Zydelig (idelalisib) 150mg

  • Name:

    Zydelig (idelalisib) 150mg

  • Company:
    info
  • Active Ingredients:

    Idelalisib

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 13/05/19

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Summary of Product Characteristics last updated on medicines.ie: 13/5/2019
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.

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Gilead Sciences Ltd

Gilead Sciences Ltd

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Medicine Name YESCARTA (axicabtagene ciloleucel) Active Ingredients Axicabtagene Ciloleucel
Medicine Name Zydelig (idelalisib) 100mg Active Ingredients Idelalisib
Medicine Name Zydelig (idelalisib) 150mg Active Ingredients Idelalisib
1 - 0 of 24 items.Total: Infinity pages

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 13 May 2019 PIL

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 SmPC

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 SmPC

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 PIL

Reasons for updating

  • Change to section 6 - marketing authorisation holder

Updated on 21 May 2018 SmPC

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 8 May 2018 PIL

Reasons for updating

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

Updated on 16 March 2018 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 16 March 2018 SmPC

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 PIL

Reasons for updating

  • New PIL for new product

Updated on 15 March 2018 PIL

Reasons for updating

  • Change to other sources of information section

Updated on 23 February 2018 PIL

Reasons for updating

  • Change to section 6 - date of revision

Updated on 26 January 2018 SmPC

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 SmPC

Reasons for updating

  • 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

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 PIL

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 SmPC

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 SmPC

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 SmPC

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 3 October 2016 SmPC

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 PIL

Reasons for updating

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

Updated on 21 September 2016 SmPC

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

Section 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. $0- Section 4.4 updated with additional information regarding serious infections.$0$0Section 4.8 updated with additional information regarding infections.$0

Updated on 20 September 2016 PIL

Reasons for updating

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

Updated on 24 June 2016 SmPC

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 PIL

Reasons for updating

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

Updated on 18 April 2016 SmPC

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 PIL

Reasons for updating

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

Updated on 16 July 2015 SmPC

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 SmPC

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 PIL

Reasons for updating

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

Updated on 25 September 2014 SmPC

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 PIL

Reasons for updating

  • New PIL for new product