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Women who are considering Nolvadex therapy should consult their health care professional for an assessment of the potential benefits and risks prior to starting therapy for reduction in breast cancer incidence (See Table 3in CLINICAL PHARMACOLOGY ). Women should understand that Nolvadex reduces the incidence of breast cancer, but may not eliminate risk. Nolvadex decreased the incidence of small estrogen receptor positive tumors, but did not alter the incidence of estrogen receptor negative tumors or larger tumors. In women with breast cancer who are at high risk of developing a second breast cancer, treatment with about 5 years of Nolvadex reduced the annual incidence rate of a second breast cancer by approximately 50%. Women who are pregnant or who plan to become pregnant should not take Nolvadex to reduce her risk of breast cancer. Effective nonhormonal contraception must be used by all premenopausal women taking Nolvadex and for approximately two months after discontinuing therapy if they are sexually active. Tamoxifen does not cause infertility, even in the presence of menstrual irregularity. For sexually active women of child-bearing potential, Nolvadex therapy should be initiated during menstruation. In women with menstrual irregularity, a negative B-HCG immediately prior to the initiation of therapy is sufficient (See WARNINGS-Pregnancy Category D ). Two European trials of tamoxifen to reduce the risk of breast cancer were conducted and showed no difference in the number of breast cancer cases between the tamoxifen and placebo arms. These studies had trial designs that differed from that of NSABP P-1, were smaller than NSABP P-1, and enrolled women at a lower risk for breast cancer than those in P-1. Monitoring During Nolvadex Therapy: Women taking or having previously taken Nolvadex should be instructed to seek prompt medical attention for new breast lumps, vaginal bleeding, gynecologic symptoms (menstrual irregularities, changes in vaginal discharge, or pelvic pain or pressure), symptoms of leg swelling or tenderness, unexplained shortness of breath, or changes in vision, buy proviron 25 mg oral steroids proviron. Women should inform all care providers, regardless of the reason for evaluation, that they take Nolvadex. Women taking Nolvadex to reduce the incidence of breast cancer should have a breast examination, a mammogram, and a gynecologic examination prior to the initiation of therapy. These studies should be repeated at regular intervals while on therapy, in keeping with good medical practice. Women taking Nolvadex as adjuvant breast cancer therapy should follow the same monitoring procedures as for women taking Nolvadex for the reduction in the incidence of breast cancer. 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