Source: European Medicines Agency (EU) Revision Year: 2023 Publisher: Gilead Sciences Ireland UC, Carrigtohill, County Cork, T45 DP77, Ireland
Truvada is indicated in antiretroviral combination therapy for the treatment of HIV-1 infected adults (see section 5.1).
Truvada is also indicated for the treatment of HIV-1 infected adolescents, with NRTI resistance or toxicities precluding the use of first line agents (see sections 4.2, 4.4 and 5.1).
Truvada is indicated in combination with safer sex practices for pre-exposure prophylaxis to reduce the risk of sexually acquired HIV-1 infection in adults and adolescents at high risk (see sections 4.2, 4.4 and 5.1).
Truvada should be initiated by a physician experienced in the management of HIV infection.
Treatment of HIV in adults and adolescents aged 12 years and older, weighing at least 35 kg: One tablet, once daily.
Prevention of HIV in adults and adolescents aged 12 years and older, weighing at least 35 kg: One tablet, once daily.
Separate preparations of emtricitabine and tenofovir disoproxil are available for treatment of HIV-1 infection if it becomes necessary to discontinue or modify the dose of one of the components of Truvada. Please refer to the Summary of Product Characteristics for these medicinal products.
If a dose of Truvada is missed within 12 hours of the time it is usually taken, Truvada should be taken as soon as possible and the normal dosing schedule should be resumed. If a dose of Truvada is missed by more than 12 hours and it is almost time for the next dose, the missed dose should not be taken and the usual dosing schedule should be resumed.
If vomiting occurs within 1 hour of taking Truvada, another tablet should be taken. If vomiting occurs more than 1 hour after taking Truvada a second dose should not be taken.
No dose adjustment is required (see section 5.2).
Emtricitabine and tenofovir are eliminated by renal excretion and the exposure to emtricitabine and tenofovir increases in individuals with renal dysfunction (see sections 4.4 and 5.2).
Adults with renal impairment:
Truvada should only be used in individuals with creatinine clearance (CrCl) <80 mL/min if the potential benefits are considered to outweigh the potential risks. See Table 1.
Table 1. Dosing recommendations in adults with renal impairment:
| Treatment of HIV-1 infection | Pre-exposure prophylaxis | |
|---|---|---|
| Mild renal impairment (CrCl 50-80 mL/min) | Limited data from clinical studies support once daily dosing (see section 4.4). | Limited data from clinical studies support once daily dosing in HIV-1 uninfected individuals with CrCl 60-80 mL/min. Use is not recommended in HIV-1 uninfected individuals with CrCl <60 mL/min as it has not been studied in this population (see sections 4.4 and 5.2). |
| Moderate renal impairment (CrCl 30-49 mL/min) | Administration every 48 hours is recommended based on modelling of single-dose pharmacokinetic data for emtricitabine and tenofovir disoproxil in non-HIV infected subjects with varying degrees of renal impairment (see section 4.4). | Not recommended for use in this population. |
| Severe renal impairment (CrCl <30 mL/min) and haemodialysis patients | Not recommended because appropriate dose reductions cannot be achieved with the combination tablet. | Not recommended for use in this population. |
Paediatrics with renal impairment:
Not recommended for use in individuals under the age of 18 years with renal impairment (see section 4.4).
No dose adjustment is required in patients with hepatic impairment (see sections 4.4 and 5.2).
The safety and efficacy of Truvada in children under the age of 12 years have not been established (see section 5.2).
Oral administration. It is preferable that Truvada is taken with food.
The film-coated tablet can be disintegrated in approximately 100 mL of water, orange juice or grape juice and taken immediately.
If overdose occurs the individual must be monitored for evidence of toxicity (see section 4.8), and standard supportive treatment applied as necessary.
Up to 30% of the emtricitabine dose and approximately 10% of the tenofovir dose can be removed by haemodialysis. It is not known whether emtricitabine or tenofovir can be removed by peritoneal dialysis.
4 years.
Store in the original package in order to protect from moisture.
Keep the bottle tightly closed.
High density polyethylene (HDPE) bottle with a polypropylene child-resistant closure containing 30 film-coated tablets and a silica gel desiccant.
The following pack sizes are available: outer cartons containing 1 bottle of 30 film-coated tablets and outer cartons containing 60 (2 bottles of 30) and 90 (3 bottles of 30) film-coated tablets. Not all pack sizes may be marketed.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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