Jevtana

cabazitaxel

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This is a summary of the European public assessment report (EPAR) for Jevtana. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Jevtana.

What is Jevtana and what is it used for?

Jevtana is a cancer medicine used to treat men with metastatic castration-resistant prostate cancer. This is cancer that affects the prostate gland in men that produces the liquid in semen. Jevtana is used when the cancer has spread to other parts of the body (metastatic) despite treatments to prevent the production of testosterone or after surgical removal of the testes (castration). Jevtana is used in combination with prednisone or prednisolone (anti-inflammatory medicines) in patients who have previously been treated with docetaxel (another cancer medicine).

Jevtana contains the active substance cabazitaxel.

How is Jevtana used?

Jevtana can only be obtained with a prescription and should only be used in units specialising in chemotherapy (medicines to treat cancer) under the supervision of a doctor experienced in the use of chemotherapy.

Jevtana is available as a concentrate and a solvent to be made up into a solution for infusion (drip) into a vein. It is given once every three weeks as an infusion lasting one hour, at a dose of 25 mg per square metre body surface area (calculated using the patient’s weight and height). It is given in combination with prednisone or prednisolone, taken daily throughout treatment.

The dose of Jevtana should be reduced or treatment stopped if the patient has certain side effects. The doses should also be reduced in patients with mildly or moderately reduced liver function.

Before receiving Jevtana infusions, patients should first be given medicines to prevent allergic reactions and medicines to prevent vomiting.

For more information, see the package leaflet.

How does Jevtana work?

The active substance in Jevtana, cabazitaxel, belongs to the group of cancer medicines known as ‘taxanes’. Cabazitaxel works by blocking the ability of cancer cells to break down their internal ‘skeleton’ that allows them to divide and multiply. With their skeleton still in place, the cells cannot divide and they eventually die. Jevtana also affects non-cancer cells, such as blood and nerve cells, which can cause side effects.

What benefits of Jevtana have been shown in studies?

Jevtana prolonged overall survival (the average length of time the patients lived) in one main study involving 755 men with metastatic castration-resistant prostate cancer who had previously been treated with docetaxel. The effects of Jevtana were compared with another cancer medicine, mitoxantrone. Both medicines were given in combination with prednisone or prednisolone. The average overall survival for patients treated with Jevtana was 15.1 months compared with 12.7 months for patients given mitoxantrone.

What are the risks associated with Jevtana?

The most common side effects with Jevtana (seen in more than 1 patient in 10) include anaemia (low red blood cell counts), leucopenia (low white blood cell counts), neutropenia (low counts of neutrophils, a type of white blood cell), thrombocytopenia (low blood platelet counts) and diarrhoea. Some of these effects were severe. For the full list of all side effects reported with Jevtana, see the package leaflet.

Jevtana must not be used in people who are hypersensitive (allergic) to cabazitaxel, to any other taxane, or to any of the other ingredients. It must not be given to patients whose blood neutrophil count is below 1,500/mm3, who have severely reduced liver function or who recently received or are about to receive a yellow fever vaccine.

Why has Jevtana been approved?

The Agency’s Committee for Medicinal Products for Human Use (CHMP) considered that the ability of Jevtana to prolong overall survival in castration-resistant metastatic prostate cancer patients was clinically important. It decided that Jevtana’s benefits 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 Jevtana?

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

Other information about Jevtana

The European Commission granted a marketing authorisation valid throughout the European Union for Jevtana on 17 March 2011.

