Stribild 150 mg/150 mg/200 mg/245 mg film coated tablets

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 16/04/19

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Summary of Product Characteristics last updated on medicines.ie: 16/4/2019

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Gilead Sciences Ltd

Gilead Sciences Ltd

Company Products

Medicine NameActive Ingredients
Medicine Name AmBisome (Liposomal Amphotericin) Active Ingredients Amphotericin B
Medicine Name Atripla 600 mg/200 mg/245 mg film- coated tablets Active Ingredients Efavirenz, Emtricitabine, Tenofovir disoproxil fumarate
Medicine Name Biktarvy 50 mg/200 mg/25 mg film-coated tablets Active Ingredients Emtricitabine, Tenofovir alafenamide fumarate, Bictegravir sodium
Medicine Name Cayston 75 mg powder and solvent for nebuliser solution Active Ingredients Aztreonam lysine
Medicine Name Descovy 200 mg/10 mg film-coated tablets Active Ingredients Emtricitabine, Tenofovir alafenamide fumarate
Medicine Name Descovy 200 mg/25 mg film-coated tablets Active Ingredients Emtricitabine, Tenofovir alafenamide fumarate
Medicine Name Emtriva 10 mg/ml oral solution Active Ingredients Emtricitabine
Medicine Name Emtriva 200 mg hard capsules Active Ingredients Emtricitabine
Medicine Name Epclusa 400 mg/100 mg film coated tablets. Active Ingredients Sofosbuvir, Velpatasvir
Medicine Name Eviplera 200 mg/25 mg/245 mg film-coated tablets Active Ingredients Emtricitabine, Rilpivirine Hydrochloride, Tenofovir disoproxil fumarate
Medicine Name Genvoya 150mg/150mg/200mg/10mg film coated tablets Active Ingredients Cobicistat, Elvitegravir, Emtricitabine, Tenofovir alafenamide fumarate
Medicine Name Harvoni 90 mg/400 mg film-coated tablets Active Ingredients Ledipasvir, Sofosbuvir
Medicine Name Hepsera 10 mg tablets Active Ingredients Adefovir dipivoxil
Medicine Name Odefsey 200 mg/25 mg/25 mg film-coated tablets Active Ingredients Emtricitabine, Rilpivirine Hydrochloride, Tenofovir alafenamide fumarate
Medicine Name Sovaldi 400 mg film coated tablets Active Ingredients Sofosbuvir
Medicine Name Stribild 150 mg/150 mg/200 mg/245 mg film coated tablets Active Ingredients Cobicistat, Elvitegravir, Emtricitabine, Tenofovir disoproxil fumarate
Medicine Name Truvada film-coated tablets Active Ingredients Emtricitabine, Tenofovir disoproxil fumarate
Medicine Name Tybost 150mg film coated tablets Active Ingredients Cobicistat
Medicine Name Vemlidy 25 mg film coated tablets Active Ingredients Tenofovir alafenamide fumarate
Medicine Name Viread 245 mg film-coated tablets Active Ingredients Tenofovir disoproxil fumarate
Medicine Name Vosevi 400 mg/100 mg/100 mg film coated tablets Active Ingredients Sofosbuvir, Velpatasvir, Voxilaprevir
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
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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 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 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 4.6 - 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 SmPC

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 SmPC

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 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

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 SmPC

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 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 20 June 2018 PIL

Reasons for updating

  • Change to section 6 - marketing authorisation holder

Updated on 5 June 2018 SmPC

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 SmPC

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 SmPC

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

$0·Section 4.3 toclarify the mechanism of interaction (CYP3A) for drugs contraindicated withthese products, and to inform that the list of contraindicated drugs is notall-inclusive.$0$0·Reference toVitekta/elvitegravir (EVG) as single agent as this product has been withdrawnfrom the EU market.$0$0·Reference totelapravir as this product has also been withdrawn from the EU market.$0$0·Upon request from theCHMP, some references to ‘tenofovir disoproxil fumarate’ have been replaced by‘tenofovir disoproxil’ (specification of the salt removed) $0

Updated on 8 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 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 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 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

$0$0Extensionof indication to include the treatment of HIV-1 infection in adolescentsaged 12 to < 18 years weighing ≥ 35 kg who are infected with HIV-1 withoutknown mutations associated with resistance to any of the threeantiretroviral agents in Stribild and who have experienced toxicitieswhich preclude the use of other regimens that do not contain tenofovirdisoproxil fumarate (TDF). As a consequence, sections 4.1, 4.2, 4.4, 4.8,5.1 and 5.2 were updated based on pharmacokinetics, safety and efficacydata through 48 weeks of treatment with Stribild in Study GS-US-236-0112$0$0$0·Update to section4.5 with data from Study GS-US-292-1316 (sertraline drug-drug interaction data)$0$0$0Updateto section 4.8 to correct an error that had been introduced during aprevious procedure for Stribild$0$0

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 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

Updates to section 4.4 and 4.5 to include data on co-administration with sofosbuvir/velpatasvir

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 SmPC

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

$0$0Update to sections 4.5 with the PRAC adopted wording on interaction between cobicistat (COBI)-containing products and corticosteroids$0$0

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 SmPC

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

$0·Section 4.4 Special warnings and precautions foruse - reference co-administration with TAF$0

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 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



·         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 SmPC

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

• Update of section 4.5 of the SmPC, upon request by the CHMP/PRAC following the assessment of PSUSA/00010082/201502, with carbamazepine drug-drug interaction data from Study GS-US-216-0137.
• 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 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 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 4.4 & 4.8:

- 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 SmPC

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

Section 4.4:

- 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 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 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 4.4 & 4.8:

- Removal of the warnings related to lactic acidosis

Section 10:

- Change to the date of revision to May 2015

Updated on 22 June 2015 SmPC

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 22 June 2015 PIL

Reasons for updating

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

Updated on 3 September 2014 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 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 of the SmPC:

- 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 SmPC

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

• Updates to sections 4.8 and 5.1 with interim 48 weeks data from the following three antiretroviral regimen switch studies:
- 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 SmPC

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 SmPC

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

None provided

Updated on 16 December 2013 PIL

Reasons for updating

  • New PIL for medicines.ie