Vidaza

azacitidine

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

What is Vidaza?

Vidaza is a medicine that contains the active substance azacitidine. It is available as a powder to be made up into a suspension for injection.

What is Vidaza used for?

Vidaza is used for the treatment of adults with the following diseases, if they cannot have haematopoietic stem cell transplantation (when the patient receives stem cells to restore the bone marrow’s ability to produce healthy blood cells):

  • myelodysplastic syndromes, a group of conditions where too few blood cells are produced by the bone marrow. In some cases, myelodysplastic syndromes can lead to acute myeloid leukaemia (AML, a cancer affecting white blood cells called myeloid cells). Vidaza is used in patients with an intermediate to high risk of progressing to AML or death;
  • chronic myelomonocytic leukaemia (CMML, a cancer affecting white blood cells called monocytes). Vidaza is used when the bone marrow consists of 10 to 29% abnormal cells and the bone marrow is not producing large numbers of white blood cells;
  • AML that has developed from a myelodysplastic syndrome and the bone marrow consists of 20 to 30% abnormal cells;
  • AML, when the bone marrow has more than 30% abnormal cells.

Because the number of patients with these diseases is low, the diseases are considered ‘rare’, and Vidaza was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 6 February 2002 for myelodysplastic syndromes and on 29 November 2007 for AML. At the time of orphan medicine designation, CMML was classified as a type of myelodysplastic syndrome.

The medicine can only be obtained with a prescription.

How is Vidaza used?

Vidaza treatment should be started and monitored under the supervision of a doctor experienced in the use of cancer medicines. Patients should receive medicines to prevent nausea (feeling sick) and vomiting before giving Vidaza.

The recommended dose of Vidaza is 75 mg per square metre body surface area (calculated using the patient’s height and weight). It is given as an injection under the skin of the upper arm, thigh or abdomen (tummy) every day for one week, followed by three weeks with no treatment. This four-week period is one ‘cycle’. Treatment continues for at least six cycles and then for as long as it benefits the patient. The liver, kidneys and blood should be checked before each cycle. If the blood counts fall too low or if the patient develops kidney problems, the next treatment cycle should be delayed or a lower dose should be used.

See the summary of product characteristics (also part of the EPAR) for full details.

How does Vidaza work?

The active substance in Vidaza, azacitidine, belongs to the group ‘anti‑metabolites’. Azacitidine is an analogue of cytidine, which means that it is incorporated into the genetic material of cells (RNA and DNA). It is thought to work by altering the way the cell turns genes on and off and also by interfering with the production of new RNA and DNA. These actions are thought to correct the problems with the maturation and growth of young blood cells in the bone marrow that cause myelodysplastic disorders, and to kill cancerous cells in leukaemia.

How has Vidaza been studied?

Vidaza has been studied in two main studies. The first study involved 358 adults with intermediate to high-risk myelodysplastic syndromes, CMML or AML, who were unlikely to go on to have a stem cell transplant. The patients’ bone marrow contained up to 30% abnormal cells. The second study involved 488 patients with AML who were 65 years or older and could not have haematopoietic stem cell transplantation. Their bone marrow contained more than 30% abnormal cells. Both studies compared Vidaza with conventional care (treatment chosen for each patient based on local practice and the patient’s condition). The main measure of effectiveness was how long the patients survived.

What benefit has Vidaza shown during the studies?

Vidaza was more effective than conventional care in extending survival. In the first study, patients receiving Vidaza survived for an average of 24.5 months, compared with 15.0 months in patients receiving conventional care. The effect of Vidaza was similar in all three diseases.

In the second study in AML patients with more than 30% abnormal cells, patients receiving Vidaza survived for an average of 10.4 months, compared with 6.5 months in patients receiving conventional care.

What is the risk associated with Vidaza?

The most common side effects of Vidaza in more than 60% of patients with myelodysplastic syndromes, CMML or AML (20 to 30% abnormal cells) are blood reactions including thrombocytopenia (low platelet counts), neutropenia (low levels of neutrophils, a type of white blood cell) and leucopenia (low white blood cell counts), side effects affecting the stomach and gut including nausea and vomiting, and injection site reactions. Side effects were similar in AML patients with more than 30% abnormal cells. For the full list of all side effects reported with Vidaza, see the package leaflet.

Vidaza must not be used in patients with advanced liver cancer or in women who are breastfeeding. For the full list of restrictions, see the package leaflet.

Why has Vidaza been approved?

The CHMP decided that Vidaza’s benefits are greater than its risks and recommended that it be given marketing authorisation.

