tenofovir + emtricitabine


Gilead Sciences


DCH Auriga - Healthcare
Concise Prescribing Info
Emtricitabine 200 mg, tenofovir disoproxil fumarate 300 mg
Treatment of HIV-1 infected adults in antiretroviral combination therapy; HIV-1 infected adolescents w/ NRTI resistance or toxicities precluding the use of 1st line agents. Pre-exposure prophylaxis (PrEP) in combination w/ safer sex practices to reduce risk of sexually acquired HIV-1 in high risk adults & adolescents.
Dosage/Direction for Use
Treatment & prevention of HIV Adult & adolescent ≥12 yr, weighing at least 35 kg 1 tab once daily. Treatment of HIV Adult w/ moderate renal impairment (CrCl 30-49 mL/min) Recommended dosing interval: Every 48 hr.
Should be taken with food:  
Hypersensitivity. PrEP use in individuals w/ unknown or positive HIV-1 status.
Special Precautions
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.
Adverse Reactions
Nausea, diarrhea, vomiting; headache, dizziness; abdominal pain; elevated AST &/or ALT; rash; asthenia. Emtricitabine: Elevated amylase including elevated pancreatic amylase, elevated serum lipase, dyspepsia; neutropenia; allergic reaction; hyperglycaemia, hypertriglyceridaemia; insomnia, abnormal dreams; hyperbilirubinaemia; vesiculobullous rash, pustular rash, maculopapular rash, pruritus, urticaria, skin discolouration (increased pigmentation); elevated creatine kinase; pain. Tenofovir disoproxil: Hypophosphataemia; abdominal distension, flatulence.
Drug Interactions
Should not be administered concomitantly w/ other drugs containing emtricitabine, tenofovir disoproxil, tenofovir alafenamide or other cytidine analogues eg, lamivudine; adefovir dipivoxil. Not recommended w/ didanosine. Medicinal products that reduce renal function or compete for active tubular secretion (eg, cidofovir) may increase conc of emtricitabine, tenofovir, &/or the co-administered medicinal products. Avoid concurrent or recent use of nephrotoxic agent (eg, aminoglycosides, amphotericin B, foscarnet, ganciclovir, pentamidine, vancomycin, cidofovir or interleukin-2). Tenofovir disoproxil: Increased exposure w/ atazanavir/ritonavir, darunavir/ritonavir, lopinavir/ritonavir, ledipasvir/sofosbuvir, sofosbuvir/velpatasvir, sofosbuvir/velpatasvir/voxilaprevir. Increased exposure of didanosine.
MIMS Class
ATC Classification
J05AR03 - tenofovir disoproxil and emtricitabine ; Belongs to the class of antivirals for treatment of HIV infections, combinations.
Truvada FC tab
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