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Ziagen Film-Coated Tablets 300mg

*
Pharmacy Only: Prescription

  • Company:

    ViiV Healthcare UK Ltd

  • Status:

    No Recent Update

  • Legal Category:

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

  • Active Ingredient(s):

    Abacavir Sulfate

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

Updated on 17 January 2024

File name

ieukni-spc-combined-ziagentabs-issue16draft1.pdf

Reasons for updating

  • Previous version of SPC reinstated

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

Free text change information supplied by the pharmaceutical company

Presentation Ziagen Tablets updated instead of Ziagen Oral Solution in error - this was rectified immediately and previous document restored.

Updated on 17 January 2024

File name

ieukni-pl-combined-ziagentabs-issue16draft1.pdf

Reasons for updating

  • Correction of spelling/typing errors

Free text change information supplied by the pharmaceutical company

Presentation Ziagen Tablets updated instead of Ziagen Oral Solution in error - this was rectified immediately and previous document restored.

Updated on 17 January 2024

File name

ieukni-spc-combined-ziagenos-issue18draft1.pdf

Reasons for updating

  • Change to section 6.4 - Special precautions for storage

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

Free text change information supplied by the pharmaceutical company

Type IB - Update to the storage conditions from ‘Store at or below 30C’ to ‘Store at or below 25C'

Updated on 17 January 2024

File name

ieukni-pl-combined-ziagenos-issue22draft1.pdf

Reasons for updating

  • Change to section 5 - how to store or dispose

Free text change information supplied by the pharmaceutical company

Type IB - Update to the storage conditions from ‘Store at or below 30C’ to ‘Store at or below 25C'

Updated on 24 November 2023

File name

ieukni-pl-combined-ziagentabs-issue16draft1 medie.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 6 - date of revision

Free text change information supplied by the pharmaceutical company

The CHMP, having considered in accordance with Article 28 of Regulation (EC) No 726/2004 and Article 107g(3) of Directive 2001/83/EC the PSUR on the basis of the PRAC recommendation and the PRAC assessment report as appended, recommends by consensus the variation to the terms of the marketing authorisation(s) for the medicinal products containing the above referred active substance(s), concerning the following change(s):

Update of section 4.4 of the SmPC to add a warning/precaution regarding cardiovascular events. The Package leaflet is updated accordingly.

Updated on 24 November 2023

File name

ieukni-pl-combined-ziagentabs-issue16draft1 medie.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 6 - date of revision

Free text change information supplied by the pharmaceutical company

The CHMP, having considered in accordance with Article 28 of Regulation (EC) No 726/2004 and Article 107g(3) of Directive 2001/83/EC the PSUR on the basis of the PRAC recommendation and the PRAC assessment report as appended, recommends by consensus the variation to the terms of the marketing authorisation(s) for the medicinal products containing the above referred active substance(s), concerning the following change(s):

Update of section 4.4 of the SmPC to add a warning/precaution regarding cardiovascular events. The Package leaflet is updated accordingly.

Updated on 24 November 2023

File name

ieukni-pl-combined-ziagentabs-issue16draft1 medie.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 6 - date of revision

Free text change information supplied by the pharmaceutical company

The CHMP, having considered in accordance with Article 28 of Regulation (EC) No 726/2004 and Article 107g(3) of Directive 2001/83/EC the PSUR on the basis of the PRAC recommendation and the PRAC assessment report as appended, recommends by consensus the variation to the terms of the marketing authorisation(s) for the medicinal products containing the above referred active substance(s), concerning the following change(s):

Update of section 4.4 of the SmPC to add a warning/precaution regarding cardiovascular events. The Package leaflet is updated accordingly.

