Tasigna

nilotinib

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

What is Tasigna?

Tasigna is a medicine containing the active substance nilotinib. It is available as capsules (150 and 200 mg).

What is Tasigna used for?

Tasigna is used to treat adults with chronic myelogenous leukaemia (CML), a type of cancer of the white blood cells. It is used when the patient is ‘Philadelphia-chromosome-positive’ (Ph+), which means that some of the patient’s genes have re-arranged themselves to form a special chromosome called the Philadelphia chromosome. This chromosome produces an enzyme, called Bcr-Abl kinase, that leads to the development of leukaemia.

Tasigna is used to treat the ‘chronic’ and ‘accelerated’ phases of CML, in patients who cannot tolerate other treatments including imatinib (another anticancer medicine), or when their disease is not responding to them. There is no information available on its effectiveness in patients whose disease is in ‘blast crisis’ (another phase of CML).

Tasigna is also used in newly diagnosed patients with CML in the chronic phase.

Because the number of patients with CML is low, the disease is considered ‘rare’, and Tasigna was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 22 May 2006.

The medicine can only be obtained with a prescription.

How is Tasigna used?

Treatment with Tasigna should be initiated by a doctor who has experience in the diagnosis and treatment of CML.

In newly diagnosed patients with chronic-phase CML, the recommended dose of Tasigna is 300 mg twice a day. In patients with chronic- or accelerated-phase CML who cannot tolerate other treatments or whose disease does not respond to them, the recommended dose is 400 mg twice a day.

Treatment should continue for as long as the patient continues to benefit. The dose should be reduced or treatment interrupted if the patient has certain side effects affecting the blood.

The two doses of Tasigna should be taken around 12 hours apart. The capsules should be swallowed whole with a glass of water, without eating anything for two hours before and one hour after each dose. For patients who are unable to swallow capsules, the content of the capsules may be dispersed in a teaspoon of apple puree and taken immediately. Tasigna can be given with certain other medicines if appropriate.

How does Tasigna work?

The active substance in Tasigna, nilotinib, belongs to a group of medicines called ‘protein-kinase inhibitors’. These compounds act by blocking types of enzymes known as protein kinases. Nilotinib acts by blocking the protein kinase called Bcr-Abl kinase. This enzyme is produced by leukaemia cells, and causes them to multiply uncontrollably. By blocking Bcr-Abl kinase, Tasigna helps to control the spread of leukaemia cells.

How has Tasigna been studied?

Tasigna has been studied in two main studies involving a total of 439 patients with CML, who could not tolerate imatinib or whose disease had stopped responding to it. In these studies, Tasigna was not compared with any other treatment. The first study included a total of 320 patients whose disease was in the ‘chronic phase’, three quarters of whom had stopped responding to imatinib. Its main measure of effectiveness was the proportion of patients who had had a ‘major cytogenetic response’ (when the proportion of the patient’s white blood cells that contained the Philadelphia chromosome had fallen to below 35%). The second study included a total of 119 patients whose disease was in the ‘accelerated phase’, four fifths of whom had stopped responding to imatinib. Its main measure of effectiveness was the proportion of patients who had had a ‘haematological response’ (a return to normal of the number of white cells in the blood).

In a third main study in 846 newly diagnosed patients with chronic-phase CML, Tasigna, either as 300 mg twice a day or as 400 mg twice a day, was compared with imatinib. The main measure of effectiveness was the proportion of patients who had had a ‘major molecular response’ (when the proportion of the patient’s white blood cells that contained the Philadelphia chromosome had fallen to below 0.1%) after 12 months of treatment.

What benefit has Tasigna shown during the studies?

In the study in chronic-phase CML patients who could not tolerate imatinib or whose disease had stopped responding to it, 156 (49%) of the 320 patients had a major cytogenetic response after having received Tasigna for an average of 341 days (around eleven months). In the study of accelerated-phase CML, 50 (42%) of the 119 patients had a haematological response, after having received Tasigna for an average of 202 days (around seven months). In both studies, Tasigna had a similar effect in patients who could not tolerate imatinib and those whose disease had stopped responding to it.

In the study in newly diagnosed patients with chronic phase CML, Tasigna was more effective than imatinib at reducing the number of white blood cells containing the Philadelphia chromosome: 125 (44%) of the 282 patients taking Tasigna 300 mg twice a day and 120 (42.7%) of the 281 patients taking Tasigna 400 mg twice a day had a major molecular response compared with 63 (22.3%) of the 283 patients taking imatinib.

What is the risk associated with Tasigna?

The most common side effects with Tasigna (seen in more than 1 patient in 10) are thrombocytopenia (low blood platelet counts), neutropenia (low white-blood-cell counts), anaemia (low red-blood-cell counts), headache, nausea (feeling sick), rash, pruritus (itching), myalgia (muscle pain) and fatigue (tiredness). For the full list of all side effects reported with Tasigna, see the package leaflet.

Tasigna must not be used in people who are hypersensitive (allergic) to nilotinib or any of the other ingredients.

