YESCARTA (axicabtagene ciloleucel)
*Company:
Gilead Sciences LtdStatus:
No Recent UpdateLegal Category:
Product subject to medical prescription which may not be renewed (A)Active Ingredient(s):
This medicinal product is subject to additional monitoring.
*Additional information is available within the SPC or upon request to the company
Updated on 22 August 2024
File name
Yescarta IE&XI SmPC (July 2024).pdf
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 not be renewed (A)
Updated on 22 August 2024
File name
Yescarta IE&XI PIL (July 2024).pdf
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 28 May 2024
File name
Yescarta IE&XI SmPC (May 2024).pdf
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 5.1 - Pharmacodynamic properties
- Change to section 6.3 - Shelf life
- 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)
Updated on 28 May 2024
File name
Yescarta IE&XI PIL (May 2024).pdf
Reasons for updating
- Change to Section 1 - what the product is
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 2 - driving and using machines
- Change to section 3 - how to take/use
Updated on 06 March 2024
File name
Yescarta IE&XI SmPC (Jan 2024).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)
Updated on 06 March 2024
File name
Yescarta IE&XI PIL (Jan 2024).pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
Updated on 17 January 2024
File name
Yescarta IE&XI PIL (December 2023).pdf
Reasons for updating
- Change to section 4 - possible side effects
Updated on 17 January 2024
File name
Yescarta IE&XI SmPC (December 2023).pdf
Reasons for updating
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 14 December 2023
File name
Yescarta IE&UK SmPC (November 2023).pdf
Reasons for updating
- 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 not be renewed (A)
Updated on 14 December 2023
File name
Yescarta IE&XI PIL (July 2023).pdf
Reasons for updating
- New PIL for new product
Updated on 01 August 2023
File name
Yescarta IE&XI SmPC (July 2023).pdf
Reasons for updating
- Correction of spelling/typing errors
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 31 July 2023
File name
Yescarta IE&XI SmPC (July 2023).pdf
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 4.8 - Undesirable effects
- Change to section 4.9 - Overdose
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 6.4 - Special precautions for storage
- Change to section 6.6 - Special precautions for disposal and other handling
- Change to section 9 - Date of first authorisation/renewal of the authorisation
Legal category:Product subject to medical prescription which may not be renewed (A)
File name
Combined Yescarta-Tecartus HCP Educational Material_Feb-2023_Ireland.pdf
Reasons for updating
- Replace File
File name
Combined Yescarta-Tecartus Patient Alert Card_Feb2023_Ireland.pdf
Reasons for updating
- Replace File
Updated on 24 October 2022
File name
Yescarta IE&XI SmPC (October 2022).pdf
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- Change to section 4.2 - Posology and method of administration
- Change to section 4.3 - Contraindications
- 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 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 6.1 - List of excipients
- Change to section 6.3 - Shelf life
- Change to section 6.4 - Special precautions for storage
- Change to section 6.6 - Special precautions for disposal and other handling
- 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
Approval of extension of indication to include use of Yescarta in adult patients with diffuse large B cell lymphoma (DLBCL) and high-grade B-cell lymphoma (HGBL) that relapses within 12 months from completion of, or is refractory to, first-line chemoimmunotherapy.
The variation updates the product information extensively as follows:
- SmPC updates to sections 4.1, 4.2, 4.3, 4.4, 4.5, 4.8, 5.1, 5.2, 6.1. 6.3 , 6.4, and 6.6
- Consequential updates to the Package Leaflet sections 1, 2, 3, 4, and 5
Updated on 26 August 2022
File name
Yescarta IE&XI SmPC (August 2022).pdf
Reasons for updating
- 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 not be renewed (A)
Updated on 01 July 2022
File name
Yescarta SmPC IE&XI (June 2022).pdf
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- Change to section 4.8 - Undesirable effects
- 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)
File name
Combined HCP Educational Guide Ireland_Feb22.pdf
Reasons for updating
- Replace File
Free text change information supplied by the pharmaceutical company
Update so that CAR-T cell-based therapies can be used in the EU/EEA also during confirmed tocilizumab shortages by treating physicians who consider that alternative suitable treatments for CRS can be used and such treatments are made available to manage this adverse reaction associated with CAR-T cell-based therapies use.
Updated on 27 January 2022
File name
Yescarta SmPC XI&IE (Jan 2022).pdf
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 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
File name
Combined HCP Educational Guide Ireland.pdf
Reasons for updating
- Replace File
Free text change information supplied by the pharmaceutical company
Kite Pharma EU B.V., has a responsibility to inform Healthcare Professionals on important safety information related to its medicines:
• Axicabtagene ciloleucel
• Autologous anti CD19 transduced CD3+ cells
To uphold this responsibility, Kite has taken the decision to combine the risk minimisation materials for both products.
The combined version of HCP Educational Guide includes the following updates:
• Introduction of language related to Autologous anti CD19 transduced CD3+ cells
• Removal of the use of the Glasgow Coma Score and replacing with the measure of cognition and level of consciousness for supportive care in the management of Grade 2 Neurologic adverse reaction. Inclusion of levetiracetam for supportive care for the management of grade 2 Neurologic adverse reaction.
• Removal of the 3-day taper of corticosteroids for Grades 2, 3 and 4 adverse reactions in the neurotoxicity and CRS management guidance to now simply “Taper of corticosteroids”. This is to allow health care providers to taper based on the individual needs of each patient. The removal of the number of days is based on clinical practice/experience with Yescarta and aligns with the neurotoxicity management guidance approved for Tecartus.
