Dexrazoxane

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The European Medicines Agency has completed a review of the safety and effectiveness of dexrazoxane. The Agency’s Committee for Medicinal Products for Human Use (CHMP) has concluded that dexrazoxane should not be used in children and adolescents. The Committee has also made recommendations for changes to the summaries of product characteristics (SmPCs) for dexrazoxane-containing medicines.

What is dexrazoxane?

Dexrazoxane is used in patients with cancer to prevent long-tem toxic effects on the heart caused by treatment with the anticancer medicines doxorubicin and epirubicin.

The way in which dexrazoxane protects the heart is not entirely clear, but may be linked to the way the medicine attaches to charged iron particles that are involved in the processes that make anthracyclines toxic to the heart muscle.

Medicines containing dexrazoxane are authorised for the prevention of cardiotoxic effects in Austria, Czech Republic, Germany, Denmark, Finland, France, Greece, Hungary, Ireland, Italy, Lithuania, Luxembourg, Netherlands, Norway, Poland, Portugal, Romania, Slovakia Spain and the United Kingdom under the following invented names: Cardioxane, Cyrdanax, Dexrazoxane Cyathus, Enaxozar and Procard.

Why was dexrazoxane reviewed?

The French medicines regulatory agency raised concerns that dexrazoxane could be linked to an increased risk of two cancers: acute myeloid leukaemia (AML) and myelodysplastic syndrome (MDS). These concerns were based on studies in the United States reporting cases of AML and MDS in children with Hodgkin’s disease as well as cases of AML reported in breast cancer patients receiving dexrazoxane. The UK medicines regulatory agency also shared these concerns and asked the CHMP to carry out a full assessment of the benefit-risk balance of dexrazoxane and to issue an opinion on whether the marketing authorisations for products containing dexrazoxane should be maintained, varied, suspended or withdrawn across the European Union.

Which data has the CHMP reviewed?

The CHMP reviewed reports on AML and MDS in patients receiving dexrazoxane. The Committee also reviewed all available data on the safety and effectiveness of dexrazoxane, including published studies and data submitted by the companies that market the medicines.

What are the conclusions of the CHMP?

The Committee noted that there was evidence of serious harm in children receiving dexrazoxane. Studies showed a three-fold increase in the risk of new cancers such as AML and MDS. There was also an increased risk of severe myelosuppression (a condition in which the bone marrow cannot make enough blood cells) and severe infection. The CHMP concluded that the benefits of dexrazoxane-containing medicines do not outweigh its risk in children and adolescents, and the medicine should not be used in these age-groups. The use of dexrazoxane should be restricted to adult patients with advanced or metastatic breast cancer who have already received a certain amount of doxorubicin and epirubicin. The use of dexrazoxane should be contraindicated in children and adolescents.

The Committee also noted that in one study in breast cancer patients, dexrazoxane was associated with worsened response to cancer therapy while other studies showed an increased risk of dying in the first few months of treatment with dexrazoxane at a dose ratio of 20: 1 (20 parts dexrazoxane for 1 part of doxorubicin).

In addition to the restriction in the medicine’s use, the CHMP has recommended a reduced dose ratio of 10:1 with doxorubicin (the dose ratio remains 10:1 for epirubicin) in adults and has included in the SmPCs more information on what is currently known about the risks of dexrazoxane-containing medicine.

The amended information to doctors and patients is available under the All documents tab.

What are the recommendations for patients and prescribers?
  • Dexrazoxane should only be used in adult patients with advanced or metastatic breast cancer. The benefits of dexrazoxane do not outweigh its risks in children and adolescents.
  • Dexrazoxane should only be used in adult patients who have already received a minimum cumulative anthracycline dose of 300 mg/m2 of doxorubicin, or 540 mg/m2 of epirubicin.
  • When deciding whether to use dexrazoxane prescribers should consider the short- and long-term risks associated with this product (e.g. myelosuppression and the potential for AML), alongside possible benefits in relation to protection of the heart.
  • Information on recommended dosing and additional information on the risks associated with dexrazoxane can be found in the updated prescribing information.
  • Patients who have any questions should speak to their doctor.

The European Commission issued a decision on 13 September 2011.

