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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 18/12/20

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Summary of Product Characteristics last updated on medicines.ie: 18/12/2020
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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Gilead Sciences Ltd

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Medicine Name Biktarvy 50 mg/200 mg/25 mg film-coated tablets Active Ingredients Emtricitabine, Tenofovir alafenamide fumarate, Bictegravir sodium
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Medicine Name Descovy 200 mg/10 mg film-coated tablets Active Ingredients Emtricitabine, Tenofovir alafenamide fumarate
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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
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Medicine Name Sovaldi 400 mg and 200 mg film-coated tablets Active Ingredients Sofosbuvir
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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 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

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:PIL section 4

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

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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