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.
The most common adverse reactions are hot flashes, sweating, nausea, 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.
Reference: 1. Fareston [packge insert]. Bedminster, NJ: Kyowa Kirin, Inc.