What measures are being taken to ensure the safe and effective use of Vidaza?

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Vidaza have been included in the summary of product characteristics and the package leaflet.

Other information about Vidaza

The European Commission granted a marketing authorisation valid throughout the European Union for Vidaza on 17 December 2008.

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

Name Language First published Last updated
Vidaza : EPAR - Summary for the public BG = bălgarski 23/01/2009 17/08/2016
Vidaza : EPAR - Summary for the public ES = español 23/01/2009 17/08/2016
Vidaza : EPAR - Summary for the public CS = čeština 23/01/2009 17/08/2016
Vidaza : EPAR - Summary for the public DA = dansk 23/01/2009 17/08/2016
Vidaza : EPAR - Summary for the public DE = Deutsch 23/01/2009 17/08/2016
Vidaza : EPAR - Summary for the public ET = eesti keel 23/01/2009 17/08/2016
Vidaza : EPAR - Summary for the public EL = elliniká 23/01/2009 17/08/2016
Vidaza : EPAR - Summary for the public EN = English 23/01/2009 17/08/2016
Vidaza : EPAR - Summary for the public FR = français 23/01/2009 17/08/2016
Vidaza : EPAR - Summary for the public IT = italiano 23/01/2009 17/08/2016
Vidaza : EPAR - Summary for the public LV = latviešu valoda 23/01/2009 17/08/2016
Vidaza : EPAR - Summary for the public LT = lietuvių kalba 23/01/2009 17/08/2016
Vidaza : EPAR - Summary for the public HU = magyar 23/01/2009 17/08/2016
Vidaza : EPAR - Summary for the public MT = Malti 23/01/2009 17/08/2016
Vidaza : EPAR - Summary for the public NL = Nederlands 23/01/2009 17/08/2016
Vidaza : EPAR - Summary for the public PL = polski 23/01/2009 17/08/2016
Vidaza : EPAR - Summary for the public PT = português 23/01/2009 17/08/2016
Vidaza : EPAR - Summary for the public RO = română 23/01/2009 17/08/2016
Vidaza : EPAR - Summary for the public SK = slovenčina 23/01/2009 17/08/2016
Vidaza : EPAR - Summary for the public SL = slovenščina 23/01/2009 17/08/2016
Vidaza : EPAR - Summary for the public FI = suomi 23/01/2009 17/08/2016
Vidaza : EPAR - Summary for the public SV = svenska 23/01/2009 17/08/2016
Vidaza : EPAR - Summary for the public HR = Hrvatski 23/01/2009 17/08/2016

This EPAR was last updated on 17/08/2016 .

Authorisation details

Product details

Product details for Vidaza
NameVidaza
Agency product numberEMEA/H/C/000978
Active substance

azacitidine

International non-proprietary name (INN) or common name

azacitidine

Therapeutic area Myelodysplastic Syndromes
Anatomical therapeutic chemical (ATC) code L01BC07
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 Vidaza
Marketing-authorisation holder

Celgene Europe Limited

Revision14
Date of issue of marketing authorisation valid throughout the European Union17/12/2008

Contact address:

Celgene Europe Limited
1 Longwalk Road
Stockley Park
Uxbridge UB11 1DB
United Kingdom

