Faslodex

fulvestrant

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This is a summary of the European public assessment report (EPAR) for Faslodex. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Faslodex.

For practical information about using Faslodex, patients should read the package leaflet or contact their doctor or pharmacist.

What is Faslodex and what is it used for?

Faslodex is an anti-oestrogen medicine used to treat advanced or metastatic breast cancer (cancer that has spread to other parts of the body) in the following patients:

  • postmenopausal women with a type of breast cancer known as ‘oestrogen-receptor positive cancer’ who have not previously had hormonal treatment, or whose cancer had come back after treatment with another anti-oestrogen;
  • women with a type of breast cancer known as ‘HR-positive, HER-2 negative cancer’ who have previously had hormonal treatment. In women with this type of breast cancer, Faslodex is used in combination with palbociclib (another cancer medicine).

Faslodex contains the active substance fulvestrant.

How is Faslodex used?

Faslodex is available as a solution for injection in prefilled syringes (250 mg). The recommended dose is 500 mg given once a month, with an additional 500-mg dose two weeks after the first dose. The dose is given as two injections, each given into the muscle of one buttock over one to two minutes.

Faslodex can only be obtained with a prescription.

How does Faslodex work?

Most types of breast cancer are stimulated to grow when the hormone oestrogen attaches to targets (receptors) on cancer cells. The active substance in Faslodex, fulvestrant, is an anti-oestrogen. It blocks the receptors for oestrogen on cells and causes the number of oestrogen receptors to fall. As a result, the cancer cells are not stimulated to grow by oestrogen and this slows down the growth of the tumour.

What benefits of Faslodex have been shown in studies?

Five main studies showed that Faslodex is effective at prolonging the length of time patients live without their disease getting worse.

Two of these studies in 851 women showed that Faslodex was as effective as another medicine, anastrozole: women receiving Faslodex lived for an average of 5.4 months without their disease getting worse, compared with 4.1 months for those taking anastrozole.

A third study in 736 women showed that the higher dose of 500 mg of Faslodex was more effective than 250 mg: 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.

The fourth study, in 462 women with advanced or metastatic breast cancer who had not been treated with hormonal therapy, showed that women treated with Faslodex (500 mg once a month) lived for an average of 16.6 months without their disease getting worse, compared with 13.8 months for women given anastrozole.

Finally, a study investigating the use of Faslodex in combination with palbociclib in 521 women with (HR)-positive (HER2)-negative advanced or metastatic breast cancer showed that women treated with Faslodex plus palbociclib lived for an average of 9.2 months without their disease getting worse, compared with 3.8 months for women given Faslodex on its own.

What are the risks associated with Faslodex?

When Faslodex is used on its own, the most common side effects (seen in more than 1 patient in 10) are injection-site reactions (such as pain or inflammation), weakness, nausea (feeling sick) and increased liver enzyme levels in the blood (a sign of liver problems). When used in combination with palbociclib, the most common side effects with Faslodex (seen in more than 2 patients in 10) are low levels of white and red blood cells, low blood platelet counts, infections, tiredness, nausea, stomatitis (inflammation of the lining of the mouth) and diarrhoea. The most common serious side effects were low levels of white and red blood cells, low levels of blood platelets, infections, increased liver enzyme levels and tiredness.

Faslodex must not be used in women who are pregnant or breast-feeding, or in patients who have severe liver disease. For the full list of all side effects and restrictions with Faslodex, see the package leaflet.

Why is Faslodex approved?

Studies showed that Faslodex, an anti-oestrogen medicine, is effective at prolonging the time patients with oestrogen-receptor positive breast cancer can live without their disease getting worse. In addition, the medicine is effective in combination with palbociclib in patients with HR-positive, HER-2 negative breast cancer. The European Medicines Agency concluded that the benefits seen in studies with Faslodex are greater than its risks and recommended that it be given marketing authorisation.

What measures are being taken to ensure the safe and effective use of Faslodex?

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Faslodex have been included in the summary of product characteristics and the package leaflet.

Other information about Faslodex

The European Commission granted a marketing authorisation valid throughout the European Union for Faslodex on 10 March 2004. 

