Emtricitabine with tenofovir disoproxil

That hold was recorded when the bundle held only the UK SPC for the THREE-component tablet 'Efavirenz/emtricitabine/tenofovir disoproxil 600 mg/200 mg/245 mg', whose dose could not be carried across to a two-component product. A later matcher fix replaced it: the bundle now holds the UK SPC for Truvada film-coated tablets, which is this page's named brand, its exact two-drug combination, its route, and both of its indications (HIV-1 treatment backbone and PrEP). PrEP SAFETY CONDITIONS FROM §4.3 AND §4.4, which belong with the dose: use for pre-exposure prophylaxis in individuals with unknown or positive HIV-1 status is CONTRAINDICATED; 'Truvada should only be used to reduce the risk of acquiring HIV-1 in individuals confirmed to be HIV negative', who 'should be re-confirmed to be HIV-negative at frequent intervals (e.g. at least every 3 months) using a combined antigen/antibody test while taking Truvada for pre-exposure prophylaxis'; 'HIV-1 resistance mutations have emerged in individuals with undetected HIV-1 infection who are only taking Truvada'; if clinical symptoms consistent with acute viral infection are present and recent (< 1 month) exposures to HIV-1 are suspected, 'use of Truvada should be delayed for at least one month and HIV-1 status reconfirmed before starting'; and it 'should only be used for pre-exposure prophylaxis as part of an overall HIV-1 infection prevention strategy including the use of other HIV-1 prevention measures (e.g. consistent and correct condom use, knowledge of HIV-1 status, regular testing for other sexually transmitted infections)'. Truvada 'is not always effective in preventing the acquisition of HIV-1' and 'The time to onset of protection after commencing Truvada is unknown.' RESISTANCE: 'Truvada should be avoided in antiretroviral-experienced patients with HIV-1 harbouring the K65R mutation.' HEPATITIS B: 'Discontinuation of Truvada therapy in patients infected with HBV may be associated with severe acute exacerbations of hepatitis. Patients infected with HBV who discontinue Truvada should be closely monitored with both clinical and laboratory follow-up for at least several months after stopping treatment'; in advanced liver disease or cirrhosis, discontinuation is not recommended. SEPARATE COMPONENTS: '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.' Some sections of the product information we used were incomplete — check the full SPC.

THIS IS A FIXED-DOSE COMBINATION TABLET WITH NO PER-KILOGRAM DOSE — dosePerKg is deliberately null and must stay null; weight enters only as the 35 kg threshold, not as a multiplier. §4.2 verbatim: 'Paediatric population: The safety and efficacy of Truvada in children under the age of 12 years have not been established (see section 5.2)', and 'Paediatrics with renal impairment: Not recommended for use in individuals under the age of 18 years with renal impairment (see section 4.4).' §4.1 restricts adolescent TREATMENT use to HIV-1 infected adolescents 'with NRTI resistance or toxicities precluding the use of first line agents', and adolescent PrEP use to those 'at high risk'. Verify any under-18 use against a children's formulary and specialist paediatric HIV advice.