Evista

[Raloxifene]

Overdosage & Contraindications
CONTRAINDICATIONS

EVISTA is contraindicated in lactating women or women who are or may become pregnant.

EVISTA may cause fetal harm when administered to a pregnant woman. In rabbit studies, abortion and a low rate of fetal heart anomalies (ventricular septal defects) occurred in rabbits at doses 0.1 mg/ kg ( 0.04 times the human dose based on surface area, mg/ m 2 ), and hydrocephaly was observed in fetuses at doses 10 mg/ kg ( 4 times the human dose based on surface area, mg/ m 2 ).

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In rat studies, retardation of fetal development and developmental abnormalities (wavy ribs, kidney cavitation) occurred at doses 1 mg/ kg ( 0.2 times the human dose based on surface area, mg/ m 2 ). Treatment of rats at doses of 0.1 to 10 mg/ kg (0.02 to 1.6 times the human dose based on surface area, mg/ m 2 ) during gestation and lactation produced effects that included delayed and disrupted parturition; decreased neonatal survival and altered physical development; sex-and age-specific reductions in growth and changes in pituitary hormone content; and decreased lymphoid compartment size in offspring. At 10 mg/ kg, raloxifene disrupted parturition which resulted in maternal and progeny death and morbidity.

Effects in adult offspring (4 months of age) included uterine hypoplasia and reduced fertility; however, no ovarian or vaginal pathology was observed. The patient should be apprised of the potential hazard to the fetus if this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug. EVISTA is contraindicated in women with active or past history of venous thromboembolic events, including deep vein thrombosis, pulmonary embolism, and retinal vein thrombosis. EVISTA is contraindicated in women known to be hypersensitive to raloxifene or other constituents of the tablets.

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