Why has Tasigna been approved?

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

What measures are being taken to ensure the safe use of Tasigna?

The company that makes Tasigna will provide an information pack in each Member State for doctors and pharmacists who will prescribe or dispense the medicine. The pack will remind them of how Tasigna should be used safely in patients.

Other information about Tasigna

The European Commission granted a marketing authorisation valid throughout the European Union for Tasigna on 19 November 2007.

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

Name Language First published Last updated
Tasigna : EPAR - Summary for the public BG = bălgarski 02/06/2009 08/10/2012
Tasigna : EPAR - Summary for the public ES = español 02/06/2009 08/10/2012
Tasigna : EPAR - Summary for the public CS = čeština 02/06/2009 08/10/2012
Tasigna : EPAR - Summary for the public DA = dansk 02/06/2009 08/10/2012
Tasigna : EPAR - Summary for the public DE = Deutsch 02/06/2009 08/10/2012
Tasigna : EPAR - Summary for the public ET = eesti keel 02/06/2009 08/10/2012
Tasigna : EPAR - Summary for the public EL = elliniká 02/06/2009 08/10/2012
Tasigna : EPAR - Summary for the public EN = English 02/06/2009 08/10/2012
Tasigna : EPAR - Summary for the public FR = français 02/06/2009 08/10/2012
Tasigna : EPAR - Summary for the public IT = italiano 02/06/2009 08/10/2012
Tasigna : EPAR - Summary for the public LV = latviešu valoda 02/06/2009 08/10/2012
Tasigna : EPAR - Summary for the public LT = lietuvių kalba 02/06/2009 08/10/2012
Tasigna : EPAR - Summary for the public HU = magyar 02/06/2009 08/10/2012
Tasigna : EPAR - Summary for the public MT = Malti 02/06/2009 08/10/2012
Tasigna : EPAR - Summary for the public NL = Nederlands 02/06/2009 08/10/2012
Tasigna : EPAR - Summary for the public PL = polski 02/06/2009 08/10/2012
Tasigna : EPAR - Summary for the public PT = português 02/06/2009 08/10/2012
Tasigna : EPAR - Summary for the public RO = română 02/06/2009 08/10/2012
Tasigna : EPAR - Summary for the public SK = slovenčina 02/06/2009 08/10/2012
Tasigna : EPAR - Summary for the public SL = slovenščina 02/06/2009 08/10/2012
Tasigna : EPAR - Summary for the public FI = suomi 02/06/2009 08/10/2012
Tasigna : EPAR - Summary for the public SV = svenska 02/06/2009 08/10/2012

This EPAR was last updated on 17/06/2014 .

Authorisation details

Product details

Product details for Tasigna
NameTasigna
Agency product numberEMEA/H/C/000798
Active substance

nilotinib

International non-proprietary name (INN) or common name

nilotinib

Therapeutic area Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Anatomical therapeutic chemical (ATC) code L01XE08
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 Tasigna
Marketing-authorisation holder

Novartis Europharm Ltd.

Revision23
Date of issue of marketing authorisation valid throughout the European Union19/11/2007

Contact address:

Novartis Europharm Limited
Wimblehurst Road
Horsham
West Sussex
RH12 5AB
United Kingdom

Product information

Product information

20/03/2014  Tasigna -EMEA/H/C/000798 -II/0065

Name Language First published Last updated
Tasigna : EPAR - Product Information SV = svenska 29/09/2009 17/06/2014
Tasigna : EPAR - Product Information SV = svenska 29/09/2009 17/06/2014
Tasigna : EPAR - Product Information SV = svenska 29/09/2009 17/06/2014
Tasigna : EPAR - Product Information SV = svenska 29/09/2009 17/06/2014
Tasigna : EPAR - Product Information SV = svenska 29/09/2009 17/06/2014
Tasigna : EPAR - Product Information SV = svenska 29/09/2009 17/06/2014
Tasigna : EPAR - Product Information SV = svenska 29/09/2009 17/06/2014
Tasigna : EPAR - Product Information SV = svenska 29/09/2009 17/06/2014
Tasigna : EPAR - Product Information SV = svenska 29/09/2009 17/06/2014
Tasigna : EPAR - Product Information SV = svenska 29/09/2009 17/06/2014
Tasigna : EPAR - Product Information SV = svenska 29/09/2009 17/06/2014
Tasigna : EPAR - Product Information SV = svenska 29/09/2009 17/06/2014
Tasigna : EPAR - Product Information SV = svenska 29/09/2009 17/06/2014
Tasigna : EPAR - Product Information SV = svenska 29/09/2009 17/06/2014
Tasigna : EPAR - Product Information SV = svenska 29/09/2009 17/06/2014
Tasigna : EPAR - Product Information SV = svenska 29/09/2009 17/06/2014
Tasigna : EPAR - Product Information SV = svenska 29/09/2009 17/06/2014
Tasigna : EPAR - Product Information SV = svenska 29/09/2009 17/06/2014
Tasigna : EPAR - Product Information SV = svenska 29/09/2009 17/06/2014
Tasigna : EPAR - Product Information SV = svenska 29/09/2009 17/06/2014
Tasigna : EPAR - Product Information SV = svenska 29/09/2009 17/06/2014
Tasigna : EPAR - Product Information SV = svenska 29/09/2009 17/06/2014
Tasigna : EPAR - Product Information SV = svenska 29/09/2009 17/06/2014
Tasigna : EPAR - Product Information SV = svenska 29/09/2009 17/06/2014
Tasigna : EPAR - Product Information SV = svenska 29/09/2009 17/06/2014

