Raloxifene hydrochloride

RALOXIFENE HYDROCHLORIDE

Manufacturer: Aphena Pharma Solutions - Tennessee, LLC

Score: 148.0

Quick Summary

Raloxifene hydrochloride is a selective estrogen receptor modulator (SERM) used for the treatment and prevention of osteoporosis in postmenopausal women, as well as the reduction in risk of invasive breast cancer in postmenopausal women with osteoporosis or at high risk for invasive breast cancer. The recommended dosage is 60 mg orally once daily, and it is essential to consider important safety information, including the risk of venous thromboembolism and death from stroke, and contraindications such as active or past history of venous thromboembolism and pregnancy. Special population considerations include use during pregnancy, nursing mothers, pediatric use, and geriatric use.

Key Clinical Findings and Indications

Treatment and prevention of osteoporosis in postmenopausal women
Reduction in risk of invasive breast cancer in postmenopausal women with osteoporosis or at high risk for invasive breast cancer

Important Safety Information

Warning

Increased risk of deep vein thrombosis and pulmonary embolism, and death from stroke

Contraindications

Active or past history of venous thromboembolism
Pregnancy, women who may become pregnant, and nursing mothers

Adverse Reactions

Hot flashes
Leg cramps
Peripheral edema
Flu syndrome
Arthralgia
Sweating

Dosing Recommendations

General Guidance

No dose adjustment is necessary for geriatric patients

Osteoporosis treatment and prevention

Adult Dose

60 mg orally once daily

Pediatric Dose

Not established

Special Population Considerations

Pregnancy

Raloxifene should not be used in women who are or may become pregnant
Pregnancy Category X

Nursing Mothers

Raloxifene should not be used by lactating women
It is not known whether this drug is excreted in human milk

Pediatric Use

Safety and effectiveness in pediatric patients have not been established

Geriatric Use

No overall differences in safety or effectiveness were observed between geriatric and younger subjects
Greater sensitivity of some older individuals cannot be ruled out