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SOLTAMOX® Important Safety Information - WARNING: UTERINE MALIGNANCIES and THROMBOEMBOLIC EVENTS

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WARNING: UTERINE MALIGNANCIES and THROMBOEMBOLIC EVENTS

  • Serious, life-threatening, and fatal events from use of tamoxifen include uterine malignancies, stroke, and pulmonary embolism. (5.1, 5.2)
  • Discuss risks and benefits of tamoxifen with women at high risk for breast cancer and women with ductal carcinoma in situ (DCIS) when considering tamoxifen use to reduce the risk of developing breast cancer. (5.1, 5.2)
  • For most patients already diagnosed with breast cancer, the benefits of tamoxifen outweigh its risks. (5.1, 5.2)

See full prescribing information for complete boxed warning.

SOLTAMOX® Important Safety Information

  • Tamoxifen citrate is contraindicated in patients who require concomitant warfarin therapy, or a history of deep vein thrombosis or pulmonary embolus, and in patients with known hypersensitivity to the drug or any of its ingredients.
  • Uterine malignancies: Promptly evaluate abnormal vaginal bleeding in a woman with current or past tamoxifen use.
  • Thromboembolic events: Risk increases with coadministered chemotherapy. For treatment of breast cancer, consider risks and benefits in patients with a history of thromboembolic events.
  • Embryo-fetal toxicity: Can cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception.
  • Effects on the liver: Liver cancer and liver abnormalities, some fatal, have occurred. Perform periodic liver function testing.
  • The most common adverse reactions (≥20% incidence) associated with tamoxifen are hot flashes, mood disturbances, vaginal discharge, vaginal bleeding, nausea, and fluid retention.
  • Anastrozole and letrozole: Should not be used in combination with tamoxifen.
  • Warfarin: Do not use in patients taking tamoxifen for DCIS and for reduction in breast cancer incidence in women at high risk. Closely monitor coagulation indices for increased anticoagulant effect when used with tamoxifen for metastatic breast cancer or as adjuvant therapy.
  • Do not use tamoxifen in lactating women.
  • Verify pregnancy status of females prior to initiation of tamoxifen.
  • Advise females and males to use effective contraception.

Please see full Prescribing Information for SOLTAMOX®.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.