Iclusig 15mg 30mg and 45mg film-coated tablets

  • Name:

    Iclusig 15mg 30mg and 45mg film-coated tablets

  • Company:
    info
  • Active Ingredients:

    Ponatinib hydrochloride

  • Legal Category:

    Product subject to medical prescription which may be renewed (B)

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 13/08/19

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Summary of Product Characteristics last updated on medicines.ie: 13/8/2019
This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions.

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Incyte Biosciences UK Ltd

Incyte Biosciences UK Ltd

Company Products

Medicine NameActive Ingredients
Medicine Name Iclusig 15mg 30mg and 45mg film-coated tablets Active Ingredients Ponatinib hydrochloride
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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 13 August 2019 PIL

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects
  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision

Updated on 13 August 2019 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • 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 be renewed (B)

Free text change information supplied by the pharmaceutical company

· Section 4.4 (Special warnings and precautions for use) addition of a warning regarding Vascular Endothelial Growth Factor (VEGF).

· Section 4.8 (Undesirable effects) addition of a Vascular disorder -unknown side-effect -aneurysms and artery dissections, following PRAC safety signal recommendation on VEGF inhibitors for systemic administration, published on EMA website on 06 August 2019.

· Section 4.8 Reporting of suspected adverse reactions – change of address for Ireland (appendix V update)

· Section 10 (Date of Revision of the text) updated to 06 August 2019

Updated on 28 September 2018 PIL

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 27 September 2018 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

· Section 4.4 (Special warnings and precautions for use) addition of a warning regarding Posterior Reversible Encephalopathy Syndrome (PRES).

· Section 4.8 (Undesirable effects) addition of a Nervous System Disorders -uncommon side-effect -(PRES), which has been spontaneously reported from post-marketing experience.

· Section 10 (Date of Revision of the text) updated to 20 Sep 2018

 

Updated on 28 June 2018 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

· Section 4.4 (Special warnings and precautions for use) update of phase 2 trial data following conclusion of long term studies.

· Section 4.8 (Undesirable effects) update of frequency data on side effects following conclusion of long term studies.

· Section 5.1 (Pharmacodynamic properties) update of study data results from further 18 months  data following conclusion of long term studies (minimum follow up of 64 months).

​​

Updated on 28 June 2018 PIL

Reasons for updating

  • Change to section 4 - possible side effects

Updated on 11 June 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 be renewed (B)

Free text change information supplied by the pharmaceutical company

· Section 7 (Marketing Authorisation Holder) change of Authorisation Holder from Incyte Biosciences UK Ltd. to Incyte Biosciences Distribution B.V.

· Section 10 (Date of Revision of the text) updated to 05 June 2018.

Updated on 11 June 2018 PIL

Reasons for updating

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

Updated on 16 April 2018 PIL

Reasons for updating

  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Updated on 20 February 2018 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
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 9 - Date of first authorisation/renewal of the authorisation
  • Change to section 10 - Date of revision of the text
  • Change to section 6.6 - Special precautions for disposal and other handling

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

 · Section 4.2 (Posology and method of administration) wording updated to clarify administration advice.

· Section 4.4 (Special warnings and precautions for use) updates in hypertension, congestive heart failure and haemorrhage to clarify advice.

· Section 4.8 (Undesirable effects) clarification of terminology used for adverse reactions and update of Reporting of suspected adverse reactions to include Google Play and Apple App store route of reporting .

· Section 5.1 (Pharmacodynamic Properties) correction of figure in ​table 7.

· Section 6.6 (Special precautions for disposal and other handling) removal of unnecessary handling wording (oral use administration clarified in Section 4.2).

· Section 9 (Date of First Authorisation / Renewal of Authorisation) updated to include date of latest renewal 8 February 2018.

· Section 10 (Date of Revision of the text) updated to 8 February 2018.

 

 

 

Updated on 20 February 2018 PIL

Reasons for updating

  • New PIL for new product

Updated on 20 February 2018 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Product subject to medical prescription which may be renewed (B)

Updated on 20 February 2018 PIL

Reasons for updating

  • Change to section 2 - what you need to know - contraindications
  • Change to section 4 - possible side effects
  • Change to section 4 - how to report a side effect
  • Change to section 5 - how to store or dispose
  • Change to section 6 - what the product contains
  • Change to section 6 - date of revision

Updated on 19 February 2018 SmPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects

Legal category: Product subject to medical prescription which may be renewed (B)

Updated on 31 January 2018 PIL

Reasons for updating

  • Change to section 4 - possible side effects

Updated on 9 October 2017 SmPC

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.2 - Posology and method of administration
  • Change to section 6.5 - Nature and contents of container
  • Change to section 8 - Marketing authorisation number(s)
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Addition of new 30mg strength film-coated tablets to be launched on 1st October 2017.

