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EVISTA should be discontinued at least 72 hours prior to and during prolonged immobilization (e. Hot Flashes Or Flushes. EVISTA may increase the incidence of hot flashes and is not effective in reducing hot flashes or flushes associated with estrogen deficiency. In some asymptomatic patients, hot flashes may occur upon beginning EVISTA therapy. Reduction In Risk of Invasive Breast Cancer in Postmenopausal Women with Osteoporosis Or At High Risk Of Invasive Breast Cancer. Use of EVISTA is associated with the reduction of the risk of invasive breast cancer in postmenopausal women. EVISTA has not been shown to reduce the risk of noninvasive breast cancer. When considering treatment, physicians need to discuss the potential benefits and risks of EVISTA treatment with the patient. EVISTA is not indicated for the treatment of invasive breast cancer or reduction of the risk of recurrence. Patients should have breast exams and mammograms before starting EVISTA and should continue regular breast exams and mammograms in keeping with good medical practice after beginning treatment with EVISTA. Carcinogenesis Mutagenesis, Impairment Of Fertility. In a 21-month carcinogenicity study in mice, there was an increased incidence of ovarian tumors in female animals given 9 to 242 mg/kg, which included benign and malignant tumors of granulosa/theca cell origin and benign tumors of epithelial cell origin. Systemic exposure (AUC) of raloxifene in this group was 0. There was also an increased incidence of testicular interstitial cell tumors and prostatic adenomas and adenocarcinomas in male mice given 41 or 210 mg/kg (4. In a 2-year carcinogenicity study in rats, an increased incidence in ovarian tumors of granulosa/theca cell origin was observed in female rats given 279 mg/kg (approximately 400 times the AUC in humans). The female rodents in these studies were treated during their reproductive lives when their ovaries were functional and responsive to hormonal stimulation. Raloxifene HCl was not genotoxic in any of the following test systems: the Ames test for bacterial mutagenesis with and without metabolic activation, the unscheduled DNA synthesis assay in rat hepatocytes, the mouse lymphoma assay for mammalian cell mutation, the chromosomal aberration assay in Chinese hamster ovary cells, the in vivo sister chromatid exchange assay in Chinese hamsters, and the in vivo micronucleus test in mice. When male and female rats were given daily doses ? 5 mg/kg ( ? 0. In male rats, daily doses up to 100 mg/kg (16 times the human dose based on surface area, mg/m) for at least 2 weeks did not affect sperm production or quality or reproductive performance., testo e 250 e10d. In female rats, at doses of 0. These effects of raloxifene were reversible. In another study in rats in which raloxifene was given during the preimplantation period at doses ? 0. The reproductive and developmental effects observed in animals are consistent with the estrogen receptor activity of raloxifene. Use In Specific Populations. EVISTA should not be used in women who are or may become pregnant [see CONTRAINDICATIONS ].
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