VIREAD Dosage and Administration
- Recommended dose, in adults and pediatric patients ≥12 years of age (≥35 kg), for the treatment of chronic hepatitis B: one 300 mg tablet, once daily, taken orally, without regard to food
- In the treatment of chronic hepatitis B, the optimal duration of treatment is unknown
- Safety and efficacy in pediatric patients <12 years of age or weighing <35 kg with chronic hepatitis B have not been established
- The dosing interval of VIREAD should be adjusted (using recommendations in the table below) and renal function closely monitored in patients with baseline creatinine clearance <50 mL/min
Dosage Adjustment for Patients with Altered Creatinine Clearance
aCalculated using ideal (lean) body weight.
bGenerally once weekly assuming three hemodialysis sessions a week of approximately 4 hours duration.
VIREAD should be administered following completion of dialysis.
- The 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 dose adjustment is necessary for patients with mild renal impairment (creatinine clearance 50-80 mL/min). Routine monitoring of estimated creatinine clearance, serum phosphorus, urine glucose, and urine protein should be performed in these patients
- No data are available to make dose recommendations in pediatric patients with renal impairment
aIn the treatment of CHB, the optimal treatment duration is unknown.