"The U.S. Food and Drug Administration today approved Osphena (ospemifene) to treat women experiencing moderate to severe dyspareunia (pain during sexual intercourse), a symptom of vulvar and vaginal atrophy due to menopause.
Alora (estradiol transdermal system) is indicated in:
- Treatment of moderate to severe vasomotor symptoms associated with the menopause.
- Treatment of moderate to severe symptoms of vulvar and vaginal atrophy associated with the menopause. When prescribing solely for the treatment of symptoms of vulvar and vaginal atrophy, topical vaginal products should be considered.
- Treatment of hypoestrogenism due to hypogonadism, castration or primary ovarian failure.
- Prevention of postmenopausal osteoporosis. When prescribing solely for the prevention of postmenopausal osteoporosis, therapy should only be considered for women at significant risk of osteoporosis and non-estrogen medications should be carefully considered.
The mainstays for decreasing the risk of postmenopausal osteoporosis are weight bearing exercise, adequate calcium and vitamin D intake, and, when indicated, pharmacologic therapy. Postmenopausal women require an average of 1500 mg/day of elemental calcium to remain in neutral calcium balance. Therefore, when not contraindicated, calcium supplementation may be helpful for women with suboptimal dietary intake. Vitamin D supplementation of 400-800 IU/day may also be required to ensure adequate daily intake in postmenopausal women.
DOSAGE AND ADMINISTRATION
Alora (estradiol transdermal system) should be administered twice weekly, as instructed. The adhesive side of the Alora (estradiol transdermal system) system should be placed on a clean, dry area of skin. The recommended application site is the lower abdomen. In addition, the upper quadrant of the buttocks or outer aspect of the hip may be used. Alora (estradiol transdermal system) should not be applied to the breasts. The sites of application should be rotated, with an interval of at least 1 week allowed between applications to a particular site. The area selected should not be oily, damaged, or irritated. The waistline should be avoided, since tight clothing may rub the system off. The system should be applied immediately after opening the pouch and removing the rotective liner. The system should be pressed firmly in place with the palm of the hand for about 10 seconds, making sure there is good contact, especially around the edges. In the event that a system should fall off, the same system may be reapplied. If necessary, a new system may be applied to another site. The original treatment schedule should be maintained.
Initiation of Therapy
For treatment of moderate-to-severe vasomotor symptoms, vulvar and vaginal atrophy associated with the menopause, hypogonadism, castration, or primary ovarian failure, treatment is usually initiated with Alora (estradiol transdermal system) 0.05 mg/day applied to the skin twice weekly. The lowest dose and regimen that will control symptoms should be chosen and medication should be discontinued as promptly as possible. Attempts to discontinue or taper medication should be made at 3-month to 6-month intervals.
For the prevention of postmenopausal osteoporosis, the minimum dose of Alora (estradiol transdermal system) that has been studied and shown to be effective is 0.025 mg/day applied to the skin twice weekly. Bone mineral density measurements should be repeated to monitor treatment efficacy. The dosage may be increased as necessary, depending on bone mineral density and adverse events.
In women who are not currently taking oral estrogens or in women switching from topical therapy or another transdermal estradiol therapy, treatment with Alora (estradiol transdermal system) can be initiated at once. In women who are currently taking oral estrogens, treatment with Alora (estradiol transdermal system) should be initiated one week after withdrawal of oral therapy or sooner if menopausal symptoms reappear in less than one week.
When estrogen is prescribed for a postmenopausal woman with a uterus, progestin should also be initiated to reduce the risk of endometrial cancer. A woman without a uterus does not need progestin. Use of estrogen, alone or in combination with a progestin, should be limited to the shortest duration consistent with treatment goals and risks for the individual woman. Patients should be reevaluated periodically as clinically appropriate (e.g., 3-month to 6-month intervals) to determine if treatment is still necessary (see BOXED WARNINGS and WARNINGS). For women who have a uterus, adequate diagnostic measures, such as endometrial sampling, when indicated, should be undertaken to rule out malignancy in cases of undiagnosed persistent or recurring abnormal vaginal bleeding.
Alora (estradiol transdermal system) may be administered in a continuous regimen in patients who do not possess an intact uterus. In those patients with an intact uterus who are not using concomitant progestin therapy, Alora (estradiol transdermal system) can be administered on a cyclic schedule (e.g., three weeks of therapy followed by one week without) for the treatment of postmenopausal symptoms. However, no studies have been conducted using this intermittent regimen for the prevention of postmenopausal osteoporosis.
Alora 0.025 mg/day (estradiol transdermal system). Each 9 cm2 system contains 0.77 mg of estradiol, USP for nominal delivery of 0.025 mg of estradiol per day when dosed in a twice weekly regimen.
NDC 52544-884-08 Patient Calendar Box of 8 Systems
Alora 0.05 mg/day (estradiol transdermal system). Each 18 cm2 system contains 1.5 mg of estradiol, USP for nominal delivery of 0.05 mg of estradiol per day when dosed in a twice weekly regimen.
NDC 52544-471-08 Patient Calendar Box of 8 Systems
NDC 52544-471-23 Patient Calendar Box of 24 Systems
Alora 0.075 mg/day (estradiol transdermal system). Each 27 cm2 system contains 2.3 mg of estradiol, USP for nominal delivery of 0.075 mg of estradiol per day when dosed in a twice weekly regimen.
NDC 52544-472-08 Patient Calendar Box of 8 Systems
Alora 0.1 mg/day (estradiol transdermal system). Each 36 cm2 system contains 3.1 mg of estradiol, USP for nominal delivery of 0.1 mg of estradiol per day when dosed in a twice weekly regimen.
NDC 52544-473-08 Patient Calendar Box of 8 Systems
Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F).
Do not store unpouched. Apply immediately upon removal from the protective pouch.
Discard used Alora (estradiol transdermal system) in household trash in a manner that prevents accidental application or ingestion by children, pets, or others.
Watson Pharma, Inc. A subsidiary of Watson Pharmaceuticals, Inc. Corona, CA 92880 USA. Revised: May 2005. FDA rev dtae: 5/19/2005This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 10/23/2008
Additional Alora Information
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