Increased risk for severe & potentially fatal hepatic adverse reactions in HIV patients co-infected w/ HBV or HCV. Increased frequency of liver function abnormalities in patients w/ pre-existing liver dysfunction, including chronic active hepatitis. Increase in wt & blood lipid & glucose levels during antiretroviral therapy. Mitochondrial dysfunction in HIV-negative infants following exposure
in utero &/or postnatally. Immune reactivation syndrome. Opportunistic infections & other HIV complications may still develop. Osteonecrosis in patients w/ advanced HIV disease &/or long-term exposure to combination antiretroviral therapy (CART). Potential nephrotoxicity risk from chronic exposure to low tenofovir levels. Do not co-administer simultaneously w/ Mg/Al-containing antacids or Fe supplements under fasted conditions. Not recommended for co-administration w/ atazanavir, boceprevir, carbamazepine, ciclosporin (IV or oral use), oxcarbazepine, phenobarb, phenytoin, rifabutin, rifapentine, or sucralfate. Should not be co-administered w/ other antiretroviral medicinal products. May impair ability to drive or operate machinery. Not recommended in patients w/ CrCl <30 mL/min & in severe hepatic impairment (Child-Pugh Class C). Pregnancy. Should not be used during breast-feeding. Childn <18 yr.
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