Dacogen

decitabine

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

What is Dacogen?

Dacogen is a powder that is made up into a solution for infusion (drip into a vein). It contains the active substance decitabine.

What is Dacogen used for?

Dacogen is used to treat adults aged 65 or older with acute myeloid leukaemia (AML), a type of cancer affecting the white blood cells. It is used in patients with newly diagnosed AML who are not eligible for initial treatment with standard chemotherapy (anticancer medicines).

Because the number of patients with AML is low, the disease is considered ‘rare’, and Dacogen was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 8 June 2006.

The medicine can only be obtained with a prescription.

How is Dacogen used?

Treatment with Dacogen should be started under the supervision of a doctor who has experience in the use of chemotherapy.

Dacogen is given as treatment cycles over five days, with a recommended dose of 20 mg per square metre body surface area (calculated using the patient’s height and weight) per day. Dacogen is given as an infusion into a vein over one hour. This treatment cycle should be repeated every four weeks depending on how well the patient responds to and tolerates treatment. If a patient develops certain severe side effects, the doctor may decide to delay treatment.

Patients should be treated for a minimum of four cycles and the doctor may continue treatment with Dacogen for as long as there is a benefit from the treatment.

How does Dacogen work?

The active substance in Dacogen, decitabine, is a ‘cytidine deoxynucleoside analogue’. This means that it is similar to cytidine deoxynucleoside, a fundamental component of the genetic material of cells. In the body, decitabine is converted into decitabine triphosphate, which is then incorporated into the DNA (genetic material) where it blocks the activity of enzymes called DNA methyltransferases (DNMTs), which are responsible for promoting the development and progression of cancer. By blocking DNMTs, decitabine will block the division of tumour cells and lead to their death.

How has Dacogen been studied?

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

Dacogen has been studied in one main study involving 485 adults aged 65 or older, who were newly diagnosed with AML. Dacogen was compared with either supportive care (any medicine or technique to help patients, excluding anticancer medicines or surgery) or low-dose cytarabine (another anticancer medicine). Treatment was given for as long as patients benefited from it. The main measure of effectiveness was how long the patients lived.

What benefit has Dacogen shown during the studies?

Patients receiving Dacogen lived for an average of 7.7 months compared with 5.0 months for patients receiving supportive care or treatment with cytarabine.

What is the risk associated with Dacogen?

The most common side effects with Dacogen (seen in more than 35% of patients) are pyrexia (fever), anaemia (low red blood cell count) and thrombocytopenia (low blood count of platelets). The most common serious side effects (seen in more than 20% of patients) include pneumonia (infection of the lungs), thrombocytopenia, neutropenia (low blood count of neutrophils, a type of white blood cell), febrile neutropenia (low white-blood-cell count with fever) and anaemia. For the full list of all side effects reported with Dacogen, see the package leaflet.

Dacogen must not be used in people who are hypersensitive (allergic) to decitabine or any of the other ingredients. As it is not known whether the active substance is excreted in breast milk, in the event that a patient is breastfeeding, they must discontinue breastfeeding if they require treatment with Dacogen.

Why has Dacogen been approved?

The CHMP noted that the improvement in survival seen with Dacogen in patients with AML was modest but relevant, as the benefits of currently available treatments are limited in adults aged 65 years or older. In addition, there were no major safety concerns with Dacogen and the overall safety profile was similar to that of low-dose cytarabine with the exception of some side effects such as infections and neutropenia, which were more common with Dacogen. The CHMP decided that Dacogen’s benefits are greater than its risks and recommended that it be given marketing authorisation.

Other information about Dacogen

The European Commission granted a marketing authorisation valid throughout the European Union for Dacogen on 20 September 2012.

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

Name Language First published Last updated
Dacogen : EPAR - Summary for the public BG = bălgarski 16/10/2012  
Dacogen : EPAR - Summary for the public ES = español 16/10/2012  
Dacogen : EPAR - Summary for the public CS = čeština 16/10/2012  
Dacogen : EPAR - Summary for the public DA = dansk 16/10/2012  
Dacogen : EPAR - Summary for the public DE = Deutsch 16/10/2012  
Dacogen : EPAR - Summary for the public ET = eesti keel 16/10/2012  
Dacogen : EPAR - Summary for the public EL = elliniká 16/10/2012  
Dacogen : EPAR - Summary for the public EN = English 16/10/2012  
Dacogen : EPAR - Summary for the public FR = français 16/10/2012  
Dacogen : EPAR - Summary for the public IT = italiano 16/10/2012  
Dacogen : EPAR - Summary for the public LV = latviešu valoda 16/10/2012  
Dacogen : EPAR - Summary for the public LT = lietuvių kalba 16/10/2012  
Dacogen : EPAR - Summary for the public HU = magyar 16/10/2012  
Dacogen : EPAR - Summary for the public MT = Malti 16/10/2012  
Dacogen : EPAR - Summary for the public NL = Nederlands 16/10/2012  
Dacogen : EPAR - Summary for the public PL = polski 16/10/2012  
Dacogen : EPAR - Summary for the public PT = português 16/10/2012  
Dacogen : EPAR - Summary for the public RO = română 16/10/2012  
Dacogen : EPAR - Summary for the public SK = slovenčina 16/10/2012  
Dacogen : EPAR - Summary for the public SL = slovenščina 16/10/2012  
Dacogen : EPAR - Summary for the public FI = suomi 16/10/2012  
Dacogen : EPAR - Summary for the public SV = svenska 16/10/2012  

This EPAR was last updated on 27/01/2014 .

