Names and pronunciation
(ta-mox′i-fen) Nolvadex-D Soltamox
Source page 1255
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Individual generic drug information
Extracted information for tamoxifen only.
(ta-mox′i-fen) Nolvadex-D Soltamox
Source page 1255
Func. class.: Antineoplastic
Source page 1255
Chem. class.: Antiestrogen hormone T
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ACTION: Inhibits cell division by binding to cytoplasmic estrogen receptors; resembles normal cell complex but inhibits DNA synthesis and estrogen response of target tissue
Source page 1255
USES: Advanced breast carcinoma not responsive to other therapy in estrogen- receptor–positive patients (usually postmenopausal), prevention of breast cancer, after breast surgery/radiation for ductal carcinoma in situ
Source page 1255
Unlabeled uses: Mastalgia, to reduce pain/size of gynecomastia, bipolar disorder, infertility, osteoporosis, ovarian cancer, precocious puberty
Source pages 1255, 1256
Extracted information for tamoxifen only.
CONTRAINDICATIONS: Preg- nancy, breastfeeding, hypersensitivity
Source page 1256
Black Box Warning: Thromboembolic disease, endometrial cancer, stroke Precautions: Women of childbearing age, leukopenia, thrombocytopenia, cataracts Black Box Warning: Uterine cancer, new primary malignancy Black Box Warning: Bleeding q8hr: hematuria, guaiac, bruising, petechiae, mucosa, or orifices • Effects of alopecia on body image; discuss feelings about body changes Black Box Warning: Uterine malignan- cies, symptoms of stroke, pulmonary embolism that may occur in women with ductal carcinoma in situ (DCIS) and women at high risk for breast cancer; monitor gynecologic exams baseline and periodically • Severe allergic reactions: rash, pru ritus, urticaria, purpuric skin lesions, itch ing, flushing • Bone pain: may give analgesics; pain usually transient • Pregnancy/breastfeeding: do not use in pregnancy, breastfeeding
Source pages 1256, 1257
SIDE EFFECTS CNS: Hot flashes, headache, light- headedness, depression, mood changes, stroke CV: Chest pain, stroke, fluid retention, flushing EENT: Blurred vision (high doses) GI: Nausea, vomiting, altered taste GU: Vaginal bleeding, uterine malignan cies, altered menses, amenorrhea HEMA: Thrombocytopenia, leukopenia, DVT INTEG: Rash, alopecia META: Hypercalcemia RESP: Pulmonary embolism
Source page 1256
INTERACTIONS Increase: risk for death from breast cancer—PARoxetine Increase: bleeding—anticoagulants Increase: tamoxifen levels—bromocriptine Increase: thromboembolic events— cytotoxics Increase: toxicity—CYP3A4 inhibitors (aprepitant, antiretroviral protease inhibi tors, clarithromycin, danazol, delavirdine, diltiaZEM, erythromycin, fluconazole, FLUoxetine, fluvoxaMINE, imatinib, keto conazole, mibefradil, nefazodone, telithro mycin, voriconazole) Decrease: tamoxifen levels—aminoglu- tethimide, rifamycin Decrease: letrozole levels—letrozole Decrease: tamoxifen effect—CYP3A4 inducers (barbiturates, bosentan, carBA- Mazepine, efavirenz, phenytoins, nevira pine, rifabutin, rifampin) Decrease: tamoxifen effects—CYP2D6 inhibitors (antidepressants) Drug/Herb • Avoid use with St. John’s wort, dong quai, black cohosh Drug/Lab Test Increase: serum calcium, T4, AST, ALT, cholesterol, triglycerides, BUN
Source page 1256
Extracted information for tamoxifen only.
DOSAGE AND ROUTES Breast cancer (men/women) • Adult: PO 20 mg/day for 5 yr; doses >20 mg/day, divide AM/PM High risk for breast cancer • Adult: PO 20 mg/day × 5 yr Mastalgia/gynecomastia in men with prostate cancer (unlabeled) • Adult (male): PO 20 mg/day for ≤1 yr
Source page 1256
Available forms: Tabs 10, 20 mg; oral solution 10 mg/5 mL
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Administer: • Do not break, crush, or chew tabs • Do not give antacid within 1-2 hr of dosing; give product after evening meal, before bedtime; give with food or fluids for GI symptoms • Antiemetic 30-60 min before product to prevent vomiting • Store in light-resistant container at room temperature Oral solution: Use calibrated container, dose >20 mg/day should be divided morning and evening, may be used with food for gastric irritation
Source page 1256
Extracted information for tamoxifen only.
Assess: • Labs/diagnostics: CBC, differential, platelet count baseline and weekly, with- hold product if WBC is <3.5 × 10 9/L or platelets <100 × 10 9/L notify pre- scriber; breast exam, mammogram, pregnancy test, bone mineral density, LFTs, serum calcium, serum lipid profile, periodic eye exams (cataracts, retinopa- thy), pap smear
Source page 1256
Evaluate: • Therapeutic response: decreased tu- mor size, spread of malignancy
Source page 1257
CLINICAL CONSIDERATIONS
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Patient and caregiver information: • About risk of stroke and PE: to seek medical attention immediately in case of blurred vision, headache, weakness on one side of the body (stroke signs); or chest pain, fainting, sweating, difficulty breathing (PE) • To report any complaints, side effects to prescriber; that use may be 5 yr • To increase fluids to 2 L/day unless contraindicated • To wear sunscreen, protective cloth- ing, sunglasses • That vaginal bleeding, pruritus, hot flashes are reversible after discontinuing treatment • To immediately report decreased visual acuity, which may be irreversible; about need for routine eye exams; that care provid ers should be told about tamoxifen therapy • To report vaginal bleeding immediately • That tumor flare—increase in size of tumor, increase in bone pain—may occur and will subside rapidly; that analgesics may be taken for pain • That hair may be lost during treatment; that a wig or hairpiece may make patient feel better; that new hair may be different in color, texture • To use nonhormonal contraception during and for 2 mo after discontinuing treatment, that premenopausal women must use mechanical birth control be cause ovulation may be induced
Source page 1257
Extracted information for tamoxifen only.
PHARMACOKINETICS PO: Peak 4-7 hr, half-life 7 days (1 wk terminal), metabolized in liver, excreted primarily in feces
Source page 1256
Filter the extracted dose blocks for this individual drug.
Breast cancer (men/women)
• Adult: PO 20 mg/day for 5 yr; doses >20 mg/day, divide AM/PM High risk for breast cancer
Candidate age grouping · source page 1256
Breast cancer (men/women)
• Adult: PO 20 mg/day × 5 yr Mastalgia/gynecomastia in men with prostate cancer (unlabeled)
Candidate age grouping · source page 1256
Breast cancer (men/women)
• Adult (male): PO 20 mg/day for ≤1 yr
Candidate age grouping · source page 1256