Name Language First published Last updated
Questions and answers on the review of dexrazoxane-containing medicines, powder for solution for infusion, 500 mg BG = bălgarski 24/06/2011 16/01/2012
Questions and answers on the review of dexrazoxane-containing medicines, powder for solution for infusion, 500 mg ES = español 24/06/2011 16/01/2012
Questions and answers on the review of dexrazoxane-containing medicines, powder for solution for infusion, 500 mg CS = čeština 24/06/2011 16/01/2012
Questions and answers on the review of dexrazoxane-containing medicines, powder for solution for infusion, 500 mg DA = dansk 24/06/2011 16/01/2012
Questions and answers on the review of dexrazoxane-containing medicines, powder for solution for infusion, 500 mg DE = Deutsch 24/06/2011 16/01/2012
Questions and answers on the review of dexrazoxane-containing medicines, powder for solution for infusion, 500 mg ET = eesti keel 24/06/2011 16/01/2012
Questions and answers on the review of dexrazoxane-containing medicines, powder for solution for infusion, 500 mg EL = elliniká 24/06/2011 16/01/2012
Questions and answers on the review of dexrazoxane-containing medicines, powder for solution for infusion, 500 mg EN = English 24/06/2011 16/01/2012
Questions and answers on the review of dexrazoxane-containing medicines, powder for solution for infusion, 500 mg FR = français 24/06/2011 16/01/2012
Questions and answers on the review of dexrazoxane-containing medicines, powder for solution for infusion, 500 mg IT = italiano 24/06/2011 16/01/2012
Questions and answers on the review of dexrazoxane-containing medicines, powder for solution for infusion, 500 mg LV = latviešu valoda 24/06/2011 16/01/2012
Questions and answers on the review of dexrazoxane-containing medicines, powder for solution for infusion, 500 mg LT = lietuvių kalba 24/06/2011 16/01/2012
Questions and answers on the review of dexrazoxane-containing medicines, powder for solution for infusion, 500 mg HU = magyar 24/06/2011 16/01/2012
Questions and answers on the review of dexrazoxane-containing medicines, powder for solution for infusion, 500 mg MT = Malti 24/06/2011 16/01/2012
Questions and answers on the review of dexrazoxane-containing medicines, powder for solution for infusion, 500 mg NL = Nederlands 24/06/2011 16/01/2012
Questions and answers on the review of dexrazoxane-containing medicines, powder for solution for infusion, 500 mg PL = polski 24/06/2011 16/01/2012
Questions and answers on the review of dexrazoxane-containing medicines, powder for solution for infusion, 500 mg PT = português 24/06/2011 16/01/2012
Questions and answers on the review of dexrazoxane-containing medicines, powder for solution for infusion, 500 mg RO = română 24/06/2011 16/01/2012
Questions and answers on the review of dexrazoxane-containing medicines, powder for solution for infusion, 500 mg SK = slovenčina 24/06/2011 16/01/2012
Questions and answers on the review of dexrazoxane-containing medicines, powder for solution for infusion, 500 mg SL = slovenščina 24/06/2011 16/01/2012
Questions and answers on the review of dexrazoxane-containing medicines, powder for solution for infusion, 500 mg FI = suomi 24/06/2011 16/01/2012
Questions and answers on the review of dexrazoxane-containing medicines, powder for solution for infusion, 500 mg SV = svenska 24/06/2011 16/01/2012

Key facts

Approved nameDexrazoxane
International non-proprietary name (INN) or common name

dexrazoxane

Associated namesCardioxane, Cyrdanax, Dexrazoxane Cyathus, Enaxozar, Procard
Class
Reference numberEMEA/H/A-31/1275
TypeArticle 31 referrals

This type of referral is triggered when the interest of the Community is involved, following concerns relating to the quality, safety or efficacy of a medicine or a class of medicines.

