Savene

dexrazoxane

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This is a summary of the European public assessment report (EPAR) for Savene. 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 Savene.

What is Savene?

Savene is a powder and diluent that are made up into a solution for infusion (drip into a vein). It contains the active substance dexrazoxane.

What is Savene used for?

Savene is used to treat extravasation of anthracyclines (a group of anticancer medicines). Extravasation happens when an anticancer medicine that is normally injected into a vein leaks or is accidentally injected in the tissue surrounding the vein, where it can cause serious damage.

Because the number of patients who have extravasation of anthracyclines is low, the condition is considered ‘rare’, and Savene was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 19 September 2001.

The medicine can only be obtained with a prescription.

How is Savene used?

Savene must be used under the supervision of a doctor who has experience in the use of anticancer medicines.

The first infusion of Savene is given as soon as possible after the accident, and no later than six hours after it happened. Two further infusions are then given, one on day 2 and another on day 3, at the same time as the first infusion. The infusion should last between one and two hours, and be given at a site other than where the extravasation happened.

How does Savene work?

The active substance in Savene, dexrazoxane, is an antidote to anthracyclines. The way it works is not entirely clear, but may be linked to the way the medicine attaches to iron in the body to form a ‘chelate’ and to its effect on some enzymes, such as topoisomerase II. Together, these effects can reduce the amount of tissue damage caused by anthracycline extravasation.

Dexrazoxane has been in use since the 1990s as a medicine to help prevent the cardiomyopathy (harm to the heart muscle) associated with the use of anthracyclines.

How has Savene been studied?

Savene has been tested in two main studies involving a total of 80 patients who had extravasation of anthracyclines such as epirubicin or doxorubicin. Savene was not compared with any other medicines in these studies. The studies looked at how many patients needed surgery to correct the damage due to the extravasation.

What benefit has Savene shown during the studies?

Only one patient among the 54 in whom the effectiveness of Savene could be measured had tissue damage requiring surgery.

What is the risk associated with Savene?

The most common side effects with Savene (seen in more than 1 patient in 10) are nausea (feeling sick), and pain and infection at the site of the injection. Patients can also develop low blood levels of white blood cells and platelets. Although this may be caused by their anticancer treatment, it can also be caused by Savene, because it is a cytotoxic (a medicine that destroys cells that are multiplying) that can affect the bone marrow. Patients will be monitored for these side effects before, during and after treatment. For the full list of all side effects reported with Savene, see the package leaflet.

Savene should not be used in people who may be hypersensitive (allergic) to dexrazoxane or any of the other ingredients. It must not be used in women who could become pregnant or who are breastfeeding, or in patients receiving vaccination against yellow fever.

Why has Savene been approved?

Anthracycline extravasation is a condition that can currently be managed using various methods, but for which there is no standard authorised treatment. The CHMP concluded that Savene had shown its ability to treat anthracycline extravasation, allowing patients to continue their anticancer treatment. The Committee decided that Savene’s benefits are greater than its risks and recommended that it be given marketing authorisation.

Other information about Savene

The European Commission granted a marketing authorisation valid throughout the European Union for Savene on 28 July 2006.

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

Name Language First published Last updated
Savene : EPAR - Summary for the public BG = bălgarski 05/09/2006 16/08/2011
Savene : EPAR - Summary for the public ES = español 05/09/2006 16/08/2011
Savene : EPAR - Summary for the public CS = čeština 05/09/2006 16/08/2011
Savene : EPAR - Summary for the public DA = dansk 05/09/2006 16/08/2011
Savene : EPAR - Summary for the public DE = Deutsch 05/09/2006 16/08/2011
Savene : EPAR - Summary for the public ET = eesti keel 05/09/2006 16/08/2011
Savene : EPAR - Summary for the public EL = elliniká 05/09/2006 16/08/2011
Savene : EPAR - Summary for the public EN = English 05/09/2006 16/08/2011
Savene : EPAR - Summary for the public FR = français 05/09/2006 16/08/2011
Savene : EPAR - Summary for the public IT = italiano 05/09/2006 16/08/2011
Savene : EPAR - Summary for the public LV = latviešu valoda 05/09/2006 16/08/2011
Savene : EPAR - Summary for the public LT = lietuvių kalba 05/09/2006 16/08/2011
Savene : EPAR - Summary for the public HU = magyar 05/09/2006 16/08/2011
Savene : EPAR - Summary for the public MT = Malti 05/09/2006 16/08/2011
Savene : EPAR - Summary for the public NL = Nederlands 05/09/2006 16/08/2011
Savene : EPAR - Summary for the public PL = polski 05/09/2006 16/08/2011
Savene : EPAR - Summary for the public PT = português 05/09/2006 16/08/2011
Savene : EPAR - Summary for the public RO = română 05/09/2006 16/08/2011
Savene : EPAR - Summary for the public SK = slovenčina 05/09/2006 16/08/2011
Savene : EPAR - Summary for the public SL = slovenščina 05/09/2006 16/08/2011
Savene : EPAR - Summary for the public FI = suomi 05/09/2006 16/08/2011
Savene : EPAR - Summary for the public SV = svenska 05/09/2006 16/08/2011

This EPAR was last updated on 30/09/2014 .

Authorisation details

Product details

Product details for Savene
NameSavene
Agency product numberEMEA/H/C/000682
Active substance

dexrazoxane hydrochloride

International non-proprietary name (INN) or common name

dexrazoxane

Therapeutic area Extravasation of Diagnostic and Therapeutic Materials
Anatomical therapeutic chemical (ATC) code V03AF02
Treatment of rare diseases

This medicine has an "orphan designation" which means that it is used to treat life-threatening or chronically debilitating conditions that affect no more than five in 10,000 people in the European Union, or are medicines which, for economic reasons, would be unlikely to be developed without incentives.

