Zytiga

abiraterone

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This is a summary of the European public assessment report (EPAR) for Zytiga. 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 Zytiga.
For practical information about using Zytiga, patients should read the package leaflet or contact their doctor or pharmacist.

What is Zytiga and what is it used for?

Zytiga is a medicine used to treat cancer of the prostate (a gland of the male reproductive system) in adult men when the cancer is metastatic (has spread to other parts of the body). It is used with the medicines prednisone or prednisolone when:
• medical castration (using medicines to stop the production of male hormones in the body) with a treatment called androgen deprivation therapy has not worked or no longer works in men who have either no symptoms or only mild symptoms of the disease, and who do not yet need chemotherapy (cancer medicines);
• medical or surgical castration and chemotherapy containing docetaxel have not worked or no longer work.
Zytiga contains the active substance abiraterone acetate.

How is Zytiga used?

Zytiga is available as tablets (250 and 500 mg) and can only be obtained with a prescription.
The recommended dose of Zytiga is 1,000 mg taken once a day at least two hours after eating and at least one hour before further food. If patients develop liver problems treatment should be stopped. Treatment may be resumed at a reduced dose if liver function returns to normal. For further information, see the summary of product characteristics.

How does Zytiga work?

The active substance in Zytiga, abiraterone acetate, is changed in the body to abiraterone which stops the body producing testosterone, a male hormone. Abiraterone does this by blocking an enzyme called CYP17 found in the testes and elsewhere in the body. Because the cancer needs a supply of testosterone to survive and grow, by reducing the production of testosterone, Zytiga may slow the growth of the prostate cancer.

What benefits of Zytiga have been shown in studies?

Zytiga was compared with placebo (a dummy treatment) in two main studies. In both studies, patients were also treated with prednisone or prednisolone.
The first study involved 1,195 men with metastatic prostate cancer whose disease had got worse despite surgical or medical castration treatment and chemotherapy with docetaxel. The main measure of effectiveness was overall survival (how long the patients lived). Patients treated with Zytiga lived for just under 15 months from the start of treatment compared with just under 11 months for patients given placebo.
The second study involved 1,088 men with metastatic prostate cancer who had either no symptoms or only mild symptoms of the disease and for whom castration treatment had not worked or had stopped working. The main measure of effectiveness was how long the patients lived without their disease getting worse. Patients treated with Zytiga lived for an average of around 16 months without their disease getting worse, compared with around 8 months in patients given placebo.

What are the risks associated with Zytiga?

The most common side effects with Zytiga (seen in more than 1 patient in 10) are urinary tract infection, hypokalaemia (low blood potassium levels), high blood pressure and peripheral oedema (swelling of the limbs due to fluid retention). Other important side effects include heart problems, liver problems, fractures and allergic alveolitis (a lung reaction causing cough and shortness of breath). For the full list of all side effects reported with Zytiga, see the package leaflet.
Zytiga must not be used in patients with severely reduced liver function. It is not for use in women and must not be given to women who are or who may be pregnant. For the full list of restrictions, see the package leaflet.

Why is Zytiga approved?

The Agency’s Committee for Medicinal Products for Human Use (CHMP) decided that Zytiga’s benefits are greater than its risks and recommended that it be approved for use in the EU. The CHMP noted that Zytiga in combination with prednisone or prednisolone improved survival compared with placebo in patients whose disease had got worse despite castration treatment and chemotherapy with docetaxel. The Committee noted that there were very few alternative treatments for those patients. The Committee also considered the fact that Zytiga is given by mouth to be a further advantage. In patients where medical castration has not worked and who have no or only mild symptoms, Zytiga is of benefit when chemotherapy is not yet required. Zytiga is well tolerated and its risks are considered manageable.

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

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

Other information about Zytiga

The European Commission granted a marketing authorisation valid throughout the European Union for Zytiga on 5 September 2011.

