Truvada film-coated tablets

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 16/05/19

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Summary of Product Characteristics last updated on medicines.ie: 21/12/2018

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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
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 16 May 2019 PIL

Reasons for updating

  • Change to section 2 - pregnancy, breast feeding and fertility

Updated on 21 December 2018 PIL

Reasons for updating

  • Change to section 2 - excipient warnings

Updated on 21 December 2018 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • 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

Sections 4.4 and 5.1 of the products SmPC have been updated with final safety data from Study GS-US-104-0352.

Updated on 8 October 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 29 August 2018 PIL

Reasons for updating

  • Change to section 2 - interactions with other medicines, food or drink

Updated on 29 August 2018 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

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

Updated on 14 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 14 June 2018 PIL

Reasons for updating

  • Change to section 6 - marketing authorisation holder

Updated on 14 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 14 February 2018 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 4.5 - 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

SPC updated to extend the indication for use of pre-exposure prophylaxis(PrEP) in adolescents aged 12 years and older, weighing at least 35Kg. 

Updated on 13 February 2018 PIL

Reasons for updating

  • New PIL for new product

Updated on 13 February 2018 PIL

Reasons for updating

  • Change to section 3 - use in children/adolescents
  • Change to section 6 - date of revision
  • Change to section 1 - what the product is used for
  • Change to section 3 - dose and frequency

Updated on 5 July 2017 PIL

Reasons for updating

  • Change to section 6 - date of revision
  • Change to other sources of information section

Updated on 13 June 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 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·Updateto sections 4.4 and 4.5 with data from studies GS-US-342-1167/1326 and fromstudy GS-US-377-1501$0

Updated on 6 June 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 6 April 2017 SmPC

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • 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 5.1 - 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

$0Change of indication to add ‘treatment ofHIV-1 infected adolescents, with NRTI resistance or toxicities precluding theuse of first line agents, aged 12 to < 18 years’$0

Updated on 3 April 2017 PIL

Reasons for updating

  • Change to section 1 - what the product is used for
  • Change to section 2 - use in children and adolescents
  • Change to section 3 - use in children/adolescents
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 1 September 2016 SmPC

Reasons for updating

  • Change to section 4 - Clinical particulars
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • 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 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 5 - Pharmacological properties
  • 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 7 - Marketing authorisation holder
  • 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 Section 4.1 (Therapeutic indications)– addition ofPrEP indication.$0$0·Update to Section 4.2 (Posology and method of administration) –dosing recommendations in individuals with renal impairment has been tabulated(Table 1) and PrEP specific wording has been included. Method of administrationhas been amended.$0$0·Update to Section 4.3 (Contraindications) and section 4.4(Special warnings and precautions for use) - addition of PrEP wording andrepositioning of text.$0$0·Update to Section 4.5 (Interaction with other medicinal productsand other forms of interaction) update to table 2 and text under concomitantuse.$0$0·Update to Section 4.7 (Effects on ability to drive and usemachines) and section 4.9 (Overdose) – “patients” changed to “individuals”.$0$0·Update to Section 4.8 (Undesirable effects) - addition of PrEPwording, removal of elderly wording. $0$0·Update to Section 5.1, 5.2 and 5.3 - addition of PrEP data$0$0·Update to Section 7 – ‘Limited’ changed to ‘Ltd’$0

Updated on 26 August 2016 PIL

Reasons for updating

  • Change to, or new use for medicine
  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to instructions about missed dose
  • Change to instructions about overdose
  • Change to side-effects
  • Change to drug interactions
  • Change to information about pregnancy or lactation
  • Change to information about driving or using machinery
  • Change to how the medicine works
  • Change to date of revision
  • Change to MA holder contact details

Updated on 17 May 2016 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 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 4.4

 

o    Revise the HIV class label wording on mitochondrial dysfunction following the review of existing data on mitochondrial toxicity including the Mitochondrial Toxicity in Children (MITOC) Study

o    The PILs were also updated accordingly

 

·         Sections 4.4 and 4.5  

o     Addition of a warning update to the safety information with the potential drug interaction of ledipasvir/sofosbuvir (LDV/SOF), as well as that of LDV and SOF as single agents with tenofovir disoproxil fumarate

o    The PILs were also updated accordingly

 

Updated on 13 May 2016 PIL

Reasons for updating

  • Change to side-effects
  • Change to drug interactions
  • Change to date of revision
  • Change to MA holder contact details

Updated on 15 February 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 January 2016.

