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In the treatment of chronic hepatitis B, the optimal duration of treatment is unknown.
Recommended Dose in Pediatric Patients (≥12 Years of Age and ≥35 kg): For the treatment of HIV-1 in pediatric patients 12 years of age and older with body weight ≥ 35 kg ( ≥77 lb): The dose is one 300 mg tenofovir disoproxil fumarate tablet once daily taken orally, without regard to food.
Dose Adjustment for Renal Impairment in Adults: Significantly increased drug exposures occurred when tenofovir disoproxil fumarate was administered to subjects with moderate to severe renal impairment (see Pharmacology under Actions). Therefore, the dosing interval of tenofovir disoproxil fumarate should be adjusted in patients with baseline creatinine clearance <50 mL/min using the recommendations in Table 10. These dosing interval recommendations are based on modeling of single-dose pharmacokinetic data in non-HIV and non-HBV infected subjects with varying degrees of renal impairment, including end-stage renal disease requiring hemodialysis. The safety and effectiveness of these dosing interval adjustment recommendations have not been clinically evaluated in patients with moderate or severe renal impairment, therefore clinical response to treatment and renal function should be closely monitored in these patients (see Precautions).
No dose adjustment is necessary for patients with mild renal impairment (creatinine clearance 50 to 80 mL/min). Routine monitoring of calculated creatinine clearance, serum phosphorus, urine glucose and urine protein should be performed in patients with mild renal impairment (see Precautions). (See Table 10.)
Click on icon to see table/diagram/imageThe pharmacokinetics of tenofovir have not been evaluated in non-hemodialysis patients with creatinine clearance <10 mL/min; therefore, no dosing recommendation is available for these patients.
No data are available to make dose recommendations in pediatric patients 12 years of age and older with renal impairment.
