Jevtana

cabazitaxel

  • Email
  • Help

About

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?

Jevtana is a medicine that contains the active substance cabazitaxel. It is available as a concentrate and a solvent to be made up into a solution for infusion (drip into a vein).

What is Jevtana used for?

Jevtana is used to treat men with hormone-refractory metastatic prostate cancer. This is cancer that affects the prostate gland, the gland below the bladder in men that produces the liquid in semen. Jevtana is used when the cancer has spread to other parts of the body (metastatic) and has stopped responding to hormonal treatment (hormone-refractory). It is used in combination with prednisone or prednisolone (anti-inflammatory medicines) in patients who have previously been treated with docetaxel (another anticancer medicine).

The medicine can only be obtained with a prescription.

How is Jevtana used?

Jevtana 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 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, which are taken daily throughout treatment. The dose of Jevtana should be reduced if the patient experiences certain side effects, and treatment should be stopped if side effects continue at a reduced dose of 20 mg/m2.

Before receiving Jevtana infusions, patients should first be given anti-allergic medicines to reduce the risk of allergic reactions and anti-emetic medicines to prevent vomiting.

How does Jevtana work?

The active substance in Jevtana, cabazitaxel, belongs to the group of anticancer 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.

How has Jevtana been studied?

The effects of Jevtana were first tested in experimental models before being studied in humans.

Jevtana was investigated in one main study involving 755 men with hormone-refractory metastatic prostate cancer who had previously been treated with docetaxel. The effects of Jevtana were compared with another anticancer medicine, mitoxantrone. Both medicines were given in combination with daily prednisone or prednisolone. The main measure of effectiveness was overall survival (the average length of time the patients lived).

What benefit has Jevtana shown during the studies?

In the main study, Jevtana prolonged overall survival compared with the comparator medicine mitoxantrone. The average overall survival for patients treated with Jevtana was 15.1 months compared with 12.7 months for patients given mitoxantrone.

What is the risk associated with Jevtana?

The most common side effects with Jevtana (seen in more than 1 patient in 10) are 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. For the full list of all side effects reported with Jevtana, see the package leaflet.

Jevtana should not be used in people who may be 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 abnormal liver test results indicating liver problems or who recently received or are about to receive a yellow-fever vaccine.

Why has Jevtana been approved?

The CHMP considered the ability of Jevtana to prolong overall survival in hormone-refractory metastatic prostate cancer patients to be clinically important. It decided that Jevtana’s benefits are greater than its risks and recommended that it be given marketing authorisation.

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 05/04/2011 04/05/2012
Jevtana : EPAR - Summary for the public ES = español 05/04/2011 04/05/2012
Jevtana : EPAR - Summary for the public CS = čeština 05/04/2011 04/05/2012
Jevtana : EPAR - Summary for the public DA = dansk 05/04/2011 04/05/2012
Jevtana : EPAR - Summary for the public DE = Deutsch 05/04/2011 04/05/2012
Jevtana : EPAR - Summary for the public ET = eesti keel 05/04/2011 04/05/2012
Jevtana : EPAR - Summary for the public EL = elliniká 05/04/2011 04/05/2012
Jevtana : EPAR - Summary for the public EN = English 05/04/2011 04/05/2012
Jevtana : EPAR - Summary for the public FR = français 05/04/2011 04/05/2012
Jevtana : EPAR - Summary for the public IT = italiano 05/04/2011 04/05/2012
Jevtana : EPAR - Summary for the public LV = latviešu valoda 05/04/2011 04/05/2012
Jevtana : EPAR - Summary for the public LT = lietuvių kalba 05/04/2011 04/05/2012
Jevtana : EPAR - Summary for the public HU = magyar 05/04/2011 04/05/2012
Jevtana : EPAR - Summary for the public MT = Malti 05/04/2011 04/05/2012
Jevtana : EPAR - Summary for the public NL = Nederlands 05/04/2011 04/05/2012
Jevtana : EPAR - Summary for the public PL = polski 05/04/2011 04/05/2012
Jevtana : EPAR - Summary for the public PT = português 05/04/2011 04/05/2012
Jevtana : EPAR - Summary for the public RO = română 05/04/2011 04/05/2012
Jevtana : EPAR - Summary for the public SK = slovenčina 05/04/2011 04/05/2012
Jevtana : EPAR - Summary for the public SL = slovenščina 05/04/2011 04/05/2012
Jevtana : EPAR - Summary for the public FI = suomi 05/04/2011 04/05/2012
Jevtana : EPAR - Summary for the public SV = svenska 05/04/2011 04/05/2012

This EPAR was last updated on 08/10/2014 .

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
Additional monitoring

This medicine is under additional monitoring. This means that it is being monitored even more intensively than other medicines. For more information, see medicines under additional monitoring.

