Genvoya 150mg/150mg/200mg/10mg film coated tablets

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 08/08/19

files-icon(Click to Download)
Summary of Product Characteristics last updated on medicines.ie: 7/8/2019
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.

Click on this link to Download PDF directly

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
1 - 0 of 24 items.Total: Infinity pages

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 8 August 2019 PIL

Reasons for updating

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

Updated on 7 August 2019 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

Update to section 4.8 of SmPC to include suicidal ideation

Updated on 10 July 2019 PIL

Reasons for updating

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

Updated on 9 July 2019 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)

Updated on 26 June 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 4.8 - 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 25 June 2019 PIL

Reasons for updating

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

Updated on 25 June 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 4.8 - 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)

Free text change information supplied by the pharmaceutical company

Update of sections 4.2, 4.4, 4.8, 5.1 and 5.2 of the SmPC with data in patients on chronic haemodialysis from the Study GS-US-292-1825; this is a Phase 3b Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of E/C/F/TAF Fixed Dose Combination (FDC) in HIV-1 Infected Subjects on Chronic Haemodialysis.

The Patient information leaflet (PIL) for all three products was updated accordingly.

 

In addition, changes to the lactose wording for Genvoya and Odefsey were introduced and an administrative correction to the Genvoya Patient information leaflet (PIL) in order to add “lurasidone” to the second list of contra-indicated drugs appearing in the PIL was also introduced.
 

Updated on 6 June 2019 SmPC

Reasons for updating

  • 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

B.II.f.1.a.1 To reduce the shelf-life of the finished product as packaged for sale, from 36 months to 24 months

Updated on 16 April 2019 PIL

Reasons for updating

  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 2 - pregnancy, breast feeding and fertility

Updated on 15 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.

 

Updated on 15 November 2018 SmPC

Reasons for updating

  • Change to section 6.3 - Shelf life

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

Updated on 20 September 2018 SmPC

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 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

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

Updated on 8 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

Updated on 8 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 4.8 – Undesirable effects - how to report a side effect
  • Change to section 5.1 - Pharmacodynamic properties

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

Updated on 21 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 21 June 2018 PIL

Reasons for updating

  • Change to section 6 - marketing authorisation holder

Updated on 2 May 2018 SmPC

Reasons for updating

  • 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 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

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 27 December 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

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

Free text change information supplied by the pharmaceutical company

SPC

·        Sections 4.1, 4.2, 4.4, 4.8, 5.1 and 5.2 of the SmPC are updated based on the analysis of the paediatric study GS-US-292-0106 (Cohort 2).

Updated on 19 December 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 19 December 2017 PIL

Reasons for updating

  • Change to section 1 - what the product is used for
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 3 - how to take/use

Updated on 26 October 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

 Section 4.5 (Interaction with other medicinal products and other forms of interaction) of the Summary of Product Characteristics (SmPC) has been updated based on data from an in vitro study (AD-120-2045)

Updated on 6 September 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 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.3 - Preclinical safety data

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 4.4, 4.8 and 5.1 to provide 48 weeks data from Study GS-US-292-1249
  • Updates to section 4.5: deletion of telaprevir DDI due to the withdrawal of telaprevir from the EU
  • Updates to section 4.5 (in line with the CCDS): clarification that co-administration with other breast cancer resistance protein (BCRP) inhibitors (as well as P-glycoprotein [P-gp] inhibitors) is not expected to further increase TAF exposures . SmPC section 4.4 for DVY was also updated.
  • Updates to section 4.5 (in line with the CCDS): correction of the spelling of “norelgestromin”.
  • Updates to sections 4.4 and 4.5 (in line with the CCDS): added warning against the co-administration with TAF
  • Updates to sections 4.6, 5.1, 5.3 and throughout as needed: correction of abbreviations and/or formatting as needed in line with the CCDS and/or EU QRD template.

