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
Drugs Generic
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