Truvada film-coated tablets
*Company:
Gilead Sciences LtdStatus:
No Recent UpdateLegal Category:
Product subject to medical prescription which may not be renewed (A)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 27 February 2024
File name
Truvada IE&XI PIL (February 2024).pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 27 February 2024
File name
Truvada IE&XI SmPC (February 2024).pdf
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)
File name
Prep_checklist_for_prescribers_leaflet.pdf
Reasons for updating
- Add New Doc
File name
PreP_reminder_card.pdf
Reasons for updating
- Add New Doc
File name
Important information about Truvada to reduce the risk of getting HIV infection.pdf
Reasons for updating
- Add New Doc
Updated on 07 February 2023
File name
Truvada IE & XI PIL (January 2023).pdf
Reasons for updating
- Change to section 1 - what the product is used for
- Change to section 2 - pregnancy, breast feeding and fertility
- Change to section 6 - what the product contains
Free text change information supplied by the pharmaceutical company
Modifications of the class labelling text related to HIV transmission and breastfeeding
Update to quantity of lactose excipient
Updated on 07 February 2023
File name
Truvada IE & XI SmPC (January 2023).pdf
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.6 - Pregnancy and lactation
- Change to section 6.1 - List of excipients
Legal category:Product subject to medical prescription which may not be renewed (A)
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Modifications of the class labelling text related to HIV transmission and breastfeeding
Update to quantity of lactose excipient
Updated on 20 May 2021
File name
Truvada XI & IE PIL (April 2021).pdf
Reasons for updating
- Change to other sources of information section
Updated on 20 May 2021
File name
Truvada XI & IE SmPC (April 2021).pdf
Reasons for updating
- Change to Section 4.8 – Undesirable effects - how to report a side effect
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 20 May 2021
File name
Truvada PIL - January 2021.pdf
Reasons for updating
- Change to other sources of information section
- Improved presentation of PIL
File name
3612_GIL_TruvadaPrepSafetyBrochure_IEVersion_V4.pdf
Reasons for updating
- Replace File
Free text change information supplied by the pharmaceutical company
Minor update - word ‘currently unknown’ updated to ‘uncertain’ in the following sentence: ‘The effects of TDF associated changes in BMD on long term bone health and future fracture risk are uncertain’.
File name
3612_GIL_TruvadaPrepSafetyBrochure_IEVersion_final.pdf
Reasons for updating
- Add New Doc
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Minor update to existing brochure - word ‘currently unknown’ replaced to ‘uncertain’ in the following sentence: ‘The effects of TDF associated changes in BMD on long term bone health and future fracture risk are uncertain’.
Updated on 19 January 2021
File name
Truvada SmPC - January 2021.pdf
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- Change to section 5.1 - Pharmacodynamic properties
Legal category:Product subject to medical prescription which may not be renewed (A)
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Truvada PSUR n#18, reporting period 03 April 2019 to 02 April 2020
During the procedure, Gilead was requested by the PRAC to update the Truvada Product Information (PI) Annexes to enhance the information on bone effects:
- Update to sections 4.4 and 5.1 of the SmPC
Administrative changes have also been made throughout the Truvada PI Annexes.
Updated on 19 January 2021
File name
Truvada PIL - January 2021.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
Free text change information supplied by the pharmaceutical company
Truvada PSUR n#18, reporting period 03 April 2019 to 02 April 2020
During the procedure, Gilead was requested by the PRAC to update the Truvada Product Information (PI) Annexes to enhance the information on bone effects:
- Update to section 2 of the patient information leaflet (PIL)
Administrative changes have also been made throughout the Truvada PI Annexes.