Publication details

Publication details for Savene
Marketing-authorisation holder

Clinigen Healthcare Ltd

Revision8
Date of issue of marketing authorisation valid throughout the European Union28/07/2006

Contact address:

Clinigen Healthcare Ltd
Pitcairn House
Crown Square
First Avenue
Staffordshire
Burton-on-Trent
DE14 2WW
United Kingdom

Product information

Product information

18/07/2014  Savene -EMEA/H/C/000682 -T/0017

Name Language First published Last updated
Savene : EPAR - Product Information SV = svenska 15/02/2008 30/09/2014
Savene : EPAR - Product Information SV = svenska 15/02/2008 30/09/2014
Savene : EPAR - Product Information SV = svenska 15/02/2008 30/09/2014
Savene : EPAR - Product Information SV = svenska 15/02/2008 30/09/2014
Savene : EPAR - Product Information SV = svenska 15/02/2008 30/09/2014
Savene : EPAR - Product Information SV = svenska 15/02/2008 30/09/2014
Savene : EPAR - Product Information SV = svenska 15/02/2008 30/09/2014
Savene : EPAR - Product Information SV = svenska 15/02/2008 30/09/2014
Savene : EPAR - Product Information SV = svenska 15/02/2008 30/09/2014
Savene : EPAR - Product Information SV = svenska 15/02/2008 30/09/2014
Savene : EPAR - Product Information SV = svenska 15/02/2008 30/09/2014
Savene : EPAR - Product Information SV = svenska 15/02/2008 30/09/2014
Savene : EPAR - Product Information SV = svenska 15/02/2008 30/09/2014
Savene : EPAR - Product Information SV = svenska 15/02/2008 30/09/2014
Savene : EPAR - Product Information SV = svenska 15/02/2008 30/09/2014
Savene : EPAR - Product Information SV = svenska 15/02/2008 30/09/2014
Savene : EPAR - Product Information SV = svenska 15/02/2008 30/09/2014
Savene : EPAR - Product Information SV = svenska 15/02/2008 30/09/2014
Savene : EPAR - Product Information SV = svenska 15/02/2008 30/09/2014
Savene : EPAR - Product Information SV = svenska 15/02/2008 30/09/2014
Savene : EPAR - Product Information SV = svenska 15/02/2008 30/09/2014
Savene : EPAR - Product Information SV = svenska 15/02/2008 30/09/2014
Savene : EPAR - Product Information SV = svenska 15/02/2008 30/09/2014
Savene : EPAR - Product Information SV = svenska 15/02/2008 30/09/2014
Savene : EPAR - Product Information SV = svenska 15/02/2008 30/09/2014

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
Savene : EPAR - All Authorised presentations SV = svenska 07/09/2006 10/09/2012
Savene : EPAR - All Authorised presentations SV = svenska 07/09/2006 10/09/2012
Savene : EPAR - All Authorised presentations SV = svenska 07/09/2006 10/09/2012
Savene : EPAR - All Authorised presentations SV = svenska 07/09/2006 10/09/2012
Savene : EPAR - All Authorised presentations SV = svenska 07/09/2006 10/09/2012
Savene : EPAR - All Authorised presentations SV = svenska 07/09/2006 10/09/2012
Savene : EPAR - All Authorised presentations SV = svenska 07/09/2006 10/09/2012
Savene : EPAR - All Authorised presentations SV = svenska 07/09/2006 10/09/2012
Savene : EPAR - All Authorised presentations SV = svenska 07/09/2006 10/09/2012
Savene : EPAR - All Authorised presentations SV = svenska 07/09/2006 10/09/2012
Savene : EPAR - All Authorised presentations SV = svenska 07/09/2006 10/09/2012
Savene : EPAR - All Authorised presentations SV = svenska 07/09/2006 10/09/2012
Savene : EPAR - All Authorised presentations SV = svenska 07/09/2006 10/09/2012
Savene : EPAR - All Authorised presentations SV = svenska 07/09/2006 10/09/2012
Savene : EPAR - All Authorised presentations SV = svenska 07/09/2006 10/09/2012
Savene : EPAR - All Authorised presentations SV = svenska 07/09/2006 10/09/2012
Savene : EPAR - All Authorised presentations SV = svenska 07/09/2006 10/09/2012
Savene : EPAR - All Authorised presentations SV = svenska 07/09/2006 10/09/2012
Savene : EPAR - All Authorised presentations SV = svenska 07/09/2006 10/09/2012
Savene : EPAR - All Authorised presentations SV = svenska 07/09/2006 10/09/2012
Savene : EPAR - All Authorised presentations SV = svenska 07/09/2006 10/09/2012
Savene : EPAR - All Authorised presentations SV = svenska 07/09/2006 10/09/2012
Savene : EPAR - All Authorised presentations SV = svenska 07/09/2006 10/09/2012

Pharmacotherapeutic group

All other therapeutic products

Therapeutic indication

Savene is indicated for the treatment of anthracycline extravasation.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated
Savene : EPAR - Procedural steps taken and scientific information after authorisation SV = svenska 15/02/2008 30/09/2014

Initial marketing-authorisation documents

Name Language First published Last updated
Savene : EPAR - Procedural steps taken before authorisation SV = svenska 07/09/2006  
Savene : EPAR - Scientific Discussion SV = svenska 07/09/2006  

Authorised

This medicine is approved for use in the European Union

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