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Indication

FARESTON^® (toremifene citrate) is an estrogen agonist/antagonist indicated for the treatment of metastatic breast cancer in postmenopausal women with estrogen-receptor positive or unknown tumors.

Important Safety Information

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.

CONTRAINDICATIONS

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.

WARNINGS AND PRECAUTIONS

Fareston has been shown to prolong the QT interval. Caution should be exercised in patients with congestive heart failure, hepatic impairment and electrolyte abnormalities. In patients at increased risk, ECGs should be obtained at baseline and as clinically indicated.
Both increases in the serum concentration for grade 3 and 4 transaminitis and hyperbilirubinemia have been reported. Liver function tests should be performed periodically.
Hypercalcemia and tumor flare have been reported during the first weeks of treatment with Fareston in some breast cancer patients with bone metastases. If hypercalcemia is severe, Fareston treatment should be discontinued.
Patients with preexisting endometrial hyperplasia should not be given long-term Fareston treatment, and patients at high risk for endometrial cancer should be closely monitored.
Patients with a history of thromboembolic diseases should generally not be treated with Fareston.
Periodic complete blood counts, calcium levels, and liver function tests should be obtained.
Fareston can cause fetal harm when administered to a pregnant woman.
Fareston is only indicated only in postmenopausal women. However, premenopausal women prescribed Fareston should use effective nonhormonal contraception and should be apprised of the potential hazard to the fetus should pregnancy occur.

ADVERSE REACTIONS

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.

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