Truvada

Truvada

tenofovir + emtricitabine

Manufacturer:

Gilead Sciences

Distributor:

DCH Auriga - Healthcare
Concise Prescribing Info
Contents
Emtricitabine 200 mg, tenofovir disoproxil fumarate 300 mg
Indications/Uses
Treatment of HIV-1 infected adults in combination w/ other antiretroviral agents. Treatment of HIV-1 infected adolescents, w/ NRTI resistance or toxicities precluding the use of 1st line agents. In combination w/ safer sex practices for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 in adults & adolescents at high risk.
Dosage/Direction for Use
Treatment of HIV Adult & adolescent ≥12 yr, weighing at least 35 kg 1 tab once daily. Moderate renal impairment, CrCl 30-49 mL/min Recommended dosing interval for adult: Every 48 hr. Not recommended for use in individuals <18 yr w/ renal impairment. Prevention of HIV Adult & adolescent ≥12 yr, weighing at least 35 kg 1 tab once daily. Not recommended in HIV-1 uninfected adult w/ CrCl <60 mL/min. Not recommended for use in individuals <18 yr w/ renal impairment.
Administration
Should be taken with food:  
Contraindications
Hypersensitivity. Use for pre-exposure prophylaxis in individuals w/ unknown or positive HIV-1 status.
Special Precautions
Avoid use in antiretroviral-experienced patients w/ HIV-1 harbouring the K65R mutation. Use Truvada for PrEP only as part of an overall prevention strategy that includes other prevention measures. Use Truvada to reduce the risk of acquiring HIV-1 only 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. Risk of renal failure, renal impairment, elevated creatinine, hypophosphataemia & proximal tubulopathy (including Fanconi syndrome). Evaluate renal function prior to initiating treatment & monitor during therapy. Decreases in bone mineral density associated w/ use of tenofovir disoproxil. Risk of increase in wt & blood lipid & glucose levels; immune reactivation syndrome; osteonecrosis. 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/ 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. Rare hereditary problems of galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption. Lactation. Childn <18 yr. Elderly >65 yr.
Adverse Reactions
Nausea, diarrhoea; headache, dizziness; abdominal pain; elevated AST &/or ALT; asthenia. Emtricitabine: Elevated amylase including elevated pancreatic amylase, elevated serum lipase, vomiting, dyspepsia; neutropenia; allergic reaction; hyperglycaemia, hypertriglyceridaemia; insomnia, abnormal dreams; hyperbilirubinaemia; vesiculobullous rash, pustular rash, maculopapular rash, rash, pruritus, urticaria, skin discolouration (increased pigmentation); elevated creatine kinase; pain. Tenofovir disoproxil: Hypophosphataemia; vomiting; 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.
Presentation/Packing
Form
Truvada FC tab
Packing/Price
30's
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