raloxifene hydrochloride
Evista
Pregnancy Risk Category X
How supplied
Tablets: 60 mg
Action
A selective estrogen receptor modulator that reduces resorption of bone and decreases overall bone turnover. These effects on bone are manifested as reductions in serum and urine levels of bone turnover markers and increases in bone mineral density.
Indications & dosage
Prevention of osteoporosis in postmenopausal women--
Adults: 60 mg P.O. once daily.
Adverse reactions
CNS: depression, insomnia, migraine.
CV: chest pain.
EENT: sinusitis, pharyngitis, laryngitis.
GI: nausea, dyspepsia, vomiting, flatulence, GI disorder, gastroenteritis, abdominal pain.
GU: vaginitis, urinary tract infection, cystitis, leukorrhea, endometrial disorder, vaginal bleeding.
Metabolic: weight gain, fever.
Musculoskeletal: arthralgia, myalgia, arthritis, leg cramps, breast pain.
Respiratory: increased cough, pneumonia.
Skin: rash, sweating.
Other: infection, flu syndrome, hot flashes, peripheral edema.
Interactions
Drug-drug. Cholestyramine: causes significant reduction in absorption of raloxifene. Avoid concomitant use.
Highly protein-bound drugs (such as clofibrate, diazepam, diazoxide, ibuprofen, indomethacin, naproxen): may interfere with binding sites. Use with caution.
Warfarin: may cause a decrease in PT. Monitor PT and INR closely.
Effects on diagnostic tests
None reported.
Contraindications
Contraindicated in women with hypersensitivity to drug or its components; in those with past history or currently active venous thromboembolic events, including deep vein thrombosis, pulmonary embolism, and retinal vein thrombosis; in pregnant women or those planning pregnancy; in breast-feeding women; and in children.
Nursing considerations
- Use cautiously in patients with severe hepatic impairment.
- Watch for signs of blood clots. Greatest risk of thromboembolic events occurs during first 4 months of treatment.
- Discontinue drug at least 72 hours before prolonged immobilization and resume only after patient is fully mobilized.
- Report unexplained uterine bleeding because endometrial proliferation hasn't been associated with drug use.
- Watch for breast abnormalities that occur during treatment. No association between breast enlargement, breast pain, or an increased risk of breast cancer has been shown.
- The following laboratory changes may occur: increased apolipoprotein A levels; reduced serum total cholesterol, low-density lipoprotein cholesterol, fibrinogen, apolipoprotein B, and lipoprotein (a) levels; modest increases in hormone-binding globulin levels; small decreases in serum total calcium, inorganic phosphate, total protein, and albumin levels, and platelet count.
- Safety and efficacy of drug haven't been evaluated in men.
- Effect on bone mineral density beyond 2 years of drug treatment isn't known.
- Use with hormone replacement therapy or systemic estrogen hasn't been evaluated and, therefore, isn't recommended.
Patient teaching
- Advise patient to avoid long periods of restricted movement (such as during traveling) because of increased risk of venous thromboembolic events.
- Inform patient that hot flashes or flushing may occur and that drug doesn't aid in reducing them.
- Instruct patient to practice other bone loss prevention measures, including supplemental calcium and vitamin D if dietary intake is inadequate, weight-bearing exercises, and discontinuing alcohol consumption and smoking.
- Tell patient that drug may be taken without regard to food.
- Advise patient to report unexplained uterine bleeding or breast abnormalities during therapy.
- Explain adverse reactions and instruct patient to read patient package insert before starting therapy and to reread it each time prescription is renewed.
*Liquid contains alcohol. **May contain tartrazine. †Canada ‡Australia §U.K. OTCOver the counter
Reactions may be common, uncommon, life-threatening, or COMMON AND LIFE-THREATENING