HBV Ab testing should be done before initiating therapy. Use only for PrEP & PEP as part of a comprehensive prevention strategy including other preventive measures because it is not always effective in preventing HIV-1 acquisition; on individuals w/ confirmed HIV -ve to reduce the risk of acquiring HIV-1. Delay starting PrEP for at least 1 mth if clinical symptoms consistent w/ acute viral infection is present & recent (<1 mth) HIV-exposure is suspected. Repeat HIV-1 screening tests for at least every 3 mth while on use for PrEP or PEP. Discontinue PrEP if symptoms consistent w/ acute HIV-1 infection develop following a potential exposure event until -ve infection status is confirmed. Patients w/ estimated GFR <50 mL/min, or in long-term diabetes, uncontrolled HTN & renal failure. Should not be used for PrEP or PEP in HIV-1 uninfected individuals w/ estimated CrCl <60 mL/min; undertake quarterly creatinine testing during the 1st 12 mth & annually thereafter. May affect bone metabolism. Has anti-HBV activity when used in antiretroviral combination therapy to control HIV infection. Not indicated for the treatment of chronic HBV infection. Discontinuation of treatment may be associated w/ severe acute exacerbations of hepatitis in patients co-infected w/ HIV & HBV. Treatment discontinuation is not recommended in patients w/ advanced liver disease or cirrhosis since post-treatment exacerbation of hepatitis may lead to hepatic decompensation. Lactic acidosis may occur after a few to several mth of treatment. Increase in wt, & levels of blood lipid & glucose may occur during therapy. Mitochondrial dysfunction. Stop treatment immediately if clinical signs, symptoms or lab abnormalities suggestive of pancreatitis occur. May develop opportunistic infections & other complications of HIV infection. Inflammatory reaction to asymptomatic or residual opportunistic pathogens may arise & cause serious clinical conditions or aggravation of symptoms in HIV infected patients w/ preexisting severe immune deficiency. Autoimmune disorders (eg, Grave's disease) may occur in the setting of immune reactivation. Osteonecrosis may occur in patients w/ advanced HIV-disease &/or long-term exposure to combination antiretroviral therapy. Residual risk of sexual transmission cannot be excluded. Re-evaluate renal function w/in 1 wk including measurements of blood glucose, blood K & urine glucose conc if serum phosphate is <1.5 mg/dL (0.48 mmol/L) or CrCl is decreased to <50 mL/min. Do not give w/ any other medicinal products containing tenofovir disoproxil, adefovir dipivoxil, lamivudine or emtricitabine. Coadministration w/ didanosine & cladribine is not recommended. High rate of virological failure & emergence of resistance at early stage in HIV patients in combination as a once-daily regimen w/ abacavir or didanosine. Avoid concurrent use w/ nephrotoxic agents (eg, aminoglycosides, amphotericin B, foscarnet, ganciclovir, pentamidine, vancomycin, cidofovir or interleukin-2). Concomitant use w/ NSAIDs; ritonavir or cobicistat boosted PI; ledipasvir/sofosbuvir. Do not initiate in patients w/ moderate or severe renal impairment (CrCl < 50 mL/min). Not recommended in patients who require haemodialysis. Pregnancy & lactation. Elderly. Child <10 yr & adolescent <30 kg.
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