Zydelig (idelalisib) 100mg

*
Pharmacy Only: Prescription
  • Company:

    Gilead Sciences Ltd
  • Status:

    No Recent Update
  • Legal Category:

    Product subject to medical prescription which may not be renewed (A)
  • Active Ingredient(s):

    *Additional information is available within the SPC or upon request to the company

Updated on 30 June 2023

File name

Zydelig NI & Ireland 100mg_PIL - June 2023.pdf

Reasons for updating

  • Change to section 6 - marketing authorisation holder

Updated on 09 February 2023

File name

Zydelig NI Ireland 100 mg-SmPC Sept 2021.pdf

Reasons for updating

  • Document format updated

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

Updated on 12 October 2021

File name

Zydelig NI Ireland 100 mg-SmPC Sept 2021.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)

Free text change information supplied by the pharmaceutical company

The ATC code has changed

Updated on 21 April 2021

File name

Zydelig NI & Ireland 100mg_PIL - April 2021.pdf

Reasons for updating

  • Change to other sources of information section

Free text change information supplied by the pharmaceutical company

Article 61(3) Notification - QRD template 10.2

EU Zydelig package leaflet updated and aligned to the most recent QRD template to specify Northern Ireland in the list of local representatives at the end of the package leaflet following Brexit

Updated on 22 October 2020

File name

Zydelig UK (Ireland and Malta) - SmPC 100mg - October 2020.pdf

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

Addition of ‘drug reaction with eosinophilia and systemic symptoms (DRESS)’ to SmPC sections 4.4, and 4.8; and to PIL sections 3 and 4, in annexes for both strengths of Zydelig 100mg and 150mg. This update was done following a safety signal review and PRAC recommendation to update the Product Annexes accordingly.

Updated on 22 October 2020

File name

Zydelig UK (Ireland and Malta) PIL - 100mg - October 2020.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects

Free text change information supplied by the pharmaceutical company

Addition of ‘drug reaction with eosinophilia and systemic symptoms (DRESS)’ to SmPC sections 4.4, and 4.8; and to PIL sections 3 and 4, in annexes for both strengths of Zydelig 100mg and 150mg. This update was done following a safety signal review and PRAC recommendation to update the Product Annexes accordingly.

Updated on 18 May 2020

File name

Zydelig UK (Ireland, Malta) - PIL 100mg - November 2019.pdf

Reasons for updating

  • Change to section 1 - what the product is used for
  • Change to section 6 - date of revision
  • Removal of Black Inverted Triangle

Updated on 16 December 2019

File name

Zydelig UK (Ireland, Malta) - SmPC 100mg - November 2019.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 10 - Date of revision of the text
  • Removal of Black Inverted Triangle

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

Free text change information supplied by the pharmaceutical company

Submission of the final clinical study report for study 101-09, A Phase 2 Study to Assess the Efficacy and Safety of Idelalisib in Subjects with Indolent B-Cell Non-Hodgkin Lymphomas Refractory to Rituximab and Alkylating Agents. This submission was an Annex II post-authorisation measure (ANX 002) and a category I commitment in the Zydelig Risk Management Plan (RMP).

The SmPC was updated to include the safety and efficacy data from Study 101-09 and the SmPC and PIL were updated to remove the inverted black triangle and requirement for additional monitoring as this submission fulfilled the last outstanding commitment in the Product Information Annex II.

We also took the opportunity to remove ofatumumab from the SmPC and PIL indication statement following the withdrawal of the Arzerra (ofatutumumab) licence in the EU.

Updated on 16 December 2019

File name

Zydelig UK (Ireland and Malta) - PIL 100mg - April 2019.pdf

Reasons for updating

  • Change to section 1 - what the product is used for
  • Change to section 6 - date of revision
  • Removal of Black Inverted Triangle

Free text change information supplied by the pharmaceutical company

Submission of the final clinical study report for study 101-09, A Phase 2 Study to Assess the Efficacy and Safety of Idelalisib in Subjects with Indolent B-Cell Non-Hodgkin Lymphomas Refractory to Rituximab and Alkylating Agents. This submission was an Annex II post-authorisation measure (ANX 002) and a category I commitment in the Zydelig Risk Management Plan (RMP).

The SmPC was updated to include the safety and efficacy data from Study 101-09 and the SmPC and PIL were updated to remove the inverted black triangle and requirement for additional monitoring as this submission fulfilled the last outstanding commitment in the Product Information Annex II.

We also took the opportunity to remove ofatumumab from the SmPC and PIL indication statement following the withdrawal of the Arzerra (ofatutumumab) licence in the EU.

Updated on 13 May 2019

File name

Zydelig UK (Ireland and Malta) - PIL 100mg - April 2019.pdf

Reasons for updating

  • Change to Section 1 - what the product is
  • Change to section 6 - what the product contains
  • Change to section 6 - date of revision

Updated on 13 May 2019

File name

Zydelig UK (Ireland and Malta) - SmPC 100mg - April 2019.pdf

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.6 - Pregnancy and lactation
  • 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)

Free text change information supplied by the pharmaceutical company

Following the submission of the Zydelig five year renewal application, the CHMP, based on the review of data on quality, safety and efficacy, including all variations introduced since the marketing authorisation was granted, the benefit-risk balance of Zydelig in its approved indication(s) remains favourable and therefore recommends the renewal of the marketing authorization for another five years.

