EstroGel

Clinical summary

Indications and usage 1 INDICATIONS AND USAGE EstroGel 0.06% is an estrogen indicated for: Treatment of moderate to severe vasomotor symptoms due to menopause ( 1.1 ) Treatment of moderate to severe symptoms of vulvar and vaginal atrophy due to menopause ( 1.2 ) 1.1 Treatment of Moderate to Severe Vasomotor Symptoms due to Menopause. 1.2 Treatment of Moderate to Severe Symptoms of Vulvar and Vaginal Atrophy due to Menopause. Limitation of Use When prescribing solely for the treatment of moderate to severe symptoms of vulvar and vaginal atrophy due to menopause, first consider the use of topical vaginal products. Dosage and administration 2 DOSAGE AND ADMINISTRATION Metered-dose pump: Daily administration of EstroGel 0.06% 1.25 g per day (1 pump depression) to the arm ( 2.1 , 2.2 , 2.3 ) 2.1 Important Use Information The timing of EstroGel initiation can affect the overall benefit-risk profile. Consider initiating EstroGel in women < 60 years old or < 10 years since menopause onset [ see Warning and Precautions ( 5 ), Use in Specific Populations ( 8.5 ) and Clinical Studies ( 14 ) ]. When estrogen is prescribed for a menopausal woman with a uterus, the addition of a progestogen has been shown to reduce the risk of endometrial cancer. There are possible risks associated with the use of progestogens plus estrogens that differ from those of estrogen-alone regimens. See prescribing information for progestogens indicated for the prevention of endometrial hyperplasia in non-hysterectomized menopausal women receiving estrogens [ see Warning and Precautions ( 5.2 , 5.3 ) ]. Generally, a woman without a uterus does not need to use a progestogen with estrogen therapy. In some cases, however, hysterectomized women with a history of endometriosis may benefit from the addition of a progestogen [ see Warning and Precautions ( 5.13 ) ]. 2.2 Treatment of Moderate to Severe Vasomotor Symptoms due to Menopause. EstroGel 0.06% 1.25 g per day is the single approved dose for the treatment of moderate to severe vasomotor symptoms due to menopause. Before using the canister for the first time, it must be primed. Remove the large canister cover, and fully depress the pump 5 times. Discard the unused gel by thoroughly rinsing down the sink or placing it in the household trash. After priming, the pump is ready to use. The recommended area of application is the arm. Apply a thin layer over the entire arm on the inside and outside from wrist to shoulder. 2.3 Treatment of Moderate to Severe Symptoms of Vulvar and Vaginal Atrophy due to Menopause. EstroGel 0.06% 1.25 g per day is the single approved dose for the treatment of moderate to severe symptoms of vulvar and vaginal atrophy due to menopause. The lowest effective dose of EstroGel 0.06% for this indication has not been determined. When prescribing solely for the treatment of moderate to severe symptoms of vulvar and vaginal atrophy, first consider the use of topical vaginal products. Before using the canister for the first time, it must be primed. Remove the large canister cover, and fully depress the pump 5 times. Discard the unused gel by thoroughly rinsing down the sink or placing it in the household trash. After priming, the pump is ready to use. The recommended area of application is the arm. Apply a thin layer over the entire arm on the inside and outside from wrist to shoulder. Warnings and cautions 5 WARNINGS AND PRECAUTIONS Estrogens increase the risk of gallbladder disease ( 5.4 ) Discontinue estrogen if severe hypercalcemia, loss of vision, severe hypertriglyceridemia or cholestatic jaundice occurs ( 5.5 , 5.6 , 5.8 , 5.9 ) Monitor thyroid function in women on thyroid replacement therapy ( 5.10 ) 5.1 Cardiovascular Disorders EstroGel is contraindicated in women with active DVT, PE, stroke, or a history of these conditions [ see Contraindications ( 4 ) ]. Immediately discontinue EstroGel if a PE, DVT, or stroke, occurs or is suspected. If feasible, discontinue EstroGel at least 4 to 6 weeks before surgery of the type associated with an increased risk of thromboembolism, or during periods of prolonged immobilization. The safety and efficacy of EstroGel for the prevention of cardiovascular disorders have not been established. The Women’s Health Initiative (WHI) estrogen-alone trial reported increased risks of pulmonary embolism (PE), deep vein thrombosis (DVT), and stroke, in postmenopausal women (50 to 79 years of age, average age 63.4 years) during 7.2 years of treatment with daily oral conjugated estrogens (CE) [0.625 mg] relative to placebo. Analyses were also conducted in women aged 50-59 years, a group of women more likely to present with new onset of moderate to severe VMS compared to women of other age groups in the trial. Only daily oral 0.625 mg CE was studied in the WHI estrogen-alone trial. Therefore, the relevance of the WHI findings regarding adverse cardiovascular events to lower CE doses, other routes of administration, or other estrogen products is not kn