Names and pronunciation
(ral-ox′ih-feen) Evista
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Drug reference
(ral-ox′ih-feen) Evista
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Func. class.: Bone resorption inhibitor
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Chem. class.: Hormone modifier, selective estrogen receptor modulator (SERM)
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ACTION: Tissue-selective estrogen agonist/antagonist; agonist activity in bone and on lipid metabolism; antagonist activity on breast and uterus; reduces resorption of bone and decreases bone turnover
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USES: Prevention, treatment of osteo- porosis in postmenopausal women; breast cancer prophylaxis in postmenopausal women with osteoporosis or in postmeno- pausal women at high risk for developing the disease; invasive breast cancer risk reduction
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Unlabeled uses: Uterine leiomyomata in postmenopausal women with osteopo- rosis or in postmenopausal women who are at high risk for developing the disease
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CONTRAINDICATIONS: Preg- nancy, breastfeeding, hypersensitivity
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Black Box Warning: Women with ac- tive or history of venous thromboembolic events Precautions: CV/hepatic disease, cervi- cal/uterine cancer, elevated triglycerides, pulmonary embolism Black Box Warning: Stroke Black Box Warning: History of stroke, TIA, thrombosis, atrial fibrillation, hypertension, smoking; venous thrombosis may occur; avoid prolonged sitting; discontinue 3 days before surgery, other immobilization; mor- tality is increased after stroke • Bone density test at baseline, through- out treatment, bone-specific alk phos, osteocalcin Pregnancy/breastfeeding: do not use in pregnancy/breastfeeding Black Box Warning: To discontinue product 72 hr before prolonged bedrest; to avoid staying in one position for long periods, to report possible blood clots im- mediately, usually during first few months of therapy • To take calcium supplements, vit D if intake is inadequate • To increase exercise using weights • To stop smoking; to decrease alcohol consumption • That product does not help to control hot flashes; hot flashes may be increased, as these are a common side effect • To report fever, acute migraine, insom- nia, emotional distress; urinary tract in- fection, vaginal burning/itching; swelling, warmth, pain in calves; uterine bleeding, abnormal breast changes • To notify prescriber if pregnancy is planned or suspected; not to use in preg- nancy, breastfeeding • Provide product package insert and discuss with patient
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SIDE EFFECTS CNS: Insomnia, depression, migraines CV: Hot flashes, peripheral edema, throm- boembolism, stroke, fever, chest pain EENT: Pharyngitis, sinusitis, laryngitis GI: Nausea, vomiting, diarrhea, dyspep- sia, abdominal pain, gastroenteritis GU: Vaginitis, leukorrhea, cystitis, UTI, vaginal bleeding INTEG: Rash, sweating META: Weight gain, peripheral edema MS: Arthralgia, myalgia, leg cramps, arthritis RESP: Increased cough
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INTERACTIONS • Administer cautiously with other highly protein-bound products, (ibuprofen, diaz- ePAM, naproxen, systemic estrogens) Decrease: action of anticoagulants, des- iccated thyroid, levothyroxine, liotrix Decrease: action of raloxifene—ampicil- lin, bile acid sequestrants Drug/Food Decrease: raloxifene, effect of—soy Drug/Lab Test Increase: triglycerides
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DOSAGE AND ROUTES • Adult postmenopausal women: PO 60 mg/day, max 60 mg/day
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Available forms: Tabs 60 mg
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Administer: • PO: without regard to meals, give with vit D • Add calcium supplement if inadequate • Do not use during immobilization or prolonged bedrest
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Assess:
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Evaluate: • Therapeutic response: prevention, treat- ment of osteoporosis in postmenopausal women; prevention of breast cancer in postmenopausal women with osteoporosis or in those who are at high risk for develop- ing the disease
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CLINICAL CONSIDERATIONS
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Patient and caregiver information:
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PHARMACOKINETICS Duration 24 hr, elimination half-life 28-32 hr; excreted in feces, breast milk; highly bound to plasma proteins
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• Adult postmenopausal women: PO 60 mg/day, max 60 mg/day
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