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Pharmacologic class: Nonsteroidal antiestrogen
Therapeutic class: Antineoplastic
Pregnancy risk category D
FDA Box Warning
For women with ductal carcinoma in situ or high risk of breast cancer, serious and life-threatening events associated with drug use in riskreduction setting include stroke, pulmonary embolism, and uterine cancer. Some of these events were fatal. Discuss potential benefits versus potential risks of these events with these patients. In women already diagnosed with breast cancer, drug's benefits outweigh risks.
Competes with estrogen receptors in tumor cells for binding to target tissues (such as breast); reduces DNA synthesis and estrogen response
Oral solution: 10 mg/5 ml
Tablets: 10 mg, 20 mg
Tablets (enteric-coated): 20 mg
Indications and dosages
➣ Adjunctive treatment of breast cancer
Adults: 20 to 40 mg P.O. daily for 5 years. Daily dosages of 20 mg may be taken as a single dose; daily dosages above 20 mg should be divided and taken b.i.d. (morning and evening).
➣ To reduce breast cancer incidence in high-risk women; treatment of ductal carcinoma in situ
Adults: 20 mg P.O. daily for 5 years
• Ovulation stimulation
• Hypersensitivity to drug
• Concurrent warfarin use
• Women with a history of deep-vein thrombosis or pulmonary embolism
• Pregnancy or breastfeeding
Use cautiously in:
• decreased bone marrow reserve, leukopenia, thrombocytopenia, cataracts, hyperlipidemia
• females of childbearing age.
• Don't break or crush enteric-coated tablets.
• Know that drug is indicated for reducing breast cancer risk only in high-risk women, defined as those older than age 35 who have at least a 1.67% chance of developing breast cancer over 5 years.
CNS: confusion, depression, headache, weakness, fatigue, light-headedness
CV: chest pain, deep-vein thrombosis
EENT: blurred vision, ocular lesion, retinopathy, corneal opacity
GI: nausea, vomiting, abdominal cramps, anorexia
GU: vaginal bleeding, discharge, or dryness; irregular menses; amenorrhea; oligomenorrhea; ovarian cyst; pruritus vulvae; endometrial or uterine cancer
Hematologic: leukopenia, thrombocytopenia
Metabolic: hypercalcemia, fluid retention
Musculoskeletal: bone pain
Respiratory: cough, pulmonary embolism
Skin: skin changes, hair thinning or partial hair loss
Other: altered taste, weight loss, tumor flare, tumor pain, hot flashes, edema
Drug-drug. Aminoglutethimide, estrogens: decreased tamoxifen effects
Antineoplastics: increased risk of thromboembolic events
Bromocriptine: increased tamoxifen blood level
Warfarin: increased anticoagulant effect
Drug-diagnostic tests. Aspartate aminotransferase, bilirubin, calcium, creatinine, hepatic enzymes: increased levels
Platelets, white blood cells: decreased counts
• Monitor lipid panel, calcium level, mammography results, and gynecologic exam results.
Watch for signs and symptoms of thromboembolic events, including cerebrovascular accident and pulmonary embolism.
• Monitor menstrual cycle pattern for changes that may signal endometrial or uterine cancer.
• Tell patient to swallow enteric-coated tablets whole without breaking or crushing.
Instruct patient to immediately report leg or calf pain, swelling, or tenderness; unexpected shortness of breath; sudden chest pain; coughing up blood; new breast lumps; vaginal bleeding; menstrual irregularities; changes in vaginal discharge; pelvic pain or pressure; and vision changes.
• Inform patient that increase in bone or tumor pain usually means drug will be effective. Advise her to discuss pain management with prescriber.
• Stress importance of undergoing regular blood tests, mammograms, and gynecologic exams to identify early signs of serious adverse reactions.
• As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the drugs and tests mentioned above.
Time/action profile (tumor response)
|PO||4–10 wk||several mo||several wk|
Adverse Reactions/Side Effects
Central nervous system
- stroke (life-threatening)
Ear, Eye, Nose, Throat
- blurred vision
- thromboembolism (life-threatening)
- nausea (most frequent)
- uterine malignancies (life-threatening)
- vaginal bleeding
Fluid and Electrolyte
- hot flashes (most frequent)
- bone pain
- tumor flare
Drug-Drug interactionEstrogens may ↓ effectiveness of concurrently administered tamoxifen.Blood levels are ↑ by bromocriptine.May ↑ the anticoagulant effect of warfarin.Risk of thromboembolic events is ↑ by concurrent use of other antineoplastics.
Route/DosageTreatment of Breast Cancer
Availability (generic available)
- Assess for an increase in bone or tumor pain. Confer with health care professional regarding analgesics. This transient pain usually resolves despite continued therapy.
- Lab Test Considerations: Monitor CBC, platelets, and calcium levels before and during therapy. May cause transient hypercalcemia in patients with metastases to the bone. An estrogen receptor assay should be assessed before initiation of therapy.
- Monitor serum cholesterol and triglyceride concentrations in patients with pre-existing hyperlipidemia. May cause ↑ concentrations.
- Monitor hepatic function tests and thyroxine (T4) periodically during therapy. May cause ↑ serum hepatic enzyme and thyroxine concentrations.
- Gynecologic examinations should be performed regularly; may cause variations in Papanicolaou and vaginal smears.
Potential Nursing DiagnosesDeficient knowledge, related to medication regimen (Patient/Family Teaching)
- Oral: Administer with food or fluids if GI irritation becomes a problem. Consult health care professional if patient vomits shortly after administration of medication to determine need for repeat dose.
- Do not crush, break, chew, or administer an antacid within 1–2 hr of enteric-coated tablet.
- Instruct patient to take medication as directed. If a dose is missed, it should be omitted.
- If skin lesions are present, inform patient that lesions may temporarily increase in size and number and may have increased erythema.
- Advise patient to report bone pain to health care professional promptly. This pain may be severe. Analgesics should be ordered to control pain. Inform patient that this may be an indication of the drug’s effectiveness and will resolve over time.
- Instruct patient to monitor weight weekly. Weight gain or peripheral edema should be reported to health care professional.
- Advise patient that medication may cause hot flashes. Notify health care professional if these become bothersome.
- Instruct patient to notify health care professional promptly if pain or swelling of legs, shortness of breath, weakness, sleepiness, confusion, nausea, vomiting, weight gain, dizziness, headache, loss of appetite, or blurred vision occurs. Patient should also report menstrual irregularities, vaginal bleeding, pelvic pain or pressure.
- This medication may induce ovulation and may have teratogenic properties. Advise patient to use a nonhormonal method of contraception during and for 1 mo after the therapy.
- Decrease in the size or spread of breast cancer. Observable effects of therapy may not be seen for 4–10 wk after initiation.