Benlysta 120 mg and 400 mg powder for concentrate for solution for infusion
*Company:
GlaxoSmithKline (Ireland) LtdStatus:
No Recent UpdateLegal Category:
Product subject to medical prescription which may not be renewed (A)Active Ingredient(s):
This medicinal product is subject to additional monitoring.
*Additional information is available within the SPC or upon request to the company
Updated on 18 January 2024
File name
ieukni-spc-combined-benlystaIV-issue26draft1-Master.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 18 January 2024
File name
ieukni-pl-combined-benlystaIV-issue22draft1-Master.pdf
Reasons for updating
- Change to section 4 - possible side effects
Updated on 08 December 2022
File name
ieukni-spc-combined-benlystaIV-issue25draft1-clean.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 10 - Date of revision of the text
- Change to improve clarity and readability
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 08 December 2022
File name
ieukni-pl-combined-benlystaIV-issue21draft1-clean.pdf
Reasons for updating
- Change to section 6 - date of revision
- Improved presentation of PIL
- Change to improve clarity and readability
Updated on 21 October 2021
File name
ieukni-pl-combined-benlystaiv-issue20draft1-clean.pdf
Reasons for updating
- Change to section 4 - how to report a side effect
- Change to other sources of information section
Updated on 12 May 2021
File name
ie-pl-benlystaiv-issue19draft1.pdf
Reasons for updating
- Change to section 1 - what the product is used for
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 3 - how to take/use
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
#1 What Benlysta is and what it is used for
Added the indication, in combination with other medicines, for the treatment of adult patients with active lupus nephritis.
#2 What you need to know before you are given Benlysta
Removed the precaution to talk to the doctor before using Benlysta if lupus affects the kidneys
Removed cyclophosphamide as a medicine of concern if being co-administered.
Added contraindication of use in children and adolescents under 8 years with active lupus nephritis.
Updated on 12 May 2021
File name
ie-spc-benlystaIV-issue24draft1.pdf
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 4.8 – 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 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
#4.1 Addition of the indication, in combination with background immunosuppressive therapies, for the treatment of adult patients with active lupus nephritis.
#4.2 Posology is updated to include the requirements for treating lupus nephritis, and clarification for systemic lupus erythematosus. A statement is added to warn against the use of Benlysta in children and adolescents aged below 18 years with severe active lupus nephritis. Additional detail is included regarding the method of administration of the IV presentation.
#4.4 Lupus nephritis is removed from the list of patient groups that Benlysta has not been studied in. Removal of reference to coadministration with cyclophosphamide.
#4.8 Statements are added regarding the safety of use of Benlysta in patients with active lupus nephritis and clarification regarding SLE.
#5.1 Statement and data added regarding lupus nephritis and clarification regarding SLE.
#5.2 Statements added regarding lupus nephritis and clarification regarding SLE.
#10 Changed date of revision to 30 April 2021
Updated on 26 September 2020
File name
ie-pil-benlystaiv-issue18draft1-clean medicines.ie.pdf
Reasons for updating
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
update to date of revision
Updated on 26 September 2020
File name
ie-spc-benlystaIV-issue23draft1-clean medicines.ie.pdf
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
correction to section 5.1
Updated on 07 July 2020
File name
ie-pil-benlysta-issue17draft1-medicine ie.pdf
Reasons for updating
- Change to section 4 - how to report a side effect
Free text change information supplied by the pharmaceutical company
section 4 - 4000 subject large safety study, studying mortality and adverse events of special interest; inclusion of infections as adeverse event
Updated on 07 July 2020
File name
ie-spc-benlysta IV-issue23draft1-medicines ie.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 4.8 - Undesirable effects
- 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 section 4.2 and 5.2 of the SmPC in order to update the information on elderly patients based on the interim results from study BEL116559 listed as a category 3 study in the RMP; this is a meta-analysis to assess efficacy and safety in elderly subjects treated in selected belimumab studies.
Update 4.4 and 4.8 of the SPC, inclusion of 4000 subject large safety study, studying mortality and adverse events of special interest. Additon of infections adverse events.
