Evista (raloxifene hydrochloride) is a selective estrogen receptor modulator (SERM) specifically engineered for the management and prevention of osteoporosis in postmenopausal women. It represents a significant advancement in bone health therapeutics, offering a targeted approach that mimics estrogen’s beneficial effects on bone density without the associated risks to breast and uterine tissues seen with traditional hormone replacement therapy. Clinically proven to reduce vertebral fractures and maintain skeletal integrity, Evista provides a well-tolerated, non-hormonal option for long-term osteoporosis management, supported by extensive research and real-world efficacy data.

Features

• Contains 60 mg raloxifene hydrochloride per tablet
• Selective estrogen receptor modulator (SERM) class
• Oral administration, once-daily dosing
• Available in blister packs of 28 or 84 tablets
• White, elliptical, film-coated tablets
• Requires no dose titration for initiation
• Stable at room temperature; no refrigeration needed

Benefits

• Significantly increases bone mineral density in the lumbar spine and femoral neck
• Reduces the risk of new vertebral fractures by approximately 50% in high-risk populations
• Demonstrates a favorable safety profile with long-term use (up to 8 years in clinical trials)
• Lowers the risk of invasive breast cancer in postmenopausal women with osteoporosis
• Does not stimulate endometrial proliferation, eliminating need for progestin co-therapy
• Provides cardiovascular benefit through lipid profile improvement (reduces LDL cholesterol)

Common use

Evista is primarily indicated for the treatment and prevention of osteoporosis in postmenopausal women. It is particularly valuable for patients who cannot or prefer not to use bisphosphonates or hormone replacement therapy. Physicians often prescribe it for women with low bone density (T-score between -1.0 and -2.5) who have additional risk factors for fracture, including family history, petite body frame, or early menopause. The medication is also used off-label for breast cancer risk reduction in certain high-risk postmenopausal populations, though this constitutes a secondary application outside formal labeling in some regions.

Dosage and direction

The recommended dosage is one 60 mg tablet taken orally once daily, with or without food. Patients should swallow the tablet whole with adequate water; crushing or chewing should be avoided. Administration timing should be consistent each day, preferably in the morning to establish routine. No initial dose adjustment is required for elderly patients or those with mild to moderate renal impairment. For patients with severe hepatic impairment, use is not recommended due to insufficient safety data. Treatment should be combined with adequate calcium (1500 mg/day) and vitamin D (400-800 IU/day) intake unless contraindicated.

Precautions

Patients should undergo baseline mammography and gynecological examination before initiation due to rare but serious risk of venous thromboembolism (VTE), therapy should be discontinued at least 72 hours prior to prolonged immobilization (e.g., surgery, prolonged bed rest) and resumed only after full mobilization. Regular monitoring of bone mineral density is recommended every 1-2 years during treatment. Use with caution in patients with a history of deep vein thrombosis, pulmonary embolism, or retinal vein thrombosis. Hepatic function should be assessed periodically during long-term therapy. Patients should report any unusual leg pain, chest discomfort, or vision changes immediately.

Contraindications

Evista is contraindicated in women with active or past history of venous thromboembolic events, including deep vein thrombosis, pulmonary embolism, and retinal vein thrombosis. Additional contraindications include pregnancy, lactation, and women who may become pregnant (Category X). It must not be used in patients with hypersensitivity to raloxifene hydrochloride or any tablet components. Concomitant use with estrogen-containing products or cholestyramine is contraindicated. Women with hepatic impairment (Child-Pugh Class B or C) should not use this medication due to significantly increased exposure.

Possible side effects

Most common side effects (occurring in >5% of patients) include hot flashes, leg cramps, and peripheral edema. These are generally mild to moderate and often diminish with continued therapy. Serious but less frequent adverse effects (<1%) include venous thromboembolism (deep vein thrombosis, pulmonary embolism), superficial thrombophlebitis, and fatal stroke. Other reported effects include influenza-like symptoms, arthralgia, sweating, and gastrointestinal disturbances. Rare cases of significant triglyceride elevation have been observed in women with pre-existing hypertriglyceridemia. Vasodilation-related flushing typically occurs during the first 6 months of treatment.

Drug interaction

Concomitant warfarin use requires careful monitoring of prothrombin time due to potential protein-binding displacement. Cholestyramine and other anion-exchange resins significantly reduce raloxifene absorption and should not be co-administered. Highly protein-bound drugs (e.g., diazepam, diazoxide, NSAIDs) may compete for binding sites. No clinically significant interactions have been observed with corticosteroids, aminophylline, or ampicillin. Concurrent use with systemic estrogen is not recommended. Caution is advised with concomitant lipid-lowering agents despite generally favorable interaction profile.

Missed dose

If a dose is missed, the patient should take it as soon as remembered on the same day. If missed entirely, the patient should resume the regular schedule the following day; doubling the dose is not recommended. Consistency in daily administration is important for maintaining therapeutic effect, though occasional single missed doses have minimal clinical impact on overall efficacy. Patients should be educated to maintain a regular dosing routine and use pill organizers if necessary to improve adherence.

Overdose

No specific antidote exists for raloxifene overdose. Reported cases of accidental ingestion (up to 600 mg single dose) resulted only in increased frequency of minor side effects such as flushing and leg cramps. Management should be symptomatic and supportive. Hemodialysis is not expected to enhance elimination due to high protein binding (95%). Gastric lavage may be considered if ingestion occurred within 2-3 hours. Medical supervision is recommended for doses exceeding 600 mg. No fatalities have been reported from overdose in clinical trials or post-marketing surveillance.

Storage

Store at controlled room temperature (20-25°C or 68-77°F) with excursions permitted between 15-30°C (59-86°F). Keep in original blister packaging to protect from moisture and light. Keep tightly closed and out of reach of children. Do not transfer to alternative containers. Discard any tablets that appear discolored, cracked, or otherwise compromised. Proper disposal of unused medication through take-back programs is recommended to prevent accidental ingestion or environmental contamination.

Disclaimer

This information is provided for educational purposes only and does not constitute medical advice. Treatment decisions must be made by qualified healthcare professionals based on individual patient circumstances. Full prescribing information including boxed warnings should be reviewed before initiation. Patients should report any adverse events to their physician and to the appropriate regulatory authorities. Efficacy and safety data are based primarily on clinical trials in postmenopausal women with osteoporosis; results may vary in different populations.

Reviews

Clinical studies demonstrate consistent satisfaction among prescribing physicians regarding Evista’s efficacy in maintaining bone density and reducing fracture risk. The Multiple Outcomes of Raloxifene Evaluation (MORE) trial, involving 7,705 postmenopausal women, showed 30-50% reduction in vertebral fractures over 3 years. The Continuing Outcomes Relevant to Evista (CORE) trial demonstrated maintained efficacy through 8 years of treatment. Patient-reported outcomes indicate high tolerance despite vasomotor symptoms, with 80% continuation rates at 12 months in real-world studies. The additional benefit of breast cancer risk reduction is frequently cited as a significant advantage over other osteoporosis treatments.