Odefsey 200 mg/25 mg/25 mg film-coated tablets

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 29/07/19

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Summary of Product Characteristics last updated on medicines.ie: 29/7/2019
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 29 July 2019 PIL

Reasons for updating

  • Change to date of revision

Updated on 29 July 2019 SmPC

Reasons for updating

  • Change to section 4.9 - Overdose
  • 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 4.9 to remove recommendation to use oral activated charcoal in the event of an overdose of rilpilvirine

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 angioedema and urticaria

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
  • 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)

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 5 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)

Free text change information supplied by the pharmaceutical company

Approval of MA Transfer application changing the Odefsey MA Holder (MAH) from Gilead Sciences International Ltd., Cambridge - UK (GSIL; ‘transferor’) to Gilead Sciences Ireland UC, Cork - Ireland (GSIUC; ‘transferee’) as a result of ‘BREXIT’. The full details of the new MAH is:

 

Gilead Sciences Ireland UC

Carrigtohill

County Cork, T45 DP77

Ireland

 

The application updates the product information annexes as follows:

 

  • Updates to the Summary of Product Characteristics (SmPC) Section 7 (Marketing Authorisation Holder),

Updated on 5 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
  • 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 3 April 2018 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·Updatesto the Summary of Product Characteristics (SmPC) sections 4.8 (Undesirableeffects) and 5.1 (Pharmacodynamic properties) with no consequentialupdates to the Patient Information Leaflet (PIL).$0

Updated on 3 April 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 3 January 2018 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 5.1 - 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$0Updatesto section 4.2 (Posology and method of administration), 4.4 (Specialwarnings and precautions for use), 4.6 (Fertility, pregnancy andlactation), 5.1 (Pharmacodynamic properties) 5.2 (Pharmacokineticproperties) in line with Study TMC114HIV3015, additional pregnancydata.$0$0

Updated on 3 January 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

·        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 4.8 – 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 10 July 2017 SmPC

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

Update Section 4.8 and 5.1 with long term clinical efficacy and safety data in HIV-infected, virologically suppressed adults with estimated glomerular filtration rate (eGFR) measured by the Cockcroft-Gault formula (eGFRCG) 30 to 69 mL/min in Study GS-US-292-0112 through 144 weeks of treatment; a category 4 study in the Risk Management Plan

Updated on 7 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 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

Updated on 8 March 2017 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 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$0Updateto sections 4.8, 5.1 and 5.2 per 48-Week clinical study reports for twoOdefsey switch studies GS-US-366-1216 and GS-US-366-1160. Note: datapertaining to two Eviplera 48-Week switch studies (GS-US-264-0106 [switchfrom a PI-containing regimen] and GS-US-264-0111 [switch from Atripla])were deleted.$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$0Administrativeupdate to section 4.4 to delete “as fumarate” from tenofovir disoproxil(as fumarate) when it appears as a warning$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 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$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 5.1 of the SmPC have been updated to reflect these data. $0$0

Updated on 11 August 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 9 August 2016 PIL

Reasons for updating

  • New PIL for new product