Updated on 24 November 2023

File name

ieukni-pl-combined-ziagentabs-issue16draft1 medie.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 6 - date of revision

Free text change information supplied by the pharmaceutical company

The CHMP, having considered in accordance with Article 28 of Regulation (EC) No 726/2004 and Article 107g(3) of Directive 2001/83/EC the PSUR on the basis of the PRAC recommendation and the PRAC assessment report as appended, recommends by consensus the variation to the terms of the marketing authorisation(s) for the medicinal products containing the above referred active substance(s), concerning the following change(s):

Update of section 4.4 of the SmPC to add a warning/precaution regarding cardiovascular events. The Package leaflet is updated accordingly.

Updated on 24 November 2023

File name

ieukni-spc-combined-ziagentabs-issue16draft1 medie.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

The CHMP, having considered in accordance with Article 28 of Regulation (EC) No 726/2004 and Article 107g(3) of Directive 2001/83/EC the PSUR on the basis of the PRAC recommendation and the PRAC assessment report as appended, recommends by consensus the variation to the terms of the marketing authorisation(s) for the medicinal products containing the above referred active substance(s), concerning the following change(s):

Update of section 4.4 of the SmPC to add a warning/precaution regarding cardiovascular events. The Package leaflet is updated accordingly.

Updated on 24 November 2023

File name

ieukni-spc-combined-ziagentabs-issue16draft1 medie.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

The CHMP, having considered in accordance with Article 28 of Regulation (EC) No 726/2004 and Article 107g(3) of Directive 2001/83/EC the PSUR on the basis of the PRAC recommendation and the PRAC assessment report as appended, recommends by consensus the variation to the terms of the marketing authorisation(s) for the medicinal products containing the above referred active substance(s), concerning the following change(s):

Update of section 4.4 of the SmPC to add a warning/precaution regarding cardiovascular events. The Package leaflet is updated accordingly.

Updated on 03 October 2023

File name

ieukni-pl-combined-ziagentabs-issue15draft1.pdf

Reasons for updating

  • Change to section 6 - date of revision
  • Improved presentation of PIL

Updated on 03 October 2023

File name

ieukni-spc-combined-ziagentabs-issue15draft1_medie.pdf

Reasons for updating

  • Improved presentation of SPC

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

Updated on 11 November 2022

File name

ieukni-pl-combined-ziagentabs-issue14draft3 Compendia.pdf

Reasons for updating

  • Change to section 6 - date of revision

Updated on 11 November 2022

File name

ieukni-pl-combined-ziagentabs-issue14draft3.pdf

Reasons for updating

  • Change to section 6 - date of revision

Updated on 25 August 2022

File name

ieukni-spc-combined-ziagentabs-issue14draft2-medie.pdf

Reasons for updating

  • Change to section 4.6 - Pregnancy and lactation

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

Free text change information supplied by the pharmaceutical company

Further updates to Breastfeeding wording.

Updated on 25 August 2022

File name

ieukni-pl-combined-ziagentabs-issue14draft2-emc-medie.pdf

Reasons for updating

  • Change to section 2 - pregnancy, breast feeding and fertility

Free text change information supplied by the pharmaceutical company

Further updates to Breastfeeding wording.

Updated on 08 July 2022

File name

ieukni-spc-combined-ziagentabs-issue14draft1_medie.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Pregnancy and lactation
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • 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

Presentation impacted: Ziagen 300 mg film-coated tablets- EU/1/99/112/001

Type IAIN - Variation for the name change of the Poznan site (responsible for manufacturing, packaging, QC testing and batch release of the finished product) from GlaxoSmithKline Pharmaceutical S.A. to Delpharm Poznań Spółka Akcyjna

Section 6 of the PIL - Manufacturer has been impacted.


and


Presentation impacted: Ziagen 20 mg/ml oral solution- EU/1/99/112/002 and Ziagen 300 mg film-coated tablets- EU/1/99/112/001

Type IAIN variation for CHMP adopted update to the product information for all approved HIV products, recommending the removal of the disease information relating to sexual transmission of HIV and amendment of the sections relating to breast-feeding.


SPC and PIL impacted refer to attached product information for updates.

