Avoid use in antiretroviral-experienced patients w/ HIV-1 harbouring the K65R mutation. Should only be used for PrEP as part of an overall prevention strategy that includes other prevention measures. Should only be used to reduce the risk of acquiring HIV-1 in individuals confirmed to be HIV negative. Individuals should be re-confirmed to be HIV-negative at frequent intervals (eg, at least every 3 mth) while taking Truvada for PrEP. Increased risk for severe & potentially fatal hepatic adverse reactions in HIV-1 patients w/ chronic hepatitis B or C treated w/ antiretroviral therapy. Not approved for the treatment of chronic HBV infection. Increased frequency of liver function abnormalities during combination antiretroviral therapy in HIV-1 patients w/ pre-existing liver dysfunction including chronic active hepatitis. Risk of renal failure, renal impairment, elevated creatinine, hypophosphataemia & proximal tubulopathy (including Fanconi syndrome). Evaluate renal function prior to initiating treatment & monitor during therapy. Bone abnormalities in adults may be associated w/ proximal renal tubulopathy. Decreases in bone mineral density associated w/ use of tenofovir disoproxil in ped patients. Risk of increase in wt & blood lipid & glucose levels; immune reactivation syndrome; osteonecrosis. Reports of mitochondrial dysfunction in HIV negative infants exposed
in utero &/or postnatally to nucleoside analogues. Opportunistic infections & other HIV complications may continue to develop. Avoid concurrent or recent use of nephrotoxic medicinal product. Do not co-administer w/ other drugs containing emtricitabine, tenofovir disoproxil, tenofovir alafenamide, or other cytidine analogues eg, lamivudine; adefovir dipivoxil. Co-administration of tenofovir disoproxil w/ high dose or multiple NSAIDs; ritonavir or cobicistat boosted PI; ledipasvir/sofosbuvir, sofosbuvir/velpatasvir or sofosbuvir/velpatasvir/voxilaprevir; didanosine. Risk of virological failure & emergence of resistance w/ triple nucleoside therapy. Patients w/ rare hereditary problems of galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption. Not recommended as PrEP in HIV-1 uninfected adult w/ CrCl <60 mL/min; adult w/ moderate renal impairment (CrCl 30-49 mL/min). Not recommended as treatment &/or PrEP in adult w/ severe renal impairment (CrCl <30 mL/min) & undergoing haemodialysis. Not recommended for use in individuals <18 yr w/ renal impairment. Should not be used during breast-feeding. Childn <12 yr. Elderly >65 yr.
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