Stribild 150 mg/150 mg/200 mg/245 mg film coated tablets
- Name:
Stribild 150 mg/150 mg/200 mg/245 mg film coated tablets
- Company:
Gilead Sciences Ltd
- Active Ingredients:
Cobicistat, Elvitegravir, Emtricitabine, Tenofovir disoproxil fumarate
- Legal Category:
Product subject to medical prescription which may not be renewed (A)
Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 01/07/20
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Gilead Sciences Ltd
Company Products
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 1 July 2020 PIL
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 2 - excipient warnings
- Change to section 3 - how to take/use
- Change to section 6 - what the product contains
Updated on 1 July 2020 SPC
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- 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 4.8 – Undesirable effects - how to report a side effect
Legal category: Product subject to medical prescription which may not be renewed (A)
Updated on 16 April 2019 PIL
Reasons for updating
- Change to section 2 - what you need to know - contraindications
- Change to section 2 - pregnancy, breast feeding and fertility
Updated on 16 April 2019 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 4.6 - Pregnancy and lactation
- Change to section 5.2 - Pharmacokinetic properties
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 4.2, 4.4, 4.6 and 5.2 of the Summary of Product Characteristics (SmPC) to recommend to not initiate these products during pregnancy, and to switch to an alternative regimen for women who become pregnant during therapy with these products based on the data from the IMPAACT study P1026s. This study is an ongoing prospective study assessing the pharmacokinetics of antiretroviral treatment in pregnant women; this study has showed that treatment with cobicistat and elvitegravir-containing regimens resulted in lower elvitegravir and cobicistat exposures during the second and third trimesters of pregnancy compared to postpartum.
With this procedure, Gilead has been requested to issue a Dear Healthcare Professional Communication (DHPC) to inform about the increased risk of treatment failure and increased risk of mother-to-child transmission of HIV infection due to lower exposure of elvitegravir and cobicistat during the second and third trimesters of pregnancy. The DHPC was disseminated as per the agreed communication plan.
The Package Information Leaflet (PIL) for all three products was updated accordingly.
Updated on 21 December 2018 PIL
Reasons for updating
- Change to section 2 - excipient warnings
Updated on 21 December 2018 SPC
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- 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
Sections 4.4 and 5.1 of the products SmPC have been updated with final safety data from Study GS-US-104-0352.
Gilead has taken the opportunity to update the lactose information text in Section 4.4 of the SmPC and Section 2 of the PIL in line with the latest annex to the EC excipient guideline (EMA/CHMP/302620; 09 October 2017).
Updated on 19 September 2018 SPC
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to Section 4.8 – Undesirable effects - how to report a side effect
Legal category: Product subject to medical prescription which may not be renewed (A)
Updated on 29 August 2018 PIL
Reasons for updating
- Change to section 2 - interactions with other medicines, food or drink
Updated on 29 August 2018 SPC
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)
Updated on 7 August 2018 PIL
Reasons for updating
- Change to section 2 - what you need to know - contraindications
Updated on 6 August 2018 SPC
Reasons for updating
- Change to section 4.3 - Contraindications
- 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)
Updated on 20 June 2018 SPC
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 20 June 2018 PIL
Reasons for updating
- Change to section 6 - marketing authorisation holder
Updated on 5 June 2018 SPC
Reasons for updating
- Change to section 4.3 - Contraindications
- 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)
Updated on 5 June 2018 PIL
Reasons for updating
- Change to section 2 - what you need to know - contraindications
Updated on 13 May 2018 PIL
Reasons for updating
- Change to Section 1 - what the product is
- Change to section 2 - what you need to know - contraindications
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 2 - driving and using machines
- Change to section 3 - how to take/use
- Removal of Black Inverted Triangle
Updated on 9 May 2018 SPC
Reasons for updating
- Change to section 4.6 - Pregnancy and lactation
- Change to section 4.7 - Effects on ability to drive and use machines
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 9 - Date of first authorisation/renewal of the authorisation
- Removal of Black Inverted Triangle
Legal category: Product subject to medical prescription which may not be renewed (A)
Updated on 8 March 2018 SPC
Reasons for updating
- Change to section 4.3 - Contraindications
- 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
Updated on 8 March 2018 SPC
Reasons for updating
- New SPC for new product
Legal category: Product subject to medical prescription which may not be renewed (A)
Updated on 7 March 2018 PIL
Reasons for updating
- New PIL for new product
Updated on 7 March 2018 PIL
Reasons for updating
- Change to section 1 - what the product is used for
- Change to section 2 - what you need to know - contraindications
- Change of distributor details
Updated on 8 November 2017 SPC
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 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
Updated on 7 November 2017 PIL
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 - dose and frequency
- Change to section 3 - use in children/adolescents
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 2 June 2017 SPC
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
Updated on 25 May 2017 PIL
Reasons for updating
- Change to section 2 - what you need to know - contraindications
- Change to section 6 - date of revision
Updated on 8 March 2017 SPC
Reasons for updating
- 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
Updated on 6 March 2017 PIL
Reasons for updating
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 6 - date of revision
Updated on 27 September 2016 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
Updated on 23 September 2016 PIL
Reasons for updating
- Change to warnings or special precautions for use
- Change to drug interactions
- Change to date of revision
- Change to MA holder contact details
Updated on 17 May 2016 SPC
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
· Section 4.4
o Revise the HIV class label wording on mitochondrial dysfunction following the review of existing data on mitochondrial toxicity including the Mitochondrial Toxicity in Children (MITOC) Study
o The PILs were also updated accordingly
· Sections 4.4 and 4.5
o Addition of a warning update to the safety information with the potential drug interaction of ledipasvir/sofosbuvir (LDV/SOF), as well as that of LDV and SOF as single agents with tenofovir disoproxil fumarate
o The PILs were also updated accordingly
Updated on 13 May 2016 PIL
Reasons for updating
- Change to side-effects
- Change to information about pregnancy or lactation
- Change to date of revision
- Change to MA holder contact details
Updated on 18 April 2016 SPC
Reasons for updating
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- 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 of the SmPC has been updated to include well-established resistance information in relation to dolutegravir. In addition, minor editorial changes in the labelling and the Package Leaflet.