StatusEuropean Commission final decision
Opinion date23/06/2011

All documents

Name Language First published Last updated
Questions and answers on the review of dexrazoxane-containing medicines, powder for solution for infusion, 500 mg BG = bălgarski 24/06/2011 16/01/2012
Questions and answers on the review of dexrazoxane-containing medicines, powder for solution for infusion, 500 mg ES = español 24/06/2011 16/01/2012
Questions and answers on the review of dexrazoxane-containing medicines, powder for solution for infusion, 500 mg CS = čeština 24/06/2011 16/01/2012
Questions and answers on the review of dexrazoxane-containing medicines, powder for solution for infusion, 500 mg DA = dansk 24/06/2011 16/01/2012
Questions and answers on the review of dexrazoxane-containing medicines, powder for solution for infusion, 500 mg DE = Deutsch 24/06/2011 16/01/2012
Questions and answers on the review of dexrazoxane-containing medicines, powder for solution for infusion, 500 mg ET = eesti keel 24/06/2011 16/01/2012
Questions and answers on the review of dexrazoxane-containing medicines, powder for solution for infusion, 500 mg EL = elliniká 24/06/2011 16/01/2012
Questions and answers on the review of dexrazoxane-containing medicines, powder for solution for infusion, 500 mg EN = English 24/06/2011 16/01/2012
Questions and answers on the review of dexrazoxane-containing medicines, powder for solution for infusion, 500 mg FR = français 24/06/2011 16/01/2012
Questions and answers on the review of dexrazoxane-containing medicines, powder for solution for infusion, 500 mg IT = italiano 24/06/2011 16/01/2012
Questions and answers on the review of dexrazoxane-containing medicines, powder for solution for infusion, 500 mg LV = latviešu valoda 24/06/2011 16/01/2012
Questions and answers on the review of dexrazoxane-containing medicines, powder for solution for infusion, 500 mg LT = lietuvių kalba 24/06/2011 16/01/2012
Questions and answers on the review of dexrazoxane-containing medicines, powder for solution for infusion, 500 mg HU = magyar 24/06/2011 16/01/2012
Questions and answers on the review of dexrazoxane-containing medicines, powder for solution for infusion, 500 mg MT = Malti 24/06/2011 16/01/2012
Questions and answers on the review of dexrazoxane-containing medicines, powder for solution for infusion, 500 mg NL = Nederlands 24/06/2011 16/01/2012
Questions and answers on the review of dexrazoxane-containing medicines, powder for solution for infusion, 500 mg PL = polski 24/06/2011 16/01/2012
Questions and answers on the review of dexrazoxane-containing medicines, powder for solution for infusion, 500 mg PT = português 24/06/2011 16/01/2012
Questions and answers on the review of dexrazoxane-containing medicines, powder for solution for infusion, 500 mg RO = română 24/06/2011 16/01/2012
Questions and answers on the review of dexrazoxane-containing medicines, powder for solution for infusion, 500 mg SK = slovenčina 24/06/2011 16/01/2012
Questions and answers on the review of dexrazoxane-containing medicines, powder for solution for infusion, 500 mg SL = slovenščina 24/06/2011 16/01/2012
Questions and answers on the review of dexrazoxane-containing medicines, powder for solution for infusion, 500 mg FI = suomi 24/06/2011 16/01/2012
Questions and answers on the review of dexrazoxane-containing medicines, powder for solution for infusion, 500 mg SV = svenska 24/06/2011 16/01/2012
Dexrazoxane - Article 31 referral - Annex I BG = bălgarski 16/01/2012  
Dexrazoxane - Article 31 referral - Annex I ES = español 16/01/2012  
Dexrazoxane - Article 31 referral - Annex I CS = čeština 16/01/2012  
Dexrazoxane - Article 31 referral - Annex I DA = dansk 16/01/2012  
Dexrazoxane - Article 31 referral - Annex I DE = Deutsch 16/01/2012  
