What is Fareston?
Fareston is a medicine that contains the active substance toremifene. It is available as round white tablets (60 mg).
What is Fareston used for?
Fareston is indicated in the treatment of hormone-dependent metastatic breast cancer in postmenopausal women. The term "metastatic" indicates that the tumor has spread to other parts of the body. Fareston is not recommended in patients suffering from estrogen receptor-negative tumors (ie when tumor cells are free of estrogen hormone receptors on their surface).
The medicine can only be obtained with a prescription.
How is Fareston used?
The recommended dose of Fareston is one tablet once a day. The medicine should be used with caution in people with liver disorders.
How does Fareston work?
Most breast cancers grow in response to the estrogen hormone. The active ingredient in Fareston, toremifene, is an antiestrogen. It binds to the estrogen receptors on the cell surface, where it acts mainly by blocking the effects of the hormone. As a result, cancer cells are not stimulated to grow by estrogen and carcinoma proliferation is therefore reduced.
How has Fareston been studied?
The effects of Fareston were first tested in experimental models before being studied in humans.
Fareston has been studied in four main studies involving 1, 869 post-menopausal patients with metastatic breast cancer. The effects of Fareston have been compared to those of tamoxifen (another antiestrogen used in the treatment of breast cancer). The main measures of effectiveness were the response rate (number of patients whose cancer responded to treatment), time to progression (time elapsed before the disease got worse) and increased survival.
What benefit has Fareston shown during the studies?
The efficacy of Fareston and tamoxifen was equivalent. Looking at the results of the three main studies together, the patients who took Fareston reported similar response rates, timing and survival rates to tamoxifen patients. These results were subsequently confirmed by the fourth study.
What is the risk associated with Fareston?
The most common side effects with Fareston (seen in more than 1 patient in 10) are hot flushes and sweating. For the full list of all side effects reported with Fareston, see the Package Leaflet.
Fareston should not be used in patients who may be hypersensitive (allergic) to toremifene or any of the other substances. It should not be used for a long time in patients suffering from endometrial hyperplasia (thickening of the mucous membrane of the uterus) or severe liver problems. Fareston should not be administered to patients with "QT interval prolongation" (an alteration in the electrical activity of the heart), electrolyte disturbances (abnormal changes in blood salt levels), especially hypokalemia (low blood potassium levels)., bradycardia (very low heart rate), heart failure (inability of the heart to pump enough blood into the body) or with a history of symptomatic arrhythmias (abnormal heart rhythm) or in patients who also take other drugs that can cause an extension of the QT interval. For the complete list of these medicines, see the package leaflet.
Why has Fareston been approved?
The Committee for Medicinal Products for Human Use (CHMP) concluded that the benefits and risks of Fareston are comparable to those of tamoxifen in women with estrogen receptor-positive tumors. Therefore, the committee decided that Fareston's benefits outweigh its risks for the first-line hormone treatment of hormone-dependent metastatic breast cancer in postmenopausal patients. The committee recommended that Fareston be given marketing authorization.
More information on Fareston:
On 14 February 1996 the European Commission issued a marketing authorization for Fareston, valid throughout the European Union. The marketing authorization was renewed on February 14, 2001 and February 14, 2006. The marketing authorization holder is Orion Corporation.
The full EPAR for Fareston can be found here.
Last update of this summary: 03-2009.
