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    Indicated to reduce the incidence of breast cancer in women at high risk for breast cancer; high risk is defined as women aged ≥35 years with a 5-year predicted risk of breast cancer ≥1.67% (calculated by the Gail Model) 20 mg PO q Day for 5 years Data are limited for use Hypersensitivity Pregnancy Undiagnosed vaginal bleeding Patients who require concomitant warfarin therapy or have a history of deep vein thrombosis or pulmonary embolus if indication for treatment is either reduction of breast cancer incidence in high-risk patients or risk reduction of invasive breast cancer after treatment of DCIS Liver cancer and changes in liver enzyme levels reported with use; on rare occasions, a spectrum of more severe liver abnormalities including fatty liver, cholestasis, hepatitis and hepatic necrosis, that have included fatalities, also reported; monitor liver function periodically Unknown whether an increased risk for other (non-uterine) cancers is associated with tamoxifen Hypercalcemia reported in some breast cancer patients with bone metastases within a few weeks of starting treatment; if hypercalcemia occurs, treat as appropriate; if hypercalcemia is severe, discontinue therapy CYP2D6 polymorphism-CYP2D6 converts tamoxifen to active metabolite endoxifen; lowered CYP2D6 activity or concomitant CYP2D6 inhibitors may reduce tamoxifen efficacy Decreases in platelet counts, usually to 50,000-100,000/mm3, infrequently lower, reported in patients receiving therapy for breast cancer; hemorrhagic episodes have occurred, but not certain if episodes were due to tamoxifen therapy; leukopenia, sometimes in association with anemia and/or thrombocytopenia reported; neutropenia and pancytopenia also reported; perform periodic complete blood counts, including platelet counts Ocular disturbances, including corneal changes, decrement in color vision perception, retinal vein thrombosis, and retinopathy reported; an increased incidence of cataracts and need for cataract surgery reported; patients should seek medical attention if they experience visual disturbance There is increased incidence of thromboembolic events, including deep vein thrombosis and pulmonary embolism, during tamoxifen therapy; when tamoxifen is coadministered with chemotherapy, there is further increase in risk of thromboembolic events; for treatment of breast cancer, carefully consider risks and benefits of tamoxifen in women with a history of thromboembolic events; advise patients to seek medical attention immediately if signs or symptoms of a thromboembolic event occur Increased incidence of uterine malignancies (endometrial adenocarcinoma and uterine sarcoma), including fatal cases, reported with treatment; underlying mechanism unknown, most uterine malignancies seen with tamoxifen are classified as adenocarcinoma of the endometrium; however, uterine sarcomas, including malignant mixed mullerian tumors (MMMT), generally associated with a higher FIGO stage (III/IV), also reported; uterine sarcoma at diagnosis usually associated with poor prognosis, and short survival; uterine sarcoma reported to occur more frequently among long-term users (≥2 years) of tamoxifen than non-users; promptly evaluate patient receiving or who has previously received therapy who reports abnormal vaginal bleeding; patients receiving or who have previously received tamoxifen should have annual gynecological examinations Therapy can cause fetal harm when administered to pregnant woman; there are postmarketing reports of vaginal bleeding, spontaneous abortions, birth defects, and fetal deaths in pregnant women taking tamoxifen; in primate model, administration of drug at doses 2 times maximum recommended human dose resulted in spontaneous abortion; advise pregnant women of potential risks to a fetus, including potential long-term risk of a DES-like syndrome; advise females of reproductive potential to use effective non-hormonal contraception during treatment with tamoxifen and for 9 months following the last dose Fetal harm may occur when administered to a pregnant woman There are postmarketing reports of vaginal bleeding, spontaneous abortions, birth defects, and fetal deaths in pregnant women taking tamoxifen In a primate model, administration of tamoxifen at doses 2 times the maximum recommended human dose resulted in spontaneous abortion Advise pregnant women of potential risks to a fetus, including potential long term risk of a DES-like syndrome Prior to initiating treatment, a negative pregnancy test should be confirmed Tamoxifen reported to inhibit lactation Two placebo-controlled studies in over 150 women have shown that tamoxifen significantly inhibits early postpartum milk production; both studies tamoxifen was administered within 24 hr of delivery for between 5 and 18 days; effect of tamoxifen on established milk production is not known There are no data that address whether tamoxifen is excreted into human milk; direct neonatal exposure of tamoxifen to mice and rats (not via breast milk) produced 1) reproductive tract lesions in female rodents (similar to those seen in humans after intrauterine exposure to diethylstilbestrol) and 2) functional defects of the reproductive tract in male rodents such as testicular atrophy and arrest of spermatogenesis Unknown if tamoxifen is excreted in human milk Because of potential for serious adverse reactions in nursing infants from tamoxifen, women taking tamoxifen should not breast feed Selective estrogen receptor modulator: nonsteroid with potent antiestrogenic effects in breast (but may be estrogen agonist in uterus); has cytostatic effect rather than cytocidal effects (cells accumulate in Go and G1 phase of the cell cycle) Half-Life: 7-14 hr Peak Plasma Time: 3-6 hr Protein binding: 99% Peak Plasma Concentration: 40 ng/m L Metabolism: by hepatic P450 enzyme CYP2C9, CYP2D6, CYP3A4 Metabolites: N-desmethyl tamoxifen, endoxifen Excretion: Feces (65%), urine (9%) Metabolized via CYP2D6 into endoxifen (4-OH-N-desmethyl-tamoxifen), its primary active metabolite Lowered CYP2D6 activity or concomitant CYP2D6 inhibitors may reduce tamoxifen efficacy Poor CYP2D6 metabolizers are defined as those with *4/*4 alleles On October 18, 2006, the Pharmaceutical Science Clinical Pharmacology Subcommittee of the FDA recommended including information on CYP2D6 genotypes and their potential effect on patient outcomes in the label for tamoxifen, but they did not come to consensus on whether testing should be recommended or considered optional Subsequent to that recommendation, branded tamoxifen (Nolvadex) was discontinued and no further guidance was given by FDA on whether to amend the label for generic tamoxifen Recent data presented at the 2010 San Antonio Breast Cancer Symposium found the CYP2D6 allele status had no effect on any outcomes, including disease recurrence, distant recurrence, and overall survival Further research will help elucidate the potential effect of strong CYP2D6 inhibitors, such as SSRIs, on tamoxifen metabolism, but there is no evidence to suggest that the use of such medications should influence the use of tamoxifen Therefore, based on the data available to date, routine testing for CYP2D6 variants is not recommended CYP2C19 heterozygous *2 carriership may be a predictive factor for patients with breast cancer using tamoxifen; this factor was associated with a longer survival among tamoxifen users in a recent study (Pharmacogenomics. 2010;11[10]:1367-75) The above information is provided for general informational and educational purposes only. 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