Raloxifene - Use Raloxifene hydrochloride

Raloxifene 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)].

Raloxifene is contraindicated in pregnancy, in women who may become pregnant, and in nursing mothers [see Use in Specific Populations (8.1, 8.3)]. Raloxifene may cause fetal harm when administered to a pregnant woman. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus.

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/m²), and hydrocephaly was observed in fetuses at doses >10 mg/kg (>4 times the human dose based on surface area, mg/m²). 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/m²). 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/m²) 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. 

Pregnancy Category X. Raloxifene should not be used in women who are or may become pregnant [see Contraindications (4.2)].

Raloxifene should not be used by lactating women [see Contraindications (4.2)]. 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.

Safety and effectiveness in pediatric patients have not been established.

Of the total number of patients in placebo-controlled clinical studies of 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 (12.3)].

Raloxifene should be used with caution in patients with moderate or severe renal impairment [see Warnings and Precautions (5.8) and Clinical Pharmacology (12.3)].

Raloxifene should be used with caution in patients with hepatic impairment [see Warnings and Precautions (5.5) and Clinical Pharmacology (12.3)].