Updated on 18 December 2019
File name
ie-pil-benlysta-issue16draft2-clean no headers.pdf
Reasons for updating
- Change to section 4 - how to report a side effect
Free text change information supplied by the pharmaceutical company
Section 4 - revision to reporting side effects text
Updated on 01 November 2019
File name
ie-spc-benlysta-issue21draft1-clean-medicines.ie.pdf
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 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 6.6 - Special precautions for disposal and other handling
- 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 01 November 2019
File name
ie-pil-benlysta-issue16draft1-clean-medicines.ie.pdf
Reasons for updating
- Change to section 1 - what the product is used for
- Change to section 2 - use in children and adolescents
- Change to section 3 - use in children/adolescents
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 19 July 2019
File name
ie-pil-benlysta-issue15draft1-clean HPRA.pdf
Reasons for updating
- Change to section 2 - what you need to know - contraindications
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 19 July 2019
File name
ie-spc-benlysta-issue20draft1-clean HPRA.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 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 4.4 - warnings and precaution of use as studies show psychiatric disorders reported in patients receiving Benlysta
section 4.8 - clarity on safety profile
Section 4.8 - addition of Suicidal behaviour and suicidal ideation as an uncommon side effect
section 4.8 - inclusion of clinical findings for psychiatric disorders
section 5.1 - inclusion of studies in Black patients
Section 10 - revision date updated
Updated on 30 November 2018
File name
ie-pl-benlysta-issue14draft1-MED.IE.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Updated on 30 November 2018
File name
ie-spc-benlysta-issue19draft1-MED.IE.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
Section 6: MAH Name and address updated from Glaxo Group Limited to GlaxoSmithKline (Ireland) Limited.
Section 4.8: The combined UK/IE SPC has been split into individual market SPCs and thus the reporting details have been updated to reflect this.
Updated on 01 June 2018
File name
ukie-spc-benlysta.docx
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 16 May 2018
Reasons for updating
- Other
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 11 May 2018
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 12 February 2018
File name
PIL_16029_825.pdf
Reasons for updating
- New PIL for new product
Updated on 12 February 2018
Reasons for updating
- Change to section 4 - how to report a side effect
- Change to section 6 - date of revision
- Joint PIL superseded by individual PILs
Updated on 27 November 2017
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 27 November 2017
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- 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 4.5: Addition of interaction information
Section 4.8: Update to summary and description of adverse reactions. Addition of side effects to the table (urinary tract infection, upper respiratory tract infection, injection site reaction, angioedema. Deletion of insomnia.
Section 5.1 - clarity that biomarkers were seen in clinical trials with Benlysta administered intravenously.
Section 5.2: Transitioning from intravenous to subcutaneous administration added.
Updated on 24 November 2017
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 2 - driving and using machines
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 23 September 2016
Reasons for updating
- Change to section 4.9 - Overdose
- Change to section 6.3 - Shelf life
- Change to section 6.6 - Special precautions for disposal and other handling
- 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 4.9 – Update to product information text in relation to overdose
Section 6.3 and 6.6 - update the product information text in relation to compatibility with reconstitution diluents and container closure system and regarding compatibility with needle gauge.
Updated on 23 September 2016
Reasons for updating
- Change to further information section
- Change to date of revision
- Improved electronic presentation
Updated on 26 July 2016
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 9 - Date of renewal of authorisation
- 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
4.4 Special warnings and precautions for use - infections can be severe and fatal and to consider dose interruption of immunosuppressant therapy
in the midst of acute infection.
4.6 Fertility, pregnancy and lactation - Benlysta should not be used during pregnancy unless the potential benefit justifies the potential risk to
the foetus.
4.8 Undesirable effects - Some infections were severe or fatal.
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION - 18 February 2016 added.
Updated on 26 July 2016
Reasons for updating
- Change to warnings or special precautions for use
- Change of contraindications
- Change to side-effects
- Change to date of revision
Updated on 06 July 2016
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
4.4 Special warnings and precautions for use – text added around immunisations and study evaluating the response to a 23-valent pneumococcal vaccine.
Removal of following text: There are insufficient data to draw conclusions regarding the ability of subjects receiving Benlysta to mount protective responses to vaccines.
Updated on 25 June 2014
Reasons for updating
- New SPC for medicines.ie
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 24 June 2014
Reasons for updating
- New PIL for medicines.ie