Raloxifene
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From MedlinePlus, U.S. National Library of Medicine
Boxed warning
WARNING: INCREASED RISK OF VENOUS THROMBOEMBOLISM AND DEATH FROM STROKE Increased risk of deep vein thrombosis and pulmonary embolism have been reported with EVISTA [see Warnings and Precautions ( 5.1 )] . Women with active or past history of venous thromboembolism should not take EVISTA [see Contraindications ( 4.1 )]. Increased risk of death due to stroke occurred in a trial in postmenopausal women with documented coronary heart disease or at increased risk for major coronary events. Consider risk-benefit balance in women at risk for stroke [see Warnings and Precautions ( 5.2 ) and Clinical Studies ( 14.5 )].
WARNING: INCREASED RISK OF VENOUS THROMBOEMBOLISM AND DEATH FROM STROKE See full prescribing information for complete boxed warning. Increased risk of deep vein thrombosis and pulmonary embolism have been reported with EVISTA ( 5.1 ). Women with active or past history of venous thromboembolism should not take EVISTA ( 4.1 ). Increased risk of death due to stroke occurred in a trial in postmenopausal women with documented coronary heart disease or at increased risk for major coronary events. Consider risk-benefit balance in women at risk for stroke ( 5.2 , 14.5 ).
Dosing in kidney impairment
Renal Impairment EVISTA should be used with caution in patients with moderate or severe renal impairment [see Warnings and Precautions and Clinical Pharmacology] .
Dosing in liver impairment
Hepatic Impairment EVISTA should be used with caution in patients with hepatic impairment [see Warnings and Precautions and Clinical Pharmacology] .
Drug interactions
Check raloxifene against a medication listLabel text (6 paragraphs)
Cholestyramine : Use with EVISTA is not recommended. Reduces the absorption and enterohepatic cycling of raloxifene. ( 7.1 , 12.3 ) Warfarin : Monitor prothrombin time when starting or stopping EVISTA. ( 7.2 , 12.3 ) Highly Protein-Bound Drugs : Use with EVISTA with caution. Highly protein-bound drugs include diazepam, diazoxide, and lidocaine. EVISTA is more than 95% bound to plasma proteins. ( 7.3 , 12.3 )
7.1 Cholestyramine Concomitant administration of cholestyramine with EVISTA is not recommended. Although not specifically studied, it is anticipated that other anion exchange resins would have a similar effect. EVISTA should not be co-administered with other anion exchange resins [see Clinical Pharmacology ( 12.3 )] .
7.2 Warfarin If EVISTA is given concomitantly with warfarin or other warfarin derivatives, prothrombin time should be monitored more closely when starting or stopping therapy with EVISTA [see Clinical Pharmacology ( 12.3 )] .
7.3 Other Highly Protein-Bound Drugs EVISTA should be used with caution with certain other highly protein-bound drugs such as diazepam, diazoxide, and lidocaine. Although not examined, EVISTA might affect the protein binding of other drugs. Raloxifene is more than 95% bound to plasma proteins [see Clinical Pharmacology ( 12.3 )] .
7.4 Systemic Estrogens The safety of concomitant use of EVISTA with systemic estrogens has not been established and its use is not recommended.
7.5 Other Concomitant Medications EVISTA can be concomitantly administered with ampicillin, amoxicillin, antacids, corticosteroids, and digoxin [see Clinical Pharmacology ( 12.3 )] . The concomitant use of EVISTA and lipid-lowering agents has not been studied.
Contraindications
Active or past history of venous thromboembolism, including deep vein thrombosis, pulmonary embolism, and retinal vein thrombosis. ( 4.1 ) Pregnancy. ( 4.2 , 8.1 )
4.1 Venous Thromboembolism EVISTA is contraindicated in women with active or past history of venous thromboembolism (VTE), including deep vein thrombosis, pulmonary embolism, and retinal vein thrombosis [see Warnings and Precautions ( 5.1 )] .
4.2 Pregnancy EVISTA is contraindicated for use in pregnancy, as it may cause fetal harm [see Use in Specific Populations ( 8.1 )] .
Pregnancy and lactation
Pregnancy
8.1 Pregnancy Risk Summary EVISTA is contraindicated for use in pregnant women, and is not indicated for use in females of reproductive potential. Based on mechanism of action, EVISTA may block the important functions that estrogen has during all stages of pregnancy [see Clinical Pharmacology ( 12.1 )] . Limited data with EVISTA use in pregnant women are insufficient to inform any drug associated risks for births defects or miscarriage.
In rabbits and rats dosed during organogenesis or during gestation and lactation, EVISTA produced multiple adverse reproductive and developmental effects, including abortion; fetal anomalies; and delayed or disrupted parturition leading to maternal and neonatal mortality, at doses less than or similar to the maximum recommended human dose (based on human body surface area comparison). Data Animal Data In the developmental and reproductive toxicity studies conducted with EVISTA, numerous adverse effects were observed in multiple animal species.
In rabbits dosed during organogenesis, abortion and a low rate of fetal heart anomalies (ventricular septal defects) occurred at doses ≥0.1 mg/kg (≥0.04 times the human dose based on surface area, mg/m 2 ). In rats dosed during organogenesis, retardation of fetal growth 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 during gestation and lactation with doses of 0.1 to 10 mg/kg (0.02 to 1.6 times the human dose based on surface area, mg/m 2 ) 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, the disruption of parturition resulted in maternal and progeny morbidity and death. Effects in adult offspring (4 months of age) included uterine hypoplasia and reduced fertility; however, no ovarian or vaginal pathology was observed.
For breastfeeding, also see LactMed (National Library of Medicine), which summarizes milk levels and infant effects.
Supply and cost
Drug shortage status
Recalls (last 24 months)
Therapeutic equivalence (Orange Book)
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