Indications
Cytotam is indicated in the treatment of some types of Breast Cancer.
Metastatic Breast Cancer
Cytotam is indicated in the treatment of metastatic breast cancer in women and men. In premenopausal women with metastatic breast cancer, Cytotam 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.
Reduction in Breast Cancer Incidence in High Risk Women
Cytotam 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 .
Cytotam 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.
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. 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. Current data from clinical trials support five years of adjuvant tamoxifen citrate therapy for patients with breast cancer.
Adjuvant Treatment of Breast Cancer
Cytotam is indicated for the treatment of node-positive breast cancer in women following total mastectomy or segmental mastectomy, axillary dissection , and breast irradiation.
Cytotam 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.
Cytotam reduces the occurrence of contralateral breast cancer in patients receiving adjuvant tamoxifen citrate therapy for breast cancer.
Warnings
Before you start a treatment with Cytotam, you should inform your personal physician if you have allergic reactions to other medicines or if you are suffering from:
- A history of blood clot or stroke;
- A history of cataract;
- High levels of fatty acids (triglycerides) in your blood;
- If you are currently receiving radiation treatment or chemotherapy;
- Liver disorders;
Taking Cytotam is known to increase the risk of developing of:
- Ablood clotting problems;
- Disorders that can sometimes be lethal;
- Stroke;
- Uterine cancer;
Drug Interactions
Before you start taking Cytotam, you should alert your personal physician if you are taking any of the following:
- Rifampin (Rifadin Rifamate Rifater Rimactane);
- Letrozole (Femara);
- Bromocriptine (Parlodel);
- Anastrozole (Arimidex);
- Aminoglutethimide (Cytadren);
- A blood thinner (warfarin Coumadin);
Dosage
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 Cytotam tablet was administered two ( ECOG and NATO) or three ( Toronto ) times a day for two 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.
Ductal Carcinoma in Situ (DCIS)
The recommended dose is tamoxifen citrate 20 mg daily for 5 years.
Contraindications
Reduction in Breast Cancer Incidence in High Risk Women and Women with DCIS.
Cytotam is contraindicated in patients with known hypersensitivity to Cytotam or any of its ingredients.
Cytotam is contraindicated in women who require concomitant coumarin-type anticoagulant therapy or in women with a history of deep vein thrombosis or pulmonary embolus .