Name Language First published Last updated
Zytiga : EPAR - Summary for the public BG = bălgarski 2011-09-23 2017-02-10
Zytiga : EPAR - Summary for the public ES = español 2011-09-23 2017-02-10
Zytiga : EPAR - Summary for the public CS = čeština 2011-09-23 2017-02-10
Zytiga : EPAR - Summary for the public DA = dansk 2011-09-23 2017-02-10
Zytiga : EPAR - Summary for the public DE = Deutsch 2011-09-23 2017-02-10
Zytiga : EPAR - Summary for the public ET = eesti keel 2011-09-23 2017-02-10
Zytiga : EPAR - Summary for the public EL = elliniká 2011-09-23 2017-02-10
Zytiga : EPAR - Summary for the public EN = English 2011-09-23 2017-02-10
Zytiga : EPAR - Summary for the public FR = français 2011-09-23 2017-02-10
Zytiga : EPAR - Summary for the public IT = italiano 2011-09-23 2017-02-10
Zytiga : EPAR - Summary for the public LV = latviešu valoda 2011-09-23 2017-02-10
Zytiga : EPAR - Summary for the public LT = lietuvių kalba 2011-09-23 2017-02-10
Zytiga : EPAR - Summary for the public HU = magyar 2011-09-23 2017-02-10
Zytiga : EPAR - Summary for the public MT = Malti 2011-09-23 2017-02-10
Zytiga : EPAR - Summary for the public NL = Nederlands 2011-09-23 2017-02-10
Zytiga : EPAR - Summary for the public PL = polski 2011-09-23 2017-02-10
Zytiga : EPAR - Summary for the public PT = português 2011-09-23 2017-02-10
Zytiga : EPAR - Summary for the public RO = română 2011-09-23 2017-02-10
Zytiga : EPAR - Summary for the public SK = slovenčina 2011-09-23 2017-02-10
Zytiga : EPAR - Summary for the public SL = slovenščina 2011-09-23 2017-02-10
Zytiga : EPAR - Summary for the public FI = suomi 2011-09-23 2017-02-10
Zytiga : EPAR - Summary for the public SV = svenska 2011-09-23 2017-02-10
Zytiga : EPAR - Summary for the public HR = Hrvatski 2011-09-23 2017-02-10

This EPAR was last updated on 28/02/2017 .

Authorisation details

Product details

Product details for Zytiga
NameZytiga
Agency product numberEMEA/H/C/002321
Active substance

abiraterone acetate

International non-proprietary name (INN) or common name

abiraterone

Therapeutic area Prostatic Neoplasms
Anatomical therapeutic chemical (ATC) code L02BX03

Publication details

Publication details for Zytiga
Marketing-authorisation holder

Janssen-Cilag International N.V.

Revision16
Date of issue of marketing authorisation valid throughout the European Union05/09/2011

Contact address:

Janssen-Cilag International N.V.
Turnhoutseweg 30
BE-2340 Beerse
Belgium

Product information

Product information

06/01/2017  Zytiga -EMEA/H/C/002321 -N/0046

Name Language First published Last updated
Zytiga : EPAR - Product Information HR = Hrvatski 2011-09-23 2017-02-28
Zytiga : EPAR - Product Information HR = Hrvatski 2011-09-23 2017-02-28
Zytiga : EPAR - Product Information HR = Hrvatski 2011-09-23 2017-02-28
Zytiga : EPAR - Product Information HR = Hrvatski 2011-09-23 2017-02-28
Zytiga : EPAR - Product Information HR = Hrvatski 2011-09-23 2017-02-28
Zytiga : EPAR - Product Information HR = Hrvatski 2011-09-23 2017-02-28
Zytiga : EPAR - Product Information HR = Hrvatski 2011-09-23 2017-02-28
Zytiga : EPAR - Product Information HR = Hrvatski 2011-09-23 2017-02-28
Zytiga : EPAR - Product Information HR = Hrvatski 2011-09-23 2017-02-28
Zytiga : EPAR - Product Information HR = Hrvatski 2011-09-23 2017-02-28
Zytiga : EPAR - Product Information HR = Hrvatski 2011-09-23 2017-02-28
Zytiga : EPAR - Product Information HR = Hrvatski 2011-09-23 2017-02-28
Zytiga : EPAR - Product Information HR = Hrvatski 2011-09-23 2017-02-28
Zytiga : EPAR - Product Information HR = Hrvatski 2011-09-23 2017-02-28
Zytiga : EPAR - Product Information HR = Hrvatski 2011-09-23 2017-02-28
Zytiga : EPAR - Product Information HR = Hrvatski 2011-09-23 2017-02-28
Zytiga : EPAR - Product Information HR = Hrvatski 2011-09-23 2017-02-28
Zytiga : EPAR - Product Information HR = Hrvatski 2011-09-23 2017-02-28
Zytiga : EPAR - Product Information HR = Hrvatski 2011-09-23 2017-02-28
Zytiga : EPAR - Product Information HR = Hrvatski 2011-09-23 2017-02-28
Zytiga : EPAR - Product Information HR = Hrvatski 2011-09-23 2017-02-28
Zytiga : EPAR - Product Information HR = Hrvatski 2011-09-23 2017-02-28
Zytiga : EPAR - Product Information HR = Hrvatski 2011-09-23 2017-02-28
Zytiga : EPAR - Product Information HR = Hrvatski 2011-09-23 2017-02-28
Zytiga : EPAR - Product Information HR = Hrvatski 2011-09-23 2017-02-28

