About
Elestrin

Concentrated on a Woman's Needs

Your patients may be struggling with hot flushes and night sweats associated with menopause.

Consider Elestrin. Elestrin offers a smart, proven approach to estrogen therapy.

Concentrated on Novel Delivery with Advanced Transdermal Delivery™ (ATD)

Elestrin (estradiol gel 0.06%) contains a novel gel composition, Advanced Transdermal Delivery™ (ATD), a permeability enhancing system with a combination of agents that enhances estradiol absorption and efficiently delivers estradiol via a small surface area of the skin.1,2

Concentrated on a Favorable Pharmacokinetic Profile

Elestrin has a favorable pharmacokinetic (PK) profile1

  • Half-life of Elestrin is 50 hours for the 2-pump (1.7 g/day) dose3
  • Steady-state serum concentrations achieved in approximately 3 days2
  • Tmax is reached within 4 hours with the 2-pump (1.7 g/day) dose; 18 hours with 1-pump (0.87g/day) dose.a,2

Concentrated on Effective Relief

Elestrin has proven efficacy in tough-to-treat patients with an average mean baseline of 93 hot flushes per week.2,4 In a clinical trial:

  • A statistically significant reduction versus placebo in the mean frequency of hot flushes was demonstrated at week 3 (P<0.01) with the 2 pump (1.7 g/day) dose and at week 5 for the 1 pump (0.87 g/day) dose (P<0.01)4
  • 76% reduction in frequency of hot flushes at the end of the study with the 2 pump (1.7 g/day) dose4
  • Approximately 40% of women were hot flush-free at the end of the study with the 2 pump (1.7 g/day) doseb,4

Concentrated on Her Health

Elestrin avoids first-pass metabolism and delivers a low exposure of estradiol.2,5,6 It is an FDA-approved estrogen therapy that contains 17ß-estradiol, the same hormone produced in the female body.2 This does not mean Elestrin is safer than other estrogen therapies. And relative to placebo, Elestrin significantly improved vasomotor, psychosocial and physical scores in the Menopause Quality of Life assessment.4

Consider more of the benefits of Elestrin:

Favorable PK profile: Elestrin has a favorable pharmacokinetic profile2

Clinically studied, FDA-approved: Elestrin is an FDA-approved hormone therapy. Safety, efficacy and potential side effects have been evaluated in a placebo-controlled clinical trial.2,4

Discreet, easy application: Elestrin is a colorless and quick-drying gel that provides patients with a cosmetically elegant treatment.2

With each Elestrin prescription, your patients will pay no more than $25.

Download and Print the Elestrin Coupon for Your Patients

a Measured at day 14.

b N=52/142

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
  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.