- Hypercalcemia may occur in some breast CA patients with bone metastases during the first weeks of treatment; if severe, discontinue use
- Increased incidence of uterine malignancies has been reported with tamoxifen treatment
- Most uterine malignancies associated with tamoxifen are classified as adenocarcinoma of the endometrium. Rare uterine sarcomas, including malignant mixed mullerian tumors (MMMT), have also been reported
- Uterine sarcomas are generally associated with a higher FIGO stage (III/IV) at diagnosis, poorer prognosis, and shorter survival; frequently occurs among long-term users (
2 yrs). Some of the uterine malignancies (endometrial carcinoma or uterine sarcoma) have been fatal - Promptly investigate abnormal gynecological symptoms, especially abnormal vaginal bleeding in patients receiving or who have previously received tamoxifen. Perform annual gynecological examinations in all patients receiving or who have previously received tamoxifen and instruct them to inform their physicians if they experience any abnormal gynecological symptoms such as menstrual irregularities, abnormal vaginal bleeding, changes in vaginal discharge, or pelvic pain or pressure
- An increased incidence of endometrial changes including hyperplasia and polyps have been reported during treatment
- Few reports of endometriosis, uterine fibroids and ovarian cysts also have been reported in women receiving tamoxifen
- An increased incidence of thromboembolic events including deep vein thrombosis and pulmonary embolism have occurred during therapy. For treatment of breast CA, carefully consider the risks and benefits of tamoxifen in women with a history of thromboembolic events
- Cases of changes in liver enzyme levels, severe liver abnormalities including fatty liver, cholestasis, hepatitis and hepatic necrosis have been reported with tamoxifen therapy
- A number of second primary tumors have been reported at sites other than the endometrium
- Ocular disturbances, including corneal changes, decrement in color vision perception, retinal vein thrombosis, retinopathy and an increased incidence of cataracts have been reported in patients receiving tamoxifen
- Advise women not to become pregnant while receiving tamoxifen or within two months of discontinuing therapy, as it may cause fetal harm. If the drug is used during pregnancy, or the patient becomes pregnant while taking the drug, or within approximately two months after discontinuing therapy, the patient should be apprised of the potential risks to the fetus including the potential long-term risk of a DES-like syndrome
- Decreases in platelet counts, resulting in rare hemorrhagic episodes, leukopenia, anemia, and rarely severe neutropenia and pancytopenia have been reported in patients receiving tamoxifen
- Increased bone and tumor pain, local disease flare have occurred, which are sometimes associated with a good tumor response. The bone pain or disease flare are seen shortly after starting tamoxifen, and generally subside rapidly
- Perform periodic CBC, including platelet counts, and LFT's
Cautions: Use cautiously in
- Thrombocytopenia
- Leukopenia
- Thromboembolism
- Poor CYP2D6 metabolizer
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