Jakavi Tablets *

  • Company:

    Novartis Ireland Limited
  • Status:

    Updated
  • Legal Category:

    Product subject to medical prescription which may not be renewed (A)
  • Active Ingredient(s):

    *Additional information is available within the SPC or upon request to the company

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 17 September 2021

File name

Jakavi_REG SPC_PF21-0235_31.08.2021_clean_1631879993.pdf

Reasons for updating

  • Change to section 5.1 - Pharmacodynamic properties

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

Updated on 17 September 2021

File name

Jakavi_REG PRO PIL_PF21-0235_31.08.2021_clean_1631879849.pdf

Reasons for updating

  • Change to section 4 - how to report a side effect
  • Change to marketing authorisation holder

Updated on 12 August 2021

File name

Jakavi_REG SPC_PF21-0195_28.07.2021_clean_1628779035.pdf

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)

Updated on 12 August 2021

File name

Jakavi_REG PIL_PF21-0195_28.07.2021_clean_1628778604.pdf

Reasons for updating

  • Change to section 3 - how to take/use
  • Change to section 6 - manufacturer

Updated on 22 December 2020

File name

Jakavi REG PIL PF20-292 TBI 11 June 2021 clean_1608640910.pdf

Reasons for updating

  • Change to section 4 - possible side effects

Free text change information supplied by the pharmaceutical company

Addition of new possible side effects:

HBV reactivation: Unknown frequency

Pancytopenia: Common frequency

 

Section 4.8: Additional information regarding pancytopenia: Pancytopenia is defined as haemoglobin level <100 g/l, platelet count <100x109/l, and neutrophil count <1.5x109/l (or low

white blood cell count of grade 2 if neutrophil count is missing), simultaneously in the same lab assessment

Updated on 22 December 2020

File name

Jakavi_REG SPC_PF20-292 December 2020 clean_1608640077.pdf

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

Section 4.4 - Following text added: It is recommended to screen for HBV prior to commencing treatment with Jakavi

Section 4.8 - Following AE’s added:

HBV reactivation: Unknown frequency

Pancytopenia: Common frequency

Updated on 04 November 2020

File name

Jakavi REGPIL PF 20-231 clean IPHA_1604507265.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions

Free text change information supplied by the pharmaceutical company

Sodium statement added

Updated on 04 November 2020

File name

Jakavi REG SPC PF20-231 October 2020 clean IPHA_1604506805.pdf

Reasons for updating

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

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

Free text change information supplied by the pharmaceutical company

Addition of sodium statement

Updated on 12 August 2020

File name

Jakavi REG SPC PF20-154 June 2020_clean_unsigned_1597244470.pdf

Reasons for updating

  • 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

Updates to Section 4.8 and 5.1 with efficacy and safety information to reflect the 5-year follow-up data from the RESPONSE study B2301

Updated on 12 August 2020

File name

Jakavi REG PIL PF20-154 June 2020 clean_1597244297.pdf

Reasons for updating

  • Change to section 4 - possible side effects

Free text change information supplied by the pharmaceutical company

Change in frequency of the following side effects from "Common" to "Very Common":

  • vomiting blood
  • fever, cough, difficult or painful breathing, wheezing, pain in chest when breathing (possible symptoms of pneumonia)
  • high blood pressure (hypertension), which may also be the cause of dizziness and headaches
  • constipation
  • high level of lipase in the blood

Updated on 05 May 2020

File name

Jakavi REG SPC PF20-090 March 2020_clean_unsigned_1588670881.pdf

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

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

Free text change information supplied by the pharmaceutical company

Include in Section 4.4 that concommitant use with cytoreductive therapies is associated with mangeable cytopenia.