Updated on 08 July 2022

File name

ieukni-pl-combined-ziagentabs-issue14draft1_eMC.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Free text change information supplied by the pharmaceutical company

Presentation impacted: Ziagen 300 mg film-coated tablets- EU/1/99/112/001

Type IAIN - Variation for the name change of the Poznan site (responsible for manufacturing, packaging, QC testing and batch release of the finished product) from GlaxoSmithKline Pharmaceutical S.A. to Delpharm Poznań Spółka Akcyjna

Section 6 of the PIL - Manufacturer has been impacted.


and


Presentation impacted: Ziagen 20 mg/ml oral solution- EU/1/99/112/002 and Ziagen 300 mg film-coated tablets- EU/1/99/112/001

Type IAIN variation for CHMP adopted update to the product information for all approved HIV products, recommending the removal of the disease information relating to sexual transmission of HIV and amendment of the sections relating to breast-feeding.


SPC and PIL impacted refer to attached product information for updates.

Updated on 10 December 2021

File name

ieukni-pl-combined-ziagentabs-issue13draft1-compendia.pdf

Reasons for updating

  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision
  • Change to other sources of information section

Updated on 05 March 2021

File name

ie-pl-ziagentabs-issue12draft1medie.pdf

Reasons for updating

  • Change to section 6 - manufacturer

Free text change information supplied by the pharmaceutical company

Removal of Inactive UK Finished Product Batch Release Site

Updated on 20 January 2021

File name

ie-pl-ziagentabs-issue11draft1- medie.pdf

Reasons for updating

  • Change to section 2 - what you need to know - contraindications
  • Change to section 2 - excipient warnings
  • Change to section 6 - date of revision

Free text change information supplied by the pharmaceutical company

Type II variation, following a worksharing procedure to update the section 4.5 of the SmPC and section 2 of the package leaflet with new information about the drug-drug interactions between abacavir and riociguat.Furthermore, the MAH took the opportunity to introduce an excipient update for Ziagen in line with the SmPC guideline, a syringe instruction update in the Package Leaflet of Ziagen.Moreover, minor editorial updates have been introduced throughout the Product Information.

Updated on 20 January 2021

File name

ie-spc-ziagentabs-issue13draft1- med ie.pdf

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

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

Free text change information supplied by the pharmaceutical company

Type II variation, following a worksharing procedure to update the section 4.5 of the SmPC and section 2 of the package leaflet with new information about the drug-drug interactions between abacavir and riociguat.Furthermore, the MAH took the opportunity to introduce an excipient update for Ziagen in line with the SmPC guideline, a syringe instruction update in the Package Leaflet of Ziagen.Moreover, minor editorial updates have been introduced throughout the Product Information.

Updated on 13 May 2020

File name

ie-spc-ziagentabs-issue12draft1.pdf

Reasons for updating

  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 7 - Marketing authorisation holder
  • 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

  • Change in the address of the Marketing Aurthorisation Holder.
  • Update to the reporting details for the HPRA

Updated on 13 May 2020

File name

ie-pl-ziagentabs-issue10draft1.pdf

Reasons for updating

  • Change to section 4 - how to report a side effect
  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - date of revision

Free text change information supplied by the pharmaceutical company

  • Change in the address of the Marketing Aurthorisation Holder.
  • Update to the reporting details for the HPRA.

Updated on 18 September 2018

File name

ukie-spc-ziagentabs-issue10draft1 Meds ie.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • 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

SmPC Section 4.4 Warnings “Autoimmune disorders (such as Graves' disease and autoimmune hepatitis) have also been reported to occur in the setting of immune reactivation; however, the reported time to onset is more variable and these events can occur many months after initiation of treatment.”

