DOSAGE AND ADMINISTRATION
For the treatment of HIV-1 or chronic hepatitis B: The dose of VIREAD 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 VIREAD was administered to patients with moderate to severe renal impairment [See Clinical Pharmacology]. Therefore, the dosing interval of VIREAD should be adjusted in patients with baseline creatinine clearance <50 mL/min using the recommendations in Table 1. 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 Warnings and Precautions].
No dose adjustment is necessary for patients with mild renal impairment (creatinine clearance 5080 mL/min). Routine monitoring of calculated creatinine clearance and serum phosphorus should be performed in patients with mild renal impairment [See Warnings and Precautions].
Table 1 Dosage Adjustment for Patients with Altered Creatinine Clearance
| ||Creatinine Clearance |
(mL/min)Calculated using ideal (lean) body weight.
| ||≥50 ||3049 ||1029 ||Hemodialysis Patients |
| Recommended 300 mg Dosing Interval ||Every 24 hours ||Every 48 hours ||Every 72 to 96 hours ||Every 7 days or after a total of approximately 12 hours of dialysisGenerally 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.
DOSAGE FORMS AND STRENGTHS
VIREAD is available as tablets. Each tablet contains 300 mg of tenofovir disoproxil fumarate, which is equivalent to 245 mg of tenofovir disoproxil. The tablets are almond-shaped, light blue, film-coated, and debossed with "GILEAD" and "4331" on one side and with "300" on the other side.