Fareston® (toremifene citrate) 60 mg Tablets is an estrogen agonist/antagonist indicated 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 prolong the QTc interval in a dose- and concentration-related manner. Prolongation of
the QT interval can result in a type of ventricular tachycardia called Torsade de pointes, which may result in syncope,
seizure, and/or death. Toremifene should not be prescribed to patients with congenital/acquired QT prolongation,
uncorrected hypokalemia, or uncorrected hypomagnesemia. Drugs known to prolong the QT interval and strong
CYP3A4 inhibitors should be avoided.
Fareston is contraindicated in patients with known hypersensitivity to the drug and in patients with congenital/acquired QT prolongation (long QT syndrome), uncorrected hypokalemia, or uncorrected hypomagnesemia.
The most common adverse reactions are hot flashes, sweating, nausea, and vaginal discharge.
To report suspected adverse reactions, contact Kyowa Kirin, Inc. at 1-877-251-4952 or the FDA at 1-800-FDA-1088 or visit www.fda.gov/medwatch.