Dexrazoxane - Article 31 referral - Annex I ET = eesti keel 16/01/2012  
Dexrazoxane - Article 31 referral - Annex I EL = elliniká 16/01/2012  
Dexrazoxane - Article 31 referral - Annex I EN = English 16/01/2012  
Dexrazoxane - Article 31 referral - Annex I FR = français 16/01/2012  
Dexrazoxane - Article 31 referral - Annex I IT = italiano 16/01/2012  
Dexrazoxane - Article 31 referral - Annex I LV = latviešu valoda 16/01/2012  
Dexrazoxane - Article 31 referral - Annex I LT = lietuvių kalba 16/01/2012  
Dexrazoxane - Article 31 referral - Annex I HU = magyar 16/01/2012  
Dexrazoxane - Article 31 referral - Annex I MT = Malti 16/01/2012  
Dexrazoxane - Article 31 referral - Annex I NL = Nederlands 16/01/2012  
Dexrazoxane - Article 31 referral - Annex I PL = polski 16/01/2012  
Dexrazoxane - Article 31 referral - Annex I PT = português 16/01/2012  
Dexrazoxane - Article 31 referral - Annex I RO = română 16/01/2012  
Dexrazoxane - Article 31 referral - Annex I SK = slovenčina 16/01/2012  
Dexrazoxane - Article 31 referral - Annex I SL = slovenščina 16/01/2012  
Dexrazoxane - Article 31 referral - Annex I FI = suomi 16/01/2012  
Dexrazoxane - Article 31 referral - Annex I SV = svenska 16/01/2012  
Dexrazoxane - Article 31 referral - Annex I IS = Islenska 16/01/2012  
Dexrazoxane - Article 31 referral - Annex I NO = Norsk 16/01/2012  
Dexrazoxane - Article 31 referral - Annex II BG = bălgarski 16/01/2012  
Dexrazoxane - Article 31 referral - Annex II ES = español 16/01/2012  
Dexrazoxane - Article 31 referral - Annex II CS = čeština 16/01/2012  
Dexrazoxane - Article 31 referral - Annex II DA = dansk 16/01/2012  
Dexrazoxane - Article 31 referral - Annex II DE = Deutsch 16/01/2012  
Dexrazoxane - Article 31 referral - Annex II ET = eesti keel 16/01/2012  
Dexrazoxane - Article 31 referral - Annex II EL = elliniká 16/01/2012  
Dexrazoxane - Article 31 referral - Annex II EN = English 16/01/2012  
Dexrazoxane - Article 31 referral - Annex II FR = français 16/01/2012  
Dexrazoxane - Article 31 referral - Annex II IT = italiano 16/01/2012  
Dexrazoxane - Article 31 referral - Annex II LV = latviešu valoda 16/01/2012  
Dexrazoxane - Article 31 referral - Annex II LT = lietuvių kalba 16/01/2012  
Dexrazoxane - Article 31 referral - Annex II HU = magyar 16/01/2012  
Dexrazoxane - Article 31 referral - Annex II MT = Malti 16/01/2012  
Dexrazoxane - Article 31 referral - Annex II NL = Nederlands 16/01/2012  
Dexrazoxane - Article 31 referral - Annex II PL = polski 16/01/2012  
Dexrazoxane - Article 31 referral - Annex II PT = português 16/01/2012  
Dexrazoxane - Article 31 referral - Annex II RO = română 16/01/2012  
Dexrazoxane - Article 31 referral - Annex II SK = slovenčina 16/01/2012  
Dexrazoxane - Article 31 referral - Annex II SL = slovenščina 16/01/2012  
Dexrazoxane - Article 31 referral - Annex II FI = suomi 16/01/2012  
Dexrazoxane - Article 31 referral - Annex II SV = svenska 16/01/2012  
Dexrazoxane - Article 31 referral - Annex III BG = bălgarski 24/06/2011 16/01/2012
Dexrazoxane - Article 31 referral - Annex III ES = español 24/06/2011 16/01/2012
Dexrazoxane - Article 31 referral - Annex III CS = čeština 24/06/2011 16/01/2012
Dexrazoxane - Article 31 referral - Annex III DA = dansk 24/06/2011 16/01/2012
Dexrazoxane - Article 31 referral - Annex III DE = Deutsch 24/06/2011 16/01/2012
Dexrazoxane - Article 31 referral - Annex III ET = eesti keel 24/06/2011 16/01/2012
Dexrazoxane - Article 31 referral - Annex III EL = elliniká 24/06/2011 16/01/2012
Dexrazoxane - Article 31 referral - Annex III EN = English 24/06/2011 16/01/2012
Dexrazoxane - Article 31 referral - Annex III FR = français 24/06/2011 16/01/2012
