YESCARTA (axicabtagene ciloleucel)
- Name:
YESCARTA (axicabtagene ciloleucel)
- Company:
Gilead Sciences Ltd
- 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: 29/06/20
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Gilead Sciences Ltd
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 2 September 2020 Ed-HCP
Reasons for updating
- Replace document
Free text change information supplied by the pharmaceutical company
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- 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.
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- 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.
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- 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.
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- Changes in the reporting of adverse reactions
These changes were made to clarify and emphasize the importance of spontaneous reporting.
Updated on 2 September 2020 Ed-HCP
Reasons for updating
- Replace document
Free text change information supplied by the pharmaceutical company
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- Changes in the guide to handling and method of administration
These changes were made to facilitate the administration of Yescarta while having a single dose per patient of tocilizumab on site, and access to an additional dose within 8 hours of each previous dose. Additional changes were made with regards to wording on GMO requirements.
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- Addition of the Sampling recommendations for secondary malignancies section
These changes were made to add recommendations for additional testing in case of secondary malignancy.
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- Change to the format to a Roll Fold format
The change in format was made to accommodate the addition of the new section on Sampling recommendations for secondary malignancies section.
Updated on 29 June 2020 PIL
Reasons for updating
- Change to section 3 - how to take/use
- Change to section 5 - how to store or dispose
- Change to section 6 - date of revision
- Change to information for healthcare professionals
- Improved presentation of PIL
Updated on 29 June 2020 SPC
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 PIL
Reasons for updating
- Change to section 6 - manufacturer
Updated on 24 January 2020 PIL
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 24 January 2020 SPC
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 PIL
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 SPC
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.
Updated on 14 October 2019 Ed-HCP
Reasons for updating
- Replace document
Updated on 14 October 2019 Ed-HCP
Reasons for updating
- Replace document
Updated on 5 June 2019 PIL
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 5 June 2019 SPC
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)
Updated on 13 May 2019 Ed-Ptnt
Reasons for updating
- Add New Doc
Free text change information supplied by the pharmaceutical company
Add New Doc
Updated on 13 May 2019 Ed-HCP
Reasons for updating
- Add New Doc
Free text change information supplied by the pharmaceutical company
Add New Doc
Updated on 13 May 2019 Ed-HCP
Reasons for updating
- Add New Doc
Updated on 14 November 2018 PIL
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 28 August 2018 PIL
Reasons for updating
- New PIL for new product
Updated on 27 August 2018 SPC
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.
YESCARTA GUIDE TO HANDLING & METHOD OF ADMIN.Risk Minimisation Materials
(Click to Download)YESCARTA HCP EDUCATIONAL GUIDERisk Minimisation Materials
(Click to Download)
Educational Materials for Medicines
Educational Materials for Medicines
YESCARTA PATIENT ALERT CARDRisk Minimisation Materials
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Educational Materials for Medicines
Educational Materials for Medicines