Fareston Overview

This is a summary of the European Public Assessment Report (EPAR). It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the studies performed, to reach their recommendations on how to use the medicine.
If you need more information about your medical condition or your treatment, read the Package Leaflet (also part of the EPAR) or contact your doctor or pharmacist. If you want more information on the basis of the CHMP recommendations, read the Scientific Discussion (also part of the EPAR).

The recommended dose of Fareston is one tablet once a day. It should be used with caution in patients who have problems with their liver.

Most types of breast cancer grow in response to the hormone oestrogen. The active substance in Fareston, toremifene, is an anti-oestrogen. It attaches to the receptors for oestrogen on the surface of cells, where its main effect is to block the effects of the hormone. As a result, the tumour cells are not stimulated to grow by oestrogen and the growth of the tumour is reduced.

The effectiveness of Fareston and tamoxifen were equivalent. Looking at the results of the three largest main studies taken together, patients taking Fareston had similar response rates, times to progression and survival rates as the patients taking tamoxifen. This was confirmed in the fourth study.

The Committee for Medicinal Products for Human Use (CHMP) concluded that the benefits and risks of Fareston were comparable to those of tamoxifen in women with oestrogen-receptor-positive tumours. Therefore, the Committee decided that Fareston’s benefits are greater than 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 authorisation.

The European Commission granted a marketing authorisation valid throughout the European Union for Herceptin on 28 August 2000.

For more information about treatment with Herceptin, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

What are the risks associated with Fareston?

The most common side effects with Fareston (seen in more than 1 patient in 10) are hot flushes and sweating. 

Fareston should not be used in people who may be hypersensitive (allergic) to toremifene or any of the other ingredients. It must not be used on a long-term basis in patients who have endometrial hyperplasia (thickening of the lining of the womb) or severe liver problems. Fareston must not be used in patients with ‘QT prolongation’ (a disruption of the electrical activity of the heart), electrolyte disturban​_ces (altered levels of salts in the blood) especially hypokalaemia (low potassium levels), bradycardia (a very slow heart rate), heart failure (an inability of the heart to pump enough blood to the rest of the body) or a history of symptomatic arrhythmias (abnormal heart rhythms), or in patients also taking other medicines that can cause QT prolongation.

Owner of copyright and other intellectual property rights to European Medicines Agency

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