Updated on 12 February 2016 PIL

Reasons for updating

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

Updated on 28 January 2016 SmPC

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)

Free text change information supplied by the pharmaceutical company

Section 4.4:

- Inclusion to state that the most pronounced decreases in bone mineral density were seen in patients treated with tenofovir DF as part of a regimen containing a boosted protease inhibitor, and also to advise that alternative treatment regimens should be considered for patients with osteoporosis that are at a high risk for fractures, in line with HIV European guidelines.

Section 10:

- Change to the date of revision to December 2015.

Updated on 23 June 2015 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:

- Removal of the warnings related to lactic acidosis

Section 10:

- Change to the date of revision to May 2015

Updated on 22 June 2015 PIL

Reasons for updating

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

Updated on 13 March 2015 PIL

Reasons for updating

  • Change to date of revision
  • Change to name of manufacturer

Updated on 2 February 2015 SmPC

Reasons for updating

  • Change to section 6.5 - Nature and contents of container
  • Change to section 10 - Date of revision of the text
  • 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

Section 5.1:

- Inclusion of a reference to the tenofovir resistance-associated substitution K70E.

Section 6.5:

- Updated to reflect the correct expression of pack sizes.

Section 10:

- Change to the date of revision to December 2014.

Updated on 28 January 2015 PIL

Reasons for updating

  • Change to date of revision
  • Introduction of new pack/pack size

Updated on 3 September 2014 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

Section 4.4 of the SmPC:

- Addition of safety information on the risk of renal injury in patients with risk factors for renal dysfunction after co-administration of non-steroidal anti-inflammatory drugs (NSAIDs) with tenofovir.
- Change of wording around the monitoring of renal function “In patients at risk for renal impairment consideration should be given to a more frequent monitoring of renal function is required.”/ “Interrupting treatment with Truvada should also be considered in case of progressive decline of renal function when no other cause has been identified.”

Section 4.8 of the SmPC:

- Addition of information about proximal renal tubulopathy.

Section 10 of the SmPC:

- Change to the date of revision to July 2014.

Updated on 28 August 2014 PIL

Reasons for updating

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

Updated on 7 April 2014 SmPC

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)

Free text change information supplied by the pharmaceutical company

·         Update to section 4.4 of the SmPC “Special warnings and precautions for use” to revise the wording regarding the risk of sexual transmission of HIV infection following CHMP request adopted in December 2013.

Updated on 2 April 2014 PIL

Reasons for updating

  • Change to, or new use for medicine
  • Change to date of revision

Updated on 1 April 2014 SmPC

Reasons for updating

  • 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 10 – Change to date of revision to February 2014

Updated on 5 March 2014 PIL

Reasons for updating

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

Updated on 11 July 2013 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 and 4.8 of the SPC have been updated to include the below wording:

 

·         “Autoimmune disorders (such as Graves’ disease) have also been reported to occur in the setting of immune reactivation; however, the reported time to onset is more variable and these events can occur many months after initiation of treatment”

 

- Additional changes to sections 4.4 and 4.8 are as follows:

 

  • Expression of combination antiretroviral therapy (CART) was amended throughout sections 4.4 and 4.8 of the SPC

 

Section 10

 

- Change to date of revision to May 2013

Updated on 21 June 2013 PIL

Reasons for updating

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

Updated on 8 March 2013 SmPC

Reasons for updating

  • 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 10: Date changed for the revision of the text to February 2013

Updated on 5 March 2013 PIL

Reasons for updating

  • Change to date of revision

Updated on 19 August 2011 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • 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 4.5 - Interaction with other medicinal products and other forms of interaction
  • 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 5.3 - Preclinical safety data
  • 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

pdate to:

 

  • Section 3 – inclusion of statement ‘of dimensions 19 mm x 8.5 mm’

 

  • Section 4.1 – Update to indication statement to ‘Truvada is a fixed dose combination of emtricitabine and tenofovir disoproxil fumarate.  It is indicated in antiretroviral combination therapy for the treatment of HIV‑1 infected adults aged 18 years and over.

