10 mg tablets containing tamoxifen as citrate in an amount equivalent to 10 mg tamoxifen (white, round, biconvex, uncoated tablet identified NOLVADEX (tamoxifen citrate) 600, imprinted on one side and cut on the other side ) They are supplied in bottles of 60 tablets. NDC 0310-0600-60.
20 mg tablets containing tamoxifen as citrate in an amount equivalent to 20 mg tamoxifen (white, round, biconvex, uncoated tablet identified NOLVADEX (tamoxifen citrate) 604, imprinted on one side and cut on the other side) supplied in bottles of 30 NDC 0310 -0604-30 tablets.
Store at controlled room temperature, 20-25°C (68-77°F). Pour into a well-sealed, easy-to-hold container.
*Coumadin® is a registered trademark of Bristol-Myers Squibb Pharmaceuticals. All other trademarks are owned by AstraZeneca Group, AstraZeneca Pharmaceuticals LP Wilmington, Delaware, 19850-5437. Rev. 09-27-05. FDA revision date: 09/03/2006
Metastatic breast cancer
NOLVADEX (tamoxifen citrate) is effective in the treatment of metastatic breast cancer in both women and men. In premenopausal women with metastatic breast cancer, NOLVADEX (tamoxifen citrate) is an alternative to ovariectomy or radiation therapy to the ovary. The available evidence indicates that patients whose tumors are estrogen receptor positive are more likely to benefit from treatment with NOLVADEX (tamoxifen citrate).
Adjuvant treatment of breast cancer
NOLVADEX (tamoxifen citrate) is indicated for the treatment of women with infected lymph nodes after total or segmental mastectomy, axillary dissection and breast irradiation. In some adjuvant studies of NOLVADEX (tamoxiphencitrate), most dat benefit was in the subgroup with four or more positive axillary lymph nodes.
NOLVADEX (tamoxifen citrate) is indicated for the treatment of axillary nodeless breast cancer in women following total or segmental mastectomy, axillary dissection, and breast radiation.
Estrogen receptor and progesterone receptor titers can help predict whether adjuvant therapy with NOLVADEX (tamoxifen citrate) is likely to be beneficial.
NOLVADEX (tamoxifen citrate) reduces the occurrence of contralateral breast cancer in patients receiving adjuvant therapy with NOLVADEX (tamoxifen citrate) for breast cancer.
Ductal carcinoma in situ (DCIS)
In women with DCIS, following breast surgery and radiation therapy, NOLVADEX (tamoxifen citrate) is indicated to reduce the risk of invasive breast cancer (see INSERT WARNING at beginning of label). The decision about treatment with NOLVADEX (tamoxifen citrate) to reduce the incidence of breast cancer should be based on an individual assessment of the benefits and risks of treatment with NOLVADEX (tamoxifen citrate).
Current clinical trial data supports five years of NOLVADEX (tamoxifen citrate) adjuvant therapy for breast cancer patients.
Decreased incidence of breast cancer in high-risk women
NOLVADEX (tamoxifen citrate) is indicated to reduce the incidence of breast cancer in women at high risk of developing breast cancer. This effect was demonstrated in a 5-year planned study with an average follow-up of 4.2 years. Twenty-five percent of participants had received the drug for 5 years. Long term effects are not known. In this study, tamoxifen had no effect on overall or breast cancer mortality (see WARNING ADDENDUM at front of label).
NOLVADEX (tamoxifen citrate) is indicated only in women at high risk. “High risk” is defined as women aged 35 or older with a 5-year projected risk of developing breast cancer ≥ 1.67%, calculated using Gale’s model.
Examples of combinations of factors predicting a 5-year risk ≥ 1.67%:
- 35 years or older and one of the following combinations of factors:
- A first-degree relative with a history of breast cancer, 2 or more benign biopsies, and a breast biopsy showing atypical hyperplasia; Where
- At least 2 first-degree relatives with a history of breast cancer and a personal history of at least one breast biopsy; Where
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