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Raloxifene

    Brands

    DEA Class; Rx

    Common Brand Names; Evista

    • Selective Estrogen Receptor Modulators

    Oral selective estrogen receptor modulator (SERM)
    Approved for the treatment and prevention of postmenopausal osteoporosis and to reduce risk of invasive breast cancer in postmenopausal women with osteoporosis or at high risk for breast cancer
    Boxed warning regarding an increased risk for thromboembolism and stroke

    Indicated for the treatment of osteoporosis or for osteoporosis prophylaxis in postmenopausal women.

    For invasive breast cancer prophylaxis in postmenopausal women with osteoporosis or in postmenopausal women at high risk for developing the disease.
    For the treatment of uterine leiomyomata in postmenopausal women.

    Pregnancy, lactation

    Active history of thromboembolic disorders

    Women who could become pregnant

    • Hot flashes (8-29%)
    • Flu syndrome (14-15%)
    • Cramps/muscle spasm (6-12%)
    • Arthralgia (11-16%)
    • Infection (11%)
    • Insomnia (6%)
    • Vomiting (5%)
    • Sinusitis (10%)
    • Venous thromboembolism (1-2% )
    • Bronchitis (10%)
    • Pharyngitis (8%)
    • Breast pain (4%)
    • Gastroenteritis (<3%)
    • Diaphoresis (3%)
    • Deep vein thrombosis
    • Cerebrovascular accident
    • Thrombosis of retinal vein (rare)
    • Pulmonary embolism
    • Decreased fibrinogen

    Discontinue 72 hours prior to and during prolonged immobilization

    Associated with increased risk of deep vein thrombosis, pulmonary embolism, and retinal vein thrombosis

    Increased risk of death due to stroke; consider risk-benefit balance in women at risk for stroke

    Supplemental calcium and vitamin D recommended

    Therapy should not be used for primary or secondary prevention of cardiovascular disease

    Triglyceride levels may increase in women with history of triglyceride elevation in response to oral estrogens; monitor serum triglycerides

    Concomitant use of estrogens not recommended; taper off estrogen treatment, then wait month before starting raloxifene

    Examine unexplained uterine bleeding

    Use with caution in renal or hepatic impairment

    Premenopausal use not recommended

    Pregnancy Category: X

    Lactation: Excretion in milk unknown; contraindicated

    Adults

    60 mg/day PO.

    Elderly

    60 mg/day PO.

    Adolescents

    Safety and efficacy have not been established.

    Children

    Safety and efficacy have not been established.

    Raloxifene hydrochloride

    tablet

    • 60mg