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

Name Language First published Last updated
Faslodex : EPAR - Summary for the public BG = bălgarski 2009-01-29 2018-01-26
Faslodex : EPAR - Summary for the public ES = español 2009-01-29 2018-01-26
Faslodex : EPAR - Summary for the public CS = čeština 2009-01-29 2018-01-26
Faslodex : EPAR - Summary for the public DA = dansk 2009-01-29 2018-01-26
Faslodex : EPAR - Summary for the public DE = Deutsch 2009-01-29 2018-01-26
Faslodex : EPAR - Summary for the public ET = eesti keel 2009-01-29 2018-01-26
Faslodex : EPAR - Summary for the public EL = elliniká 2009-01-29 2018-01-26
Faslodex : EPAR - Summary for the public EN = English 2009-01-29 2018-01-26
Faslodex : EPAR - Summary for the public FR = français 2009-01-29 2018-01-26
Faslodex : EPAR - Summary for the public IT = italiano 2009-01-29 2018-01-26
Faslodex : EPAR - Summary for the public LV = latviešu valoda 2009-01-29 2018-01-26
Faslodex : EPAR - Summary for the public LT = lietuvių kalba 2009-01-29 2018-01-26
Faslodex : EPAR - Summary for the public HU = magyar 2009-01-29 2018-01-26
Faslodex : EPAR - Summary for the public MT = Malti 2009-01-29 2018-01-26
Faslodex : EPAR - Summary for the public NL = Nederlands 2009-01-29 2018-01-26
Faslodex : EPAR - Summary for the public PL = polski 2009-01-29 2018-01-26
Faslodex : EPAR - Summary for the public PT = português 2009-01-29 2018-01-26
Faslodex : EPAR - Summary for the public RO = română 2009-01-29 2018-01-26
Faslodex : EPAR - Summary for the public SK = slovenčina 2009-01-29 2018-01-26
Faslodex : EPAR - Summary for the public SL = slovenščina 2009-01-29 2018-01-26
Faslodex : EPAR - Summary for the public FI = suomi 2009-01-29 2018-01-26
Faslodex : EPAR - Summary for the public SV = svenska 2009-01-29 2018-01-26
Faslodex : EPAR - Summary for the public HR = Hrvatski 2009-01-29 2018-01-26

This EPAR was last updated on 09/04/2018 .

Authorisation details

Product details

Product details for Faslodex
NameFaslodex
Agency product numberEMEA/H/C/000540
Active substance

fulvestrant

International non-proprietary name (INN) or common name

fulvestrant

Therapeutic area Breast Neoplasms
Anatomical therapeutic chemical (ATC) code L02BA03

Publication details

Publication details for Faslodex
Marketing-authorisation holder

AstraZeneca AB

Revision19
Date of issue of marketing authorisation valid throughout the European Union10/03/2004

Contact address:

AstraZeneca AB
SE-151 85 Södertälje
Sweden

Product information

Product information

21/03/2018  Faslodex -EMEA/H/C/000540 -T/0063

Name Language First published Last updated
Faslodex : EPAR - Product Information HR = Hrvatski 2009-02-17 2018-04-09
Faslodex : EPAR - Product Information HR = Hrvatski 2009-02-17 2018-04-09
Faslodex : EPAR - Product Information HR = Hrvatski 2009-02-17 2018-04-09
Faslodex : EPAR - Product Information HR = Hrvatski 2009-02-17 2018-04-09
Faslodex : EPAR - Product Information HR = Hrvatski 2009-02-17 2018-04-09
Faslodex : EPAR - Product Information HR = Hrvatski 2009-02-17 2018-04-09
Faslodex : EPAR - Product Information HR = Hrvatski 2009-02-17 2018-04-09
Faslodex : EPAR - Product Information HR = Hrvatski 2009-02-17 2018-04-09
Faslodex : EPAR - Product Information HR = Hrvatski 2009-02-17 2018-04-09
Faslodex : EPAR - Product Information HR = Hrvatski 2009-02-17 2018-04-09
Faslodex : EPAR - Product Information HR = Hrvatski 2009-02-17 2018-04-09
Faslodex : EPAR - Product Information HR = Hrvatski 2009-02-17 2018-04-09
Faslodex : EPAR - Product Information HR = Hrvatski 2009-02-17 2018-04-09
Faslodex : EPAR - Product Information HR = Hrvatski 2009-02-17 2018-04-09
Faslodex : EPAR - Product Information HR = Hrvatski 2009-02-17 2018-04-09
Faslodex : EPAR - Product Information HR = Hrvatski 2009-02-17 2018-04-09
Faslodex : EPAR - Product Information HR = Hrvatski 2009-02-17 2018-04-09
Faslodex : EPAR - Product Information HR = Hrvatski 2009-02-17 2018-04-09
Faslodex : EPAR - Product Information HR = Hrvatski 2009-02-17 2018-04-09
Faslodex : EPAR - Product Information HR = Hrvatski 2009-02-17 2018-04-09
Faslodex : EPAR - Product Information HR = Hrvatski 2009-02-17 2018-04-09
Faslodex : EPAR - Product Information HR = Hrvatski 2009-02-17 2018-04-09
Faslodex : EPAR - Product Information HR = Hrvatski 2009-02-17 2018-04-09
Faslodex : EPAR - Product Information HR = Hrvatski 2009-02-17 2018-04-09
Faslodex : EPAR - Product Information HR = Hrvatski 2009-02-17 2018-04-09

