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Pharmacologic class: Nonsteroidal benzothiophene derivative
Therapeutic class: Selective estrogen receptor modulator, bone resorption inhibitor
Pregnancy risk category X
Binds to estrogen receptors, activating estrogen pathways and increasing bone mineral density. These effects decrease bone resorption and turnover.
Tablets: 60 mg
Indications and dosages
➣ Treatment and prevention of osteoporosis in postmenopausal women; reduction of invasive breast cancer risk in postmenopausal women with osteoporosis; reduction of invasive breast cancer risk in postmenopausal women at high risk for invasive breast cancer
Adults: 60 mg P.O. daily
• Prophylaxis of cardiovascular disease
• Hypersensitivity to drug or its components
• History of thromboembolic events
• Premenopausal women
• Females of childbearing age
• Pregnancy or breastfeeding
Use cautiously in:
• altered lipid metabolism, hepatic dysfunction
• concurrent estrogen therapy (use not recommended)
• immobilized patients and others at increased risk for thromboembolic events.
• Give with or without food.
CNS: depression, insomnia, vertigo, syncope, hypoesthesia, migraine, neuralgia
CV: chest pain, peripheral edema, varicose veins, deep-vein thrombosis, thrombophlebitis
EENT: conjunctivitis, sinusitis, rhinitis, pharyngitis, laryngitis
GI: nausea, vomiting, diarrhea, abdominal pain dyspepsia, flatulence, gastroenteritis
GU: urinary tract infection or disorder, cystitis, vaginitis, leukorrhea, endometrial disorder, vaginal hemorrhage
Musculoskeletal: leg cramps, joint pain, myalgia, arthritis, tendon disorder
Respiratory: cough, pneumonia, bronchitis, pulmonary embolism
Skin: rash, diaphoresis
Other: weight gain, hot flashes, infection, pain, flulike symptoms
Drug-drug. Cholestyramine: reduced raloxifene absorption
Highly protein-bound drugs (such as diazepam, diazoxide, lidocaine): interference with binding of these drugs
Warfarin: decreased prothrombin time
Drug-diagnostic tests. Albumin, apolipoprotein B, calcium, fibrinogen, inorganic phosphate, low-density lipoproteins, platelets, protein, total cholesterol: decreased levels
Apolipoprotein A1; corticosteroid-binding, sex steroid-binding, and thyroid-binding globulin: increased levels
☞ Watch for thromboembolic events, especially during first 4 months of therapy.
• Stay alert for other adverse effects, particularly leg cramps, other musculoskeletal complaints, and respiratory disorders.
• Assess bone mineral density test results.
• Monitor for unexplained vaginal bleeding.
• Tell patient she may take with or without food.
• Instruct patient to read package insert before starting drug and then periodically.
☞ Teach patient to recognize and immediately report symptoms of blood clots.
• Instruct patient to stop taking drug 3 days before anticipated period of prolonged immobility, and to restart it only after she regains normal mobility.
• Tell patient that drug may cause hot flashes, but that these are normal effects.
• Advise patient to report unexplained vaginal bleeding or leg cramps.
• As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the drugs and tests mentioned above.
ClassificationTherapeutic: bone resorption inhibitors
Pharmacologic: selective estrogen receptor modulators
Time/action profile (effects on bone turnover)
Adverse Reactions/Side Effects
Central nervous system
- stroke (life-threatening)
- thromboembolism (life-threatening)
Ear, Eye, Nose, Throat
- retinal vein thrombosis
- leg cramps (most frequent)
- hot flashes (most frequent)
Drug-Drug interactionCholestyramine ↓ absorption (avoid concurrent use).May alter effects of warfarin and other highly protein-bound drugs.Concurrent systemic estrogen therapy is not recommended.
- Assess patient for bone mineral density with x-ray, serum, and urine bone turnover markers (bone-specific alkaline phosphatase, osteocalcin, and collagen breakdown products) before and periodically during therapy.
- Lab Test Considerations: May cause ↑ apolipoprotein A-I and reduced serum total cholesterol, LDL cholesterol, fibrinogen, apolipoprotein B, and lipoprotein.
- May cause ↑ hormone-binding globulin (sex steroid-binding globulin, thyroxine-binding globulin, corticosteroid-binding globulin) with ↑ total hormone concentrations.
- May cause small ↓ in serum total calcium, inorganic phosphate, total protein, and albumin.
- May also cause slight decrease in platelet count.
Potential Nursing DiagnosesRisk for injury (Indications)
- Do not confuse Evista (raloxifene) with Avinza (morphine sulfate, extended release).
- Oral: May be administered without regard to meals.
- Calcium supplementation should be added to diet if daily intake is inadequate.
- Instruct patient to take raloxifene as directed. Discuss the importance of adequate calcium and vitamin D intake or supplementation. Instruct patient to read the Medication Guide when initiating therapy and again with each prescription refill in case of changes.
- Advise patient to discontinue smoking and alcohol consumption.
- Emphasize the importance of regular weight-bearing exercise. Advise patient that raloxifene should be discontinued at least 72 hr before and during prolonged immobilization (recovery from surgery, prolonged bedrest). Instruct patient to avoid prolonged restrictions of movement during travel because of the increased risk of venous thrombosis.
- Advise patient that raloxifene will not reduce hot flashes or flushes associated with estrogen deficiency and may cause hot flashes.
- Instruct patient to notify health care professional immediately if leg pain or a feeling of warmth in the lower leg (calf); swelling of the legs, hands, or feet; sudden chest pain; shortness of breath or coughing up blood; or sudden change in vision, such as loss of vision or blurred vision occur. Being still for a long time (sitting still during a long car or airplane trip, being in bed after surgery) can increase risk of blood clots.
- Advise patient that raloxifene may have teratogenic effects. Instruct patient to notify health care provider immediately if pregnancy is planned or suspected.
- Prevention of osteoporosis in postmenopausal women.
- Reduced risk of breast cancer in postmenopausal women with osteoporosis and those at high risk for invasive breast cancer.