Generic name: emtricitabine and tenofovir disoproxil fumarate
Dosage form: tablet, film coated
This dosage information does not include all the information needed to use Truvada safely and effectively. See full prescribing information for Truvada.
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Recommended Dose for Treatment of HIV-1 Infection
â€‹The recommended dose of TRUVADA in adults and in pediatric patients 12 years of age and older with body weight greater than or equal to 35 kg (greater than or equal to 77 lb) is one tablet (containing 200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) once daily taken orally with or without food.
Recommended Dose for Pre-exposure Prophylaxis
â€‹The dose of TRUVADA in HIV-1 uninfected adults is one tablet (containing 200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) once daily taken orally with or without food.
Dose Adjustment for Renal Impairment
Treatment of HIV-1 Infection
Significantly increased drug exposures occurred when EMTRIVA or VIREAD were administered to subjects with moderate to severe renal impairment [See EMTRIVA or VIREAD Package Insert]. Therefore, adjust the dosing interval of TRUVADA in HIV-1 infected adult patients with baseline creatinine clearance 30–49 mL/min using the recommendations in Table 1. These dosing interval recommendations are based on modeling of single-dose pharmacokinetic data in non-HIV infected subjects. The safety and effectiveness of these dosing interval adjustment recommendations have not been clinically evaluated in patients with moderate renal impairment, therefore clinical response to treatment and renal function should be closely monitored in these patients [See Warnings and Precautions (5.3)].
No dose adjustment is necessary for HIV-1 infected patients with mild renal impairment (creatinine clearance 50–80 mL/min). No data are available to make dose recommendations in pediatric patients with renal impairment.
|Creatinine Clearance (mL/min)*|
(Including Patients Requiring Hemodialysis)
|Recommended Dosing Interval||Every 24 hours||Every 48 hours||TRUVADA should not be administered.|
Routine monitoring of calculated creatinine clearance and serum phosphorus should be performed in all individuals with mild renal impairment [See Warnings and Precautions (5.3)].
â€‹Do not use TRUVADA for a PrEP indication in HIV-1 uninfected individuals with creatinine clearance below 60 mL/min [See Warnings and Precautions (5.3)].
â€‹Routine monitoring of calculated creatinine clearance and serum phosphorus should be performed in all individuals with mild renal impairment. If a decrease in creatinine clearance is observed in uninfected individuals while using TRUVADA for PrEP, evaluate potential causes and re-assess potential risks and benefits of continued use [See Warnings and Precautions (5.3)].