Dexrazoxane - Article 31 referral - Annex III IT = italiano 24/06/2011 16/01/2012
Dexrazoxane - Article 31 referral - Annex III LV = latviešu valoda 24/06/2011 16/01/2012
Dexrazoxane - Article 31 referral - Annex III LT = lietuvių kalba 24/06/2011 16/01/2012
Dexrazoxane - Article 31 referral - Annex III HU = magyar 24/06/2011 16/01/2012
Dexrazoxane - Article 31 referral - Annex III MT = Malti 24/06/2011 16/01/2012
Dexrazoxane - Article 31 referral - Annex III NL = Nederlands 24/06/2011 16/01/2012
Dexrazoxane - Article 31 referral - Annex III PL = polski 24/06/2011 16/01/2012
Dexrazoxane - Article 31 referral - Annex III PT = português 24/06/2011 16/01/2012
Dexrazoxane - Article 31 referral - Annex III RO = română 24/06/2011 16/01/2012
Dexrazoxane - Article 31 referral - Annex III SK = slovenčina 24/06/2011 16/01/2012
Dexrazoxane - Article 31 referral - Annex III SL = slovenščina 24/06/2011 16/01/2012
Dexrazoxane - Article 31 referral - Annex III FI = suomi 24/06/2011 16/01/2012
Dexrazoxane - Article 31 referral - Annex III SV = svenska 24/06/2011 16/01/2012
Dexrazoxane - Article 31 referral - Annex III IS = Islenska 24/06/2011 16/01/2012
Dexrazoxane - Article 31 referral - Annex III NO = Norsk 24/06/2011 16/01/2012
Dexrazoxane - Article 31 referral - Annex IV BG = bălgarski 16/01/2012  
Dexrazoxane - Article 31 referral - Annex IV ES = español 16/01/2012  
Dexrazoxane - Article 31 referral - Annex IV CS = čeština 16/01/2012  
Dexrazoxane - Article 31 referral - Annex IV DA = dansk 16/01/2012  
Dexrazoxane - Article 31 referral - Annex IV DE = Deutsch 16/01/2012  
Dexrazoxane - Article 31 referral - Annex IV ET = eesti keel 16/01/2012  
Dexrazoxane - Article 31 referral - Annex IV EL = elliniká 16/01/2012  
Dexrazoxane - Article 31 referral - Annex IV EN = English 16/01/2012  
Dexrazoxane - Article 31 referral - Annex IV FR = français 16/01/2012  
Dexrazoxane - Article 31 referral - Annex IV IT = italiano 16/01/2012  
Dexrazoxane - Article 31 referral - Annex IV LV = latviešu valoda 16/01/2012  
Dexrazoxane - Article 31 referral - Annex IV LT = lietuvių kalba 16/01/2012  
Dexrazoxane - Article 31 referral - Annex IV HU = magyar 16/01/2012  
Dexrazoxane - Article 31 referral - Annex IV MT = Malti 16/01/2012  
Dexrazoxane - Article 31 referral - Annex IV NL = Nederlands 16/01/2012  
Dexrazoxane - Article 31 referral - Annex IV PL = polski 16/01/2012  
Dexrazoxane - Article 31 referral - Annex IV PT = português 16/01/2012  
Dexrazoxane - Article 31 referral - Annex IV RO = română 16/01/2012  
Dexrazoxane - Article 31 referral - Annex IV SK = slovenčina 16/01/2012  
Dexrazoxane - Article 31 referral - Annex IV SL = slovenščina 16/01/2012  
Dexrazoxane - Article 31 referral - Annex IV FI = suomi 16/01/2012  
Dexrazoxane - Article 31 referral - Annex IV SV = svenska 16/01/2012  
Dexrazoxane-H-A-31-1275: Article 31 referral - Assessment report (English only) 16/01/2012  

Document description

  • Questions and answers (Q&A) - easy-to-understand summary of key issues and Committee conclusions
  • Summary of Opinion - contains the CHMP opinion of the referred medicine(s)
  • List of the medicines affected by the referral (Annex I)
  • Scientific conclusions of the Committee (Annex II)

The following two documents are sometimes available:

  • Changes to the summary of product characteristics, labeling or package leaflet (also known as Annex III) - available when changes have been recommended by the Committee
  • Conditions of the marketing authorisation (also known as Annex IV) - available when the Committee recommends measures to be taken for the marketing authorisation(s) such as safety measures or extra studies

Current status:
European Commission final decision

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