Vivelle-DOT (Estradiol) - Indications and Dosage

INDICATIONS AND USAGE

Vivelle-Dot^® (estradiol transdermal system) is indicated in:

1. Treatment of moderate to severe vasomotor symptoms associated with the menopause.
   
2. 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.
   
3. Treatment of hypoestrogenism due to hypogonadism, castration, or primary ovarian failure.
   
4. 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. 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

The adhesive side of Vivelle-Dot^® (estradiol transdermal system) should be placed on a clean, dry area of the abdomen. Vivelle -Dot should not be applied to the breasts. Vivelle-Dot should be replaced twice weekly. The sites of application must 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 protective 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 the same system cannot be reapplied, a new system should be applied to another location. In either case, the original treatment schedule should be continued. If a woman has forgotten to apply a patch, she should apply a new patch as soon as possible. The new patch should be applied on the original treatment schedule. The interruption of treatment in women taking Vivelle-Dot might increase the likelihood of breakthrough bleeding, spotting and recurrence of symptoms.

Initiation of Therapy

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 with the lowest effective dose and 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 whether 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.

      Patients should be started at the lowest dose. The lowest effective dose of Vivelle-Dot has not been determined for any indication. For treatment of moderate to severe vasomotor symptoms and vulvar and vaginal atrophy associated with the menopause, start therapy with Vivelle-Dot 0.0375 mg/day applied to the skin twice weekly. For the prevention of postmenopausal osteoporosis, start therapy with Vivelle-Dot 0.025 mg/day applied to the skin twice weekly. The dosage may be adjusted as necessary. Reproductive system-associated adverse events were encountered more frequently in the highest dose group (0.1 mg/day) than in other active treatment groups or in placebo-treated patients.

      In women not currently taking oral estrogens or in women switching from another estradiol transdermal therapy, treatment with Vivelle-Dot may be initiated at once. In women who are currently taking oral estrogens, treatment with Vivelle-Dot should be initiated 1 week after withdrawal of oral hormone therapy, or sooner if menopausal symptoms reappear in less than 1 week.

Therapeutic Regimen

Vivelle-Dot may be given continuously in patients who do not have an intact uterus. In those patients with an intact uterus, Vivelle-Dot may be given on a cyclic schedule (e.g., three weeks on drug followed by one week off drug).

HOW SUPPLIED

Vivelle -Dot ^® (estradiol transdermal system), 0.025 mg/day  - each 2.5 cm² system contains 0.39 mg of estradiol USP for nominal* delivery of 0.025 mg of estradiol per day.

Patient Calendar Pack of 8 Systems……………………………………….NDC 0078-0365-42

Carton of 3 Patient Calendar Packs of 8 Systems…………………………NDC 0078-0365-45

Vivelle -Dot ^® (estradiol transdermal system), 0.0375 mg/day  - each 3.75 cm² system contains 0.585 mg of estradiol USP for nominal* delivery of 0.0375 mg of estradiol per day.

Patient Calendar Pack of 8 Systems……………………………………….NDC 0078-0343-42

Carton of 3 Patient Calendar Packs of 8 Systems…………………………NDC 0078-0343-45

Vivelle -Dot ^® (estradiol transdermal system), 0.05 mg/day  - each 5.0 cm² system contains 0.78 mg of estradiol USP for nominal* delivery of 0.05 mg of estradiol per day.

Patient Calendar Pack of 8 Systems……………………………………….NDC 0078-0344-42

Carton of 3 Patient Calendar Packs of 8 Systems…………………………NDC 0078-0344-45

Vivelle -Dot ^® (estradiol transdermal system), 0.075 mg/day  - each 7.5 cm² system contains 1.17 mg of estradiol USP for nominal* delivery of 0.075 mg of estradiol per day.

Patient Calendar Pack of 8 Systems……………………………………….NDC 0078-0345-42

Carton of 3 Patient Calendar Packs of 8 Systems…………………………NDC 0078-0345-45

Vivelle -Dot ^® (estradiol transdermal system), 0.1 mg/day  - each 10.0 cm² system contains 1.56 mg of estradiol USP for nominal* delivery of 0.1 mg of estradiol per day.

Patient Calendar Pack of 8 Systems……………………………………….NDC 0078-0346-42

Carton of 3 Patient Calendar Packs of 8 Systems…………………………NDC 0078-0346-45

________________________________________

*See DESCRIPTION.

Store at controlled room temperature at 25ºC (77°F).

Do not store unpouched. Apply immediately upon removal from the protective pouch.

REV: AUGUST 2004                                         T2004-65