Home » Drug Information » FDA Approved Drugs » 1998
Medical Areas: Oncology
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The following drug information is obtained from various newswires, published
medical journal articles, and medical conference presentations.
Approval Status: Approved October 1998
Treatment Area: Oncology
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
Adverse reactions to Nolvadex are relatively mild and rarely
severe enough to require discontinuation of treatment in breast
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.