Patient
Benefits

Benefits of Elestrin Therapy

Elestrin Provides Relief of Vasomotor Symptoms at a Low Exposure to 17 ß-estradiol

Your patients want relief of their vasomotor symptoms associated with menopause. Elestrin is a smart approach to estrogen therapy—concentrated on a woman's needs.

Elestrin is concentrated on:

Novel Delivery: Elestrin offers Advanced Transdermal Delivery™ (ATD) that enhances skin permeability and estradiol absorption.1

Favorable Pharmacokinetic Profile: The 2-pump (1.7 g/day) dose reaches maximum concentration of serum estradiol (Tmax) within 4 hours, with a half-life of 50 hours.a,b,2,3 Tmax for the 1-pump (0.87 g/day) dose was 18 hours.2 Steady-state serum concentrations are achieved in approximately 3 days.2

Effective relief: Elestrin (2-pump, 1.7g/d of gel) dose significantly reduced the frequency of hot flushes as early as week 3.4 The 1-pump (0.87 g/day) dose significantly reduced the frequency of hot flushes at week 5.4

Low exposure of estradiol: Elestrin avoids first-pass metabolism, delivers a low exposure of estradiol.2,4,5,6

Ease of Use: Elestrin contains 17ß-estradiol, was originally derived from a plant and is an FDA-approved estrogen therapy.2,5 And, Elestrin provides your patients with discreet estrogen delivery—it's colorless and will not leave an adhesive residue or fall off.2

Convenient Dosing

Elestrin is dispensed via metered dose pump and available in two low-dose options—one pump or two per day.2 This convenient, flexible, low-dose titration allows for adjustments in dosing.

Quality of Life Assessment Scores Were Significantly Improved with Elestrin

Elestrin is concentrated on a woman's needs. Elestrin significantly improved vasomotor, psychosocial and physical scores in the Menopause Quality of Life assessment.4

Elestrin Patient Education Brochure

You and your patients have options when it comes to estrogen therapy. Naturally, you take into consideration many things when devising an effective treatment strategy for patients.

This Patient Education Brochure is a useful resource for your patients as they consider the treatment options.

Help Your Patients Save with Elestrin

You can help your patients save with Elestrin. Your patients will pay no more than $25 with each Elestrin prescription.

Download and Print the Elestrin Coupon for Your Patients

a Measured at day 14.

b A systemic delivery of 0.0375 mg of estradiol daily (dose of 1.7 g of gel).

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. Alberti I, Grenier A, Kraus H, Carrara DN. Pharmaceutical development and clinical effectiveness of a novel gel technology for transdermal drug delivery. Expert Opin Drug Deliv. 2005;2(5):935-950.
  2. Elestrin (estradiol gel) full Prescribing Information. Azur Pharma, Philadelphia, PA, July 2010.
  3. Data on file-PK.
  4. Simon JA, Bouchard C, Waldbaum A, et al. Low dose of transdermal estradiol gel for the treatment of symptomatic postmenopausal women: a randomized controlled trial. Obstet Gynecol. 2007;109:588-596.
  5. Carroll N. A review of transdermal nonpatch estrogen therapy for the management of menopausal symptoms. J Womens Health. 2010;19(1):47-55.
  6. Cheang A, Sitruk-Ware R, Utian WH. A Risk Benefit Appraisal of Transdermal Estradiol Therapy. Drug Safety. 1993;9(5):365-379.