What is the recommended follow-up for a postmenopausal woman with a history of osteoporosis or increased risk of breast cancer starting on Evista (raloxifene)?

Follow-Up for Patients Starting Raloxifene (Evista)

Patients starting raloxifene require baseline breast imaging and regular breast surveillance, monitoring for venous thromboembolism (particularly in the first 4 months), and should discontinue the medication at least 72 hours before any prolonged immobilization. 1, 2

Pre-Treatment Requirements

Before initiating raloxifene, patients must have:

• Breast examination and mammogram to establish baseline status 2
• Assessment to exclude contraindications (history of deep vein thrombosis, pulmonary embolism, stroke, or transient ischemic attack) 3, 1
• Confirmation of postmenopausal status (raloxifene is contraindicated in premenopausal women) 1, 2

Ongoing Monitoring Schedule

Breast Cancer Surveillance

• Continue regular breast examinations and mammograms according to standard screening guidelines throughout treatment 2
• Raloxifene does not eliminate breast cancer risk, making ongoing surveillance essential 2

Venous Thromboembolism Monitoring

• Heightened vigilance during the first 4 months of therapy when thromboembolism risk is highest 1
• Monitor for signs and symptoms of deep vein thrombosis (leg pain, swelling, warmth) and pulmonary embolism (chest pain, shortness of breath, hemoptysis) 2, 4
• The relative risk of thromboembolism is approximately 2.17 compared to placebo, though the absolute risk remains low 5

Management During Immobilization

• Discontinue raloxifene at least 72 hours before any planned prolonged immobilization (surgery, extended bed rest, long-distance travel) 1
• Resume only after the patient is fully ambulatory 1

Common Side Effects to Counsel About

Patients should be informed about expected side effects:

• Hot flashes and night sweats are common, particularly in women in early menopause 6
• Leg cramps occur more frequently than with placebo 6, 7
• Peripheral edema and influenza-like syndromes may occur 3, 6

These vasomotor symptoms are similar to those seen with tamoxifen but are generally well-tolerated 6. Women with active vasomotor symptoms may not be ideal candidates for raloxifene 8.

Duration of Treatment

• Standard duration is 5 years for breast cancer risk reduction alone 3, 1
• Extended use beyond 5 years is appropriate when osteoporosis treatment is the primary indication, with breast cancer risk reduction as a secondary benefit 3, 1
• Eight-year safety data from the MORE and CORE trials demonstrate continued efficacy and no increase in mortality with prolonged use 1, 5

Critical Safety Considerations

Absolute Contraindications Requiring Immediate Discontinuation

• Development of venous thromboembolism 1, 2
• Stroke or transient ischemic attack 1, 2
• Pregnancy (though unlikely in postmenopausal women) 1, 2

Stroke Risk

The FDA black box warning notes increased risk of death from stroke in postmenopausal women with documented coronary heart disease or at increased risk for major coronary events 2. While raloxifene is not contraindicated in these patients, a careful risk-benefit assessment is essential 2.

Calcium and Vitamin D Supplementation

• Ensure adequate calcium intake (1,200 mg/day for women over 50) and vitamin D (600-800 IU/day) 3, 2
• Add supplementation if dietary intake is inadequate 2

What Follow-Up Does NOT Require

Unlike tamoxifen, raloxifene does not require:

• Routine endometrial monitoring or workup of vaginal bleeding (raloxifene has no stimulatory effect on the endometrium) 3, 7
• Ophthalmologic surveillance for cataracts (lower risk than tamoxifen) 1, 9