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Novartis Ireland Limited

Vista Building, Elm Park Business Park, Merrion Road, Dublin 4, Ireland
Telephone: +353 1 2601255
Fax: +353 1 2601263
Medical Information e-mail: medinfo.dublin@novartis.com
Summary of Product Characteristics last updated on medicines.ie: 11/01/2018
SPC Tasigna 150mg Capsules

When a pharmaceutical company changes an SPC or PIL, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

Updated on 11/01/2018 and displayed until Current
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 6.1 - List of excipients
Date of revision of text on the SPC:   15-Nov-2017
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company

Information regarding the Paediatric population has been added to the following Sections of the SmPC: 4.1, 4.2, 4.4, 4.5, 4.6, 4.7, 4.8, 5.1, 5.2
Typographical changes have been added to Sections 2 and 6.1
Updated on 06/06/2017 and displayed until 11/01/2018
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.6 - Special precautions for disposal and other handling
Date of revision of text on the SPC:   30-May-2017
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company



In section 4.2     Posology and method of administration, information has been added on Philadelphia chromosome positive CML patients in chronic phase who have been treated with Tasigna as first-line therapy and who achieved a sustained deep molecular response (MR4.5)

 

In section 4.4 Special warnings and precautions for use, information has been added on Eligibility for discontinuation of treatment & Monitoring of patients who have discontinued therapy

 

In section 4.6     Fertility, pregnancy and lactation addition information has been added on pregancy regarding treatment-free remission (TFR)

 

In Section 4.8  Undesirable effects information on Treatment discontinuation in Ph+ CML patients in chronic phase who have achieved a sustained deep molecular response has been added

 

In Section 5.1     Pharmacodynamic properties,  information has been added on Treatment discontinuation in newly diagnosed Ph+ CML patients in chronic phase who have achieved a sustained deep molecular response

 

Section 6.6          Special precautions for disposal, has been updated

Updated on 13/05/2016 and displayed until 06/06/2017
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
Date of revision of text on the SPC:   12-May-2016
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company



In Section 4.4  Special warnings and precautions for use, information has been added on Hepatitis B reactivation

In Section 4.8 Undesirable effects information has been added on Hepatitis B reactivation

Updated on 22/10/2015 and displayed until 13/05/2016
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 5.1 - Pharmacodynamic properties
Date of revision of text on the SPC:   21-Oct-2015
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company



 

4.2          Posology and method of administration

Admin changes

5.1       Pharmacodynamic properties

Information has been added on MMR rate at 72 Months

 

Updated on 08/07/2015 and displayed until 22/10/2015
Reasons for adding or updating:
  • Change to section 5.3 - Preclinical safety data
Date of revision of text on the SPC:   25-Jun-2015
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company

Section 5.3, Preclinical Safety Data -Has been updated with mouse carcinogenicity results
Updated on 10/06/2015 and displayed until 08/07/2015
Reasons for adding or updating:
  • Change to section 6.5 - Nature and contents of container
  • Change to section 8 - MA number
Date of revision of text on the SPC:   01-Jun-2015
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company



 

Section  6.5 Nature and contents of container

New pack size added

Nature of blisters updated

 

Section  8.           MARKETING AUTHORISATION NUMBER(S)

New number added

Updated on 10/12/2014 and displayed until 10/06/2015
Reasons for adding or updating:
  • Change to section 7 - Marketing authorisation holder
Date of revision of text on the SPC:   08-Dec-2014
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company

In Section 7 the address of MAH Holder has changed.
Updated on 06/08/2014 and displayed until 10/12/2014
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
Date of revision of text on the SPC:   25-Jul-2014
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company



In Section 4.2  Posology and method of administration

Additional information has been added for Patients with cardiac disorders.

In Section 4.4  Special warnings and precautions for use

In Cardiovascular events data has been updated.

For Laboratory tests and monitoring of Blood lipids and Blood glucose data has been updated.

4.5     Interaction with other medicinal products and other forms of interaction

Information on nilotinib and CYP3A4 has been added.

Some typographical changes have been made.

4.8       Undesirable effects

Frequency of some side effects have changed, other side effects have been added of varying frequency.