Authorisation details

Product details

Product details for Dacogen
NameDacogen
Agency product numberEMEA/H/C/002221
Active substance

decitabine

International non-proprietary name (INN) or common name

decitabine

Therapeutic area Leukemia, Myeloid
Anatomical therapeutic chemical (ATC) code L01BC08
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.

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 Dacogen
Marketing-authorisation holder

Janssen-Cilag International N V  

Revision2
Date of issue of marketing authorisation valid throughout the European Union20/09/2012

Contact address:

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

Product information

Product information

16/01/2014  Dacogen -EMEA/H/C/002221 -PSUV/0008

Name Language First published Last updated
Dacogen : EPAR - Product Information SV = svenska 16/10/2012 27/01/2014
Dacogen : EPAR - Product Information SV = svenska 16/10/2012 27/01/2014
Dacogen : EPAR - Product Information SV = svenska 16/10/2012 27/01/2014
Dacogen : EPAR - Product Information SV = svenska 16/10/2012 27/01/2014
Dacogen : EPAR - Product Information SV = svenska 16/10/2012 27/01/2014
Dacogen : EPAR - Product Information SV = svenska 16/10/2012 27/01/2014
Dacogen : EPAR - Product Information SV = svenska 16/10/2012 27/01/2014
Dacogen : EPAR - Product Information SV = svenska 16/10/2012 27/01/2014
Dacogen : EPAR - Product Information SV = svenska 16/10/2012 27/01/2014
Dacogen : EPAR - Product Information SV = svenska 16/10/2012 27/01/2014
Dacogen : EPAR - Product Information SV = svenska 16/10/2012 27/01/2014
Dacogen : EPAR - Product Information SV = svenska 16/10/2012 27/01/2014
Dacogen : EPAR - Product Information SV = svenska 16/10/2012 27/01/2014
Dacogen : EPAR - Product Information SV = svenska 16/10/2012 27/01/2014
Dacogen : EPAR - Product Information SV = svenska 16/10/2012 27/01/2014
Dacogen : EPAR - Product Information SV = svenska 16/10/2012 27/01/2014
Dacogen : EPAR - Product Information SV = svenska 16/10/2012 27/01/2014
Dacogen : EPAR - Product Information SV = svenska 16/10/2012 27/01/2014
Dacogen : EPAR - Product Information SV = svenska 16/10/2012 27/01/2014
Dacogen : EPAR - Product Information SV = svenska 16/10/2012 27/01/2014
Dacogen : EPAR - Product Information SV = svenska 16/10/2012 27/01/2014
Dacogen : EPAR - Product Information SV = svenska 16/10/2012 27/01/2014
Dacogen : EPAR - Product Information SV = svenska 16/10/2012 27/01/2014
Dacogen : EPAR - Product Information SV = svenska 16/10/2012 27/01/2014
Dacogen : EPAR - Product Information SV = svenska 16/10/2012 27/01/2014

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
Dacogen : EPAR - All Authorised presentations SV = svenska 16/10/2012  
Dacogen : EPAR - All Authorised presentations SV = svenska 16/10/2012  
Dacogen : EPAR - All Authorised presentations SV = svenska 16/10/2012  
Dacogen : EPAR - All Authorised presentations SV = svenska 16/10/2012  
Dacogen : EPAR - All Authorised presentations SV = svenska 16/10/2012  
Dacogen : EPAR - All Authorised presentations SV = svenska 16/10/2012  
Dacogen : EPAR - All Authorised presentations SV = svenska 16/10/2012  
Dacogen : EPAR - All Authorised presentations SV = svenska 16/10/2012  
Dacogen : EPAR - All Authorised presentations SV = svenska 16/10/2012  
Dacogen : EPAR - All Authorised presentations SV = svenska 16/10/2012  
Dacogen : EPAR - All Authorised presentations SV = svenska 16/10/2012  
Dacogen : EPAR - All Authorised presentations SV = svenska 16/10/2012  
Dacogen : EPAR - All Authorised presentations SV = svenska 16/10/2012  
Dacogen : EPAR - All Authorised presentations SV = svenska 16/10/2012  
Dacogen : EPAR - All Authorised presentations SV = svenska 16/10/2012  
Dacogen : EPAR - All Authorised presentations SV = svenska 16/10/2012  
Dacogen : EPAR - All Authorised presentations SV = svenska 16/10/2012  
Dacogen : EPAR - All Authorised presentations SV = svenska 16/10/2012  
Dacogen : EPAR - All Authorised presentations SV = svenska 16/10/2012  
Dacogen : EPAR - All Authorised presentations SV = svenska 16/10/2012  
Dacogen : EPAR - All Authorised presentations SV = svenska 16/10/2012  
Dacogen : EPAR - All Authorised presentations SV = svenska 16/10/2012  
Dacogen : EPAR - All Authorised presentations SV = svenska 16/10/2012  
Dacogen : EPAR - All Authorised presentations SV = svenska 16/10/2012  

Pharmacotherapeutic group

Antineoplastic agents

Therapeutic indication

Treatment of adult patients aged 65 years and above with newly diagnosed de novo or secondary acute myeloid leukaemia (AML), according to the World Health Organization (WHO) classification, who are not candidates for standard induction chemotherapy.

Assessment History

Changes since initial authorisation of medicine

Initial marketing-authorisation documents

Name Language First published Last updated
Dacogen : EPAR - Public assessment report SV = svenska 16/10/2012  
CHMP summary of positive opinion for Dacogen SV = svenska 20/07/2012  

Authorised

This medicine is approved for use in the European Union