Details added in:

Section 1 - Name of Medicinal Product,

Section 2 - Qualitative and Quantitative Composition,

Section 3 - Pharmaceutical Form,

Section 4.2 Posology and Method of Administration - updated to clarify instructions for Dose modifications for Myelosuppression (Table 1) and for Pancreatitis and elevation of lipase/amylase(Table 2).

Section 6.5- Nature and Contents of Container,

Section 8 - Marketing Authorisation Number

In Section 10 - Date of Revision of Text updated to 21st September 2017

Updated on 5 October 2017 PIL

Reasons for updating

  • Change to section 3 - dose and frequency
  • Change to section 6 - what the product contains
  • Change to section 6 - what the product looks like and pack contents

Updated on 7 September 2017 SmPC

Reasons for updating

  • Change to section 6.3 - Shelf life
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

  • Section 6.3 (Shelf life) changed from 2 to 3 years.
  • Section 10 (Date of Revision of the text) updated to 04 August 2017.

 

Updated on 9 February 2017 PIL

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 3 - how to take/use
  • Change to section 4 - possible side effects

Updated on 8 February 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 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

  •          Section 4.2 (Posology and method of administration) updates on arterial occlusion and venous thromboembolism.
  •          Section 4.4 (Special warnings and precautions for use) updates in myelosuppression, arterial occlusion, hepatotoxicity, haemorrhage and the addition of venous thromboembolism.
  •          Section 4.8 (Undesirable effects) vascular occlusive events, thromboembolism and various updates to the table 4 list of adverse reactions and clinical data in table 5.
  •          Section 5.1 (Pharmacodynamic Properties) clinical efficacy data on major cytogenetic (MCyR) and molecular (MMR) response affecting  tables 7, 8, 9. Dose reduction and vascular events for CP-CML patients with updated tables 10 and 11.
  •         Section 10 (Date of Revision of the text) updated to 26 January 2017.

Updated on 6 December 2016 PIL

Reasons for updating

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

Updated on 24 November 2016 PIL

Reasons for updating

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

Updated on 24 November 2016 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 be renewed (B)

Free text change information supplied by the pharmaceutical company

 

·         Section 7 (Marketing Authorisation Holder) Update from Ariad Pharma UK Ltd to new MAH - Incyte Biosciences UK Ltd

·          Section 10 (Date of Revision of Text) updated to 09 November 2016

Updated on 25 October 2016 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 5.2 - Pharmacokinetic properties
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

  • Section 4.2 (Posology and Method of Administration)
    Update on dose interruption or discontinuation for the management of Hepatic Toxicity and amendment to the recommendation on Hepatic Impairment
  • Section 4.4 (Special Warnings and Precautions for use):
    Amendment to the recommendation for Hepatic Impairment.
  • Section 5.2 (Pharmacokinetic properties)
    Amendment to the recommendation for Hepatic Impairment.
  • Section 10 (Date of Revision of Text)
    updated to 26 August 2016.

Updated on 20 October 2016 PIL

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 3 - how to take/use
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 19 July 2016 SmPC

Reasons for updating

  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 5.3 - Preclinical safety data
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company



 In Section 4.6 (Fertility, Pregnancy and Lactation) non-clinical data on Fertility has been added
In Section 5.3 (Preclinical safety data) update on carcinogenicity and fertility
In Section 10 (date of revision of text) updated to 21 June 2016

 

Updated on 18 July 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 be renewed (B)

Free text change information supplied by the pharmaceutical company



In Section 4.4 (special warnings and precautions for use) renal artery stenosis has been added as an important adverse reaction for vascular occlusion and hypertension
In Section 4.8 (undesirable effects) renal artery stenosis has been added to the Table of Adverse Reactions under "Vascular disorders" and hypothyroidism has been added to the Table under "Endocrine disorders"
In Section 10 (date of revision of text) updated to 22 March 2016

 

Updated on 18 July 2016 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company