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

Name Language First published Last updated
Jevtana : EPAR - Summary for the public BG = bălgarski 2011-04-05 2017-05-05
Jevtana : EPAR - Summary for the public ES = español 2011-04-05 2017-05-05
Jevtana : EPAR - Summary for the public CS = čeština 2011-04-05 2017-05-05
Jevtana : EPAR - Summary for the public DA = dansk 2011-04-05 2017-05-05
Jevtana : EPAR - Summary for the public DE = Deutsch 2011-04-05 2017-05-05
Jevtana : EPAR - Summary for the public ET = eesti keel 2011-04-05 2017-05-05
Jevtana : EPAR - Summary for the public EL = elliniká 2011-04-05 2017-05-05
Jevtana : EPAR - Summary for the public EN = English 2011-04-05 2017-05-05
Jevtana : EPAR - Summary for the public FR = français 2011-04-05 2017-05-05
Jevtana : EPAR - Summary for the public IT = italiano 2011-04-05 2017-05-05
Jevtana : EPAR - Summary for the public LV = latviešu valoda 2011-04-05 2017-05-05
Jevtana : EPAR - Summary for the public LT = lietuvių kalba 2011-04-05 2017-05-05
Jevtana : EPAR - Summary for the public HU = magyar 2011-04-05 2017-05-05
Jevtana : EPAR - Summary for the public MT = Malti 2011-04-05 2017-05-05
Jevtana : EPAR - Summary for the public NL = Nederlands 2011-04-05 2017-05-05
Jevtana : EPAR - Summary for the public PL = polski 2011-04-05 2017-05-05
Jevtana : EPAR - Summary for the public PT = português 2011-04-05 2017-05-05
Jevtana : EPAR - Summary for the public RO = română 2011-04-05 2017-05-05
Jevtana : EPAR - Summary for the public SK = slovenčina 2011-04-05 2017-05-05
Jevtana : EPAR - Summary for the public SL = slovenščina 2011-04-05 2017-05-05
Jevtana : EPAR - Summary for the public FI = suomi 2011-04-05 2017-05-05
Jevtana : EPAR - Summary for the public SV = svenska 2011-04-05 2017-05-05
Jevtana : EPAR - Summary for the public HR = Hrvatski 2011-04-05 2017-05-05

This EPAR was last updated on 05/05/2017 .

Authorisation details

Product details

Product details for Jevtana
NameJevtana
Agency product numberEMEA/H/C/002018
Active substance

cabazitaxel

International non-proprietary name (INN) or common name

cabazitaxel

Therapeutic area Prostatic Neoplasms
Anatomical therapeutic chemical (ATC) code L01CD

Publication details

Publication details for Jevtana
Marketing-authorisation holder

sanofi-aventis groupe
 

Revision15
Date of issue of marketing authorisation valid throughout the European Union17/03/2011

Contact address:

sanofi-aventis groupe
54, rue la Boétie
F-75008 Paris
France

Product information

Product information

03/04/2017  Jevtana -EMEA/H/C/002018 -II/0035

Name Language First published Last updated
Jevtana : EPAR - Product Information HR = Hrvatski 2011-04-05 2017-05-05
Jevtana : EPAR - Product Information HR = Hrvatski 2011-04-05 2017-05-05
Jevtana : EPAR - Product Information HR = Hrvatski 2011-04-05 2017-05-05
Jevtana : EPAR - Product Information HR = Hrvatski 2011-04-05 2017-05-05
Jevtana : EPAR - Product Information HR = Hrvatski 2011-04-05 2017-05-05
Jevtana : EPAR - Product Information HR = Hrvatski 2011-04-05 2017-05-05
Jevtana : EPAR - Product Information HR = Hrvatski 2011-04-05 2017-05-05
Jevtana : EPAR - Product Information HR = Hrvatski 2011-04-05 2017-05-05
Jevtana : EPAR - Product Information HR = Hrvatski 2011-04-05 2017-05-05
Jevtana : EPAR - Product Information HR = Hrvatski 2011-04-05 2017-05-05
Jevtana : EPAR - Product Information HR = Hrvatski 2011-04-05 2017-05-05
Jevtana : EPAR - Product Information HR = Hrvatski 2011-04-05 2017-05-05
Jevtana : EPAR - Product Information HR = Hrvatski 2011-04-05 2017-05-05
Jevtana : EPAR - Product Information HR = Hrvatski 2011-04-05 2017-05-05
Jevtana : EPAR - Product Information HR = Hrvatski 2011-04-05 2017-05-05
Jevtana : EPAR - Product Information HR = Hrvatski 2011-04-05 2017-05-05
Jevtana : EPAR - Product Information HR = Hrvatski 2011-04-05 2017-05-05
Jevtana : EPAR - Product Information HR = Hrvatski 2011-04-05 2017-05-05
Jevtana : EPAR - Product Information HR = Hrvatski 2011-04-05 2017-05-05
Jevtana : EPAR - Product Information HR = Hrvatski 2011-04-05 2017-05-05
Jevtana : EPAR - Product Information HR = Hrvatski 2011-04-05 2017-05-05
Jevtana : EPAR - Product Information HR = Hrvatski 2011-04-05 2017-05-05
Jevtana : EPAR - Product Information HR = Hrvatski 2011-04-05 2017-05-05
Jevtana : EPAR - Product Information HR = Hrvatski 2011-04-05 2017-05-05
Jevtana : EPAR - Product Information HR = Hrvatski 2011-04-05 2017-05-05

