Tybost 150mg film coated tablets *
Pharmacy Only: Prescription

  • Company:

    Gilead Sciences Ltd
  • Status:

    No Recent Update
  • Legal Category:

    Product subject to medical prescription which may not be renewed (A)
  • Active Ingredient(s):

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

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 21 October 2021

File name

Tybost IE & XI SmPC (September 2021)_1634806069.pdf

Reasons for updating

  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 6.1 - List of excipients

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

Free text change information supplied by the pharmaceutical company

Type II workshare variation to update the product information (PI) of Genvoya, Stribild and Tybost to include data on drug-drug interactions (DDI) between cobicistat-containing products and cutaneously-administered corticosteroids.

 

Gilead has also taken the opportunity to make the following changes:

  • Some minor linguistic amendments for Stribild, Tybost and Genvoya
  • addition of E-numbers of excipients for Genvoya, Stribild and Tybost

Updated on 21 October 2021

File name

Tybost IE & XI PIL (September 2021)_1634805970.pdf

Reasons for updating

  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 6 - what the product contains

Free text change information supplied by the pharmaceutical company

Type II workshare variation to update the product information (PI) of Genvoya, Stribild and Tybost to include data on drug-drug interactions (DDI) between cobicistat-containing products and cutaneously-administered corticosteroids.

 

Gilead has also taken the opportunity to make the following changes:

  • Some minor linguistic amendments for Stribild, Tybost and Genvoya
  • addition of E-numbers of excipients for Genvoya, Stribild and Tybost

Updated on 27 September 2021

File name

Tybost PIL IE-XI - September 2021_1632739545.pdf

Reasons for updating

  • Change to other sources of information section

Updated on 02 July 2020

File name

Tybost UK (Ireland and Malta) PIL - May 2020_1593706815.pdf

Reasons for updating

  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 2 - excipient warnings

Free text change information supplied by the pharmaceutical company

Type II variation to include data on drug-drug interactions between Tybost and thienopyridines (CCDS v12 Category 2)

Update of sections 4.4 and 4.5 of the SmPC in order to add information regarding drug-drug interactions between cobicistat -containing products and thienopyridines

The proposed addition is based on a cumulative safety review conducted by MAH and related to the Pharmacovigilance Risk Assessment Committee recommendation dated June 2019 with regards to the interaction of clopidogrel with boosted antiviral HIV therapy leading to insufficient inhibition of platelet aggregation. The section 2 of the Package Leaflet is updated accordingly.

In addition, the amount of sunset yellow FCF aluminium lake (E110) per tablet in section 2 of the SmPC was corrected and Sodium wording was introduced to both the SmPC (section 4.4) and PIL (section 2).

Finally, the PI is brought in line with the latest QRD template version 10.1

Updated on 02 July 2020

File name

Tybost UK (Ireland and Malta) SmPC - May 2020_1593706429.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 to include data on drug-drug interactions between Tybost and thienopyridines (CCDS v12 Category 2)

Update of sections 4.4 and 4.5 of the SmPC in order to add information regarding drug-drug interactions between cobicistat -containing products and thienopyridines

The proposed addition is based on a cumulative safety review conducted by MAH and related to the Pharmacovigilance Risk Assessment Committee recommendation dated June 2019 with regards to the interaction of clopidogrel with boosted antiviral HIV therapy leading to insufficient inhibition of platelet aggregation. The section 2 of the Package Leaflet is updated accordingly.

In addition, the amount of sunset yellow FCF aluminium lake (E110) per tablet in section 2 of the SmPC was corrected and Sodium wording was introduced to both the SmPC (section 4.4) and PIL (section 2).

Finally, the PI is brought in line with the latest QRD template version 10.1

Updated on 03 June 2020

File name

Tybost - SmPC - May 2020_1591189160.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 4.6 - 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)

Updated on 03 June 2020

File name

Tybost - PIL - May 2020_1591189109.pdf

Reasons for updating

  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 6 - date of revision

Updated on 23 March 2020

File name

Tybost - SmPC - March 2020_1584982277.pdf

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.5 - 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

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

Updated on 23 March 2020

File name

Tybost - PIL - March 2020_1584982220.pdf

Reasons for updating

  • Change to Section 1 - what the product is
  • Change to section 1 - what the product is used for
  • Change to section 3 - use in children/adolescents
  • Change to section 3 - how to take/use

Updated on 16 April 2019

File name

Tybost_PIL_Apr 2019_1555377026.pdf

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

File name

Tybost_SmPC_Apr 2019_1555377098.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 4.6 - 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

Update to Sections 4.2, 4.4, 4.6 of the SmPC for Tybost to recommend to not initiate darunavir/cobicistat (DRV/co) during pregnancy, and to switch to an alternative regimen (DRV/ritonavir may be considered as an alternative) for women who become pregnant during therapy with DRV/co in alignment with the SmPCs for Prezista and Rezolsta (Janssen products). The Janssen SmPCs were updated based on data from study TMC114HIV3015. This study has showed that treatment with DRV/co in pregnant women resulted in lower darunavir and cobicistat exposures during the second and third trimesters of pregnancy compared to postpartum.

