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WARNINGS

Included as part of the PRECAUTIONS section.

PRECAUTIONS

Cardiovascular Disease

EVISTA (raloxifene) should not be used for the primary or secondary prevention of cardiovascular disease. In a clinical trial of postmenopausal women with documented coronary heart disease or at increased risk for coronary events, no cardiovascular benefit was demonstrated after treatment with raloxifene for 5 years [see Clinical Studies].

Venous Thromboembolism

In clinical trials, EVISTA (raloxifene) -treated women had an increased risk of venous thromboembolism (deep vein thrombosis and pulmonary embolism). Other venous thromboembolic events also could occur. A less serious event, superficial thrombophlebitis, also has been reported more frequently with EVISTA (raloxifene) . The greatest risk for deep vein thrombosis and pulmonary embolism occurs during the first 4 months of treatment, and the magnitude of risk appears to be similar to the reported risk associated with use of hormone therapy. Because immobilization increases the risk for venous thromboembolic events independent of therapy, EVISTA (raloxifene) should be discontinued at least 72 hours prior to and during prolonged immobilization (e.g., post-surgical recovery, prolonged bed rest), and EVISTA (raloxifene) therapy should be resumed only after the patient is fully ambulatory. In addition, women taking EVISTA (raloxifene) should be advised to move about periodically during prolonged travel. The risk-benefit balance should be considered in women at risk of thromboembolic disease for other reasons, such as congestive heart failure, superficial thrombophlebitis, and active malignancy [see CONTRAINDICATIONS, ADVERSE REACTIONS].

Death Due to Stroke

In a clinical trial of postmenopausal women with documented coronary heart disease or at increased risk for coronary events, an increased risk of death due to stroke was observed after treatment with EVISTA (raloxifene) . During an average follow-up of 5.6 years, 59 (1.2%) EVISTA (raloxifene) -treated women died due to a stroke compared to 39 (0.8%) placebo-treated women (22 versus 15 per 10,000 women-years; hazard ratio 1.49; 95% confidence interval, 1.00- 2.24; p=0.0499). There was no statistically significant difference between treatment groups in the incidence of stroke (249 in EVISTA (raloxifene) [4.9%] versus 224 placebo [4.4%]). EVISTA (raloxifene) had no significant effect on all-cause mortality. The risk-benefit balance should be considered in women at risk for stroke, such as prior stroke or transient ischemic attack (TIA), atrial fibrillation, hypertension, or cigarette smoking [see Clinical Studies].

Premenopausal Use

There is no indication for premenopausal use of EVISTA (raloxifene) . Safety of EVISTA (raloxifene) in premenopausal women has not been established and its use is not recommended.

Renal Impairment

EVISTA (raloxifene) should be used with caution in patients with moderate or severe renal impairment. Safety and efficacy have not been established in patients with moderate or severe renal impairment [see CLINICAL PHARMACOLOGY].

Hepatic Impairment

EVISTA (raloxifene) should be used with caution in patients with hepatic impairment. Safety and efficacy have not been established in patients with hepatic impairment [see CLINICAL PHARMACOLOGY].

Concomitant Estrogen Therapy

The safety of concomitant use of EVISTA (raloxifene) with systemic estrogens has not been established and its use is not recommended.

History of Hypertriglyceridemia when Treated with Estrogens

Limited clinical data suggest that some women with a history of marked hypertriglyceridemia (> 5.6 mmol/L or > 500 mg/dL) in response to treatment with oral estrogen or estrogen plus progestin may develop increased levels of triglycerides when treated with EVISTA (raloxifene) . Women with this medical history should have serum triglycerides monitored when taking EVISTA (raloxifene) .

History of Breast Cancer

EVISTA (raloxifene) has not been adequately studied in women with a prior history of breast cancer.

Use in Men

There is no indication for the use of EVISTA (raloxifene) in men. EVISTA (raloxifene) has not been adequately studied in men and its use is not recommended.

Unexplained Uterine Bleeding

Any unexplained uterine bleeding should be investigated as clinically indicated. EVISTA (raloxifene) -treated and placebo-treated groups had similar incidences of endometrial proliferation [see Clinical Studies].

Breast Abnormalities

Any unexplained breast abnormality occurring during EVISTA (raloxifene) therapy should be investigated. EVISTA (raloxifene) does not eliminate the risk of breast cancer [see Clinical Studies].

NonClinical Toxicology

Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenesis — 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 0.3 to 34 times that in postmenopausal women administered a 60 mg dose. 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 (4.7 or 24 times the AUC in humans) and prostatic leiomyoblastoma in male mice given 210 mg/kg.

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.

Mutagenesis — 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.

Impairment of Fertility — When male and female rats were given daily doses ≥ 5 mg/kg (≥ 0.8 times the human dose based on surface area, mg/m2) prior to and during mating, no pregnancies occurred. In male rats, daily doses up to 100 mg/kg (16 times the human dose based on surface area, mg/m2) for at least 2 weeks did not affect sperm production or quality or reproductive performance. In female rats, at doses of 0.1 to 10 mg/kg/day (0.02 to 1.6 times the human dose based on surface area, mg/m2), raloxifene disrupted estrous cycles and inhibited ovulation. These effects of raloxifene were reversible. In another study in rats in which raloxifene was given during the preimplantation period at doses ≥ 0.1 mg/kg (≥ 0.02 times the human dose based on surface area, mg/m2), raloxifene delayed and disrupted embryo implantation, resulting in prolonged gestation and reduced litter size. The reproductive and developmental effects observed in animals are consistent with the estrogen receptor activity of raloxifene.

Use In Specific Populations

Pregnancy

Pregnancy Category X. EVISTA (raloxifene) should not be used in women who are or may become pregnant [see CONTRAINDICATIONS].

Nursing Mothers

EVISTA (raloxifene) should not be used by lactating women [see CONTRAINDICATIONS]. It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when raloxifene is administered to a nursing woman.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

Geriatric Use

Of the total number of patients in placebo-controlled clinical studies of EVISTA (raloxifene) , 61% were 65 and over, while 15.5% were 75 and over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. Based on clinical trials, there is no need for dose adjustment for geriatric patients [see CLINICAL PHARMACOLOGY].

Renal Impairment

EVISTA (raloxifene) should be used with caution in patients with moderate or severe renal impairment [see Warnings and PRECAUTIONS and CLINICAL PHARMACOLOGY].

Hepatic Impairment

EVISTA (raloxifene) should be used with caution in patients with hepatic impairment [see Warnings and PRECAUTIONS and CLINICAL PHARMACOLOGY].

Last reviewed on RxList: 9/26/2007
This monograph has been modified to include the generic and brand name in many instances.

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