Increased risk for severe & potentially fatal hepatic adverse reactions in HIV patients co-infected w/ HBV or HCV. Treatment discontinuation in patients co-infected w/ HIV & HBV may be associated w/ severe acute exacerbations of hepatitis. Patients co-infected w/ HIV & HBV who discontinue treatment should be closely monitored w/ both clinical & lab follow-up for at least several mth after stopping treatment. Increased frequency of liver function abnormalities in patients w/ pre-existing liver dysfunction, including chronic active hepatitis. Consider interruption or discontinuation of treatment if there is evidence of worsening liver disease. Increase in wt & blood lipid & glucose levels may occur. Reports of mitochondrial dysfunction in HIV -ve infants following exposure
in utero &/or postnatally. Risk of immune reactivation syndrome. Opportunistic infections & other HIV complications may still develop. Reports of osteonecrosis, particularly in patients w/ advanced HIV disease &/or long-term exposure to combination antiretroviral therapy (CART). Increased risk of developing renal-related adverse reactions in patients taking tenofovir prodrugs who have impaired renal function & those taking nephrotoxic agents, including NSAIDs. Assess serum creatinine, estimated CrCl, urine glucose & protein in all patients prior to, when initiating, & during treatment; also assess serum P in patients w/ CKD. Discontinue treatment in patients who develop clinically significant decreases in renal function or evidence of Fanconi syndrome. Should not be co-administered simultaneously w/ Mg/Al-containing antacids or Fe supplements under fasted conditions. Not recommended for co-administration w/ atazanavir, 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. Generally avoid use in adults w/ ESRD (estimated CrCl <15 mL/min) on chronic haemodialysis, but may be used if potential benefits outweigh potential risks. Avoid treatment initiation in patients w/ estimated CrCl ≥15 & <30 mL/min, or <15 mL/min not on chronic haemodialysis. Not recommended in patients w/ severe hepatic impairment (Child-Pugh class C). Should be used during pregnancy only if potential benefit justifies potential risk to the foetus. Should not be used during breast-feeding. Safety & efficacy have not yet been established in childn <18 yr.
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