Important Safety Information
FARESTON has been shown to cause a change in heart rhythm. This change can lead to fainting, seizures, and/or death. Before taking FARESTON talk to your doctor about all your medical conditions, all the other medicines you are taking, and if you have had an irregular heartbeat. There are certain medicines that should not be taken with FARESTON.
FARESTON is not right for everyone. Before taking FARESTON tell your doctor if you are allergic to FARESTON or any of its ingredients. If you are pregnant, nursing or may become pregnant, do not take FARESTON, as it may cause fetal harm. Side effects may include hot flashes, sweating, nausea, vaginal discharge, dizziness, and swelling.
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.
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.
BOXED WARNING and additional important safety information:
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. Patients with a history of thromboembolic diseases should generally not be treated with FARESTON. As with other antiestrogens, tumor flare, hypercalcemia, and endometrial hyperplasia have been reported in some breast cancer patients being treated with FARESTON. In general, patients with preexisting endometrial hyperplasia should not be given long-term FARESTON treatment. During clinical trials involving 1157 patients treated with FARESTON or tamoxifen, the incidence of serious side effects were as follows: cardiac events (2.03% vs. 2.42%), ocular events (10.30% vs. 9.38%), thromboembolic events (3.21% vs. 3.28%), and elevated liver tests (26.2% and 23.7%), respectively.
References: FARESTON Prescribing Information, 2004. Data on file, GTx, Inc.. Hayes DF, Van Zyl JA, Hacking A, et al. Randomized comparison of tamoxifen and two separate doses of toremifene in postmenopausal patients with metastatic breast cancer. J Clin Oncol. 1995;13:2556-2566. Gershanovich M, Garin A, Baltina D, et al. A phase III comparison of two toremifene doses to tamoxifen in postmenopausal women with advanced breast cancer. Breast Cancer Res Treat. 1997;45:251-262. Pyrhönen S, Valavaara R, Modig H, et al. Comparison of toremifene and tamoxifen in postmenopausal patients with advanced breast cancer: a randomized double-blind, the ‘nordic’ phase III study. Br J Cancer. 1997;76:270-277.
