Evista (raloxifene hydrochloride)
Increased risk of deep vein thrombosis (DVT) and pulmonary embolism (PE) reported. Avoid use in women with active or past history of venous thromboembolism (VTE). Increased risk of death due to stroke 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.
Selective estrogen receptor modulator
Treatment and prevention of osteoporosis in postmenopausal women. Reduction in risk of invasive breast cancer in postmenopausal women with osteoporosis and in postmenopausal women at high risk for invasive breast cancer.
Treatment and Prevention in Postmenopausal Women:
Reduction in Risk of Invasive Breast Cancer
Postmenopausal Women w/ Osteoporosis/Postmenopausal Women at High Risk for Invasive Breast Cancer:
Other Important Considerations
Ca2+ and Vitamin D Supplementation:
Total Daily Ca2+ Requirement: 1500mg/day
Total Daily Vitamin D: 400-800 IU/day
May be given at any time of day w/o regard to meals
Active/past history of VTE (eg, DVT, PE, retinal vein thrombosis), pregnancy, women who may become pregnant, nursing mothers.
VTE events, including superficial venous thrombophlebitis, reported. D/C at least 72 hrs prior to and during prolonged immobilization (eg, postsurgical recovery, prolonged bed rest); resume therapy only after patient is fully ambulatory. Caution in women at risk of thromboembolic disease for other reasons (eg, CHF, superficial thrombophlebitis, active malignancy). Should not be used for primary or secondary prevention of cardiovascular disease (CVD). Avoid use in premenopausal women. Monitor serum TG levels in women with history of hypertriglyceridemia in response to treatment with estrogen or estrogen plus progestin. Use in women with history of breast cancer has not been adequately studied. Caution with hepatic impairment or with moderate or severe renal impairment. Not recommended for use in men. Monitor for unexplained uterine bleeding and breast abnormalities.
DVT, PE, hot flashes, leg cramps, infection, flu syndrome, headache, N/V, diarrhea, peripheral edema, arthralgia, vaginal bleeding, pharyngitis, sinusitis, cough increased.
Avoid concomitant administration with cholestyramine, other anion exchange resins, and systemic estrogens. Monitor PT with warfarin and other warfarin derivatives. Caution with certain other highly protein-bound drugs (eg, diazepam, diazoxide, lidocaine).
PREGNANCY AND LACTATION
Category X, not for use in nursing.
MECHANISM OF ACTION
Selective estrogen receptor modulator; binds to estrogen receptors. Binding results in activation of estrogenic pathways in some tissues and blockade of estrogenic pathways in others, depending on extent of recruitment of coactivators and corepressors to estrogen receptor target gene promoters. Acts as an estrogen agonist in bone; decreases bone resorption and bone turnover, increases bone mineral density, and decreases fracture incidence.
Absorption: Rapid; absolute bioavailability (2%). Single dose: Cmax=0.5(ng/mL)/(mg/kg); AUC=27.2(ng•hr/mL)/(mg/kg). Multiple doses: Cmax=1.36(ng/mL)/(mg/kg); AUC=24.2(ng•hr/mL)/(mg/kg). Distribution: Vd=2348L/kg (single dose), 2853L/kg (multiple doses); plasma protein binding (95%). Metabolism: Extensive; glucuronidation; raloxifene-4'-glucuronide, raloxifene-6-glucuronide, raloxifene-6',4'-diglucuronide (metabolites). Elimination: Feces (primary), urine (<0.2% unchanged); T1/2=27.7 hrs (single dose), 32.5 hrs (multiple doses).
Assess for active or history of VTE (eg, DVT, PE, retinal vein thrombosis), CVD, risk factors for stroke, history of breast cancer, history of hypertriglyceridemia, prolonged immobilization, renal/hepatic impairment, pregnancy/nursing status, and for possible drug interactions. Perform breast exams and mammograms prior to treatment.
Monitor for VTE (eg, DVT, PE, retinal vein thrombosis), stroke, unexplained uterine bleeding, breast abnormalities, and other adverse reactions. Monitor serum TG levels with history of hypertriglyceridemia. Monitor PT with warfarin and other warfarin derivatives. Perform regular breast exams and mammograms after initial treatment.
For osteoporosis treatment/prevention, instruct to take supplemental Ca2+ and/or vitamin D if intake is inadequate. Counsel on weight-bearing exercise and modification of certain behavioral factors (eg, smoking, excessive alcohol consumption) for osteoporosis treatment/prevention. Advise to d/c therapy at least 72 hrs prior to and during prolonged immobilization. Instruct to avoid prolonged restrictions of movement during travel. Counsel that therapy may increase incidence of hot flashes or hot flashes may occur upon initiation of therapy. Inform that regular breast exams and mammography should be done before initiation of therapy and should continue during therapy.
20-25°C (68-77°F); excursions permitted to 15-30°C (59-86°F).
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