Activella (Estradiol) - Indications and Dosage

INDICATIONS AND USAGE

Activella 1.0 mg/0.5 mg and 0.5 mg/0.1 mg are indicated in women who have a uterus for the:

1. Treatment of moderate to severe vasomotor symptoms associated with menopause.

2. 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.

Activella 1.0 mg/0.5 mg is also indicated in women who have a uterus for the:

3. Treatment of moderate to severe symptoms of vulvar and vaginal atrophy associated with menopause. When used solely for the treatment of symptoms of vulvar and vaginal atrophy, topical vaginal products should be considered.

DOSAGE AND ADMINISTRATION

Use of estrogen, alone or in combination with a progestin, should be with the lowest effective dose and for the shortest duration consistent with treatment goals and risks for the individual woman. Patients should be re-evaluated periodically as clinically appropriate (e.g., 3 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.

Activella therapy consists of a single tablet to be taken once daily.

1. For the treatment of moderate to severe vasomotor symptoms associated with menopause, and the 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.

• Activella 1.0 mg/0.5 mg
• Activella 0.5 mg/0.1 mg

2. For the treatment of moderate to severe symptoms of vulvar and vaginal atrophy. When used solely for the treatment of symptoms of vulvar and vaginal atrophy, topical vaginal products should be considered.

• Activella 1.0 mg/0.5 mg

Patients should be started at the lowest dose.

HOW SUPPLIED

Activella 1.0 mg/0.5 mg is a white, film-coated tablet, engraved with NOVO 288 on one side and the APIS bull on the other. It is round, 6mm in diameter and bi-convex. (NDC 0169-5174-02). It is supplied as 28 tablets in a calendar dial pack dispenser. Store in a dry place protected from light.

Activella 0.5 mg/0.1 mg is a white, film-coated tablet, engraved with NOVO 291 on one side and the APIS bull on the other. It is round, 6mm in diameter and bi-convex. (NDC 0169-5175-10). It is supplied as 28 tablets in a calendar dial pack dispenser. Keep the container in the outer carton.

Store at 25°C (77°F), excursions permitted to 15-30°C (59-86°F). [See USP Controlled Room Temperature.]

© 2000-2006 Novo Nordisk Inc.

Activella is a trademark owned by Novo Nordisk FemCare AG

Revised December 2006

Version 7

Novo Nordisk Inc.

Princeton, NJ 08540

1-866-668-6336

www.novonordisk-us.com

Manufactured by

Novo Nordisk A/S

2880 Bagsvaerd, Denmark