Basic Information
EMA regulatory identification and product classification information
EMA Identifiers
Overview Summary
Comprehensive product overview and regulatory summary
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.
Active Substances (1)
decitabine
Documents (16)
Dacogen-H-C-PSUSA-00009118-201605 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
February 28, 2017
CHANGES_SINCE_INITIAL_AUTHORISATION
Dacogen : EPAR - Public assessment report
October 15, 2012
INITIAL_MARKETING_AUTHORISATION_DOCUMENTS
CHMP summary of positive opinion for Dacogen
July 19, 2012
INITIAL_MARKETING_AUTHORISATION_DOCUMENTS
Dacogen : EPAR - Public assessment report
October 15, 2012
CHANGES_SINCE_INITIAL_AUTHORISATION
CHMP summary of positive opinion for Dacogen
July 19, 2012
CHANGES_SINCE_INITIAL_AUTHORISATION
Dacogen : EPAR - Paediatric investigation plan compliance statement
April 30, 2021
CHANGES_SINCE_INITIAL_AUTHORISATION
Dacogen-H-C-PSUSA-00009118-201805 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
February 20, 2019
CHANGES_SINCE_INITIAL_AUTHORISATION
Dacogen-H-C-2221-PSUV-0008 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation
January 26, 2014
CHANGES_SINCE_INITIAL_AUTHORISATION
Dacogen : EPAR - Risk-management-plan summary
February 20, 2019
RISK_MANAGEMENT_PLAN_SUMMARY
Dacogen : EPAR - Procedural steps taken and scientific information after authorisation
February 3, 2013
CHANGES_SINCE_INITIAL_AUTHORISATION
Dacogen-H-C-PSUSA-00009118-202005 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
April 30, 2021
CHANGES_SINCE_INITIAL_AUTHORISATION
Dacogen-H-C-2221-P46-008: EPAR - Assessment Report
June 6, 2016
CHANGES_SINCE_INITIAL_AUTHORISATION
Dacogen : EPAR - All Authorised presentations
October 15, 2012
AUTHORISED_PRESENTATIONS
Dacogen : EPAR - Product Information
October 15, 2012
DRUG_PRODUCT_INFORMATION
Dacogen : EPAR - Summary for the public
October 15, 2012
OVERVIEW_DOCUMENT
Dacogen-H-C-2221-PSUV-0011 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation
July 28, 2014
CHANGES_SINCE_INITIAL_AUTHORISATION
Overview Q&A (10)
Question
What is Dacogen?
Answer
Dacogen is a powder that is made up into a solution for infusion (drip) into a vein. It contains the active substance decitabine.
Question
Why has Dacogen been approved?
Answer
The CHMP noted that the improvement in survival with Dacogen in patients with AML was modest but relevant, as the benefits of current treatments are limited in patients who are not eligible for standard induction chemotherapy. There were no major safety concerns with Dacogen and the overall safety profile was similar to that of low-dose cytarabine but some side effects such as infections and neutropenia 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.
Question
How is Dacogen used?
Answer
Dacogen can only be obtained with a prescription. Treatment with Dacogen should be started under the supervision of a doctor who has experience in the use of chemotherapy.
Dacogen is given as an infusion into a vein over one hour. The dose is calculated using the patient’s height and weight. In a 4-week treatment cycle, Dacogen is given daily for the first 5 days. At least 4 treatment cycles are recommended but they can be continued for as long as the AML remains under control. If a patient develops certain severe side effects, the doctor may decide to delay or stop Dacogen treatment.
Question
How does Dacogen work?
Answer
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 DNA (genetic material) of cells. In the body, decitabine is converted into decitabine triphosphate, which is then incorporated into the DNA where it blocks the activity of enzymes called DNA methyltransferases (DNMTs). These enzymes promote the development and progression of cancer. By blocking DNMTs, decitabine will prevent the increase of tumour cells and lead to their death.
Question
What measures are being taken to ensure the safe and effective use of Dacogen?
Answer
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Dacogen have been included in the summary of product characteristics and the package leaflet.
Question
Other information about Dacogen
Answer
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.
Question
How has Dacogen been studied?
Answer
Dacogen has been studied in one main study involving 485 adults, who were newly diagnosed with AML but were not eligible for standard induction chemotherapy. Dacogen was compared with either supportive care (any medicine or technique to help patients, excluding cancer medicines or surgery) or low-dose cytarabine (another cancer medicine). Treatment was given for as long as patients benefited from it. The main measure of effectiveness was how long the patients lived.
Question
What benefit has Dacogen shown during the studies?
Answer
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.
Question
What is Dacogen used for?
Answer
Dacogen is used to treat adults with newly diagnosed acute myeloid leukaemia (AML), a type of cancer affecting the white blood cells. It is used in patients who are not eligible for standard induction chemotherapy (initial treatment with cancer 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.
Question
What is the risk associated with Dacogen?
Answer
The most common side effects with Dacogen (seen in more than 35% of patients) are fever, anaemia (low red blood cell count) and thrombocytopenia (low blood platelet count). The most common serious side effects (seen in more than 20% of patients) include pneumonia (lung infection), thrombocytopenia, neutropenia (low blood count of neutrophils, a type of white blood cell), febrile neutropenia (low white blood cell count with fever) and anaemia.
Dacogen must not be used in people who are breastfeeding. 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.
For the full list of all restrictions and side effects reported with Dacogen, see the package leaflet.