Viread 245 mg film-coated tablets

  • Name:

    Viread 245 mg film-coated tablets

  • Company:
    info
  • Active Ingredients:

    Tenofovir disoproxil fumarate

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 02/05/19

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Summary of Product Characteristics last updated on medicines.ie: 2/5/2019

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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 2 May 2019 PIL

Reasons for updating

  • Change to section 2 - use in children and adolescents
  • Change to section 2 - excipient warnings
  • Change to section 6 - date of revision

Updated on 2 May 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
  • 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 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 7 August 2018 PIL

Reasons for updating

  • Change to section 6 - marketing authorisation holder

Updated on 6 August 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 Viread 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),
  • Updates to Annex IIIA Section 11 (Name and Address of the Marketing Authorisation Holder),
  • Updates to Patient Information Leaflet (PIL) Section 6 (Contents of the pack and other information; Marketing Authorisation Holder) and PIL Section 6 Legal Representative details (change of contact information for Ireland, Bulgaria, Croatia, Hungary, Malta, Romania and Slovenia) - with regards to the provision of scientific service.

Updated on 5 July 2017 PIL

Reasons for updating

  • New PIL for new product

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 8 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 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

$0·Updateto sections 4.4 and 4.5 with data from studies GS-US-342-1167/1326 and fromstudy GS-US-377-1501$0$0·Administrativeedit in section 4.8$0

Updated on 8 June 2017 SmPC

Reasons for updating

  • New SmPC for new product

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

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 26 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$0Type II variation to update SmPC section 5.1 based on new data from the final (Week 192) CSR for Study GS-US-174-0115: a Randomised, Double-Blind Evaluation of the Antiviral Efficacy, Safety, and Tolerability of Tenofovir Disoproxil Fumarate Versus Placebo in Adolescents with Chronic Hepatitis B Infection.$0$0

Updated on 3 October 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

$0·Section 4.4 Specialwarnings and precautions for use - reference co-administration with TAF$0$0·Section 4.5Interaction with other medicinal products and other forms of interaction -reference co-administration with TAF $0$0 $0

Updated on 23 September 2016 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to drug interactions
  • 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 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

·         Section 4.4 of  

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

 

·         Section 4.8 and 5.1 
 

o    based on the final CSR (240 weeks) for Study GS-US-174-0121; a study evaluating the antiviral efficacy, safety and tolerability of tenofovir disoproxil fumarate (DF) monotherapy vs emtricitabine (FTC) plus tenofovir DF fixed-dose combination therapy in subjects with chronic hepatitis B who are resistant to lamivudine (LAM

Updated on 13 May 2016 PIL

Reasons for updating

  • 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 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:

- 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 4.8:

- Update to the tabulated summary of adverse reactions associated with tenofovir DF and to reflect the renal safety data from the extension phase of the study GS-US-104-0352 and also change the frequency of proximal renal tubulopathy (including Fanconi syndrome) from ‘rare’ to ‘uncommon’.

Section 10:

- Change to the date of revision to December 2015.

Updated on 27 January 2016 PIL

Reasons for updating

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

Updated on 24 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 3 June 2015 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

• Update to sections 4.8 and 5.1 with the 384 week (8 year) data from Study GS-US-174-102 and Study GS-US-174-103
• Change to the date of revision in section 10 to April 2015

Updated on 13 March 2015 PIL

Reasons for updating

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

Updated on 3 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 4 September 2014 SmPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text
  • Change to section 4.4 - Special warnings and precautions for use

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:

- 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 Viread should also be considered in case of progressive decline of renal function when no other cause has been identified.”

Section 4.8:

- Addition of information about proximal renal tubulopathy.