 

  • Section 4.2 – additional statements for the Posology section

 

  • Section 4.4 – inclusion of a statement to the section on Co-administration of other medicinal products

 

 

 

Section 4.6 – Now titled ‘Fertility, pregnancy and lactation’

 

Update to the information in this section

 

Pregnancy

A moderate amount of data on pregnant women (between 300‑1,000 pregnancy outcomes) indicate no malformations or foetal/neonatal toxicity associated with emtricitabine and tenofovir disoproxil fumarate.  Animal studies on emtricitabine and tenofovir disoproxil fumarate do not indicate reproductive toxicity (see section 5.3).  Therefore the use of Truvada may be considered during pregnancy, if necessary.

 

Breast‑feeding

Emtricitabine and tenofovir have been shown to be excreted in human milk.  There is insufficient information on the effects of emtricitabine and tenofovir in newborns/infants.  Therefore Truvada should not be used during breast-feeding.

 

As a general rule, it is recommended that HIV infected women do not breast‑feed their infants under any circumstances in order to avoid transmission of HIV to the infant.

 

Fertility

No human data on the effect of Truvada are available.  Animal studies do not indicate harmful effects of emtricitabine or tenofovir disoproxil fumarate on fertility.

 

Section 5.1 – Inclusion of statement ‘Paediatric population: The safety and efficacy of Truvada in children under the age of 18 years have not been established.

 

Section 5.2

 

Inclusion of the following:

 

Gender: Emtricitabine and tenofovir pharmacokinetics are similar in male and female patients.

 

Ethnicity: No clinically important pharmacokinetic difference due to ethnicity has been identified for emtricitabine.  The pharmacokinetics of tenofovir have not been specifically studied in different ethnic groups.

 

Paediatric population: In general, the pharmacokinetics of emtricitabine in infants, children and adolescents (aged 4 months up to 18 years) are similar to those seen in adults.  Pharmacokinetic studies have not been performed with tenofovir in children and adolescents (under 18 years of age).

 

 

Section 5.3

 

Tenofovir disoproxil fumarate: Non‑clinical safety pharmacology studies on tenofovir disoproxil fumarate reveal no special hazard for humans.  Repeated dose toxicity studies in rats, dogs and monkeys at exposure levels greater than or equal to clinical exposure levels and with possible relevance to clinical use include renal and bone toxicity and a decrease in serum phosphate concentration.  Bone toxicity was diagnosed as osteomalacia (monkeys) and reduced bone mineral density (BMD) (rats and dogs).  The bone toxicity in young adult rats and dogs occurred at exposures ≥ 5‑fold the exposure in paediatric or adult patients; bone toxicity occurred in juvenile infected monkeys at very high exposures following subcutaneous dosing (≥ 40‑fold the exposure in patients).  Findings in the rat and monkey studies indicated that there was a substance-related decrease in intestinal absorption of phosphate with potential secondary reduction in BMD.

 

Genotoxicity studies revealed positive results in the in vitro mouse lymphoma assay, equivocal results in one of the strains used in the Ames test, and weakly positive results in an UDS test in primary rat hepatocytes.  However, it was negative in an in vivo mouse bone marrow micronucleus assay.

 

Oral carcinogenicity studies in rats and mice only revealed a low incidence of duodenal tumours at an extremely high dose in mice.  These tumours are unlikely to be of relevance to humans.

 

Reproductive toxicity studies in rats and rabbits showed no effects on mating, fertility, pregnancy or foetal parameters.  However, tenofovir disoproxil fumarate reduced the viability index and weight of pups in peri-postnatal toxicity studies at maternally toxic doses.

 

Combination of emtricitabine and tenofovir disoproxil fumarate: Genotoxicity and repeated dose toxicity studies of one month or less with the combination of these two components found no exacerbation of toxicological effects compared to studies with the separate components.

