This information is produced and provided originally by the European Medicines Agency (EMA). We only provide general information and advice from medical professionals should be followed. It is very important to consult more information about the drug, such as side-effects, benefits, indications, approval and so forth. More information concerning the use of this drug is available on the EMA website at www.ema.europa.eu. This information was last updated by EMA in February 2013. It is always important to consult the leaflet information.
Fulvestrant is the active substance of Faslodex® (AstraZeneca UK Limited).
Faslodex® is used to treat locally advanced or metastatic breast cancer in women who have been through the menopause. It is used for cancer that is ‘estrogen-receptor positive’ (when the cancer cells have receptors for the hormone estrogen on their surface). Faslodex® is used when the disease has returned during or after treatment with an anti-estrogen, or when the disease has got worse during treatment with an anti-estrogen.
The medicine can only be obtained with a prescription.
What is it?
Most types of breast cancer grow in response to the hormone estrogen. The active substance in Faslodex®, fulvestrant, is an anti-estrogen. It attaches to the receptors for estrogen on the surface of cells, where it blocks the effects of the hormone and causes the number of estrogen receptors to fall. As a result, the tumour cells are not stimulated to grow by estrogen and the growth of the tumour is reduced.
Faslodex® is absorbed slowly into the body, with the effects of each dose lasting over a month. The levels of the medicine in the body reach a steady level within a month of starting treatment.
Does it work?
Faslodex® has been studied in three main studies involving women who had been through the menopause with advanced breast cancer that had come back or got worse after previous hormonal treatment. Two of the studies compared Faslodex® taken at a dose of 250 mg once a month with anastrozole (another anticancer medicine) taken at a dose of 1 mg every day in 851 women. The third study compared two doses of Faslodex® (250 and 500 mg) in 736 women. In all of the studies, the main measure of effectiveness was how long the patients lived without their disease getting worse.
In the first two studies, Faslodex® was as effective as anastrozole: the women receiving Faslodex® lived for an average of 5.4 months without their disease getting worse, compared with 4.1 months in those taking anastrozole. In the third study, the 500-mg dose of Faslodex® was more effective than the 250-mg dose: the women receiving the higher dose lived for an average of 6.5 months without their disease getting worse, compared with 5.5 months in those receiving the lower dose.
Is it safe?
The most common side effects with Faslodex® (seen in more than 1 patient in 10) are nausea, weakness, injection-site reactions such as pain or inflammation and increased liver enzyme levels in the blood. For the full list of all side effects reported with Faslodex®, see the Package Leaflet.
Faslodex® should not be used in people who may be hypersensitive to fulvestrant or any of the other ingredients. Faslodex® must not be used in women who are pregnant or breast-feeding, or in patients who have severe liver disease.
This information is based on the Summary for the public of this drug produced by the European Medicines Agency. For more information click here.
Faslodex (brand name)