Section 10:

- 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 3 July 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

Updated on 4 November 2013 SmPC

Reasons for updating

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


·         Update to section 4.2 of the 245mg SmPC to allow daily dose adjustment in renal impairment

·         Section 5.1- Include the 288 week efficacy and resistance data from studies GS-US-174-0102 & GS-US-174-0103

·         Section 5.2- Update to incorporate minor correction of the “AUC” wording

·         Section 10- Date changed for the revision of the text

Updated on 30 October 2013 PIL

Reasons for updating

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

Updated on 6 September 2013 SmPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • 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
  • 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 4.8 & 5.1- Longer term (168 weeks) safety and efficacy data from study GS-US-174-0108 

·         Section 4.8- Update to the reporting of suspected adverse reactions section

·         Section 5.3- Addition of statement ‘The active substance tenofovir disoproxil fumarate and its main transformation products are persistent in the environment’ as previously agreed with the EMA / CHMP

·         Section 10- Date changed for the revision of the text

Updated on 3 September 2013 PIL

Reasons for updating

  • Change to date of revision
  • Addition of information on reporting a side effect.

Updated on 26 June 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 16 May 2013 SmPC

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • 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

Section 4.1:

Inclusion of the following:

  • include a new indication for the treatment of patients chronically infected with hepatitis B virus resistant to lamivudine.

Section 4.8

Patients with lamivudine‑resistant chronic hepatitis B:
No new adverse reactions to tenofovir disoproxil fumarate were identified from a randomised, double-blind study (GS‑US‑174‑0121) in which 280 lamivudine‑resistant patients received treatment with tenofovir disoproxil fumarate (n = 141) or emtricitabine/tenofovir disoproxil fumarate (n = 139) for 96 weeks.

Section 5.1

Inclusion of text describing the data for 'Experience in patients with lamivudine‑resistant chronic hepatitis B at 96weeks'

Section 10

Date changed to 04/2013 

Updated on 24 April 2013 PIL

Reasons for updating

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

Updated on 20 February 2012 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

In section 4.8 (undesirable effects) the following statement now states:

·        
The adverse reactions observed with continued treatment for 240 weeks were consistent with the safety profile of
tenofovir disoproxil fumarate. (192 weeks replaced with 240)

 

In section 5.1:

 

  • The 5 year efficacy and safety data from long term studies ‘0102 and ‘0103 has been included here.

 

In section 10:

 

  • the date of revision has been updated to January 2012

Updated on 9 January 2012 SmPC

Reasons for updating

  • Change due to harmonisation of SPC
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.1 - Therapeutic indications
  • Change to section 9 - Date of renewal of authorisation
  • 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

1. Administrative changes throughout the Viread SPC

2. Changes to the qualitative and quantitative composition section to now state “Each film-coated tablet contains 245mg of tenofovir disoproxil (as fumarate)” (Section 2)

3. In the therapeutic indications, removal of wording “aged 18 years and over” (Section 4.1)

4. Date changed for the latest renewal of authorisation (Section 9)

5. Date changed for the revision of the text (Section 10)

Updated on 6 January 2012 PIL

Reasons for updating

  • Change to date of revision
  • Change due to harmonisation of PIL

Updated on 3 January 2012 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

Change to Secton 10:

Date of revision to 08/2011

Updated on 30 August 2011 PIL

Reasons for updating

  • Change to, or new use for medicine
  • Change to warnings or special precautions for use
  • Change to further information section
  • Change to date of revision

Updated on 22 August 2011 SmPC

Reasons for updating

  • 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 4.6 - 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 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 3 – inclusion of statement of ‘dimensions 16.8 mm x 10.3 mm’

 

Section 4.1 – Update to indication statement to Viread is indicated in combination with other antiretroviral medicinal products for the treatment of HIV‑1 infected adults aged 18 years and over.

 

Section 4.2 – additional statements and amendments for the Posology section including:

 

Paediatric population: Viread is not recommended for use in children.

 

The clinical data available in HIV‑1 infected adolescents are inadequate to support the use of tenofovir disoproxil fumarate in this population (see sections 4.4 and 5.1) and no data are currently available in younger children.

 

No data are currently available in paediatric patients infected with chronic hepatitis B.

 

 

Section 4.4 – additional statements and amendments

 

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 300-1000 pregnancy outcomes) indicate no malformations or foetal/neonatal toxicity associated with tenofovir disoproxil fumarate. 

 

Animal studies do not indicate reproductive toxicity (see section 5.3).

 

The use of tenofovir disproxil fumurate may be considered during pregnancy, if necessary.