 

Section 10 – Change to date of revision

Updated on 16 August 2011 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to information about pregnancy or lactation
  • Change to further information section
  • Change to date of revision
  • Changes to therapeutic indications

Updated on 10 June 2011 PIL

Reasons for updating

  • Change to date of revision
  • Change to name of manufacturer

Updated on 7 December 2010 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 5.1 - 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

Change to:

 

  • Section 4.4 – with an additional warning about hepatic events as a manifestation of Immune Reconstitution syndrome in HIV infected patients co-infected with HBV
  • Deletions of all references to "zalcitabine" in Sections 4.4 and 5.1 of the SPC
  • Section 4.5 - has been reformatted
  • Section 10 - Change to date of revsion to 11/2010
– with an additional warning about hepatic events as a manifestation of Immune Reconstitution syndrome in HIV infected patients co-infected with HBV

Updated on 7 December 2010 PIL

Reasons for updating

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

Updated on 17 September 2010 SmPC

Reasons for updating

  • Change to section 4 - Clinical particulars
  • 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 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 4.4: Include the statement - 

Elderly:
Truvada has not been studied in patients over the age of 65. Elderly patients are more likely to have decreased renal function, therefore caution should be exercised when treating elderly patients with Truvada.


Section 4.5: Include statement - 


As a fixed combination, Truvada should not be administered concomitantly with other medicinal products containing any of the components, emtricitabine or tenofovir disoproxil fumarate (Viread, Emtriva or Atripla).

 

Truvada should not be administered concomitantly with adefovir dipivoxil.


Section 4.8:

 

This section has been completely modified. It includes a section on:

 

a) Summary of the safety profile

b) Tabulated Summary of Adverse Reactions

c) Description of selected adverse reactions

d) Paediatric population

e) Other special population(s)

 

Section 10:

 

Change of date of revision to – 08/2010

 

Updated on 15 September 2010 PIL

Reasons for updating

  • Change to side-effects
  • Change to date of revision

Updated on 27 April 2010 SmPC

Reasons for updating

  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text
  • Change to improve clarity and readability

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

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Change to:

9.       DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION



10.     DATE OF REVISION OF THE TEXT to 01/2010

Updated on 3 February 2010 PIL

Reasons for updating

  • Change to date of revision
  • Change due to harmonisation of patient information leaflet

Updated on 12 June 2009 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


  • In section 6.3, the shelf-life has been changed from 3 to 4 years.

    

  • In section 10, the date of revision has been updated to 05/2009

Updated on 30 January 2009 PIL

Reasons for updating

  • Addition of marketing authorisation holder

Updated on 30 January 2009 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 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

 

Section 4.2

  • The information on renal insufficiency has been updated. The first paragraph has been replaced with the following wording:        

Emtricitabine and tenofovir are eliminated by renal excretion and the exposure to emtricitabine and tenofovir increases in patients with renal dysfunction.  There are limited data on the safety and efficacy of Truvada in patients with moderate and severe renal impairment (creatinine clearance < 50 ml/min) and long term safety data has not been evaluated for mild renal impairment (creatinine clearance 50‑80 ml/min).  Therefore, in patients with renal impairment Truvada should only be used if the potential benefits of treatment are considered to outweigh the potential risks.  Patients with renal impairment may require close monitoring of renal function (see section 4.4).  Dose interval adjustments are recommended for patients with creatinine clearance between 30 and 49 ml/min.  These dose adjustments have not been confirmed in clinical studies and the clinical response to treatment should be closely monitored in these patients (see sections 4.4 and 5.2).

  • The table has been deleted and the information relating to mild, moderate and severe renal impairment and its associated creatinine clearance has been made clearer.

Section 4.4

  • The section on renal impairment has been updated to include the sentence

In patients at risk for renal impairment, including patients who have previously experienced renal events while receiving adefovir dipivoxil, consideration should be given to more frequent monitoring of renal function.