In Section 4.4 (special warnings and precautions for use) information and recommendations on Hepatitis B reactivation has been added
In Section 4.8 (undesirable effects) Hepatitis B reactivation has been added to the description of selected adverse reactions
In Section 10 (date of revision of text) updated to 11 May 2016

Updated on 1 October 2015 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company


  • Section 4.4 - (Special warnings and precautions for use) Information about vascular occlusion, potenial risk associated with permanent visual impairment or vision loss. An Update on an ophthalmic examination.
  • Section 4.8 - (Undesirable effects) Update on hypertensive crisi and  hepatic failure as an adverse reactions.
  • Section 10 (Date of Revision of Text) updated to 18 September 2015

Updated on 30 September 2015 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 8 June 2015 SmPC

Reasons for updating

  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 6.5 - Nature and contents of container
  • Change to section 8 - MA number
  • Change to section 10 - Date of revision of the text
  • Change to section 4.8 - Undesirable effects

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company


  •   Section 4.8 (Undesirable effects) Update on frequency of pneumonia as an adverse reaction.
  • Section 5.1 (Pharmacodynamic Properties) Updated Tables 5, 6, and 7 to reflect data now available from an updated study report (PACE). Correction of figure in Table 10.
  • Section 5.2 (Pharmacokinetics) Updated information on Hepatic Impairment.
  • Section 6.5 (Nature and contents of container) addition of pack size.
  • Section 8 (Marketing Authorisation Number) Addition of authorisation number for new pack size.
  • Section 10 (Date of Revision of Text) updated to 22 April 2015.

Updated on 19 February 2015 SmPC

Reasons for updating

  • Change to section 6.5 - Nature and contents of container
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 10 - Date of revision of the text
  • Change to section 4.2 - Posology and method of administration
  • Change to section 6.4 - Special precautions for storage

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company



·         Section 4.2 (Method of administration), updated to include information on dessicant canister.

·         Section 6.4 (Special precautions for storage) updated to include advice on dessicant canister.

·         Section 6.5 (Nature and contents of container) Addition of dessicant canister to contents of container 

·         Section 6.6 (Special precautions for disposal and other handling) Addition of guidance on handling the dessicant canister

·         Section 10 (Date of Revision of Text) updated to 02 February 2015.

Updated on 6 February 2015 SmPC

Reasons for updating

  • 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 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

  • Section 4.1 (Therapeutic Indications) Reference to sections 4.2 and 4.4 regarding assessment of cardiovascular status and alternative treatment
  • Section 4.2 (Posology), amended guidance to include updated information on cardiovascular risk and dose-related management.
  • Section 4.4 (Warnings) addition of information on risk of vascular occlusive events and warning for congestive heart failure and haemorrhage.
  • Section 4.8 (Undesirable Events) Updated summary of the safety profile  with regard to cardiovascular adverse reactions
  • Section 5.1 (Pharmacodynamic Properties) Updated information on cardiovascular system events and the relationship with dose intensity
  • Section 5.2 (Pharmacokinetics) Updated information on Elimination  
  • Section 10 (Date of Revision of Text) updated to 15 January 2015.

Updated on 13 October 2014 SmPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • 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 be renewed (B)

Free text change information supplied by the pharmaceutical company

· Section 4.8 (Undesirable effects) -  updated frequencies of adverse events in the body text and Tables 3 and 4.

· Section 7 (Market Authorisation Holder)  - change of address.

· Section 10 (Date of Revision of Text)  - updated to 18 September 2014.

Updated on 8 July 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 4.6 - Pregnancy and lactation
  • Change to section 5.2 - Pharmacokinetic properties
  • 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 be renewed (B)

Free text change information supplied by the pharmaceutical company

·         Section 4.2 (Posology), amended guidance for patients with hepatic impairment.

·         Section 4.4 (Warnings) removal of warning on elevated gastric pH and updated warning for hepatic impairment.

·         Section 4.5 (Interactions) Amended information on CYP3A Inhibitors and CYP3A Inducers and removal of information on elevated gastric pH

·         Section 4.6 (Fertility) Updated advice on Contraception

·         Section 5.2 (Pharmacokinetics) Updated information on Absorption, Distribution and Hepatic Impairment

·         Section 6.1  (Excipients) Ingredient has been changed from Macrogol 3000 to Macrogol 4000

·         Section 10 (Date of Revision of Text) updated to 22 May 2014.

 

Updated on 12 March 2014 SmPC

Reasons for updating

  • New SPC for medicines.ie

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

None provided