Tybost 150mg film coated tablets
- Name:
Tybost 150mg film coated tablets
- Company:
Gilead Sciences Ltd
- Active Ingredients:
- Legal Category:
Product subject to medical prescription which may not be renewed (A)
Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 02/07/20
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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 2 July 2020 PIL
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 2 July 2020 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)
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 3 June 2020 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 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may not be renewed (A)
Updated on 3 June 2020 PIL
Reasons for updating
- Change to section 2 - pregnancy, breast feeding and fertility
- Change to section 6 - date of revision
Updated on 23 March 2020 SmPC
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- Change to section 4.2 - Posology and method of administration
- Change to section 4.5 - 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 PIL
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 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
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 PIL
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 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
- 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 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 14 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)
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 5 June 2018 PIL
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 4 May 2018 PIL
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 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 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
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
- 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 7 March 2018 PIL
Reasons for updating
- New PIL for new product
Updated on 16 March 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
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 13 May 2016 SmPC
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 5 May 2016 PIL
Reasons for updating
- Change to further information section
- Change to date of revision
Updated on 9 June 2015 SmPC
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 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 PIL
Reasons for updating
- Change to date of revision
- Change to name of manufacturer
Updated on 2 December 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
• Change to the date of revision in section 10 to October 2014
Updated on 29 August 2014 SmPC
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
• Change to the date of revision in section 10 to July 2014
Updated on 26 August 2014 PIL
Reasons for updating
- Change to date of revision
Updated on 7 April 2014 SmPC
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 6.1 - update the designation of the excipients
- Section 10 - change to date of revision
Updated on 28 March 2014 PIL
Reasons for updating
- Change to drug interactions
- Change to date of revision
Updated on 9 October 2013 SmPC
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
Updated on 7 October 2013 PIL
Reasons for updating
- New PIL for new product