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Nolvadex

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Nolvadex

Indications
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INDICATIONS

Metastatic Breast Cancer

NOLVADEX (tamoxifen citrate) is effective in the treatment of metastatic breast cancer in women and men. In premenopausal women with metastatic breast cancer, NOLVADEX (tamoxifen citrate) 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 (tamoxifen citrate) therapy.

Adjuvant Treatment of Breast Cancer

NOLVADEX (tamoxifen citrate) is indicated for the treatment of node-positive breast cancer in women following total mastectomy or segmental mastectomy, axillary dissection, and breast irradiation. In some NOLVADEX (tamoxifen citrate) adjuvant studies, most of the benefit to date has been in the subgroup with four or more positive axillary nodes.

NOLVADEX (tamoxifen citrate) is indicated for the treatment of axillary node-negative breast cancer in women following total mastectomy or segmental mastectomy, axillary dissection, and breast irradiation.

The estrogen and progesterone receptor values may help to predict whether adjuvant NOLVADEX (tamoxifen citrate) therapy is likely to be beneficial.

NOLVADEX (tamoxifen citrate) reduces the occurrence of contralateral breast cancer in patients receiving adjuvant NOLVADEX (tamoxifen citrate) therapy for breast cancer.

Ductal Carcinoma in Situ (DCIS)

In women with DCIS, following breast surgery and radiation, NOLVADEX (tamoxifen citrate) is indicated to reduce the risk of invasive breast cancer (see BOXED WARNING at the beginning of the label). The decision regarding therapy with NOLVADEX (tamoxifen citrate) for the reduction in breast cancer incidence should be based upon an individual assessment of the benefits and risks of NOLVADEX (tamoxifen citrate) therapy.

Current data from clinical trials support five years of adjuvant NOLVADEX (tamoxifen citrate) therapy for patients with breast cancer.

Reduction in Breast Cancer Incidence in High Risk Women

NOLVADEX (tamoxifen citrate) is indicated to reduce the incidence of breast cancer in women at high risk for breast cancer. This effect was shown in a study of 5 years planned duration with a median follow-up of 4.2 years. Twenty-five percent of the participants received drug for 5 years. The longer-term effects are not known. In this study, there was no impact of tamoxifen on overall or breast cancer-related mortality (see BOXED WARNING at the beginning of the label).

NOLVADEX (tamoxifen citrate) is indicated only for high-risk women. “High risk” is defined as women at least 35 years of age with a 5-year predicted risk of breast cancer ≥ 1.67%, as calculated by the Gail Model.

Examples of combinations of factors predicting a 5-year risk ≥ 1.67% are:

Age 35 or older and any of the following combination of factors:
  • One first degree relative with a history of breast cancer, 2 or more benign biopsies, and a history of a breast biopsy showing atypical hyperplasia; or
  • At least 2 first degree relatives with a history of breast cancer, and a personal history of at least one breast biopsy; or
  • LCIS
Age 40 or older and any of the following combination of factors:
  • One first degree relative with a history of breast cancer, 2 or more benign biopsies, age at first live birth 25 or older, and age at menarche 11 or younger; or
  • At least 2 first degree relatives with a history of breast cancer, and age at first live birth 19 or younger; or
  • One first degree relative with a history of breast cancer, and a personal history of a breast biopsy showing atypical hyperplasia.
Age 45 or older and any of the following combination of factors:
  • At least 2 first degree relatives with a history of breast cancer and age at first live birth 24 or younger; or
  • One first degree relative with a history of breast cancer with a personal history of a benign breast biopsy, age at menarche 11 or less and age at first live birth 20 or more.
Age 50 or older and any of the following combination of factors:
  • At least 2 first degree relatives with a history of breast cancer; or
  • History of one breast biopsy showing atypical hyperplasia, and age at first live birth 30 or older and age at menarche 11 or less; or
  • History of at least two breast biopsies with a history of atypical hyperplasia, and age at first live birth 30 or more.
Age 55 or older and any of the following combination of factors:
  • One first degree relative with a history of breast cancer with a personal history of a benign breast biopsy, and age at menarche 11 or less; or
  • History of at least 2 breast biopsies with a history of atypical hyperplasia, and age at first live birth 20 or older.
Age 60 or older and:
  • 5-year predicted risk of breast cancer ≥ 1.67%, as calculated by the Gail Model.

