Recommended Dose
For treatment of HIV-1 and chronic hepatitis B : The dose of TENVIR is 300 mg once daily taken orally, without regard to food.
In the treatment of chronic hepatitis B, the optimal duration of treatment is unknown.
Dose Adjustment for Renal Impairment
Significantly increased drug exposures occurred when tenofovir disoproxil fumarate was administered to patients with moderate to severe renal impairment. 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 2. 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; therefore, clinical response to treatment and renal function should be closely monitored in these patients. [See WARNINGS AND PRECAUTIONS]
No dose adjustment is necessary for patients with mild renal impairment (creatinine clearance 50–80 mL/min). Routine monitoring of calculated creatinine clearance and serum phosphorus should be performed for these patients [see WARNINGS AND PRECAUTIONS]
Table 2. Dosage Adjustment for Patients with Altered Creatinine Clearance
|
Creatinine Clearance (mL/min) a |
Hemodialysis Patients |
| ≥ 50 |
30-49 |
10-29 |
Recommended 300 mg
Dosing Interval |
Every 24
hours |
Every 48
hours |
Twice
a week |
Every 7 days or after a total of approximately 12 hours of
dialysis b |
a.Calculated using ideal (lean) body weight. |
b.Generally once weekly assuming three hemodialysis sessions a week of approximately 4 hours duration. Tenofovir disoproxil fumarate 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.
|
