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Evista Uses.

For the treatment and prevention of osteoporosis in postmenopausal women.
Evista (Raloxifene) is a selective estrogen receptor modulator (SERM) that belongs to the benzothiophene class of compounds. The SERM profile of raloxifene includes estrogen agonist effects on bone and lipid metabolism but not in uterine or breast tissues.

Evista Contraindications.

In women of childbearing potential. Evista (raloxifene) therapy during pregnancy may be associated with an increased risk of congenital defects in the fetus.
evista (Raloxifene) is contraindicated in women with active or past history of venous thromboembolic events, including deep vein thrombosis, pulmonary embolism and retinal vein thrombosis.
Evista (Raloxifene) is contraindicated in women known to be hypersensitive to raloxifene or other constituents of the tablets.

Evista Cautions.

In clinical trials, raloxifene-treated women had an increased risk of venous thromboembolism (deep vein thrombosis and pulmonary embolism). Other venous thromboembolic events could also occur. A less serious event, superficial thrombophlebitis, also has been reported more frequently with raloxifene. The greatest risk for deep vein thrombosis and pulmonary embolism occurs during the first 4 months of treatment, and the magnitude of risk is similar to that associated with use of hormone replacement therapy. Evista (Raloxifene) should be discontinued at least 72 hours prior to and during prolonged immobilization (e.g., postsurgical recovery, prolonged bed rest) and raloxifene therapy should be resumed only after the patient is fully ambulatory. The risk-benefit balance should be considered in women at risk of thromboembolic disease for other reasons.
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.
Evista (Raloxifene) was studied, as a single dose, in Child-Pugh Class A patients with cirrhosis and serum total bilirubin ranging from 0.6 to 2 mg/dL (10.3 to 34.2 µmol/L). Plasma raloxifene concentrations were approximately 2.5 times higher than in controls and correlated with total bilirubin concentrations. Safety and efficacy have not been evaluated further in patients with hepatic insufficiency.

Evista Directions. 

The concurrent use of raloxifene and systemic estrogen or hormone replacement therapy (ERT or HRT) has not been studied in prospective clinical trials.
Lipid Metabolism: Raloxifene lowers serum total and LDL cholesterol by 6 to 11%, but does not affect serum concentrations of total HDL cholesterol or triglycerides. HDL-2 cholesterol subfraction is increased by raloxifene. These effects should be taken into account in therapeutic decisions for patients who may require therapy for hyperlipidemia. Concurrent use of raloxifene and lipid lowering agents has not been studied.
Evista (Raloxifene) does not cause endometrial proliferation. Unexplained uterine bleeding should be investigated as clinically indicated.
Evista (Raloxifene) is not associated with breast enlargement, breast pain, or increased risk of breast cancer . Any unexplained breast abnormality occurring during raloxifene therapy should be investigated.
Evista (Raloxifene) has not been studied in women with a prior history of breast cancer.
Evista (Raloxifene) has not been associated with deterioration of cognitive function or a change in affect. Any such change during raloxifene use is unlikely to be related to therapy, and should be investigated as clinically indicated.
There is no indication for use of Evista (Raloxifene) in men.
Evista (Raloxifene) should not be used in pediatric patients.
In the osteoporosis treatment trial of 7705 postmenopausal women, 4621 women were considered geriatric (greater than 65 years old). Of these, 845 women were greater than 75 years old. Safety and efficacy in older and younger postmenopausal women in the osteoporosis treatment trial appear to be comparable.
Patients should be instructed to take supplemental calcium and/or vitamin D if daily dietary intake is inadequate. Weight-bearing exercise should be considered along with the modification of certain behavioral factors, such as cigarette smoking and/or alcohol consumption, if these factors exist.

Evista Drug Interactions.

Evista Dose.

The recommended Evista (Raloxifene) dosage is one 60 mg tablet daily which may be administered any time of day without regard to meals.

Evista Overdose. 

Incidents of Evista (Raloxifene) overdose in humans have not been reported. In an 8-week study of 63 postmenopausal women, a dose of raloxifene HCl 600 mg/day was safely tolerated. No mortality was seen after a single oral dose in rats or mice at 5000 mg/kg or in monkeys at 1000 mg/kg. There is no specific antidote for raloxifene.

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