Emtricitabinedosage

Treatment of HIV-1 Infection Recommended dose in adults and pediatric patients weighing greater than or equal to 35 kg: One TRUVADA tablet (containing 200 mg/300 mg of emtricitabine and tenofovir disoproxil fumarate) once daily taken orally with or without food. Recommended dose in pediatric patients weighing greater than or equal to 17 kg and able to swallow a whole tablet: one TRUVADA low strength tablet (100 mg/150 mg, 133 mg/200 mg, or 167 mg/250 mg based on body weight) once daily taken orally with or without food. Recommended dose in renally impaired HIV-1 infected adult patients: Creatinine clearance 30–49 mL/min: 1 tablet every 48 hours. CrCl below 30 mL/min or hemodialysis: Do not use TRUVADA. Pre-exposure Prophylaxis Recommended dose in HIV-1 uninfected adults: One tablet (containing 200 mg/300 mg of emtricitabine and tenofovir disoproxil fumarate) once daily taken orally with or without food. Recommended dose in renally impaired HIV-uninfected individuals: Do not use TRUVADA in HIV-uninfected individuals if CrCl is below 60 mL/min. If a decrease in CrCl is observed in uninfected individuals while using TRUVADA for PrEP, evaluate potential causes and re-assess potential risks and benefits of continued use.

2.1 Recommended

Dose for Treatment of HIV-1 Infection in Adults and Pediatric Patients Weighing 35 Kg or More The recommended dose of TRUVADA in adults and in pediatric patients with body weight greater than or equal to 35 kg is one tablet (containing 200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) once daily taken orally with or without food.

2.2 Recommended

Dose for Treatment of HIV-1 Infection in Pediatric Patients Weighing at Least 17 kg and Able to Swallow a Whole Tablet The recommended oral dose for pediatric patients weighing greater than or equal to 17 kg and who are able to swallow a whole tablet, is one TRUVADA low strength tablet (emtricitabine [FTC]/tenofovir disoproxil fumarate [TDF]) (167 mg/250 mg, 133 mg/200 mg, or 100 mg/150 mg based on body weight) taken orally once daily with or without food. The recommended oral dosage of TRUVADA low strength tablets is presented in Table 1. Weight should be monitored periodically and the TRUVADA dose adjusted accordingly. Table 1 Dosing for Pediatric Patients Weighing 17 kg to less than 35 kg using TRUVADA Low Strength Tablets Body Weight (kg) Dosing of FTC (mg)/TDF (mg) 17 to less than 22 one 100/150 tablet once daily 22 to less than 28 one 133/200 tablet once daily 28 to less than 35 one 167/250 tablet once daily

2.3 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.

2.4 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. 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 2. 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. 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 2 Dosage Adjustment for HIV-1 Infected Adult Patients with Altered Creatinine Clearance Creatinine Clearance (mL/min) Calculated using ideal (lean) body weight ≥50 30–49 <30 (Including Patients Requiring Hemodialysis) 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. Pre-exposure Prophylaxis Do not use TRUVADA for a PrEP indication in HIV-1 uninfected individuals with estimated creatinine clearance below 60 mL/min. 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.