Race: Fourteen percent of patients in the North American Study were non-Caucasian.
No significant race-related differences in FARESTON effectiveness or safety were noted.
FARESTON is indicated for the treatment of metastatic breast cancer in postmenopausal women with estrogen-receptor positive or unknown tumors.
Stage IV Breast Cancer
-- Cancer has spread to other organs of the body, most often the bones, lungs, liver, or brain; or tumor has spread locally to the skin and lymph nodes inside the neck, near the collarbone.
-- New abnormal growth of tissue. Malignant neoplasms show a greater degree of anaplasia and have the properties of invasion and metastasis, compared to benign neoplasms.
FARESTON is contraindicated in patients with known hypersensitivity to the drug.
-- Altered reactivity to an antigen, which can result in pathologic reactions upon subsequent exposure to that particular antigen.
Hypercalcemia and Tumor Flare: As with other antiestrogens, hypercalcemia and tumor flare have been reported in some breast cancer patients with bone metastases during the first weeks of treatment with FARESTON.
Tumor flare is a syndrome of diffuse musculoskeletal pain and erythema with increased size of tumor lesions that later regress.
It is often accompanied by hypercalcemia.
Tumor flare does not imply failure of treatment or represent tumor progression.
If hypercalcemia occurs, appropriate measures should be instituted and if hypercalcemia is severe, FARESTON treatment should be discontinued.
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It should not to be used for self-diagnosis or treatment.