Updated on 22 August 2017 PIL

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 6 - manufacturer

Updated on 4 July 2017 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • 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 Section 4.8 and 5.1 of the SmPC withlong‑term clinical efficacy and safety data in HIV-infected, virologicallysuppressed adults with estimated glomerular filtration rate (eGFR) measured bythe Cockcroft-Gault formula (eGFRCG) 30 to 69 mL/min in Study GS-US-292-0112through 144 weeks of treatment; a category 4 study in the Risk Management Plan$0$0$0$0-  administrative update to the Genvoya SmPCSection 2 to correct the lactose content$0

Updated on 2 June 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

Section 4.5 of the SmPC has been updated

Updated on 7 April 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 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$0Updateof section 5.2 in order to provide the final results from StudyGS-US-320-1615$0$0$0·Section 4.4 was alsoupdated with regards to a warning pertaining to the co-administration ofemtricitabine/tenofovir alafenamide fumarate and other products containingtenofovir disoproxil, lamivudine or adefovir dipivoxil used for the treatmentof Hepatitis B virus infection.$0$0$0Sections4.4 and 4.5 were also updated to remove the term “fumarate”.$0$0

Updated on 5 April 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 8 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 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$0Updateto sections 4.8 and 5.1 per 144-Week clinical study reports for studiesGS-US-292-0104 and GS-US-292-0111.$0$0Updateto sections 4.5 with the PRAC adopted wording on interaction betweencobicistat (COBI)-containing products and corticosteroids.$0$0Administrativeupdates to section 4.4 and 5.1.$0$0

Updated on 3 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 24 January 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

$0Submission of final clinical study report (CSR) for Study GS-US-311-1790"A Phase 1, Randomized, Open Label, Drug Interaction Study Evaluating theEffect of Emtricitabine/Tenofovir Alafenamide Fixed-Dose Combination Tablet orGS-9883 on the Pharmacokinetics of a Representative Hormonal ContraceptiveMedication, Norgestimate/Ethinyl Estradiol".$0$0Section 4.5 of the Summary of Product Characteristics (SmPC)have been updated to reflect these data.$0

Updated on 20 October 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 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$0Submission of Week 96 data from Study GS-US-292-0112 “A Phase 3 Open-label Safety Study of Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide Single Tablet Regimen in HIV-1 Positive Patients with Mild to Moderate Renal Impairment”. Section 4.8 and 5.1 of the SmPC have been updated to reflect these data. $0$0Opportunity has been taken to update Section 4.4. of the Summary of Product Characteristics (SmPC) with the MITOC class-labelling text approved in procedure EMEA/H/C/xxxx/WS/0792. The Product Information (PI) has been updated to QRDv10 for Genvoya and Descovy. Minor linguistics amendments (MLAs) were submitted for Genvoya and Odefsey.$0$0

Updated on 19 October 2016 PIL

Reasons for updating

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

Updated on 21 September 2016 SmPC

Reasons for updating

  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 10 - Date of revision of the text
  • Correction of spelling/typing errors

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

Free text change information supplied by the pharmaceutical company

$0·Update to Section5.1 - addition of 96 Week efficacy and safety switch data from StudyGS-US-292-0109.$0

Updated on 19 September 2016 PIL

Reasons for updating

  • Change to date of revision
  • Change to MA holder contact details

Updated on 29 June 2016 SmPC

Reasons for updating

  • 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·Update to Section4.5 (Interaction with other medicinal products and other forms of interaction)updated the field in Table 1 headed Anti-hepatitis C virus medicinal productsto include a footnote for Tenofovir alafenamide which states 5Thisstudy was conducted using Genvoya.$0$0·Update to Section4.5 (Interaction with other medicinal products and other forms of interaction)updated the field in Table 1 headed ANTIDEPRESSANTS to include all componentsof Genvoya - Elvitegravir (150 mg once daily)/ Cobicistat (150 mg oncedaily)/ Emtricitabine (200 mg once daily)/ Tenofovir alafenamide (10 mg oncedaily) 5$0$0·Update to Section4.8(Undesirable effects) and 4.8(Undesirable effects) sub-heading Paediatric Population to include 48 Weekadolescent data.$0

Updated on 28 June 2016 PIL

Reasons for updating

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

Updated on 4 April 2016 SmPC

Reasons for updating

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



Update to sections 4.2, 4.8 and 5.1 of the SmPC with additional efficacy and safety interim data from studies GS-US-292-0104 and GS-US-292-0111 through 96 weeks of treatment.

Updated on 7 March 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 February 2016.

 

 

Updated on 3 March 2016 PIL

Reasons for updating

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

Updated on 27 November 2015 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

None provided

Updated on 26 November 2015 PIL

Reasons for updating

  • New PIL for new product