Publication details

Publication details for Jevtana
Marketing-authorisation holder

sanofi-aventis groupe
 

Revision9
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

18/09/2014  Jevtana -EMEA/H/C/002018 -PSUV/0023

Name Language First published Last updated
Jevtana : EPAR - Product Information SV = svenska 05/04/2011 08/10/2014
Jevtana : EPAR - Product Information SV = svenska 05/04/2011 08/10/2014
Jevtana : EPAR - Product Information SV = svenska 05/04/2011 08/10/2014
Jevtana : EPAR - Product Information SV = svenska 05/04/2011 08/10/2014
Jevtana : EPAR - Product Information SV = svenska 05/04/2011 08/10/2014
Jevtana : EPAR - Product Information SV = svenska 05/04/2011 08/10/2014
Jevtana : EPAR - Product Information SV = svenska 05/04/2011 08/10/2014
Jevtana : EPAR - Product Information SV = svenska 05/04/2011 08/10/2014
Jevtana : EPAR - Product Information SV = svenska 05/04/2011 08/10/2014
Jevtana : EPAR - Product Information SV = svenska 05/04/2011 08/10/2014
Jevtana : EPAR - Product Information SV = svenska 05/04/2011 08/10/2014
Jevtana : EPAR - Product Information SV = svenska 05/04/2011 08/10/2014
Jevtana : EPAR - Product Information SV = svenska 05/04/2011 08/10/2014
Jevtana : EPAR - Product Information SV = svenska 05/04/2011 08/10/2014
Jevtana : EPAR - Product Information SV = svenska 05/04/2011 08/10/2014
Jevtana : EPAR - Product Information SV = svenska 05/04/2011 08/10/2014
Jevtana : EPAR - Product Information SV = svenska 05/04/2011 08/10/2014
Jevtana : EPAR - Product Information SV = svenska 05/04/2011 08/10/2014
Jevtana : EPAR - Product Information SV = svenska 05/04/2011 08/10/2014
Jevtana : EPAR - Product Information SV = svenska 05/04/2011 08/10/2014
Jevtana : EPAR - Product Information SV = svenska 05/04/2011 08/10/2014
Jevtana : EPAR - Product Information SV = svenska 05/04/2011 08/10/2014
Jevtana : EPAR - Product Information SV = svenska 05/04/2011 08/10/2014
Jevtana : EPAR - Product Information SV = svenska 05/04/2011 08/10/2014
Jevtana : EPAR - Product Information SV = svenska 05/04/2011 08/10/2014

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 SV = svenska 05/04/2011  
Jevtana : EPAR - All Authorised presentations SV = svenska 05/04/2011  
Jevtana : EPAR - All Authorised presentations SV = svenska 05/04/2011  
Jevtana : EPAR - All Authorised presentations SV = svenska 05/04/2011  
Jevtana : EPAR - All Authorised presentations SV = svenska 05/04/2011  
Jevtana : EPAR - All Authorised presentations SV = svenska 05/04/2011  
Jevtana : EPAR - All Authorised presentations SV = svenska 05/04/2011  
Jevtana : EPAR - All Authorised presentations SV = svenska 05/04/2011  
Jevtana : EPAR - All Authorised presentations SV = svenska 05/04/2011  
Jevtana : EPAR - All Authorised presentations SV = svenska 05/04/2011  
Jevtana : EPAR - All Authorised presentations SV = svenska 05/04/2011  
Jevtana : EPAR - All Authorised presentations SV = svenska 05/04/2011  
Jevtana : EPAR - All Authorised presentations SV = svenska 05/04/2011  
Jevtana : EPAR - All Authorised presentations SV = svenska 05/04/2011  
Jevtana : EPAR - All Authorised presentations SV = svenska 05/04/2011  
Jevtana : EPAR - All Authorised presentations SV = svenska 05/04/2011  
Jevtana : EPAR - All Authorised presentations SV = svenska 05/04/2011  
Jevtana : EPAR - All Authorised presentations SV = svenska 05/04/2011  
Jevtana : EPAR - All Authorised presentations SV = svenska 05/04/2011  
Jevtana : EPAR - All Authorised presentations SV = svenska 05/04/2011  
Jevtana : EPAR - All Authorised presentations SV = svenska 05/04/2011  
Jevtana : EPAR - All Authorised presentations SV = svenska 05/04/2011  
Jevtana : EPAR - All Authorised presentations SV = svenska 05/04/2011  
Jevtana : EPAR - All Authorised presentations SV = svenska 05/04/2011  
Jevtana : EPAR - All Authorised presentations SV = svenska 05/04/2011  

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

Name Language First published Last updated
Jevtana : EPAR - Procedural steps taken and scientific information after authorisation SV = svenska 25/11/2011 08/10/2014

Initial marketing-authorisation documents

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

Authorised

This medicine is approved for use in the European Union

More information on Jevtana