• Administration of dexamethasone for management of grade 3 and 4 neurotoxicity with concurrent CRS no longer needs to be concomitant to administration with first dose of tocilizumab.
• Addition of discontinuation of tocilizumab for the management of grade 2 CRS and grade 2 neurotoxicity with concurrent CRS if symptoms improve.
• Update section 5: Important points to consider before you administer Yescarta or Tecartus with the following texts:
o As a part of the qualification process, HCPs will be trained on the Risk Minimisation Materials; the treatment centre is responsible for ensuring training of appropriate personnel.
o The aim of the registry is to collect long-term data for Yescarta and Tecartus. Such data is important to further understand the benefit/risk for these products.
o The inclusion of data in the registry does not replace the obligation to spontaneously report adverse events through through Safety_FC@gilead.com or telephone +44 (0) 1223 897500.
• Update Section 7: Guidance on managing neurologic adverse reactions with the following texts:
o Most patients recovered from neurologic adverse reactions, with the exception of four patients that died of other causes prior to resolution of their neurologic adverse reactions
• Improvements in readability
File name
Combined Patient Alert Card Ireland.pdf
Reasons for updating
- Replace File
Free text change information supplied by the pharmaceutical company
Kite Pharma EU B.V., has a responsibility to inform Healthcare Professionals on important safety information related to its medicines:
• Axicabtagene ciloleucel
• Autologous anti CD19 transduced CD3+ cells
To uphold this responsibility, Kite has taken the decision to combine the risk minimisation materials for both products.
The combined version of patient alert card includes updates for the introduction of language related to Autologous anti CD19 transduced CD3+ cells and inclusion of free text for HCP to write the name of product infused, product batch number.
Updated on 24 May 2021
File name
Yescarta SmPC XI&IE (April 2021).pdf
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 5.1 - 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)
File name
Yescarta_HCP Educational Guide Ireland_version3.pdf
Reasons for updating
- Replace File
Free text change information supplied by the pharmaceutical company
-
- Changes in important points to consider before you administer Yescarta
These changes are made to facilitate the administration of Yescarta to seriously ill patients with r/r Non-Hodgkin lymphoma while having a single dose of tocilizumab per patient on site, and access to an additional dose within 8 hours of each previous dose.
-
- Changes in the categories of CRS severity and management
These changes were made to provide flexibility to the HCP in the management of Grade 2 CRS.
-
- Changes in the guidance on managing neurologic adverse reactions
These changes were made to add 3 new neurologic adverse reactions reported in clinical trials and a new neurologic adverse reaction reported in the post-marketing setting.
-
- Changes in the reporting of adverse reactions
These changes were made to clarify and emphasize the importance of spontaneous reporting.
Updated on 29 June 2020
File name
Yescarta SmPC - JUNE 2020.pdf
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 6.6 - Special precautions for disposal and other handling
- Change to section 10 - Date of revision of the text
- Improved presentation of SPC
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 21 May 2020
File name
Yescarta PIL - MAY 2020.pdf
Reasons for updating
- Change to section 6 - manufacturer
Updated on 24 January 2020
File name
Yescarta PIL - JANUARY 2020.pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 24 January 2020
File name
Yescarta SmPC - JANUARY 2020.pdf
Reasons for updating
- 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 not be renewed (A)
Updated on 16 December 2019
File name
Yescarta PIL - DECEMBER 2019.pdf
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
Type IB - Registration of TCF04 (Hoofddorp, NL) for Day 0 manufacturing and final product importation/batch release
Section 6 of the PIL was updated to include the new Kite Pharma EU B.V. manufacturing facility, TCF04 (Hoofddorp, The Netherlands) as an additional manufacturing site responsible for batch release.
Updated on 16 December 2019
File name
Yescarta SmPC - DECEMBER 2019.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- 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
Type IB - Registration of TCF04 (Hoofddorp, NL) for Day 0 manufacturing and final product importation/batch release
Update to section Section 4.4 - Traceability
In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.
File name
YESCARTA_HCP Educational Guide_Ireland-YES-UK-18-07-MM-1145(1)-version2.pdf
Reasons for updating
- Replace File
Updated on 05 June 2019
File name
Yescarta PIL - APRIL 2019.pdf
Reasons for updating
- Change to Section 1 - what the product is
- Change to section 3 - how to take/use
- Change to section 4 - possible side effects
- Change to information for healthcare professionals
Updated on 05 June 2019
File name
Yescarta SmPC - APRIL 2019.pdf
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.2 - Posology and method of administration
- Change to section 4.3 - Contraindications
- 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 5.3 - Preclinical safety data
- Change to section 6.3 - Shelf life
- Change to section 6.4 - Special precautions for storage
- Change to section 6.6 - Special precautions for disposal and other handling
- Change to section 9 - Date of first authorisation/renewal of the authorisation
Legal category:Product subject to medical prescription which may not be renewed (A)
File name
YESCARTA_Patient Alert Card_Ireland - YES-UK-18-07-MM-1146.pdf
Reasons for updating
- Add New Doc
Free text change information supplied by the pharmaceutical company
Add New Doc
File name
YESCARTA_HCP educational guide_Ireland - YES-UK-18-07-MM-1145.pdf
Reasons for updating
- Add New Doc
Updated on 14 November 2018
File name
Yescarta PIL - Sept 2018.pdf
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 28 August 2018
File name
Yescarta PIL - August 2018.pdf
Reasons for updating
- New PIL for new product
Updated on 27 August 2018
File name
Yescarta SmPC - August 2018.pdf
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
New SmPC for new product.