Important Safety Information and Boxed Warning

Important Safety Information and Boxed Warning

Indication

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.
• 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 not be treated with Fareston.
• Leukocyte and platelet counts should be monitored when using Fareston in patients with leukopenia and thrombocytopenia.
• Fareston can cause fetal harm when administered to a pregnant woman.
• Fareston is only indicated for 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.