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
Zytiga : EPAR - All Authorised presentations HR = Hrvatski 2011-09-23 2017-02-10
Zytiga : EPAR - All Authorised presentations HR = Hrvatski 2011-09-23 2017-02-10
Zytiga : EPAR - All Authorised presentations HR = Hrvatski 2011-09-23 2017-02-10
Zytiga : EPAR - All Authorised presentations HR = Hrvatski 2011-09-23 2017-02-10
Zytiga : EPAR - All Authorised presentations HR = Hrvatski 2011-09-23 2017-02-10
Zytiga : EPAR - All Authorised presentations HR = Hrvatski 2011-09-23 2017-02-10
Zytiga : EPAR - All Authorised presentations HR = Hrvatski 2011-09-23 2017-02-10
Zytiga : EPAR - All Authorised presentations HR = Hrvatski 2011-09-23 2017-02-10
Zytiga : EPAR - All Authorised presentations HR = Hrvatski 2011-09-23 2017-02-10
Zytiga : EPAR - All Authorised presentations HR = Hrvatski 2011-09-23 2017-02-10
Zytiga : EPAR - All Authorised presentations HR = Hrvatski 2011-09-23 2017-02-10
Zytiga : EPAR - All Authorised presentations HR = Hrvatski 2011-09-23 2017-02-10
Zytiga : EPAR - All Authorised presentations HR = Hrvatski 2011-09-23 2017-02-10
Zytiga : EPAR - All Authorised presentations HR = Hrvatski 2011-09-23 2017-02-10
Zytiga : EPAR - All Authorised presentations HR = Hrvatski 2011-09-23 2017-02-10
Zytiga : EPAR - All Authorised presentations HR = Hrvatski 2011-09-23 2017-02-10
Zytiga : EPAR - All Authorised presentations HR = Hrvatski 2011-09-23 2017-02-10
Zytiga : EPAR - All Authorised presentations HR = Hrvatski 2011-09-23 2017-02-10
Zytiga : EPAR - All Authorised presentations HR = Hrvatski 2011-09-23 2017-02-10
Zytiga : EPAR - All Authorised presentations HR = Hrvatski 2011-09-23 2017-02-10
Zytiga : EPAR - All Authorised presentations HR = Hrvatski 2011-09-23 2017-02-10
Zytiga : EPAR - All Authorised presentations HR = Hrvatski 2011-09-23 2017-02-10
Zytiga : EPAR - All Authorised presentations HR = Hrvatski 2011-09-23 2017-02-10
Zytiga : EPAR - All Authorised presentations HR = Hrvatski 2011-09-23 2017-02-10
Zytiga : EPAR - All Authorised presentations HR = Hrvatski 2011-09-23 2017-02-10

Pharmacotherapeutic group

Endocrine therapy

Therapeutic indication

ZYTIGA is indicated with prednisone or prednisolone for:
•         the treatment of metastatic castration resistant prostate cancer in adult men who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated (see section 5.1)
•         the treatment of metastatic castration resistant prostate cancer in adult men whose disease has progressed on or after a docetaxel based chemotherapy regimen.

Assessment History

Authorised

This medicine is approved for use in the European Union

More information on Zytiga