Updated on 13 April 2016 PIL
Reasons for updating
- Change to marketing authorisation holder
- Change to MA holder contact details
Updated on 15 February 2016 SPC
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
- Update to delete previous lipodystrophy class labelling text and, to add new class labelling regarding weight and metabolic parameters (blood lipids and glucose).
Section 10:
- Change to the date of revision to January 2016.
Updated on 12 February 2016 PIL
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
- Change to date of revision
Updated on 28 January 2016 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
- Inclusion to state that the most pronounced decreases in bone mineral density were seen in patients treated with tenofovir DF as part of a regimen containing a boosted protease inhibitor, and also to advise that alternative treatment regimens should be considered for patients with osteoporosis that are at a high risk for fractures, in line with HIV European guidelines.
Section 10:
- Change to the date of revision to December 2015.
Updated on 23 June 2015 SPC
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
- Removal of the warnings related to lactic acidosis
Section 10:
- Change to the date of revision to May 2015
Updated on 22 June 2015 PIL
Reasons for updating
- Change to warnings or special precautions for use
- Change to date of revision
Updated on 22 June 2015 SPC
Reasons for updating
- 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
Reason for update
· the correction of a typographical error affecting Section 4.5 of the SmPC. See table below:
|
Incorrect text SmPC Section 4.5, Table 1 (Antimycobacterials) |
Corrected text SmPC Section 4.5, Table 1 (Antimycobacterials): |
|
Rifabutin (150 mg once daily)/Elvitegravir (150 mg once daily)/Cobicistat (150 mg once daily)
|
Rifabutin (150 mg every other day)/Elvitegravir (150 mg once daily)/Cobicistat (150 mg once daily)
|
Updated on 3 September 2014 SPC
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
- Addition of safety information on the risk of renal injury in patients with risk factors for renal dysfunction after co-administration of non-steroidal anti-inflammatory drugs (NSAIDs) with tenofovir.
- Change of wording around the monitoring of renal function “In patients at risk for renal impairment consideration should be given to a more frequent monitoring of renal function is required.”/ “Interrupting treatment with Stribild should also be considered in case of progressive decline of renal function when no other cause has been identified.”
Section 4.8 of the SmPC:
- Addition of information about proximal renal tubulopathy.
Section 10 of the SmPC:
- Change to the date of revision to July 2014.
Updated on 28 August 2014 PIL
Reasons for updating
- Change to warnings or special precautions for use
- Change to date of revision
Updated on 3 July 2014 SPC
Reasons for updating
- 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
- GS-US-236-0115 (PI switch: FTC/TDF+ PI/r switched to E/C/F/TDF )
- GS-US-236-0121 (NNRTI switch: FTC +TDF + NNRTI switched to E/C/F/TDF)
- GS-US-236-0123 (RAL switch: RAL +FTC/TDF switched to E/C/F/TDF)
• Change to the date of revision to May 2014
Updated on 25 June 2014 PIL
Reasons for updating
- Change to date of revision
Updated on 7 April 2014 SPC
Reasons for updating
- 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 6.1 - List of excipients
- 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 of section 4.4 of the SmPC of Stribild: adjustments of bone effect data
- Update of section 4.8 of the SmPC of Stribild: adjustments of side effects
- Update of section 5.1 of the SmPC of Stribild: pharmacodynamics property
- Furthermore the opportunity was taken to revise section 6.1 of the SmPC list of excipients, to update the designation of the excipients
- Update to sections 4.4, 4.8 and 5.1 of the SmPC based on 144 weeks data from the pivotal studies GS-US-236-0102 and GS-US-236-0103
- Update to Section 6.3 - Shelf life extension
Updated on 2 April 2014 PIL
Reasons for updating
- Change to, or new use for medicine
Updated on 2 January 2014 SPC
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 16 December 2013 PIL
Reasons for updating
- New PIL for medicines.ie