Does not prevent risk of transmission of HBV to others through sexual contact or blood contamination. No data on safety & efficacy in patients co-infected w/ hepatitis C or D virus. Potential risk of nephrotoxicity resulting from chronic exposure to low levels. Closely monitor hepatobiliary & renal parameters in HBV-infected patients w/ decompensated liver disease & w/ Child Pugh Turcotte score >9 (ie, class C); patients w/ cirrhosis during therapy due to higher risk for hepatic decompensation following hepatic exacerbation; hepatic function at repeated intervals w/ both clinical & lab follow-up for at least 6 mth after discontinuation of hepatitis B treatment. Perform HIV Ab testing to all HBV-infected patients whose HIV-1 infection status is unknown prior to initiating therapy. Not to be co-administered w/ medicinal products containing tenofovir alafenamide, tenofovir disoproxil fumarate or adefovir dipivoxil. Not recommended in co-administration w/ P-gp inducers eg, certain anticonvulsants (eg, carbamazepine, oxcarbazepine, phenobarb & phenytoin), antimycobacterials (eg, rifampicin, rifabutin & rifapentine) or St. John's wort; strong P-gp inhibitors eg, itraconazole & ketoconazole. Not to be taken by patients w/ galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption. Dizziness during treatment may affect ability to drive & use machines. Use in patients w/ CrCl ≥15 mL/min but <30 mL/min & patients w/ CrCl <15 mL/min who are receiving haemodialysis is based on very limited pharmacokinetic data. No safety data in HBV-infected patients w/ CrCl <30 mL/min. Not recommended in patients w/ CrCl <15 mL/min who are not receiving haemodialysis. Pregnancy. Not to be used during breastfeeding. Safety & efficacy have not been established in childn <12 yr, or weighing <35 kg.
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