 

Breast‑feeding

Tenofovir has been shown to be excreted in human milk.  There is insufficient information on the effects of tenofovir in newborns/infants.  Viread should not be used during breast-feeding. 

 

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

 

Fertility

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

 

Age: Pharmacokinetic studies have not been performed in the elderly (over 65 years of age).

 

Gender: Limited data on the pharmacokinetics of tenofovir in women indicate no major gender effect.

 

Ethnicity: Pharmacokinetics have not been specifically studied in different ethnic groups.

 

 

Section 5.3 –

 

Non-clinical safety pharmacology studies reveal no special hazard for humans.  Repeat‑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 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.

 

 

Section 10 – Change to date of revisio

Updated on 18 August 2011 PIL

Reasons for updating

  • Change to, or new use for medicine
  • Change to information about pregnancy or lactation
  • Change to further information section
  • Change to date of revision

Updated on 5 August 2011 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

The following changes to the SPC are due to the 4 year (192 weeks) update for Viread studies 102 and 103.

 

  • Section 4.8: Undesirable effects – addition of the following statement ‘The adverse reactions observed with continued treatment for 192 weeks were consistent with the safety profile of tenofovir disoproxil fumarate’.

 

  • Section 5.1: Pharmacodynamic properties & Table 4: Efficacy parameters – Inclusion of the 192 week data

Updated on 9 June 2011 PIL

Reasons for updating

  • Change of manufacturer
  • Change to date of revision

Updated on 8 April 2011 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 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 5.3 - Preclinical safety data
  • Change to section 10 - Date of revision of the text

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

Free text change information supplied by the pharmaceutical company

This is an update to sections 4.2, 4.4, 4.6, 4.8 5.1, 5.2 and 5.3 of the SPC based on the 48-week results from study GS-US-104-0321 in treatment-experienced adolescents aged 12 to 18 years old:

Section 4.2

Inclusion of statement:

"The clinical data available in HIV‑1 infected adolescents are inadequate to support the use of tenofovir disoproxil fumarate in this population (see sections 4.4 and 5.1) and no data are currently available in younger children.

 

No data are currently available in paediatric patients infected with chronic hepatitis B".

Section 4.4

Inclusion of statement:

"Paediatric population: Viread may cause a reduction in BMD.  The effects of tenofovir disoproxil fumarate‑associated changes in BMD on long‑term bone health and future fracture risk are currently unknown (see section 5.1)".

Section 4.6

Inclusion of statement:

Fertility

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

Section 4.8

Inclusion of statement:

Assessment of adverse reactions is based on one randomised trial (study GS‑US‑104‑0321) in 87 HIV‑1 infected adolescent patients (aged 12 to < 18 years) who received treatment with tenofovir disoproxil fumarate (n = 45) or placebo (n = 42) in combination with other antiretroviral agents for 48 weeks (see section 5.1).

Section 5.1

Inclusion of summary for 
study GS‑US‑104‑0321

Section 5.2

Paediatric population

Steady‑state pharmacokinetics of tenofovir were evaluated in 8 HIV‑1 infected adolescent patients (aged 12 to < 18 years) with body weight ≥ 35 kg.  Mean (± SD) Cmax and AUCtau are 0.38 ± 0.13 μg/ml and 3.39 ± 1.22 μg·h/ml, respectively.  Tenofovir exposure achieved in adolescent patients receiving oral daily doses of tenofovir disoproxil 245 mg (as fumarate) was similar to exposures achieved in adults receiving once‑daily doses of tenofovir disoproxil 245 mg (as fumarate).

 

Pharmacokinetic studies have not been performed in children under 12 years or with renal impairment.