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
Tasigna : EPAR - All Authorised presentations SV = svenska 28/11/2007 21/12/2011
Tasigna : EPAR - All Authorised presentations SV = svenska 28/11/2007 21/12/2011
Tasigna : EPAR - All Authorised presentations SV = svenska 28/11/2007 21/12/2011
Tasigna : EPAR - All Authorised presentations SV = svenska 28/11/2007 21/12/2011
Tasigna : EPAR - All Authorised presentations SV = svenska 28/11/2007 21/12/2011
Tasigna : EPAR - All Authorised presentations SV = svenska 28/11/2007 21/12/2011
Tasigna : EPAR - All Authorised presentations SV = svenska 28/11/2007 21/12/2011
Tasigna : EPAR - All Authorised presentations SV = svenska 28/11/2007 21/12/2011
Tasigna : EPAR - All Authorised presentations SV = svenska 28/11/2007 21/12/2011
Tasigna : EPAR - All Authorised presentations SV = svenska 28/11/2007 21/12/2011
Tasigna : EPAR - All Authorised presentations SV = svenska 28/11/2007 21/12/2011
Tasigna : EPAR - All Authorised presentations SV = svenska 28/11/2007 21/12/2011
Tasigna : EPAR - All Authorised presentations SV = svenska 28/11/2007 21/12/2011
Tasigna : EPAR - All Authorised presentations SV = svenska 28/11/2007 21/12/2011
Tasigna : EPAR - All Authorised presentations SV = svenska 28/11/2007 21/12/2011
Tasigna : EPAR - All Authorised presentations SV = svenska 28/11/2007 21/12/2011
Tasigna : EPAR - All Authorised presentations SV = svenska 28/11/2007 21/12/2011
Tasigna : EPAR - All Authorised presentations SV = svenska 28/11/2007 21/12/2011
Tasigna : EPAR - All Authorised presentations SV = svenska 28/11/2007 21/12/2011
Tasigna : EPAR - All Authorised presentations SV = svenska 28/11/2007 21/12/2011
Tasigna : EPAR - All Authorised presentations SV = svenska 28/11/2007 21/12/2011
Tasigna : EPAR - All Authorised presentations SV = svenska 28/11/2007 21/12/2011
Tasigna : EPAR - All Authorised presentations SV = svenska 28/11/2007 21/12/2011
Tasigna : EPAR - All Authorised presentations SV = svenska 28/11/2007 21/12/2011

Name Language First published Last updated
Tasigna : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 28/11/2007  
Tasigna : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 28/11/2007  
Tasigna : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 28/11/2007  
Tasigna : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 28/11/2007  
Tasigna : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 28/11/2007  
Tasigna : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 28/11/2007  
Tasigna : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 28/11/2007  
Tasigna : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 28/11/2007  
Tasigna : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 28/11/2007  
Tasigna : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 28/11/2007  
Tasigna : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 28/11/2007  
Tasigna : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 28/11/2007  
Tasigna : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 28/11/2007  
Tasigna : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 28/11/2007  
Tasigna : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 28/11/2007  
Tasigna : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 28/11/2007  
Tasigna : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 28/11/2007  
Tasigna : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 28/11/2007  
Tasigna : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 28/11/2007  
Tasigna : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 28/11/2007  
Tasigna : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 28/11/2007  
Tasigna : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 28/11/2007  

Pharmacotherapeutic group

Antineoplastic agents

Therapeutic indication

150 mg

Tasigna is indicated for the treatment of adult patients with newly diagnosed Philadelphia-chromosome-positive chronic myelogenous leukaemia (CML) in the chronic phase.

200 mg

Tasigna is indicated for the treatment of adult patients with:

  • newly diagnosed Philadelphia-chromosome-positive CML in the chronic phase;
  • chronic phase and accelerated phase Philadelphia-chromosome-positive CML with resistance or intolerance to prior therapy including imatinib. Efficacy data in patients with CML in blast crisis are not available.

Assessment History

Changes since initial authorisation of medicine

Initial marketing-authorisation documents

Name Language First published Last updated
Tasigna : EPAR - Procedural steps taken before authorisation SV = svenska 28/11/2007  
Tasigna : EPAR - Scientific Discussion SV = svenska 28/11/2007  

Authorised

This medicine is approved for use in the European Union

More information on Tasigna