ABOUT ORTHO-PREFEST®
 (17ß-estradiol/norgestimate) Tablets

ORTHO-PREFEST® (17ß-estradiol/norgestimate) Tablets offers a once-daily, single-tablet, hormone replacement therapy (HRT) regimen of constant estrogen/intermittent progestin.

Approved by the U.S. Food and Drug Administration in October 1999, ORTHO-PREFEST is indicated in women with an intact uterus for the treatment of moderate to severe vasomotor symptoms associated with the menopause, treatment of vulvar and vaginal atrophy (hormonal changes in the female genitalia) and prevention of osteoporosis (thinning and weakening of bones).

The estrogen component of ORTHO-PREFEST, 17ß-estradiol (1 mg), a natural estrogen derived from plant sources, is administered once daily. The progestin component, norgestimate (0.09 mg), is dosed on an intermittent basis—3 days off and 3 days on—in a continuously repeated pattern throughout therapy.

ORTHO-PREFEST is the only HRT (Hormone Replacement Therapy) to use norgestimate—introduced in oral contraceptives in 1992 as the first new progestin in 20 years, and today used in the #1 prescribed birth control pill in the United States. Norgestimate minimizes androgenic side effects such as weight gain, acne, and hirsutism (facial hair growth) in oral contraceptive use.

In ORTHO-PREFEST, 17ß-estradiol becomes available for the first time in the United States for oral HRT. However, it is the most widely prescribed oral estrogen for HRT in Europe, with almost 30 years of established efficacy and safety. Because 17ß-estradiol is the predominant estrogen secreted by the human ovary during the reproductive years, ORTHO-PREFEST can be thought of as furnishing the same form of estrogen the menopausal woman once produced herself.

ORTHO-PREFEST is available by prescription in a convenient one tablet-per-day blistercard.


ABOUT CLINICAL TRIALS, SAFETY AND TOLERABILITY

During clinical trials of postmenopausal women, ORTHO-PREFEST was proven safe and effective in reducing hot flashes and providing relief from vaginal atrophy. Additionally, ORTHO-PREFEST decreased the risk of endometrial hyperplasia versus estrogen alone therapy.

The most commonly reported side effects during one year of treatment were headache, breast pain and abdominal pain.

HRT is not suitable for all women. Women should talk to their health care professional before starting HRT.

Estrogens should not be used in women with known or suspected pregnancy, breast cancer, or estrogen-dependent neoplasia; undiagnosed abnormal genital bleeding; active or past history of thrombophlebitis; or thromboembolic disorders. Estrogens have been reported to increase the risk of serious side effects including thromboembolic disorders, breast cancer and endometrial carcinoma in postmenopausal women. Progestin taken with estrogen significantly reduces but does not eliminate the risk of endometrial cancer that is associated with the use of estrogen.

Please see Full U.S. Prescribing Information.


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