SmPC Section 4.8 Undesirable events “Autoimmune disorders (such as Graves' disease and autoimmune hepatitis) have also been reported; however, the reported time to onset is more variable and these events can occur many months after initiation of treatment. (see section 4.4)”

Updated on 01 June 2018

File name

ukie-spc-ziagentabs.docx

Reasons for updating

  • New SPC for new product

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

Updated on 13 June 2017

File name

PIL_9917_443.pdf

Reasons for updating

  • New PIL for new product

Updated on 13 June 2017

Reasons for updating

  • Change to section 6 - date of revision
  • Improved presentation of PIL

Updated on 28 July 2016

Reasons for updating

  • New SPC for new product

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

Updated on 28 July 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 of sections 4.4 and 4.5 of the SmPC to remove the current information regarding a potential interaction between abacavir and ribavirin.

Updated on 27 July 2016

Reasons for updating

  • Change to drug interactions
  • Change to date of revision

Updated on 13 April 2016

Reasons for updating

  • 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 5.2 - Pharmacokinetic 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

Update of sections 4.2, 4.3, 4.4 and 5.2 of the SmPC in order to align the Hepatic Impairment wording for the 3 older abacavir-containing products (ZIAGEN™, KIVEXA™ and TRIZIVIR™) with the TRIUMEQ™ SmPC. In addition, the MAH has taken the opportunity to correct some minor administrative errors in the labelling for the 3 products.

SmPC section 4.4 - Mitochondrial dysfunction following exposure in utero.

Updated on 12 April 2016

Reasons for updating

  • Change to information about pregnancy or lactation
  • Change to date of revision

Updated on 09 February 2016

Reasons for updating

  • 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

EU Labelling revisions on Lipodystrophy & Lactic Acidosis–PRAC recommendations

Updated on 08 February 2016

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to date of revision

Updated on 25 September 2015

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

Section 5.1 – antiviral activity update

Updated on 27 July 2015

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • 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 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 of sections 4.1, 4.2, 4.3, 4.4 and 4.8 of the SmPC to revise the information on hypersensitivity reactions

Updated on 23 July 2015

Reasons for updating

  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to storage instructions
  • Change to side-effects
  • Change to date of revision
  • Correction of spelling/typing errors

Updated on 16 July 2015

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to section 6.5 - Nature and contents of container
  • Change to section 10 - Date of revision of the text
  • Correction of spelling/typing errors

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

Free text change information supplied by the pharmaceutical company

Reverted back to previous version of SPC on medicines.ie -

Update Section 4.6 of SmPC  to include WHO Breast-feeding guidance
Update to section 6.5 to add child-resistant blister

Updated on 15 July 2015

Reasons for updating

  • Change to information about pregnancy or lactation
  • Change to date of revision
  • Addition of information on reporting a side effect.

Updated on 14 July 2015

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • 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 - how to report a side effect
  • 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 of sections 4.1, 4.2, 4.3, 4.4 and 4.8 of the SmPC to revise the information on hypersensitivity reactions

Updated on 13 July 2015

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to date of revision
  • Change to marketing authorisation holder
  • Change of special precautions for disposal
  • Correction of spelling/typing errors

Updated on 07 May 2015

Reasons for updating

  • Change to section 4.6 - Pregnancy and lactation
  • 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 Section 4.6 of SmPC  to include WHO Breast-feeding guidance

Updated on 06 May 2015

Reasons for updating

  • Change to information about pregnancy or lactation
  • Change to date of revision
  • Correction of spelling/typing errors

Updated on 19 March 2015

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.6 - Pregnancy and lactation
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic 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

Section 4.2 Update to Posology (dosing in paediatrics)

Section 4.6 correction of typo – “secreted” deleted

Section 4.8 Inclusion of Arrow trial data

Section 5.1 Inclusion of heading “Resistance” and “Clinical efficacy and safety”; inclusion of trial data in paeds

Section 5.2 added further information under “Special populations” (use in paeds)

Section 9 “Date of latest renewal” updated

Updated on 18 March 2015

Reasons for updating

  • Change to date of revision
  • Change to appearance of the medicine
  • Change to dosage and administration

