YESCARTA (axicabtagene ciloleucel)

Product Information *

  • Company:

    Gilead Sciences Ltd
  • Status:

    No Recent Update
  • Active Ingredients :

    This medicinal product is subject to additional monitoring.

    *Additional information is available upon request

  • Legal Category:

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

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 25 May 2021

File name

Yescarta PIL -April 2021_1621930894.pdf

Reasons for updating

  • Change to Section 1 - what the product is
  • Change to section 3 - how to take/use
  • Change to section 5 - how to store or dispose
  • Change to other sources of information section

Updated on 24 May 2021

File name

Yescarta SmPC XI&IE (April 2021)_1621877579.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)

EDM Updated on 02 September 2020

File name

Yescarta_HCP Educational Guide Ireland_version3_1599059144.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.

EDM Updated on 02 September 2020

File name

Yescarta_Handling Guide Ireland_version3_1599059144.pdf

Reasons for updating

  • Replace File

Free text change information supplied by the pharmaceutical company

    • 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.

    • Addition of the Sampling recommendations for secondary malignancies section

These changes were made to add recommendations for additional testing in case of secondary malignancy.

    • 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

File name

Yescarta PIL - JUNE 2020_1593428178.pdf

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

File name

Yescarta SmPC - JUNE 2020_1593427790.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_1590051569.pdf

Reasons for updating

  • Change to section 6 - manufacturer

Updated on 24 January 2020

File name

Yescarta PIL - JANUARY 2020_1579871073.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_1579870972.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_1576512917.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_1576512719.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.

EDM Updated on 14 October 2019

File name

YESCARTA_HCP Educational Guide_Ireland-YES-UK-18-07-MM-1145(1)-version2_1571066211.pdf

Reasons for updating

  • Replace File

EDM Updated on 14 October 2019

File name

YESCARTA_Handling Guide_Ireland_YES-UK-18-07-MM-1147(1)-version2_1571066189.pdf

Reasons for updating

  • Replace File

Updated on 05 June 2019

File name

Yescarta PIL - APRIL 2019_1559739694.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_1559738717.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)

EDM Updated on 13 May 2019

File name

YESCARTA_Patient Alert Card_Ireland - YES-UK-18-07-MM-1146_1557760060.pdf

Reasons for updating

  • Add New Doc

Free text change information supplied by the pharmaceutical company

Add New Doc

EDM Updated on 13 May 2019

File name

YESCARTA_Handling Guide_Ireland - YES-UK-18-07-MM-1147_1557760060.pdf

Reasons for updating

  • Add New Doc

Free text change information supplied by the pharmaceutical company

Add New Doc

EDM Updated on 13 May 2019

File name

YESCARTA_HCP educational guide_Ireland - YES-UK-18-07-MM-1145_1545647653.pdf

Reasons for updating

  • Add New Doc

Updated on 14 November 2018

File name

Yescarta PIL - Sept 2018_1542130109.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_1535391709.pdf

Reasons for updating

  • New PIL for new product

Updated on 27 August 2018

File name

Yescarta SmPC - August 2018_1535391660.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.