Biktarvy 50 mg/200 mg/25 mg film-coated tablets | Doc History | Gilead Sciences Ltd

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Biktarvy 50 mg/200 mg/25 mg film-coated tablets

Name:
Biktarvy 50 mg/200 mg/25 mg film-coated tablets
Company:
Gilead Sciences Ltd
Active Ingredients:
Emtricitabine, Tenofovir alafenamide fumarate, Bictegravir sodium
Legal Category:
Product subject to medical prescription which may not be renewed (A)

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 30/04/21

Summary of Product Characteristics last updated on medicines.ie: 30/4/2021

This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions.

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Company Products

Medicine Name	Active 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 and 200 mg/50 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 and 45 mg/200 mg film-coated tablets	Active Ingredients Ledipasvir, Sofosbuvir
Medicine Name Hepsera 10 mg tablets	Active Ingredients Adefovir dipivoxil
Medicine Name Jyseleca 100 mg and 200 mg film-coated tablets	Active Ingredients Filgotinib
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 and 200 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 Veklury 100 mg powder for concentrate for solution for infusion	Active Ingredients Remdesivir
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

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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 30 April 2021 SPC

Reasons for updating

Change to section 6.3 - Shelf life
Change to section 6.4 - Special precautions for storage
Change to section 6.5 - Nature and contents of container
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

To add blister packaging for Biktarvy tablets, 30 and 90 film-coated tablet packs.

Sections of the SmPC updated: 6.3, 6.4, 6.5, 8 and 10
Annex III A: Outer carton for 30- tablet pack
                     Outer carton for 90- tablet pack
                     Intermediate carton for 90- tablet pack
                     7- tablet blister
                     2- tablet blister
Sections of the PIL updated: 3, 4, 5 and 6

Updated on 30 April 2021 PIL

Reasons for updating

Change to section 3 - how to take/use
Change to section 4 - possible side effects
Change to section 6 - what the product looks like and pack contents
Change to section 6 - marketing authorisation number

Free text change information supplied by the pharmaceutical company

^{To add blister packaging for Biktarvy tablets, 30 and 90 film-coated tablet packs.}

^{Sections of the SmPC updated: 6.3, 6.4, 6.5, 8 and 10

Annex III A: Outer carton for 30- tablet pack

                     Outer carton for 90- tablet pack

                     Intermediate carton for 90- tablet pack

                     7- tablet blister

                     2- tablet blister

Sections of the PIL updated: 3, 4, 5 and 6}

Updated on 18 December 2020 SPC

Reasons for updating

Change to section 4.8 - Undesirable effects

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 application, to update the Biktarvy product information with the adverse drug reaction Stevens-Johnson Syndrome (SJS). This variation is a result of the CCDS v6.0 Category 2. The product information has been updated as follows: SmPC section 4.8

Updated on 18 December 2020 PIL

Reasons for updating

Change to section 4 - possible side effects

Free text change information supplied by the pharmaceutical company

Updated on 25 November 2020 SPC

Reasons for updating

Change to section 4.8 - Undesirable effects

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

Updated on 25 November 2020 PIL

Reasons for updating

Change to section 4 - possible side effects

Updated on 25 November 2020 PIL

Reasons for updating

Change to section 4 - possible side effects

Updated on 4 November 2020 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 4.8 - Undesirable effects
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

Updated on 4 November 2020 PIL

Reasons for updating

Change to section 3 - how to take/use

Updated on 21 August 2020 SPC

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)

Updated on 10 June 2020 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)

Updated on 10 June 2020 PIL

Reasons for updating

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

Updated on 31 March 2020 SPC

Reasons for updating

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 5.3 - Preclinical safety data
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 31 March 2020 PIL

Reasons for updating

Change to section 2 - what you need to know - contraindications

Updated on 16 December 2019 SPC

Reasons for updating

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)

Updated on 15 July 2019 PIL

Reasons for updating

Change to section 2 - what you need to know - contraindications
Change to section 6 - date of revision

Updated on 15 July 2019 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

section 2 of the Patient Information Leaflet (PIL) in order to remove the recommendation for caution when methadone is co-administered with Biktarvy

Updated on 9 July 2019

Updated on 9 July 2019 SPC

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

Update to section 4.8 of SmPC to include urticaria and angioedema

Updated on 8 July 2019 PIL

Reasons for updating

Change to section 4 - possible side effects
Change to section 6 - date of revision

Updated on 8 July 2019 SPC

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

Update to section 4.8. of the SmPC, specifically tabulated list of adverse reactions to include angioedema and urticarial as additional adverse reactions, following a safety review conducted by Gilead, concluding the causal association of the two adverse reactions with TAF-containing products.

Updated on 27 May 2019 PIL

Reasons for updating

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

Updated on 25 May 2019 SPC

Reasons for updating

Change to section 4.8 - Undesirable effects
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

Variation submitted to update sections 4.8 and 5.1 of the SmPC with efficacy and safety information based on pooled 96-week data from two randomized, double-blind, active controlled studies GS-US-380-1489 and GS-US-380-1490 in HIV-1 infected, antiretroviral treatment-naïve adults receiving Biktarvy compared with each of the comparator treatment groups (i.e. pooled Biktarvy (BVY) vs abacavir /dolutegravir /lamivudine and pooled BVY vs dolutegravir + emtricitabine/tenofovir alafenamide).

The opportunity was also taken to include an administrative update to the PIL to align the warnings and precautions wording related to potential kidney problems with the warnings and precautions wording in the Odefsey PIL.

Updated on 31 October 2018 SPC

Reasons for updating

Change to section 4.4 - Special warnings and precautions for use
Change to section 4.8 - Undesirable effects

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

Updated on 31 August 2018 PIL

Reasons for updating

Change to section 6 - marketing authorisation holder

Updated on 31 August 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 3 July 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 3 July 2018 PIL

Reasons for updating

New PIL for new product