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.


Name Language First published Last updated
Faslodex : EPAR - All Authorised presentations HR = Hrvatski 2006-01-08 2010-04-26
Faslodex : EPAR - All Authorised presentations HR = Hrvatski 2006-01-08 2010-04-26
Faslodex : EPAR - All Authorised presentations HR = Hrvatski 2006-01-08 2010-04-26
Faslodex : EPAR - All Authorised presentations HR = Hrvatski 2006-01-08 2010-04-26
Faslodex : EPAR - All Authorised presentations HR = Hrvatski 2006-01-08 2010-04-26
Faslodex : EPAR - All Authorised presentations HR = Hrvatski 2006-01-08 2010-04-26
Faslodex : EPAR - All Authorised presentations HR = Hrvatski 2006-01-08 2010-04-26
Faslodex : EPAR - All Authorised presentations HR = Hrvatski 2006-01-08 2010-04-26
Faslodex : EPAR - All Authorised presentations HR = Hrvatski 2006-01-08 2010-04-26
Faslodex : EPAR - All Authorised presentations HR = Hrvatski 2006-01-08 2010-04-26
Faslodex : EPAR - All Authorised presentations HR = Hrvatski 2006-01-08 2010-04-26
Faslodex : EPAR - All Authorised presentations HR = Hrvatski 2006-01-08 2010-04-26
Faslodex : EPAR - All Authorised presentations HR = Hrvatski 2006-01-08 2010-04-26
Faslodex : EPAR - All Authorised presentations HR = Hrvatski 2006-01-08 2010-04-26
Faslodex : EPAR - All Authorised presentations HR = Hrvatski 2006-01-08 2010-04-26
Faslodex : EPAR - All Authorised presentations HR = Hrvatski 2006-01-08 2010-04-26
Faslodex : EPAR - All Authorised presentations HR = Hrvatski 2006-01-08 2010-04-26
Faslodex : EPAR - All Authorised presentations HR = Hrvatski 2006-01-08 2010-04-26
Faslodex : EPAR - All Authorised presentations HR = Hrvatski 2006-01-08 2010-04-26
Faslodex : EPAR - All Authorised presentations HR = Hrvatski 2006-01-08 2010-04-26
Faslodex : EPAR - All Authorised presentations HR = Hrvatski 2006-01-08 2010-04-26
Faslodex : EPAR - All Authorised presentations HR = Hrvatski 2006-01-08 2010-04-26
Faslodex : EPAR - All Authorised presentations HR = Hrvatski 2006-01-08 2010-04-26

Pharmacotherapeutic group

Anti-oestrogen

Therapeutic indication

Faslodex is indicated

  • as monotherapy for the treatment of estrogen receptor positive, locally advanced or metastatic breast cancer in postmenopausal women:
    • not previously treated with endocrine therapy, or
    • with disease relapse on or after adjuvant antiestrogen therapy, or disease progression on antiestrogen therapy.
  • in combination with palbociclib for the treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer in women who have received prior endocrine therapy.

In pre- or perimenopausal women, the combination treatment with palbociclib should be combined with a luteinizing hormone releasing hormone (LHRH) agonist.

Assessment History

Changes since initial authorisation of medicine

Initial marketing-authorisation documents

Name Language First published Last updated
Faslodex : EPAR - Procedural steps taken before authorisation HR = Hrvatski 2006-01-08  
Faslodex : EPAR - Scientific Discussion HR = Hrvatski 2006-01-08