Section 10

Change of revision date to 03/2011

Updated on 19 November 2010 SmPC

Reasons for updating

  • Change to section 6.3 - Shelf life
  • Change to section 10 - Date of revision of the text

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Change to:

Section 6.3 - Shelf life is 5 years

Section 10 - change to revision date - 10/2010

Updated on 17 September 2010 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 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 10 - Date of revision of the text

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Section 4.1 - Addition of new indication:

 

  • decompensated liver disease

 

Section 4.4 (Liver Disease):

 

  • Safety and efficacy data are very limited in liver transplant patients.
  • There are limited data on the safety and efficacy of tenofovir disoproxil fumarate in HBV infected patients with decompensated liver disease and who have a Child‑Pugh‑Turcotte (CPT) score > 9.  These patients may be at higher risk of experiencing serious hepatic or renal adverse reactions.  Therefore, hepatobiliary and renal parameters should be closely monitored in this patient population.

 

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 ‘B’ contains the following statement in accordance with the new decompensated liver indication:

 

Patients with decompensated liver disease: The safety profile of tenofovir disoproxil fumarate in patients with decompensated liver disease was assessed in a double‑blind active controlled study (GS‑US‑174‑0108) in which patients received treatment with tenofovir disoproxil fumarate (n = 45) or emtricitabine plus tenofovir disoproxil fumarate (n = 45) or entecavir (n = 22) for 48 weeks.

 

In the tenofovir disoproxil fumarate treatment arm, 7% of patients discontinued treatment due to an adverse event; 9% of patients experienced a confirmed increase in serum creatinine of  0.5 mg/dl or confirmed serum phosphate of < 2 mg/dl through week 48; there were no statistically significant differences between the combined tenofovir‑containing arms and the entecavir arm. Subjects with a high baseline CPT score were at higher risk of developing serious adverse events (see section 4.4).

 

Hepatocellular carcinoma was diagnosed in 3 patients in the tenofovir disoproxil fumarate group and two patients in the tenofovir disoproxil fumarate group died during the study.’

 

 

 

Section 5.1:

 

Includes details of ‘Experience in patients with decompensated liver disease at 48 weeks’: Study GS‑US‑174‑0108

 

Section 10:

 

Change of date of revision to – 09/2010

 

 

Updated on 14 September 2010 PIL

Reasons for updating

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

Updated on 25 May 2010 SmPC

Reasons for updating

  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 10 - Date of revision of the text
  • Change to section 4.8 - Undesirable effects

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Update to
section 4.8 and 5.1:

 

  • to reflect the 144 week data from studies GS-US-174-0102 and GS-US-174-0103 in hepatitis B infected patients

Update to section 10:

Change to date of revision: 04/2010

 

 

 

 

Updated on 27 April 2010 PIL

Reasons for updating

  • Change to date of revision
  • Change to dosage and administration

Updated on 18 August 2009 SmPC

Reasons for updating

  • Change to section 10 - Date of revision of the text
  • Change to section 6.3 - Shelf life

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Update of section 6.3

  • to reflect the extension of the shelf-life of the finished product, as packaged for sale, from 36 months to 48 months for Viread

Update to Section 10

  • Change to date of revision of text: to 07/2009

Updated on 10 June 2009 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

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Update to Section 4.8:

  • to reflect the 96 weeks data from studies GS-US-174-0102 and GS-US-174-0103 in hepatitis B infected patients.

Update to Section 5.1:

  • to reflect the 96 weeks data from studies GS-US-174-0102 and GS-US-174-0103 in hepatitis B infected patients.
  • to reflect the 48 weeks data from study GS-US-174-0106, in hepatitis B infected patients receiving adefovir dipivoxil with persistent viral replication.

Update to Section 10:

  • Date of revision of text to April 2009

Updated on 11 May 2009 PIL

Reasons for updating

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

Updated on 24 November 2008 PIL

Reasons for updating

  • Change to date of revision
  • Addition of marketing authorisation holder

Updated on 28 October 2008 PIL

Reasons for updating

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

Updated on 28 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

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Section 4.4

Update to the statement in the SPC regarding bone effects to indicate that bone abnormalities associated with proximal renal tubulopathy may infrequently contribute to fractures. This update was based on a cumulative review of fractures and other unlisted bone events.

Update to the term Pneumocystis carinni pneumonia to Pneumocystis jiroveci pneumonia which is a more medically accepted term.
 
Section 4.8

Re-ordering of the adverse reactions under renal and urinary disorders under post-marketing experience in terms of seriousness in accordance with The Guideline on Summary of Product Characteristics (October 2005).

