Tenof-Em Dosage/Direction for Use

Recommended Dose for Treatment of HIV-1 Infection in Adults and Pediatric Patients Weighing 35 Kg or More: The recommended dose of emtricitabine and tenofovir disoproxil fumarate tablets 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.
Recommended Dose for Treatment of HIV-1 Infection in Pediatric Patients Weighing at Least 17 kg or More 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 emtricitabine and tenofovir disoproxil fumarate 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 emtricitabine and tenofovir disoproxil fumarate low strength tablets is presented in Table 7. Weight should be monitored periodically and the emtricitabine and tenofovir disoproxil fumarate tablet dose adjusted accordingly. (See Table 7).

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Recommended Dose for Pre-exposure Prophylaxis: The dose of emtricitabine and tenofovir disoproxil fumarate tablet 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 emtricitabine or tenofovir disoproxil fumarate tablets were administered to subjects with moderate to severe renal impairment. Therefore, adjust the dosing interval of emtricitabine and tenofovir disoproxil fumarate tablet in HIV- 1 infected adult patients with baseline creatinine clearance 30 to 49 mL/min using the recommendations in Table 8. 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 Precautions).
No dose adjustment is necessary for HIV-1 infected patients with mild renal impairment (creatinine clearance 50 to 80 mL/min). No data are available to make dose recommendations in pediatric patients with renal impairment. (See Table 8).

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Routine monitoring of estimated creatinine clearance, serum phosphorus, urine glucose, and urine protein should be performed in all individuals with mild renal impairment (see Precautions).
Pre-exposure Prophylaxis: Do not use emtricitabine and tenofovir disoproxil fumarate tablet for a PrEP indication in HIV-1 uninfected individuals with estimated creatinine clearance below 60 mL/min (see Precautions).
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 emtricitabine and tenofovir disoproxil fumarate tablet for PrEP, evaluate potential causes and re-assess potential risks and benefits of continued use (see Precautions).