Updated on 16 April 2014

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 4.6 - Pregnancy and lactation
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 5.2 - Pharmacokinetic 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

 

Section 4.1 Therapeutic indications

Minor update to include statement "in adults and children." in therapeutic indications

 

 

Section 4.2 Posology & method of Administration

 

Minor grammatical updates to the SPC section 4.2 dosing in paediatric patients; Amendment of ‘older patients’ to ‘elderly’

 

 

Section 4.4 Special Warnings & precautions for use

 

Update to wording of how to manage after an interruption to Ziagen therapy & risk of transmission

 

 

Section 4.6 Fertility, pregnancy & lactation

 

Update to clinical data on use of abacavir in pregnancy, breast-feeding, fertility

 

 

Section 4.8 Undesirable effects

 

Update to wording of reporting of side effects

 

 

Section 5.2 Pharmacokinetic properties

 

Minor update to the SPC Section 5.2 paediatrics sub-section, to align with Ziagen Oral Solution & to change "older people" to "elderly"

 

 

Updated on 14 October 2013

Reasons for updating

  • 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

Change to:

Section 4.8 - Undesirable effects

Updated on 11 October 2013

Reasons for updating

  • Change to side-effects
  • Change to MA holder contact details

Updated on 05 April 2013

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 6.3 - Shelf life
  • 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)

Free text change information supplied by the pharmaceutical company

·         There are a number of editorial changes in sections 2, 4.3, 4.6, 5.2, 6.3, 6.6, 9 and 10

·         The following text has been added to section 4.4 in relation to autoimmune disorders

Autoimmune disorders (such as Graves’ disease) have also been reported to occur in the setting of immune reactivation; however, the reported time to onset is more variable and can occur many months after initiation of treatment.

·         The following text has been added to section 4.8 in relation to autoimmune disordersAutoimmune disorders (such as Graves’ disease) have also been reported to occur in the setting of immune reactivation; however, the reported time to onset is more variable and these events can occur many months after initiation of treatment

Updated on 04 April 2013

Reasons for updating

  • Change to side-effects

Updated on 12 June 2012

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

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

Free text change information supplied by the pharmaceutical company

Changes to:

 

 

Section 4.4 - Special warnings and precautions for use,
Section 4.5 - Interaction with other medicinal products and other forms of interaction

 

Updated on 24 February 2011

Reasons for updating

  • Change due to harmonisation of patient information leaflet

Updated on 25 November 2010

Reasons for updating

  • Change due to harmonisation of patient information leaflet

Updated on 13 August 2010

Reasons for updating

  • Change to section 7 - Marketing authorisation holder

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

Free text change information supplied by the pharmaceutical company

Change to Section 7

Updated on 11 March 2010

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

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

Free text change information supplied by the pharmaceutical company

Important safety update regarding recommendations for HLA-B*5701 screening and reinitiation of abacavir - 'Screening is also recommended prior to re-initiation of abacavir in patients of unknown HLA-B*5701 status who have previously tolerated abacavir ..



Section 4.1Therapeutic Indictaion
Sevtion 4.4 Special Warning and Precautions for use
Section 4.8 Undesirable Effects

Updated on 22 July 2009

Reasons for updating

  • Change to section 10 - Date of revision of the text
  • Change to section 3 - Pharmaceutical form
  • 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 4.9 - Overdose
  • 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)

Free text change information supplied by the pharmaceutical company



Ziagen 300 mg film-coated tablets (EU/1/99/112/001)

 

 

SPC Changes in Red

 

Section 3

Added description in brackets ‘(tablets)’

 

Added statement ‘The tablet can be divided into equal halves.’

 

Section 4.2

The following paragraphs changed from:

Children less than three months: the data available on the use of Ziagen in this age group are very limited (see section 5.2).

 

Renal impairment: no dosage adjustment of Ziagen is necessary in patients with renal dysfunction. However, Ziagen should be avoided in patients with end-stage renal disease (see section 5.2).