 

Section 4.6 of the SmPC for Tybost was also updated in respect to atanazavir/cobisistat use during pregnancy to align with the SmPC for Evotaz (BMS product).

 

The Package Information Leaflet (PIL) for all three products was updated accordingly.

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.

Updated on 10 August 2018

File name

Tybost_PIL_Jul2018_1533895695.pdf

Reasons for updating

  • 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 6 - date of revision
  • Removal of Black Inverted Triangle

Updated on 10 August 2018

File name

Tybost_SmPC_Jul2018_1533895042.pdf

Reasons for updating

  • Change to section 4.3 - Contraindications
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.7 - Effects on ability to drive and use machines
  • 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 14 June 2018

File name

Tybost_SmPC_Jun2018.docx

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 14 June 2018

File name

Tybost_PIL_Jun2018.pdf

Reasons for updating

  • Change to section 6 - marketing authorisation holder

Updated on 05 June 2018

File name

Tybost_SmPC_May2018.docx

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)

Free text change information supplied by the pharmaceutical company

Following submission of PSUR 6 (reporting period 27 Aug 2016 to 26 Aug 2017), the PRAC adopted a recommendation to update section 4.3 and section 4.5 of the SmPC a contraindication of co-administration with lurasidone. The Package leaflet was updated accordingly in Section 2

Updated on 05 June 2018

File name

Tybost PIL - May 2018.pdf

Reasons for updating

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

Updated on 04 May 2018

File name

Tybost PIL - January 2018.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 6 - marketing authorisation holder

Updated on 08 March 2018

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 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 10 - Date of revision of the text

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

Free text change information supplied by the pharmaceutical company

$0·Section 4.3 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 has been removed as this product has also been withdrawn from the EUmarket.$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 08 March 2018

Reasons for updating

  • New SPC for new product

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

Updated on 07 March 2018

Reasons for updating

  • Change to section 1 - what the product is used for
  • Change to section 2 - what you need to know - contraindications
  • Change to section 6 - date of revision
  • Change to other sources of information section

Updated on 07 March 2018

File name

PIL_15858_991.pdf

Reasons for updating

  • New PIL for new product

Updated on 16 March 2017

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

$0$0Updateto sections 4.5 with the PRAC adopted wording on interaction betweencobicistat (COBI)-containing products and corticosteroids.$0$0Streamliningthe text in SmPC section 4.4 to remove the reference toelvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate inconsideration of the approval of Genvoya(elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide) and otherCOBI-containing products$0$0

Updated on 06 March 2017

Reasons for updating

  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 6 - date of revision

Updated on 13 May 2016

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)

Free text change information supplied by the pharmaceutical company



Type II worksharing variation to submit the final CSR for Study GS-US-236-0118 “A Phase 3 Open-label Safety Study of Cobicistat-containing Highly Active Antiretroviral Regimens in HIV-1 Infected Patients with Mild to Moderate Renal Impairment, in fulfillment of a PAM.

 

Section 4.8 of the Tybost SmPC to include 96 week data from the study. Gilead took the opportunity to implement some minor administrative changes to the Tybost SmPC

Updated on 05 May 2016

Reasons for updating

  • Change to further information section
  • Change to date of revision

Updated on 09 June 2015

Reasons for updating

  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 6.3 - Shelf life
  • Change to section 10 - Date of revision of the text

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

Free text change information supplied by the pharmaceutical company

• Section 4.5 – updated with data from the final study reports for the two drug-drug interaction studies GS-US-216-0136 and GS-US-216-0137
• Section 6.3 – shelf life change from 2 years to 4 years
• Section 10 - change to the date of revision to May 2015

Updated on 13 March 2015

Reasons for updating

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

Updated on 02 December 2014

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 144 week safety and efficacy data from Study GS-US-216-0114
• Change to the date of revision in section 10 to October 2014 

Updated on 29 August 2014

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • 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

• Updates to sections 4.2 and 4.8 of the SmPC with interim 48 weeks data from study GS-US-236-0118
• Change to the date of revision in section 10 to July 2014 

Updated on 26 August 2014

Reasons for updating

  • Change to date of revision

Updated on 07 April 2014

Reasons for updating

  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 6.1 - List of excipients
  • 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 - update based on a phase 1 study (GS-US-236-0135) evaluating the drug interaction potential between telaprevir (TVR) and cobicistat
- Section 6.1 - update the designation of the excipients
- Section 10 - change to date of revision

Updated on 28 March 2014

Reasons for updating

  • Change to drug interactions
  • Change to date of revision

Updated on 09 October 2013

Reasons for updating

  • New SPC for new product

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

Free text change information supplied by the pharmaceutical company

None provided

Updated on 07 October 2013

Reasons for updating

  • New PIL for new product