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Soltamox

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Soltamox

Indications
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INDICATIONS

Metastatic Breast Cancer

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

Adjuvant Treatment of Breast Cancer

Tamoxifen citrate 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 tamoxifen citrate adjuvant studies, most of the benefit to date has been in the subgroup with four or more positive axillary nodes.

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 tamoxifen citrate therapy is likely to be beneficial.

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

Ductal Carcinoma in Situ (DCIS)

In women with DCIS, following breast surgery and radiation, 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 tamoxifen for the reduction in breast cancer incidence should be based upon an individual assessment of the benefits and risks of tamoxifen therapy.

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

Reduction in Breast Cancer Incidence in High Risk Women

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).

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 1-800-833-3533.

There are no data available regarding the effect of tamoxifen citrate on breast cancer incidence in women with inherited mutations (BRCAl, BRCA2).

After an assessment of the risk of developing breast cancer, the decision regarding therapy with tamoxifen citrate for the reduction in breast cancer incidence should be based upon an individual assessment of the benefits and risks of tamoxifen citrate therapy. In the NSABP P-1 trial, 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). A 20 mg dose of SOLTAMOX™ (tamoxifen citrate) is administered as 10 mL (equivalent to 2 teaspoons) of the oral solution.

In three single agent adjuvant studies in women, one 10 mg 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 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 tamoxifen citrate therapy for patients with breast cancer.

Ductal Carcinoma in Situ (DCIS)

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

Reduction in Breast Cancer Incidence in High Risk Women

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

HOW SUPPLIED

SOLTAMOX™ (tamoxifen citrate) Oral Solution is a sugar-free, clear colorless liquid, with licorice and aniseed odor and taste. It is supplied in a 150mL bottle, each 5mL solution contains 15.2 mg tamoxifen citrate, equivalent to 10 mg tamoxifen.

NDC #13632-123-01

Do not store above 25° C (77° F).

Store in the original package in order to protect from light.

Use within 3 months of opening.

Storage: DO NOT freeze or refrigerate.

Manufactured by: Rosemont Pharmaceuticals Ltd, Yorkdale Industrial Park, Braithwaite Street, Leeds, LS11 9XE, UK. Manufactured for: Savient Pharmaceuticals, Inc., One Tower Center, Fourteenth Floor, East Brunswick, NJ 08816, USA. Distributed by: Cytogen Corporation, Princeton, NJ 08540, USA. Address medical inquiries to: Savient Pharmaceuticals, Inc. One Tower Center, Fourteenth Floor, East Brunswick, NJ 08816, USA. 1-800-284-2480. FDA Rev date: 3/9/2006

Last reviewed on RxList: 11/24/2008
This monograph has been modified to include the generic and brand name in many instances.

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