Tamoxifen Generic Name & Formulations
Legal Class
Rx
General Description
Tamoxifen (as citrate) 10mg, 20mg; tabs.
Pharmacological Class
Antiestrogen.
How Supplied
Contact supplier.
Manufacturer
Tamoxifen Indications
Indications
Treatment of metastatic breast cancer in men and women. Axillary node-positive breast cancer in postmenopausal women after surgery + irradiation. Axillary node-negative breast cancer in women after surgery + irradiation. Reduction in risk of invasive breast cancer in women with ductal carcinoma in situ (DCIS) after surgery + radiation. Reduction in breast cancer incidence in high-risk women.
Tamoxifen Dosage and Administration
Adult
Treatment: 20–40mg/day; give doses >20mg in divided doses (AM and PM). Reduction of incidence in high-risk women or DCIS: 20mg once daily for 5 years.
Children
McCune-Albright Syndrome, precocious puberty: see literature.
Tamoxifen Contraindications
Contraindications
For risk reduction: concomitant coumarin anticoagulants, history of deep vein thrombosis or pulmonary embolism, planned pregnancy. Pregnancy (Cat.D). Nursing mothers.
Tamoxifen Boxed Warnings
Not Applicable
Tamoxifen Warnings/Precautions
Warnings/Precautions
See literature. Do gynecological exam at least annually. DCIS and risk reduction: consider increased risk of uterine cancer (endometrial adenocarcinoma, uterine sarcoma) and thrombotic events. Women with advanced disease: discontinue if severe hypercalcemia occurs. Monitor blood, lipids, liver function, for thromboembolism symptoms (eg, leg swelling, unexplained shortness of breath), and for uterine changes/cancer (eg, pelvic pain or pressure); promptly investigate any abnormal vaginal bleeding. Breast cancer treatment: history of thromboembolic events. Premenopausal: use effective non-hormonal contraception during and within 2 months of discontinuing therapy; begin therapy during menses or, if irregular menses, obtain (–) B-hCG pregnancy test first.
Tamoxifen Pharmacokinetics
See Literature
Tamoxifen Interactions
Interactions
May potentiate oral anticoagulants (see Contraindications). Antagonizes anastrozole (avoid concomitant use); letrozole. Plasma levels reduced by CYP3A4 inducers (eg, rifampin). Cytotoxic drugs increase risk of thrombotic events. Potentiated by bromocriptine.
Tamoxifen Adverse Reactions
Adverse Reactions
Hot flashes, vaginal discharge, altered menses, rash, headache, nausea, cough, edema, fatigue, abdominal cramps, bone and tumor pain (in advanced disease), local disease flare, hypercalcemia, thrombotic events, ovarian cysts, uterine fibroids or cancer (endometrial adenocarcinoma, uterine sarcoma), endometrial or visual changes, jaundice, hypertriglyceridemia, blood dyscrasias, hair loss.
Tamoxifen Clinical Trials
See Literature
Tamoxifen Note
Notes
Formerly known under the brand name Nolvadex.
Tamoxifen Patient Counseling
See Literature