Reporting of suspected adverse reactions details have been updated to include the new name for IMB (i.e. HPRA).

5.1     Pharmacodynamic properties

Data updated

5.2     Pharmacokinetic properties

Additional information has been provided on Elimination, Linearity/non-linearity and Bioavailability/bioequivalence studies

Updated on 30/04/2014 and displayed until 06/08/2014
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
Date of revision of text on the SPC:   20-Mar-2014
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company



In Section  4.4 Special warnings and precautions for use, information on Fluid retention and oedema and Cardiovascular events has been added.

In Section 4.8 Undesirable effects, “intermittent claudication” has been added as an uncommon vascular disorder.

Updated on 24/01/2014 and displayed until 30/04/2014
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   20-Jan-2014
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company



In Section 4.2 Posology and method of administration, the following has been inserted; Increases in blood glucose levels have been reported with Tasigna therapy (see section 4.4). Blood glucose levels should be assessed prior to initiating Tasigna therapy and as clinically indicated during treatment.

 

 

In Section 4.4 Special warnings and precautions for use; Information has been added on monitoring blood glucose levels.

 

 

In Section 4.6  Fertility, pregnancy and lactation; information on contracetive use has been extended to use highly effective contraception with Tasigna and for up to two weeks after ending treatment along with during treatment.

 

 

In Section 4.8 Undesirable effects, Elevated glucose and Elevated cholesterol (total) have been added to table Grade 3‑4 laboratory abnormalities and the Address in Appendix V has been updated.

Updated on 02/09/2013 and displayed until 24/01/2014
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
Date of revision of text on the SPC:   28-Aug-2013
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company



In Section 4.2 Posology and Method of administration the following information has been added

Increases in serum cholesterol levels have been reported with Tasigna therapy (see section 4.4). Lipid profiles should be assessed prior to initiating Tasigna therapy and as clinically indicated during treatment.

In Section 4.4 Special warnings and precautions for use the following information has been added:

Laboratory tests and monitoring; In a Phase III study in newly diagnosed CML patients, 1.1% of the patients treated with 400 mg nilotinib twice daily showed a Grade 3 4 elevation in cholesterol; no Grade 3 4 elevations were however observed in the 300 mg twice daily dose group. It is recommended that the lipid profile be assessed before initiating treatment with Tasigna and monitored during treatment, as clinically indicated (see section 4.2). If lipid-lowering agents are required, please refer to section 4.5 before initiating treatment since many cholesterol-lowering agents are also metabolised by the CYP3A4 pathway.

In Section 4.8 Undesirable effects the following information has been added:

Guidance on National Reporting of suspected adverse reactions as per Appendix V of the EMA requirements.

Updated on 02/07/2013 and displayed until 02/09/2013
Reasons for adding or updating:
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
Date of revision of text on the SPC:   25-Jun-2013
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company



In Section 4.5 Interaction with other medicinal products and other forms of interaction; Typographical changes have been made.

In Section 4.8 Undesirable effects; The adverse reactions Alopecia and Dry skin have been changed from common to very common. The following common adverse reactions have also been added eosinophilia, hypertriglyceridaemia, dyslipidaemia, depression, angina pectoris, atrioventricular block, blood insulin increased, lipoprotein increased (including very low density and high density).

In Seaction 5.1 Pharmacodynamic properties; Information has been added on Major molecular response at 48 months.

Updated on 24/04/2013 and displayed until 02/07/2013
Reasons for adding or updating:
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 6.3 - Shelf life
Date of revision of text on the SPC:   01-Mar-2013
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company

Sections 4.5 and 5.2 have been updated in relation to interactions and Section 6.3 has been updated to state 3 years from previously stating 2 years for the shelf-life.
Updated on 30/08/2012 and displayed until 24/04/2013
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.1 - List of excipients
Date of revision of text on the SPC:   31-Jul-2012
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company

Update following approval of safety update II-046 for TASIGNA
Updated on 16/05/2011 and displayed until 30/08/2012
Reasons for adding or updating:
  • New SPC for new product
Date of revision of text on the SPC:  
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company

None provided

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Active Ingredients

 
   Nilotinib hydrochloride monohydrate