Descovy 200 mg/10 mg film-coated tablets

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 10/07/19

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Summary of Product Characteristics last updated on medicines.ie: 9/7/2019
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.

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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
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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 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)

Free text change information supplied by the pharmaceutical company

update to section 4.8 to include urticaria and angioedema

Updated on 25 June 2019 PIL

Reasons for updating

  • Change to section 2 - what you need to know - contraindications
  • Change to section 3 - how to take/use

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.

Some minor administrative amendments were also introduced throughout the product information for all three products as well as the implementation of some minor linguistic amendments (MLAs) to the translations of the respective product information annexes:
- Genvoya: DE, ES, FI, HR, HU, IS, IT, NO, SL and SV languages
- Descovy: DA, DE, ES, FR, HR, NL, NO, PT and SL languages
- Odefsey: CS, DE, LV, MT, NL, PL, SL and SV languages.

 

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 6 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 6 June 2018 PIL

Reasons for updating

  • Change to section 6 - marketing authorisation holder

Updated on 2 May 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 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 28 February 2018 SmPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • 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

$0TypeII variation to update the Descovy EU Product Information Annexes with datafrom the week 48 GS-US-311-1717 CSR.$0$0 $0$0Updates were made to Sections4.8 (Undesirable effects), 5.1 (Pharmacodynamic properties) and 5.2(Pharmacokinetic properties) of the Summary of Product Characteristics (SmPC)with no consequential updates to the Patient Information Leaflet (PIL).$0

Updated on 28 February 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 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

$0Section 4.5 (Interactionwith other medicinal products and other forms of interaction) of theSummary of Product Characteristics (SmPC) has been updated based on data from study AD-120-2045.$0$0$0

Updated on 20 September 2017 SmPC

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)

Free text change information supplied by the pharmaceutical company

 Section 6.3 Shelf life – changed from 2to 3 years

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 - how to report a side effect
  • 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

  • New PIL for new product

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 5 July 2017 SmPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • 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

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 

Updated on 6 June 2017 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

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

Free text change information supplied by the pharmaceutical company

Variation to update the product information (PI) annexes of the TDF- and TAF-containing products with data from Studies GS-US-342-1167/1326, two drug-drug interaction studies between Epclusa (sofosbuvir/velpatasvir; SOF/VEL) and HIV antiretroviral regimens. Sections 4.4 and 4.5 of the Summary of Product Characteristics (SmPC) and Section 2 of the Patient Information Leaflet (PIL) have been updated for Viread (all strengths), Truvada, Stribild and Atripla. Section 4.5 of the SmPC has been updated for Eviplera, Genvoya, Descovy and Odefsey.

 

Note, an administrative edit has been done in Section 4.8 of the SmPC for Viread for all strengths, Stribild, Atripla and Eviplera (not required for Truvada). This administrative update was required to align with the table ‘Tabulated summary of AR associated with ‘XXX’ based on clinical study and post marketing experience’.

 

We took the opportunity of this application to submit minor linguistics amendments

Updated on 7 April 2017 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 4.5 - 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
  • 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 of section 5.2 in order to provide the final results from Study GS-US-320-1615$0$0• Update of section 4.2 to allow for dosing in patients with severe hepatic impairment. $0$0• Section 4.4 was also updated with regards to a warning pertaining to the co-administration of emtricitabine/tenofovir alafenamide fumarate and other products containing tenofovir disoproxil, lamivudine or adefovir dipivoxil used for the treatment of Hepatitis B virus infection.$0$0• Sections 4.4 and 4.5 were also updated to remove the term “fumarate”.$0$0• Sections 4.8 and 5.1 updated to reflect the data submission of 96 week clinical study reports for Study GS-US-311-1089.$0$0$0$0$0• Administrative changes to section 5.1.$0$0$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 7 March 2017 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

$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$0Administrativeupdates to section 4.4 and 5.1.$0$0

Updated on 3 March 2017 PIL

Reasons for updating

  • 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 26 October 2016 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 4.5 - 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$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) and Section 2 of the Product Information Leaflet (PIL) with the MITOC class-labelling text approved in procedure EMEA/H/C/xxxx/WS/0792. The Product Information (PI) has been updated to QRDv10.$0$0$0

Updated on 20 October 2016 PIL

Reasons for updating

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

Updated on 4 May 2016 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 29 April 2016 PIL

Reasons for updating

  • New PIL for new product