Insufficient data to justify use in patients w/ prior NNRTI failure. Caution when co-administered w/ medicinal products w/ known risk of Torsade de Pointes. Patients w/ chronic hepatitis B or C treated w/ antiretroviral therapy are at an increased risk for severe & potentially fatal hepatic adverse reactions. Patients co-infected w/ HIV & HBV who discontinue Odefsey should be closely monitored w/ both clinical & lab follow-up for at least several mth after stopping treatment. Increased frequency of liver function abnormalities during combination antiretroviral therapy in patients w/ pre-existing liver dysfunction, including chronic active hepatitis. Interrupt or discontinue treatment in case of worsening liver disease. Increases in wt & in blood lipid & glucose levels may occur during antiretroviral therapy. Reports of mitochondrial dysfunction in HIV -ve infants following exposure
in utero &/or postnatally to nucleoside analogues. Risk of immune reactivation syndrome. Opportunistic infections & other HIV infection complications may continue to develop. Reports of osteonecrosis particularly in patients w/ advanced HIV disease &/or long-term exposure to combination antiretroviral therapy. Potential risk of nephrotoxicity resulting from chronic exposure to low levels of tenofovir. Assess serum creatinine, estimated CrCl, urine glucose, & urine protein prior to treatment initiation & during treatment on a clinically appropriate schedule; also assess serum P in patients w/ CKD. Patients w/ rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicinal product. Do not co-administer w/ other antiretrovirals or w/ other medicinal products containing tenofovir alafenamide, lamivudine, tenofovir disoproxil or adefovir dipivoxil. Discontinue treatment in patients w/ estimated CrCl that declines <30 mL/min during treatment. Avoid use in patients w/ ESRD (estimated CrCl <15 mL/min) on chronic haemodialysis, but may be used w/ caution if potential benefits outweigh potential risks. Avoid in patients w/ estimated CrCl ≥15 mL/min & <30 mL/min, or <15 mL/min who are not on chronic haemodialysis. Caution in patients w/ moderate hepatic impairment. Not recommended in patients w/ severe hepatic impairment. should be used during pregnancy only if potential benefit justifies potential risk to the foetus. Do not breastfeed while on treatment.
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