For women whose risk factors are not described in the above examples, the Gail Model is necessary to estimate absolute breast cancer risk. Health Care Professionals can obtain a Gail Model Risk Assessment Tool by dialing 1-800-544-2007.

There are insufficient data available regarding the effect of NOLVADEX (tamoxifen citrate) on breast cancer incidence in women with inherited mutations (BRCA1, BRCA2) to be able to make specific recommendations on the effectiveness of NOLVADEX (tamoxifen citrate) in these patients.

After an assessment of the risk of developing breast cancer, the decision regarding therapy with NOLVADEX (tamoxifen citrate) for the reduction in breast cancer incidence should be based upon an individual assessment of the benefits and risks of NOLVADEX (tamoxifen citrate) therapy. In the NSABP P-1 trial, NOLVADEX (tamoxifen citrate) treatment lowered the risk of developing breast cancer during the follow-up period of the trial, but did not eliminate breast cancer risk (See Table 3 in CLINICAL PHARMACOLOGY).

DOSAGE AND ADMINISTRATION

For patients with breast cancer, the recommended daily dose is 20-40 mg. Dosages greater than 20 mg per day should be given in divided doses (morning and evening).

In three single agent adjuvant studies in women, one 10 mg NOLVADEX (tamoxifen citrate) tablet was administered two (ECOG and NATO) or three (Toronto) times a day for two years. In the NSABP B-14 adjuvant study in women with node-negative breast cancer, one 10 mg NOLVADEX (tamoxifen citrate) tablet was given twice a day for at least 5 years. Results of the B-14 study suggest that continuation of therapy beyond five years does not provide additional benefit (see CLINICAL PHARMACOLOGY). In the EBCTCG 1995 overview, the reduction in recurrence and mortality was greater in those studies that used tamoxifen for about 5 years than in those that used tamoxifen for a shorter period of therapy. There was no indication that doses greater than 20 mg per day were more effective. Current data from clinical trials support 5 years of adjuvant NOLVADEX (tamoxifen citrate) therapy for patients with breast cancer.

Ductal Carcinoma in Situ (DCIS)

The recommended dose is NOLVADEX (tamoxifen citrate) 20 mg daily for 5 years.

Reduction in Breast Cancer Incidence in High Risk Women

The recommended dose is NOLVADEX (tamoxifen citrate) 20 mg daily for 5 years. There are no data to support the use of NOLVADEX (tamoxifen citrate) other than for 5 years (See CLINICAL PHARMACOLOGY-Clinical Studies - Reduction in Breast Cancer Incidence in High Risk Women).

HOW SUPPLIED

10 mg Tablets containing tamoxifen as the citrate in an amount equivalent to 10 mg of tamoxifen (round, biconvex, uncoated, white tablet identified with NOLVADEX (tamoxifen citrate) 600 debossed on one side and a cameo debossed on the other side) are supplied in bottles of 60 tablets. NDC 0310-0600-60.

20 mg Tablets containing tamoxifen as the citrate in an amount equivalent to 20 mg of tamoxifen (round, biconvex, uncoated, white tablet identified with NOLVADEX (tamoxifen citrate) 604 debossed on one side and a cameo debossed on the other side) are supplied in bottles of 30 tablets. NDC 0310-0604-30.

Store at controlled room temperature, 20-25°C (68-77°F) [see USP]. Dispense in a well-closed, light-resistant container.

*Coumadin® is a registered trademark of Bristol-Myers Squibb Pharmaceuticals. All other trademarks are the property of the AstraZeneca group, AstraZeneca Pharmaceuticals LP Wilmington, Delaware 19850-5437. Rev 09-27-05. FDA revision date: 3/9/2006

Last reviewed on RxList: 4/10/2008
This monograph has been modified to include the generic and brand name in many instances.

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