Jakavi Tablets
- Name:
Jakavi Tablets
- Company:
Novartis Ireland Limited
- Active Ingredients:
- Legal Category:
Product subject to medical prescription which may not be renewed (A)
Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 22/12/20
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Novartis Ireland Limited
Company Products
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 22 December 2020 PIL
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 SPC
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 4 November 2020 PIL
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 4 November 2020 SPC
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 SPC
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 PIL
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 5 May 2020 SPC
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 4 February 2020 PIL
Reasons for updating
- Change to section 6 - manufacturer
Updated on 28 November 2019 PIL
Reasons for updating
- Improved presentation of PIL
Updated on 10 July 2019 SPC
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 2 April 2019 SPC
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 PIL
Reasons for updating
- Change to section 6 - marketing authorisation holder
Updated on 5 June 2018 SPC
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 7 February 2018 PIL
Reasons for updating
- New PIL for new product
Updated on 7 February 2018 PIL
Reasons for updating
- Change to section 3 - how to take/use
- Change to section 4 - possible side effects
Updated on 2 January 2018 SPC
Reasons for updating
- New SPC for new product
Legal category: Product subject to medical prescription which may not be renewed (A)
Updated on 2 January 2018 SPC
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 PIL
Reasons for updating
- Change to section 3 - use in children/adolescents
- Removal of black triangle
Updated on 23 May 2017 SPC
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
Updated on 24 January 2017 SPC
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
Updated on 11 January 2017 PIL
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
Updated on 29 November 2016 SPC
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 PIL
Reasons for updating
- Deletion of a pack size
Updated on 9 August 2016 SPC
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 SPC
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
Bottle presentation deregistered.
Updated on 4 November 2015 SPC
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
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 SPC
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 PIL
Reasons for updating
- Introduction of new strength
Updated on 24 September 2014 SPC
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
Updated on 19 August 2014 PIL
Reasons for updating
- New PIL for medicines.ie
Updated on 17 December 2013 SPC
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
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 SPC
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
Updated on 19 April 2013 SPC
Reasons for updating
- New SPC for new product
Legal category: Product subject to medical prescription which may not be renewed (A)