Fareston May Be an Appropriate Alternative If You Are a Postmenopausal Woman and Have Found Other Endocrine Treatments to Be a Challenge in the Treatment of Your Metastatic Breast Cancer of ER+ or Unknown Tumors*1-7

Talk to your doctor about Fareston today
  • Fareston may be a good alternative if you have stopped using other endocrine therapies because of arthralgia (joint pain)1-4,6
  • No patients stopped using Fareston due to arthralgia (joint pain) in clinical studies1
  • In clinical studies of Fareston, only about 1% of patients stopped using Fareston because of any side effects1-4

 

*"Unknown tumors" are tumors for which the hormonal status (eg, ER+ or ER-) is not known.

Important Safety Information and Boxed Warning

 

Indication

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.

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.

References: 1. Fareston [packge insert]. Bedminster, NJ: Kyowa Kirin, Inc. 2. Gershanovich M, Garin A, Baltina D, Kurvet A, Kangas L, Ellmén J. A phase III comparison of two toremifene doses to tamoxifen in postmenopausal women with advanced breast cancer. Eastern European Study Group. Breast Cancer Res Treat. 1997;45(3):251-262. 3. 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(10):2556-2566. 4. Pyrhönen S, Valavaara R, Modig H, et al. Comparison of toremifene and tamoxifen in post-menopausal patients with advanced breast cancer: a randomized double-blind, the 'nordic' phase III study. Br J Cancer. 1997;76(2):270-277. 5. National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) Breast Cancer (Version 1.2016). http://www.nccn.org/professionals/physician_gls/pdf/breast.pdf. Accessed February 18, 2016. 6. Hong S, Didwania A, Olopade O, Ganschow P. The expanding use of third-generation aromatase inhibitors: what the general internist needs to know. J Gen Intern Med. 2009; 24(suppl 2):383-388. 7. Sestak I, Cuzick J, Sapunar F, Eastell R, Forbes J, Bianco AR, Buzdar AU on behalf of the ATAC Trialist’s Group. Risk factors for joint symptoms in patients enrolled in the ATAC trial: a retrospective, exploratory analysis. Lancet Oncol. 2008;9:866-872.

Expand Safety Information

Important Safety Information and Boxed Warning

Indication

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.
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.