ALREADY ACTIVE

  • Parent compound binds to and blocks estrogen receptors
  • Majority of pharmacologic activity associated with toremifene and CYP3A4 metabolite
  • CYP2D6 does not play a significant role in the activity of FARESTON

SAFETY PROFILE

  • Most frequently reported adverse reactions include hot flash, sweating, nausea, and vaginal discharge

500,000 PATIENT YEARS

  • Over 20 years of clinical experience
  • Positioned in the NCCN® Guidelines equivalent to other endocrine therapies for postmenopausal metastatic disease

PATIENT SAVINGS

  • Savings coupons offer up to $50 off each prescription for eligible patients
  • Available at no cost for Medicare Part D and uninsured patients who qualify

About Fareston

 

Fareston® may be the answer

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.

Fareston helps reduce the guesswork.

Already Active

  • Toremifene, the parent compound of FARESTON, is a SERM* which binds to and blocks estrogen receptors with antiestrogenic activity equivalent to its primary metabolite
  • The majority of the pharmacologic activity of FARESTON is associated with the parent compound toremifene and its CYP3A4 metabolite
  • CYP2D6 does not play a significant role in the activity of FARESTON

 

Fareston is Already Active

 

SAFETY profile established from multiple clinical trials

  • Most frequently reported adverse reactions include hot flash, sweating, nausea, and vaginal discharge

 

Fareston has a proven clinical profile

More than 500,000 Patient-Years of Fareston Therapy

 

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% vs. 23.7%), respectively.




expand safety information

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.