 

Hepatic impairment: abacavir is primarily metabolised by the liver. No dose recommendation can be made in patients with mild hepatic impairment. No data are available in patients with moderate hepatic impairment, therefore the use of abacavir is not recommended unless judged necessary. In patients with mild and moderate hepatic impairment close monitoring is required, and if feasible, monitoring of abacavir plasma levels is recommended (see section 5.2). Abacavir is contraindicated in patients with severe hepatic impairment (see section 4.3 and 4.4).

 

to:

 

Children less than three months: the experience in children aged less than three months is limited (see section 5.2).

 

Renal impairment: no dosage adjustment of Ziagen is necessary in patients with renal dysfunction. However, Ziagen is not recommended for patients with end-stage renal disease (see section 5.2).

 

Hepatic impairment: abacavir is primarily metabolised by the liver. No dose recommendation can be made in patients with mild hepatic impairment. In patients with moderate hepatic impairment, no data are available, therefore the use of abacavir is not recommended unless judged necessary. If abacavir is used in patients with mild or moderate hepatic impairment, then close monitoring is required, and if feasible, monitoring of abacavir plasma levels is recommended (see section 5.2). Abacavir is contraindicated in patients with severe hepatic impairment (see section 4.3 and 4.4).

 

Section 4.3

Deleted unnecessary detail: ‘Ziagen is contraindicated…’

 

Changed description ‘adverse events’ to ‘adverse reactions’.

 

Under the subheading ‘Pancreatitis’ changed description from ‘Ziagen’ to ‘abacavir’

 

Deleted the following paragraph:

Once daily administration (abacavir 600 mg): the benefit of abacavir as a once daily regimen is mainly based on a study performed in combination with efavirenz and lamivudine, in antiretroviral-naïve adult patients (see section 5.1).

 

Deleted the following sentence:

‘For patients with severe hepatic impairment, Ziagen is contraindicated (see section 4.3).’

 

Under the subheading ‘Osteonecrosis’, changed spelling ‘etiology’ to ‘aetiology’

 

Section 4.4

Added the following paragraph:

Myocardial Infarction:  Observational studies have shown an association between myocardial infarction and the use of abacavir. Those studied were mainly antiretroviral experienced patients. Data from clinical trials showed limited numbers of myocardial infarction and could not exclude a small increase in risk.  Overall the available data from observational cohorts and from randomised trials show some inconsistency so can neither confirm nor refute a causal relationship between abacavir treatment and the risk of myocardial infarction.  To date, there is no established biological mechanism to explain a potential increase in risk.  When prescribing Ziagen, action should be taken to try to minimize all modifiable risk factors (e.g. smoking, hypertension, and hyperlipidaemia).

 

Section 4.9

Changed sentence from ‘No unexpected adverse reactions were reported.  The effects of higher doses are not known’ to ‘No additional adverse reactions to those reported for normal doses were reported’

 

Section 6.6

Heading changed to delete ‘and other handling’

 

Section 10

Changed to 08 June 2009

 

 

Updated on 29 October 2008

Reasons for updating

  • Correction of spelling/typing errors

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

Updated on 14 October 2008

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 5.2 - Pharmacokinetic properties

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Free text change information supplied by the pharmaceutical company

 

The  following text has been added:

 

4.2     Posology and method of administration

 

………..

To ensure administration of the entire dose, the tablet(s) should ideally be swallowed without crushing.

 

 

Alternatively, for patients who are unable to swallow tablets, the tablet(s) may be crushed and added to a small amount of semi-solid food or liquid, all of which should be consumed immediately (see section 5.2).

 

5.2         Pharmacokinetic properties

 

…………………

Administration of crushed tablets with a small amount of semi-solid food or liquid would not be expected to have an impact on the pharmaceutical quality, and would therefore not be expected to alter the clinical effect. This conclusion is based on the physiochemical and pharmacokinetic data, assuming that the patient crushes and transfers 100% of the tablet and ingests immediately.

