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YESCARTA (axicabtagene ciloleucel)

  • Name:

    YESCARTA (axicabtagene ciloleucel)

  • Company:
    info
  • Active Ingredients:

    Axicabtagene Ciloleucel

  • 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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Summary of Product Characteristics last updated on medicines.ie: 29/6/2020
This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions.

Click on this link to Download PDF directly

Gilead Sciences Ltd

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Medicine Name Vosevi 400 mg/100 mg/100 mg film coated tablets Active Ingredients Sofosbuvir, Velpatasvir, Voxilaprevir
Medicine Name YESCARTA (axicabtagene ciloleucel) Active Ingredients Axicabtagene Ciloleucel
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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

    • 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 2 September 2020 Ed-HCP

Reasons for updating

  • Replace document

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 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.