The paragraph immediately below this statement has been replaced with the following text:

Patients with renal impairment (creatinine clearance < 80 ml/min), including haemodialysis patients: Renal safety with Truvada has only been studied to a very limited degree in patients with impaired renal function (creatinine clearance < 80 ml/min).  Dose interval adjustments are recommended for patients with creatinine clearance 30‑49 ml/min (see section 4.2).  Limited clinical study data suggest that the prolonged dose interval is not optimal and could result in increased toxicity and possibly inadequate response.  Furthermore, in a small clinical study, a subgroup of patients with creatinine clearance between 50 and 60 ml/min who received tenofovir disoproxil fumarate in combination with emtricitabine every 24 hours had a 2‑4‑fold higher exposure to tenofovir and worsening of renal function (see section 5.2).  Therefore, a careful benefit-risk assessment is needed when Truvada is used in patients with creatinine clearance < 60 ml/min, and renal function should be closely monitored.  In addition, the clinical response to treatment should be closely monitored in patients receiving Truvada at a prolonged dosing interval.  The use of Truvada is not recommended in patients with severe renal impairment (creatinine clearance < 30 ml/min) and in patients who require haemodialysis since appropriate dose reductions cannot be achieved with the combination tablet (see sections 4.2 and 5.2).

The statement on dose interval adjustment has been deleted.

Section 5.2

         The information on renal impairment has been updated to include information from a sub-group of patients with creatinine clearance between 50 and 60ml/min from a small clinical trial.

 

Section 10 date updated to December 2008

Updated on 22 October 2008 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

§         Section 4.4

Information regarding bone effects added to indicate that bone abnormalities associated with proximal renal tubulopathy may infrequently contribute to fractures.

Information added regarding post-treatment exacerbations of hepatitis following discontinuation of therapy. This includes addition of a recommendation not to discontinue Truvada in patients with cirrhosis or advanced liver disease since post-treatment exacerbation of hepatitis may lead to hepatic decompensation.

The term Pneumocystis carinni pneumonia updated to Pneumocystis jiroveci pneumonia which is a more medically accepted term.

§         Section 4.8

Inclusion of hypokalaemia, rhabdomyolysis, and muscular weakness and inclusion of wording to indicate that osteomalacia may be manifested as bone pain and infrequently contribute to fractures. Section 4 of the Package Leaflet was amended accordingly. Additional explanatory text added to indicate that these adverse reactions as well as myopathy and hypophosphatemia may occur as a consequence of proximal renal tubulopathy and that these events are not considered to be causally associated with tenofovir disoproxil fumarate (tenofovir DF) therapy in the absence of proximal renal tubulopathy.

Hepatic steatosis has been added for consistency as the event was already included in the section 4.4 of the SPC.

Updated on 7 July 2008 PIL

Reasons for updating

  • Introduction of new pack/pack size

Updated on 7 July 2008 SmPC

Reasons for updating

  • Introduction of new pack/pack size

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

Free text change information supplied by the pharmaceutical company

Additional pack size of 90 Truvada tablets presented as 3 x 30 tablet bottles in a single carton.

Updated on 1 April 2008 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

Updated following approval of variation II-36

Updated on 28 August 2007 SmPC

Reasons for updating

  • 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 to ATC code from J05AF30 to J05AR03 in section 5.1 of the SPC

Updated on 18 June 2007 PIL

Reasons for updating

  • Change to warnings or special precautions for use

Updated on 18 June 2007 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 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

Section 6.3 - Increase in shelf life to 3 years
Section 4.2 - Update renal dosing guidelines and renal safety information
Section 4.4 - Update renal dosing guidelines and renal safety information, Non renal CCSI changes

Updated on 17 May 2007 PIL

Reasons for updating

  • Change to side-effects
  • Addition of marketing authorisation holder

Updated on 29 March 2007 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 MA holder contact details

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

Free text change information supplied by the pharmaceutical company

Section 4.4 - Minor change to wording of paragraph 4.
Section 4.5 - Updated to include review of renal data.
MAH address updated with new post code as provided by post office.

Updated on 9 March 2007 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)

Free text change information supplied by the pharmaceutical company

Sections 4.4 & 4.8 updated to include osteonecrosis class labeling

Updated on 27 September 2006 PIL

Reasons for updating

  • Change to side-effects

Updated on 15 May 2006 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 5.3 - Preclinical safety data

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

Updated on 29 November 2005 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

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

Updated on 15 April 2005 SmPC

Reasons for updating

  • New SPC for new product

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

Updated on 15 April 2005 PIL

Reasons for updating

  • New PIL for new product