 

A number of administrative and formatting changes have been made to the SmPC and PIL following a detailed review of the product information annexes by the EMA QRD group, as part of the renewal procedure.

Updated on 26 June 2018

File name

Zydelig-UK-SmPC-100mg-June-2018.docx

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 26 June 2018

File name

Zydelig UK (Ireland and Malta) PIL 100mg - June 2018.pdf

Reasons for updating

  • Change to section 6 - marketing authorisation holder

Updated on 21 May 2018

File name

Zydelig-SmPC-100mg-April-2018.docx

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 08 May 2018

File name

Zydelig UK (Ireland and Malta) PIL 100mg - April 2018.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions

Updated on 16 March 2018

Reasons for updating

  • New SPC for new product

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

Updated on 16 March 2018

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 4.8 - Undesirable effects

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

Free text change information supplied by the pharmaceutical company

$0SPC$0$0·Sections 4.2, 4.4, and 4.8 updated to include safety informationregarding organising pneumonia.$0

Updated on 15 March 2018

File name

PIL_16103_215.pdf

Reasons for updating

  • New PIL for new product

Updated on 15 March 2018

Reasons for updating

  • Change to other sources of information section

Updated on 27 February 2018

Reasons for updating

  • Change to section 6 - date of revision

Updated on 23 February 2018

Reasons for updating

  • Change to section 6 - date of revision

Updated on 29 January 2018

Reasons for updating

  • 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

SmPC

·        Update to section 5.3 – description of carcinogenicity preclinical safety data

Updated on 30 November 2017

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • 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

SmPC

•           Update to section 4.4 – description of hepatotoxicity warning

•             Update to section 4.8 – addition of lymphocytosis and hepatocellular injury respectively as ‘very common’ and ‘common’ adverse reactions

•             Update to section 5.1 – description of drug-induced lymphocytosis PD effect

Updated on 28 November 2017

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects

Updated on 17 August 2017

Reasons for updating

  • Change to section 6.3 - Shelf life

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

Free text change information supplied by the pharmaceutical company

Update to section 6.3 – shelf life extended from 4 years to 5 years.

Updated on 19 December 2016

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

Section 5.1: updated to detail that no mechanistic explanations for the development of resistance to idelalisib treatment have been identified.

Updated on 29 November 2016

Reasons for updating

  • Change to section 6.3 - Shelf life

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

Free text change information supplied by the pharmaceutical company

  • To extend the shelf life of Zydelig from 36 to 48 months

Updated on 03 October 2016

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 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

$0·Section 4.1 updatedwith extended CLL indication. Sections 4.8 and 5.1 updated to include safetyand efficacy data from Study GS-US-312-0119.  $0

Updated on 26 September 2016

Reasons for updating

  • Change to, or new use for medicine
  • Change to MA holder contact details

Updated on 21 September 2016

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • 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)

Free text change information supplied by the pharmaceutical company

$0Section 4.1 - chronic lymphocytic leukemia (CLL) indication updated to reflect that first line treatment with idelalisib should only be used in patients with 17p deletion or TP53 mutation that are not eligible for any other therapies. Section 4.4 updated with additional information regarding serious infections. Section 4.8 updated with additional information regarding infections$0$0- Section 4.4 updated with additional information regarding serious infections. Section 4.8 updated with additional information regarding infections.$0$0Section 4.8 updated with additional information regarding infections.$0

Updated on 20 September 2016

Reasons for updating

  • Change to, or new use for medicine
  • Change to date of revision
  • Change of distributor details

Updated on 22 June 2016

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
  • 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



·         Update to Section 4.5 (Interaction with other medicinal products and other forms of interaction) updated to remove dabigatran and rivaroxaban from the table of interactions.

·         Update to Section 4.4(Special warnings and precautions for use) and Section 4.8(Undesirable effects) to include safety information regarding SJS and TEN.

 

Updated on 21 June 2016

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to further information section
  • Change to date of revision

Updated on 01 April 2016

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • 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)

Free text change information supplied by the pharmaceutical company



Sections 4.1, 4.2. 4.4 & 10:

·         Section 4.1 updated to restrict the use of Zydelig in first line treatment of patients with chronic lymphocytic leukaemia, have 17p deletion or TP53 mutation, and are unsuitable for chemo-therapy to only those patients who have already initiated therapy

·         Section 4.2 updated to include dose modification guidance for management of neutropenia

·         Section 4.4 updated to add new warnings for serious infections and neutropenia.

·         Change to the date of revision to March 2016.

 

 

 

Updated on 31 March 2016

Reasons for updating

  • Change to, or new use for medicine
  • Change to warnings or special precautions for use

Updated on 16 July 2015

Reasons for updating

  • Change to section 6.3 - Shelf life
  • 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

• Update to section 6.3 related to the extension of the shelf-life of the finished product from 2 to 3 years
• Change to the date of revision in section 10 to July 2015

Updated on 30 April 2015

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 9 - Date of renewal of authorisation
  • 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

• Update to sections 4.8 and 5.1 with the final data from clinical study GS US 312 0116
• Update section 9 to add the date of first authorisation (18th September 2014)
• Change to the date of revision in section 10 to March 2015

Updated on 13 March 2015

Reasons for updating

  • Change to date of revision
  • Change to name of manufacturer

Updated on 25 September 2014

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

None provided

Updated on 19 September 2014

Reasons for updating

  • New PIL for new product