Tasigna 150mg Capsules

  • Name:

    Tasigna 150mg Capsules

  • Company:
    info
  • Active Ingredients:

    Nilotinib hydrochloride monohydrate

  • Legal Category:

    Product subject to medical prescription which may not be renewed (A)

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 26/11/19

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Summary of Product Characteristics last updated on medicines.ie: 26/11/2019

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Novartis Ireland Limited

Novartis Ireland Limited

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1 - 0 of 115 items.Total: Infinity pages

When a pharmaceutical company changes any document, 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 26 November 2019 PIL

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects

Updated on 26 November 2019 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 6 September 2018 SmPC

Reasons for updating

  • 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 6.1 - List of excipients
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 5 September 2018 PIL

Reasons for updating

  • Change to section 6 - date of revision
  • Change to marketing authorisation holder

Updated on 14 May 2018 SmPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 9 May 2018 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 24 April 2018 PIL

Reasons for updating

  • Change to section 1 - what the product is used for
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - use in children and adolescents
  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 2 - driving and using machines
  • Change to section 3 - dose and frequency
  • Change to section 3 - use in children/adolescents
  • Change to section 4 - possible side effects
  • Change to section 6 - what the product contains
  • Change to section 6 - marketing authorisation holder

Updated on 11 January 2018 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 11 January 2018 SmPC

Reasons for 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

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 21 July 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 21 July 2017 PIL

Reasons for updating

  • Change to section 1 - what the product is used for
  • Change to section 3 - duration of treatment
  • Change to section 4 - possible side effects

Updated on 6 June 2017 SmPC

Reasons for 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

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 22 June 2016 PIL

Reasons for updating

  • Change to warnings or special precautions for use

Updated on 19 May 2016 PIL

Reasons for updating

  • Change to warnings or special precautions for use

Updated on 13 May 2016 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects

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 October 2015 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 5.1 - Pharmacodynamic properties

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 17 August 2015 PIL

Reasons for updating

  • Introduction of new pack/pack size

Updated on 8 July 2015 SmPC

Reasons for updating

  • Change to section 5.3 - Preclinical safety data

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 June 2015 SmPC

Reasons for updating

  • Change to section 6.5 - Nature and contents of container
  • Change to section 8 - MA number

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 22 April 2015 PIL

Reasons for updating

  • Change to MA holder contact details

Updated on 10 December 2014 SmPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder

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 10 December 2014 PIL

Reasons for updating

  • Change to side-effects

Updated on 6 August 2014 SmPC

Reasons for 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

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 17 June 2014 PIL

Reasons for updating

  • Change to warnings or special precautions for use

Updated on 30 April 2014 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects

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 23 April 2014 PIL

Reasons for updating

  • Change to warnings or special precautions for use

Updated on 24 January 2014 SmPC

Reasons for 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

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 25 November 2013 PIL

Reasons for updating

  • Change to warnings or special precautions for use

Updated on 2 September 2013 SmPC

Reasons for 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

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 2 July 2013 SmPC

Reasons for 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

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 April 2013 SmPC

Reasons for 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

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 23 April 2013 PIL

Reasons for updating

  • Change to drug interactions
  • Change to date of revision

Updated on 20 September 2012 PIL

Reasons for updating

  • Change to, or new use for medicine
  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to dosage and administration

Updated on 30 August 2012 SmPC

Reasons for 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

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 30 August 2011 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 16 May 2011 SmPC

Reasons for updating

  • New SPC for new product

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

None provided