogens and progestins were not studied in the WHI clinical trials and, in the absence of comparable data, these risks should be assumed to be similar. Because of these risks, 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.

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 (Food and Drug Administration).
Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

For more information, call 1-800-890-3098.

References

  1. Elestrin (estradiol gel) full Prescribing Information. Azur Pharma, Philadelphia, PA, July 2010.
  2. Data on file-Transfer Memo. Jazz Pharmaceuticals
  3. Evamist Prescribing Information. Ther-Rx Corporation. St. Louis, MO.
  4. Divigel Prescribing Information. Upsher-Smith Laboratories, Inc. Minneapolis, MN.
  5. Estrasorb Prescribing Information. Graceway Pharmaceuticals, LLC. Bristol, TN.
  6. EstroGel Prescribing Information. Ascend Therapeutics, Inc. Herndon, VA.
  7. Vivelle-Dot® (estradiol transdermal system) full Prescribing Information. Novartis Pharmaceuticals Corporation. East Hanover, NJ.