Product information

Product information

29/06/2016  Vidaza -EMEA/H/C/000978 -IB/0036

Name Language First published Last updated
Vidaza : EPAR - Product Information HR = Hrvatski 01/12/2009 17/08/2016
Vidaza : EPAR - Product Information HR = Hrvatski 01/12/2009 17/08/2016
Vidaza : EPAR - Product Information HR = Hrvatski 01/12/2009 17/08/2016
Vidaza : EPAR - Product Information HR = Hrvatski 01/12/2009 17/08/2016
Vidaza : EPAR - Product Information HR = Hrvatski 01/12/2009 17/08/2016
Vidaza : EPAR - Product Information HR = Hrvatski 01/12/2009 17/08/2016
Vidaza : EPAR - Product Information HR = Hrvatski 01/12/2009 17/08/2016
Vidaza : EPAR - Product Information HR = Hrvatski 01/12/2009 17/08/2016
Vidaza : EPAR - Product Information HR = Hrvatski 01/12/2009 17/08/2016
Vidaza : EPAR - Product Information HR = Hrvatski 01/12/2009 17/08/2016
Vidaza : EPAR - Product Information HR = Hrvatski 01/12/2009 17/08/2016
Vidaza : EPAR - Product Information HR = Hrvatski 01/12/2009 17/08/2016
Vidaza : EPAR - Product Information HR = Hrvatski 01/12/2009 17/08/2016
Vidaza : EPAR - Product Information HR = Hrvatski 01/12/2009 17/08/2016
Vidaza : EPAR - Product Information HR = Hrvatski 01/12/2009 17/08/2016
Vidaza : EPAR - Product Information HR = Hrvatski 01/12/2009 17/08/2016
Vidaza : EPAR - Product Information HR = Hrvatski 01/12/2009 17/08/2016
Vidaza : EPAR - Product Information HR = Hrvatski 01/12/2009 17/08/2016
Vidaza : EPAR - Product Information HR = Hrvatski 01/12/2009 17/08/2016
Vidaza : EPAR - Product Information HR = Hrvatski 01/12/2009 17/08/2016
Vidaza : EPAR - Product Information HR = Hrvatski 01/12/2009 17/08/2016
Vidaza : EPAR - Product Information HR = Hrvatski 01/12/2009 17/08/2016
Vidaza : EPAR - Product Information HR = Hrvatski 01/12/2009 17/08/2016
Vidaza : EPAR - Product Information HR = Hrvatski 01/12/2009 17/08/2016
Vidaza : EPAR - Product Information HR = Hrvatski 01/12/2009 17/08/2016

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
Vidaza : EPAR - All Authorised presentations HR = Hrvatski 23/01/2009  
Vidaza : EPAR - All Authorised presentations HR = Hrvatski 23/01/2009  
Vidaza : EPAR - All Authorised presentations HR = Hrvatski 23/01/2009  
Vidaza : EPAR - All Authorised presentations HR = Hrvatski 23/01/2009  
Vidaza : EPAR - All Authorised presentations HR = Hrvatski 23/01/2009  
Vidaza : EPAR - All Authorised presentations HR = Hrvatski 23/01/2009  
Vidaza : EPAR - All Authorised presentations HR = Hrvatski 23/01/2009  
Vidaza : EPAR - All Authorised presentations HR = Hrvatski 23/01/2009  
Vidaza : EPAR - All Authorised presentations HR = Hrvatski 23/01/2009  
Vidaza : EPAR - All Authorised presentations HR = Hrvatski 23/01/2009  
Vidaza : EPAR - All Authorised presentations HR = Hrvatski 23/01/2009  
Vidaza : EPAR - All Authorised presentations HR = Hrvatski 23/01/2009  
Vidaza : EPAR - All Authorised presentations HR = Hrvatski 23/01/2009  
Vidaza : EPAR - All Authorised presentations HR = Hrvatski 23/01/2009  
Vidaza : EPAR - All Authorised presentations HR = Hrvatski 23/01/2009  
Vidaza : EPAR - All Authorised presentations HR = Hrvatski 23/01/2009  
Vidaza : EPAR - All Authorised presentations HR = Hrvatski 23/01/2009  
Vidaza : EPAR - All Authorised presentations HR = Hrvatski 23/01/2009  
Vidaza : EPAR - All Authorised presentations HR = Hrvatski 23/01/2009  
Vidaza : EPAR - All Authorised presentations HR = Hrvatski 23/01/2009  
Vidaza : EPAR - All Authorised presentations HR = Hrvatski 23/01/2009  
Vidaza : EPAR - All Authorised presentations HR = Hrvatski 23/01/2009  

Pharmacotherapeutic group

Antineoplastic agents

Therapeutic indication

Vidaza is indicated for the treatment of adult patients who are not eligible for haematopoietic stem cell transplantation (HSCT) with:

  • intermediate-2 and high-risk myelodysplastic syndromes (MDS) according to the International Prognostic Scoring System (IPSS);
  • chronic myelomonocytic leukaemia (CMML) with 10-29% marrow blasts without myeloproliferative disorder;
  • acute myeloid leukaemia (AML) with 20-30% blasts and multi-lineage dysplasia, according to World Health Organization (WHO) classification.

Vidaza is indicated for the treatment of adult patients aged 65 years or older who are not eligible for HSCT with AML with >30% marrow blasts according to the WHO classification.

Assessment History

Changes since initial authorisation of medicine

Initial marketing-authorisation documents

Name Language First published Last updated
Vidaza : EPAR - Public assessment report HR = Hrvatski 23/01/2009  
Committee for medicinal products for human use, summary of positive opinion for Vidaza HR = Hrvatski 24/10/2008  

Authorised

This medicine is approved for use in the European Union

More information on Vidaza