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Home » Drug Information » FDA Approved Drugs » 1998
Medical Areas: Oncology

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Nolvadex

The following drug information is obtained from various newswires, published medical journal articles, and medical conference presentations.

Company: AstraZeneca
Approval Status: Approved October 1998
Treatment Area: Oncology

General Information

Nolvadex reduces the incidence of breast cancer in women at high risk for breast cancer.

Nolvadex is effective in the treatment of metastatic breast cancer in women and men. In premenopausal women with metastatic breast cancer, Nolvadex is an alternative to oophorectomy or ovarian irradiation. Available evidence indicates that patients whose tumors are estrogen receptor positive are more likely to benefit from Nolvadex therapy. Adjuvant Treatment of Breast Cancer: Nolvadex is indicated for the treatment of node-positive breast cancer in postmenopausal women following total mastectomy or segmental mastectomy, axillary dissection, and breast irradiation. In some NOLVADEX adjuvant studies, most of the benefit to date has been in the subgroup with 4 or more positive axillary nodes. Nolvadex is indicated for the treatment of axillary node-negative breast cancer in women following total mastectomy or segmental mastectomy, axillary dissection, and breast irradiation. Data are insufficient to predict which women are most likely to benefit and to determine if Nolvadex provides any benefit in women with tumors less than 1 cm. Nolvadex reduces the occurrence of contralateral breast cancer in patients receiving adjuvant Nolvadex therapy for breast cancer.

Side Effects

Adverse reactions to Nolvadex are relatively mild and rarely severe enough to require discontinuation of treatment in breast cancer patients.

Additional Information

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. 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. Women taking Nolvadex as treatment for metastatic breast cancer should review this monitoring plan with their care provider and select the appropriate modalities and schedule of evaluation.