Inclusion of hypokalaemia, hepatic steatosis, rhabdomyolysis, and muscular weakness and inclusion of wording to indicate that osteomalacia may be manifested as bone pain and infrequently contribute to fractures. Hepatic steatosis has been added to section 4.8 for consistency as the event was already included in the section 4.4 of the SPC. The other additions were made following cumulative reviews on hypokalaemia, fractures and other unlisted bone events, and muscle events associated with proximal renal tubulopathy.

Inclusion of additional explanatory text to indicate that the adverse reactions of rhabdomyolysis, osteomalacia (manifested as bone pain and infrequently contributing to fractures), hypokalaemia, muscular weakness, 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.

Updated on 4 June 2008 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

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The major change is to include a new therapeutic indication for the treatment of chronic Hepatitis B in adults.  The full indication is shown below.

 

Change to Section 4.1 - Therapeutic indications

Hepatitis B infection: Viread is indicated for the treatment of chronic hepatitis B in adults with compensated liver disease, with evidence of active viral replication, persistently elevated serum alanine aminotransferase (ALT) levels and histological evidence of active inflammation and/or fibrosis.

 

This indication is based on histological, virological, biochemical and serological responses mainly in adult nucleoside-naïve patients with HBeAg positive and HBeAg negative chronic hepatitis B with compensated liver function.

 

As a result of this new indication the following sections of the SmPC 4.2, 4.4, 4.5,4.8 5.1 and 5.2 have been changed to reflect new warnings, efficacy and safety information with regard to the treatment of Hepatits B.  

Updated on 4 June 2008 PIL

Reasons for updating

  • Change to, or new use for medicine
  • Changes to therapeutic indications
  • Change due to user-testing of patient information

Updated on 23 April 2008 PIL

Reasons for updating

  • Change to further information section

Updated on 23 April 2008 SmPC

Reasons for updating

  • Change to section 6.5 - Nature and contents of container
  • Change to section 8 - MA number

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Changes to sections 6.5 and 8.

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

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Section 4.2 - Updated renal dosing guidelines and renal safety information
Section 4.4 - Updated renal dosing guidelines and renal safety information and non-renal CCSI changes

Updated on 18 June 2007 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to drug interactions

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 marketing authorisation holder address

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Section 4.4 - minor changes to wording; Section 4.5 - updated to include renal data; MAH address updated to reflect post code change as implemented by the post office.

Updated on 29 March 2007 PIL

Reasons for updating

  • Addition of marketing authorisation holder
  • Change to improve clarity and readability

Updated on 9 March 2007 PIL

Reasons for updating

  • Change to warnings or special precautions for use

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
  • Change to section 10 - Date of revision of the text

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Section 4.4 - Update to Osteonecrosis class wording
Section 4.8 - Update to Osteonecrosis class wording
Section 10 - Date of Revision of the Text

Updated on 9 May 2006 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 May 2006 PIL

Reasons for updating

  • Change to further information section

Updated on 7 June 2005 PIL

Reasons for updating

  • Change to further information section

Updated on 21 March 2005 SmPC

Reasons for updating

  • 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 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 6.1 - List of excipients
  • 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 18 March 2005 PIL

Reasons for updating

  • Change of inactive ingredient
  • Change to information about driving or using machinery
  • Change to side-effects

Updated on 4 January 2005 PIL

Reasons for updating

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

Updated on 4 January 2005 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 27 August 2004 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

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Updated on 27 August 2004 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 22 July 2004 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 6.4 - Special precautions for storage
  • Change to section 10 - Date of revision of the text

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Updated on 10 March 2004 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 5.2 - Pharmacokinetic properties
  • Change to section 5.3 - Preclinical safety data

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Updated on 5 December 2003 SmPC

Reasons for updating

  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 5.1 - Pharmacodynamic properties

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Updated on 11 August 2003 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

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

Updated on 17 July 2003 SmPC

Reasons for updating

  • Correction of spelling/typing errors

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

Updated on 25 June 2003 SmPC

Reasons for updating

  • New SPC for medicines.ie

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