Updated on 04 February 2020

File name

Jakavi REG PIL PF20-015 clean IPHA_1580814076.pdf

Reasons for updating

  • Change to section 6 - manufacturer

Updated on 28 November 2019

File name

Jakavi REG PIL PF18-136 August 2018_1574955368.pdf

Reasons for updating

  • Improved presentation of PIL

Updated on 10 July 2019

File name

Jakavi REG SPC PF19-106 & 19-107 May 2019_clean IPHA_1562752722.pdf

Reasons for updating

  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • 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

Update of section 4.5 based on final results from the DDI study INC4242A2106 (fluconazole/ruxolitinib)

Update of section 5.3 based on final results from the juvenile toxicity studies 1570143 (dose range finding juvenile study) and 157014 (juvenile development study)

 

Updated on 02 April 2019

File name

Jakavi REG SPC PF18-136 May 2018_cleanIPHA_1554199883.pdf

Reasons for updating

  • File format updated to PDF

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

Updated on 23 August 2018

File name

Jakavi REG PIL 2213649 PF18-136 TBI 30 March 2019 IPHA_1535021915.pdf

Reasons for updating

  • Change to section 6 - marketing authorisation holder

Updated on 05 June 2018

File name

JakaviREGSPCPF18-136May 2018_clean.docx

Reasons for updating

  • Change to section 7 - Marketing authorisation holder

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

Updated on 07 February 2018

File name

PIL_16074_319.pdf

Reasons for updating

  • New PIL for new product

Updated on 07 February 2018

Reasons for updating

  • Change to section 3 - how to take/use
  • Change to section 4 - possible side effects

Updated on 02 January 2018

Reasons for updating

  • New SPC for new product

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

Updated on 02 January 2018

Reasons for updating

  • 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

·         Section 4.8: Addition of “pneumonia” as a common ADR in MF patients.

Updated on 16 August 2017

Reasons for updating

  • Change to section 3 - use in children/adolescents
  • Removal of black triangle

Updated on 23 May 2017

Reasons for updating

  • 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

Sepsis added as an ADR. Also SmPC updated with new data from RESPONSE and RESPONSE 2

Updated on 24 January 2017

Reasons for updating

  • 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

Inclusion of 5 year data from COMFORT clinical trials

Updated on 11 January 2017

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions

Updated on 29 November 2016

Reasons for updating

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

Section 4.4: A warning on opportunistic infections added to section 4.4

Section 4.4: Addition of information about increases in lipid parameters and a recommendation to monitor lipid levels and treat dyslipidaemia according to clinical guidelines.

Section 5.1: Addition of further clinical data for the RESPONSE trial

Updated on 14 September 2016

Reasons for updating

  • Deletion of a pack size

Updated on 09 August 2016

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction

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

Free text change information supplied by the pharmaceutical company

The statement “Avoid the concomitant use of Jakavi with fluconazole doses greater than 200 mg daily” was added to SmPC Section 4.2 and 4.5. 

 

 

Updated on 21 July 2016

Reasons for updating

  • Change to section 6.3 - Shelf life
  • Change to section 6.5 - Nature and contents of container

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

Free text change information supplied by the pharmaceutical company

Shelf life increased from 2 years to 3 years for tablets in blisters.
Bottle presentation deregistered.

Updated on 04 November 2015

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • 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)

Free text change information supplied by the pharmaceutical company

In Section 4.4 reference has been made to non-melanoma skin cancers including basal cell, squamous cell and Merkel cell carcinomas.
The address of the MAH has been updated to Frimley from Horsham.
Date of revision of text has been updated to October 2015.

Updated on 14 April 2015

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • 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 4.1 Therapeutic indications; Polycythaemia vera (PV) has been added as an indication.

 

In Section 4.2 Posology and method of administration; Information on dosing and Special Populations has changed reflecting the new indication (PV)

 

In section 4.8 Undesirable effects; section has been updated to include information on PV

In Section 5.1 Pharmacodynamic properties; Information has been updated

 

Updated on 23 January 2015

Reasons for updating

  • Introduction of new strength

Updated on 24 September 2014

Reasons for updating

  • 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

Update to Section 5.1 for survival dta for 3 years.

Updated on 19 August 2014

Reasons for updating

  • New PIL for medicines.ie

Updated on 17 December 2013

Reasons for updating

  • Addition of black triangle
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 6.5 - Nature and contents of container
  • 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

The black triangle has been introduced to this SPC as it is subject to additional monitoring.
Section 4.8 includes details in relation to the reporting of side effects.
Blister strips have been introduced for this product in addition to bottles.

Updated on 26 August 2013

Reasons for updating

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

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

Free text change information supplied by the pharmaceutical company

Update to Section 4.4 in relation to PML.

Updated on 19 April 2013

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