Truvada Dosage

Generic name: emtricitabine and tenofovir disoproxil fumarate
Dosage form: tablet, film coated

The information at Drugs.com is not a substitute for medical advice. ALWAYS consult your doctor or pharmacist.

Recommended Dose for Treatment of HIV-1 Infection

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

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.

Table 1 Dosage Adjustment for HIV-1 Infected Adult Patients with Altered Creatinine Clearance
Creatinine Clearance (mL/min)*
≥50 30–49 <30
(Including Patients Requiring Hemodialysis)
*
Calculated using ideal (lean) body weight
Recommended Dosing Interval Every 24 hours Every 48 hours TRUVADA should not be administered.

Routine monitoring of estimated creatinine clearance, serum phosphorus, urine glucose, and urine protein should be performed in all individuals with mild renal impairment [See Warnings and Precautions (5.3)].

Pre-exposure Prophylaxis

Do not use TRUVADA for a PrEP indication in HIV-1 uninfected individuals with estimated creatinine clearance below 60 mL/min [See Warnings and Precautions (5.3)].

Routine monitoring of estimated creatinine clearance, serum phosphorus, urine glucose, and urine protein should be performed in all individuals with mild renal impairment. If a decrease in estimated 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)].

Hide
(web1)