Updated on 10 September 2020
File name
Truvada SmPC - September 2020.pdf
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- 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 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 30 June 2020
File name
Truvada_PIL_June2020.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 6 - date of revision
Updated on 30 June 2020
File name
Truvada_SmPC_June2020.pdf
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)
Updated on 26 February 2020
File name
Truvada SmPC - Feb 2020.pdf
Reasons for updating
- Change to section 6.5 - Nature and contents of container
- Change to section 8 - Marketing authorisation number(s)
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 26 February 2020
File name
Truvada PIL - Feb 2020.pdf
Reasons for updating
- Change to section 6 - what the product looks like and pack contents
- Change to section 6 - date of revision
Updated on 16 May 2019
File name
Truvada PIL - Mar 2019.pdf
Reasons for updating
- Change to section 2 - pregnancy, breast feeding and fertility
Updated on 21 December 2018
File name
Truvada PIL -Dec 2018.pdf
Reasons for updating
- Change to section 2 - excipient warnings
Updated on 21 December 2018
File name
Truvada_SmPC_Dec 2018.pdf
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)
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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 08 October 2018
File name
Truvada_SmPC_Sep 2018.pdf
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
File name
Truvada_PIL_Jul2018.pdf
Reasons for updating
- Change to section 2 - interactions with other medicines, food or drink
Updated on 29 August 2018
File name
Truvada_SmPC_Jul2018.pdf
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
File name
Truvada_SmPC_Jun2018.docx
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
File name
Truvada PIL -Jun 2018.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
Updated on 14 February 2018
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 14 February 2018
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
Updated on 13 February 2018
File name
PIL_9443_625.pdf
Reasons for updating
- New PIL for new product
Updated on 13 February 2018
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 05 July 2017
Reasons for updating
- Change to section 6 - date of revision
- Change to other sources of information section
Updated on 13 June 2017
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
Updated on 06 June 2017
Reasons for updating
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 6 - date of revision
Updated on 06 April 2017
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
Updated on 03 April 2017
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 01 September 2016
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
Updated on 26 August 2016
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
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)
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· 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
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
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
- 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
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
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
- 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
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
- Removal of the warnings related to lactic acidosis
Section 10:
- Change to the date of revision to May 2015
Updated on 22 June 2015
Reasons for updating
- Change to warnings or special precautions for use
- Change to date of revision
Updated on 13 March 2015
Reasons for updating
- Change to date of revision
- Change to name of manufacturer
Updated on 02 February 2015
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
- 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
Reasons for updating
- Change to date of revision
- Introduction of new pack/pack size
Updated on 03 September 2014
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
- 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
Reasons for updating
- Change to warnings or special precautions for use
- Change to date of revision
Updated on 07 April 2014
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 02 April 2014
Reasons for updating
- Change to, or new use for medicine
- Change to date of revision
Updated on 01 April 2014
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 05 March 2014
Reasons for updating
- Change to date of revision
- Change to MA holder contact details
Updated on 11 July 2013
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
Reasons for updating
- Change to warnings or special precautions for use
- Change to date of revision
Updated on 08 March 2013
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
Updated on 05 March 2013
Reasons for updating
- Change to date of revision
Updated on 19 August 2011
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)
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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
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
Reasons for updating
- Change to date of revision
- Change to name of manufacturer
Updated on 07 December 2010
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)
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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
Updated on 07 December 2010
Reasons for updating
- Change to warnings or special precautions for use
- Change to date of revision
Updated on 17 September 2010
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
Reasons for updating
- Change to side-effects
- Change to date of revision
Updated on 27 April 2010
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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9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
10. DATE OF REVISION OF THE TEXT to 01/2010
Updated on 03 February 2010
Reasons for updating
- Change to date of revision
- Change due to harmonisation of patient information leaflet
Updated on 12 June 2009
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
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)
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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 30 January 2009
Reasons for updating
- Addition of marketing authorisation holder
Updated on 22 October 2008
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 07 July 2008
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
Updated on 07 July 2008
Reasons for updating
- Introduction of new pack/pack size
Updated on 01 April 2008
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
Reasons for updating
- Change to section 5.1 - Pharmacodynamic properties
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Free text change information supplied by the pharmaceutical company
Updated on 18 June 2007
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
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Free text change information supplied by the pharmaceutical company
Updated on 18 June 2007
Reasons for updating
- Change to warnings or special precautions for use
Updated on 17 May 2007
Reasons for updating
- Change to side-effects
- Addition of marketing authorisation holder
Updated on 29 March 2007
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
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Updated on 09 March 2007
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
Updated on 27 September 2006
Reasons for updating
- Change to side-effects
Updated on 15 May 2006
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
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
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
Reasons for updating
- New PIL for new product