Important Safety Information and Boxed Warning
Fareston® (toremifene citrate) 60 mg Tablets is a prescription medicine approved for the treatment of metastatic breast cancer in postmenopausal women with estrogen-receptor–positive or unknown tumors.
WARNING: QT PROLONGATION
Fareston has been shown to cause a change in heart rhythm (QT prolongation). This change can lead to fainting, seizures, and/or death. Do not take Fareston if you were born with or have a history of irregular heartbeats. Do not take Fareston if you have low blood potassium levels or low blood magnesium levels that are currently not corrected by treatment. There are certain medicines that should not be taken with Fareston. Talk to your doctor about all the other medicines you are taking.
Do not take Fareston if you are allergic to Fareston or any of its ingredients. You should not take Fareston if you have a history of abnormal heart rhythms (arrhythmias), are taking other medicines that can result in abnormal heart rhythms, or were born with or have had any condition that causes abnormal heart rhythms. Do not take Fareston if you have a salt imbalance in the blood, especially low concentrations of potassium (hypokalemia) or low concentrations of magnesium in the blood (hypomagnesemia) that are currently not corrected by treatment.
Talk to your doctor before taking Fareston if you have bone metastasis or increased concentration of calcium in the blood (hypercalcemia), which may occur at the beginning of your treatment. Also talk to your doctor if you have a history of thickening of the womb lining. If you are pregnant, nursing, or may become pregnant, do not take Fareston, as it may cause fetal harm. You should not take Fareston if you have had or are at risk for getting blood clots in the legs, lungs, or eyes, as it may increase the risk of blood clots. If you have leg pain or warmth; swelling of the legs, hands or feet; chest pain; shortness of breath; or a sudden vision change, stop taking Fareston and call your doctor, as these may be signs of a blood clot. The most common side effects of Fareston are hot flashes, nausea, sweating, and vaginal discharge. To report suspected adverse reactions, contact Kyowa Kirin, Inc. at 1-800-305-FARESTON (1-800-305-3273), or the FDA at 1-800-FDA-1088 or visit www.fda.gov/medwatch.