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
Jevtana : EPAR - All Authorised presentations HR = Hrvatski 2011-04-05  
Jevtana : EPAR - All Authorised presentations HR = Hrvatski 2011-04-05  
Jevtana : EPAR - All Authorised presentations HR = Hrvatski 2011-04-05  
Jevtana : EPAR - All Authorised presentations HR = Hrvatski 2011-04-05  
Jevtana : EPAR - All Authorised presentations HR = Hrvatski 2011-04-05  
Jevtana : EPAR - All Authorised presentations HR = Hrvatski 2011-04-05  
Jevtana : EPAR - All Authorised presentations HR = Hrvatski 2011-04-05  
Jevtana : EPAR - All Authorised presentations HR = Hrvatski 2011-04-05  
Jevtana : EPAR - All Authorised presentations HR = Hrvatski 2011-04-05  
Jevtana : EPAR - All Authorised presentations HR = Hrvatski 2011-04-05  
Jevtana : EPAR - All Authorised presentations HR = Hrvatski 2011-04-05  
Jevtana : EPAR - All Authorised presentations HR = Hrvatski 2011-04-05  
Jevtana : EPAR - All Authorised presentations HR = Hrvatski 2011-04-05  
Jevtana : EPAR - All Authorised presentations HR = Hrvatski 2011-04-05  
Jevtana : EPAR - All Authorised presentations HR = Hrvatski 2011-04-05  
Jevtana : EPAR - All Authorised presentations HR = Hrvatski 2011-04-05  
Jevtana : EPAR - All Authorised presentations HR = Hrvatski 2011-04-05  
Jevtana : EPAR - All Authorised presentations HR = Hrvatski 2011-04-05  
Jevtana : EPAR - All Authorised presentations HR = Hrvatski 2011-04-05  
Jevtana : EPAR - All Authorised presentations HR = Hrvatski 2011-04-05  
Jevtana : EPAR - All Authorised presentations HR = Hrvatski 2011-04-05  
Jevtana : EPAR - All Authorised presentations HR = Hrvatski 2011-04-05  
Jevtana : EPAR - All Authorised presentations HR = Hrvatski 2011-04-05  
Jevtana : EPAR - All Authorised presentations HR = Hrvatski 2011-04-05  
Jevtana : EPAR - All Authorised presentations HR = Hrvatski 2011-04-05  

Pharmacotherapeutic group

Antineoplastic agents

Therapeutic indication

Jevtana in combination with prednisone or prednisolone is indicated for the treatment of patients with hormone-refractory metastatic prostate cancer previously treated with a docetaxel-containing regimen.

Assessment History

Changes since initial authorisation of medicine

Initial marketing-authorisation documents

Name Language First published Last updated
Jevtana : EPAR - Public assessment report HR = Hrvatski 2011-04-05 2012-04-13
CHMP summary of positive opinion for Jevtana HR = Hrvatski 2011-01-21  

Authorised

This medicine is approved for use in the European Union

More information on Jevtana