Updated on 07 October 2008

Reasons for updating

  • Change to dosage and administration

Updated on 05 September 2008

Reasons for updating

  • Change to warnings or special precautions for use
  • Correction of spelling/typing errors

Updated on 27 August 2008

Reasons for updating

  • Change to warnings or special precautions for use
  • Correction of spelling/typing errors

Updated on 26 August 2008

Reasons for updating

  • Improved electronic presentation

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

Updated on 27 March 2008

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.4 - Special warnings and precautions for use

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Free text change information supplied by the pharmaceutical company

Before initiating treatment with abacavir, screening for carriage of HLA-B*5701 should be performed in any HIV-infected patient, irrespective of racial origin.

Abacavir should not be used in patients known to carry HLA-B*5701, unless no other therapeutic option is available in these patients, based on the treatment history and resistance testing.

Updated on 03 March 2008

Reasons for updating

  • Improved electronic presentation

Updated on 29 August 2007

Reasons for updating

  • Improved electronic presentation

Updated on 28 August 2007

Reasons for updating

  • Improved electronic presentation

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

Updated on 05 January 2007

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects

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Free text change information supplied by the pharmaceutical company

Section 4.4

· Risk Factors

Analyses of clinical risk factors for hypersensitivity to abacavir have consistently identified the risk for those of black race to be approximately half the risk of other racial groups combined. As this still represents a significant risk (based on the fact that approximately 5% of subjects receiving abacavir develop a hypersensitivity reaction in clinical studies), the same close monitoring should apply to patients of all racial groups.

In addition, two retrospective, case-controlled pharmacogenetic studies have shown that carriage of HLA-B*5701 is associated with a significantly increased risk of clinically suspected hypersensitivity in Caucasians. It is estimated that approximately 50% of patients with the HLA-B*5701 allele develop a suspected hypersensitivity reaction (HSR) during the course of abacavir treatment versus less than 3% of patients who do not have HLA-B*5701 allele in the Caucasian population. This genetic association has not been assessed in prospective controlled clinical studies but such studies are ongoing to better appreciate the association between occurrence of HSR and carriage of HLA-B*5701 allele. However, it is noteworthy that among patients with a suspected hypersensitivity reaction, 50% did not carry HLA-B*5701 in the Caucasian population. Therefore, the clinical diagnosis of suspected hypersensitivity to abacavir must remain the basis for clinical decision-making. It is important to permanently discontinue abacavir and not rechallenge with abacavir if hypersensitivity cannot be ruled out on clinical grounds. Absence of the HLA-B*5701 allele does not justify rechallenge with abacavir due to the potential for a fatal rechallenge reaction. The same recommendation should apply for other races and ethnic groups, although data are more limited in these groups.

Osteonecrosis: Although the etiology is considered to be multifactorial (including corticosteroid use, alcohol consumption, severe immunosuppression, higher body mass index), cases of osteonecrosis have been reported particularly in patients with advanced HIV-disease and/or long-term exposure to combination antiretroviral therapy (CART). Patients should be advised to seek medical advice if they experience joint aches and pain, joint stiffness or difficulty in movement.

 

 

Section 4.8:

Cases of osteonecrosis have been reported, particularly in patients with generally acknowledged risk factors, advanced HIV disease or long-term exposure to combination antiretroviral therapy (CART). The frequency of this is unknown (see section 4.4).

Updated on 27 July 2006

Reasons for updating

  • Improved electronic presentation

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Updated on 03 July 2006

Reasons for updating

  • Change to date of revision

Updated on 04 August 2005

Reasons for updating

  • Improved electronic presentation

Updated on 31 May 2005

Reasons for updating

  • New PIL for medicines.ie

Updated on 19 August 2003

Reasons for updating

  • Improved electronic presentation

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

Updated on 18 July 2003

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects

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Updated on 01 July 2003

Reasons for updating

  • New SPC for medicines.ie

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