Emtricitabine / Tenofovir Dosage

This dosage information may not include all the information needed to use Emtricitabine / Tenofovir safely and effectively. See additional information for Emtricitabine / Tenofovir.

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

Usual Adult Dose for:

Usual Pediatric Dose for:

Additional dosage information:

Usual Adult Dose for HIV Infection

1 tablet orally once a day

Comments:
-Not recommended as a component of a triple nucleoside regimen.
-Use in treatment-experienced patients should be guided by laboratory testing and treatment history.

Approved indication: In combination with other antiretroviral agents (such as nonnucleoside reverse transcriptase inhibitors or protease inhibitors) for treatment of HIV-1 infection

Usual Adult Dose for Pre-Exposure Prophylaxis

1 tablet orally once a day

Comments:
-Emtricitabine-tenofovir should be used only as part of a comprehensive prevention plan that includes other prevention measures (e.g., safer sex practices); emtricitabine-tenofovir not always effective in preventing acquisition of HIV-1.
-Uninfected individuals should be advised to strictly adhere to the emtricitabine-tenofovir dosing regimen; efficacy of emtricitabine-tenofovir in reducing risk of acquiring HIV-1 strongly correlated with adherence.
-The manufacturer's product information should be consulted for further information.

Approved indication: In combination with safer sex practices for preexposure prophylaxis to reduce the risk of sexually acquired HIV-1 in uninfected individuals at high risk

Usual Adult Dose for Nonoccupational Exposure

(Not approved by FDA)

Centers for Disease Control and Prevention (CDC) recommendations: 1 tablet orally once a day plus efavirenz
Duration of therapy: 28 days

Comments:
-Prophylaxis should be initiated as soon as possible, within 72 hours of exposure.

Usual Pediatric Dose for HIV Infection

12 years or older weighing 35 kg or more: 1 tablet orally once a day

Comments:
-Not recommended as a component of a triple nucleoside regimen.
-Use in treatment-experienced patients should be guided by laboratory testing and treatment history.

Approved indication: In combination with other antiretroviral agents (such as nonnucleoside reverse transcriptase inhibitors or protease inhibitors) for treatment of HIV-1 infection

Renal Dose Adjustments

Treatment of HIV-1 Infection:
Adults:
CrCl 30 to 49 mL/min: 1 tablet orally every 48 hours

Comments:
-Safety and efficacy of these dosing guidelines have not been clinically evaluated.
-Clinical response to therapy and renal function should be closely monitored in these patients.

CrCl less than 30 mL/min: Not recommended.

Pediatrics: Data not available

Preexposure Prophylaxis:
CrCl less than 60 mL/min: Not recommended.

Comments:
-If CrCl decreases during preexposure prophylaxis, potential causes should be evaluated and potential risks and benefits of continued use should be reassessed.

Liver Dose Adjustments

Data not available

Precautions

Consult WARNINGS section for dosing related precautions.

Dialysis

Not recommended.

Other Comments

The US FDA requires a Risk Evaluation and Mitigation Strategy (REMS) for emtricitabine-tenofovir for a preexposure prophylaxis indication. It includes a Medication Guide and elements to assure safe use. Additional information is available at www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm111350.htm.

Administration advice:
-May be given with or without food; however, the AUC of tenofovir is 35% higher when given with a high-fat meal.

Monitoring:
-General: HIV-1 screening tests (before starting and at least every 3 months during preexposure prophylaxis)
-Hepatic: For chronic hepatitis B (HBV) in all individuals (before therapy); hepatic function of HBV-infected patients with clinical and laboratory follow-up (for at least several months after stopping therapy)
-Metabolic: Serum phosphorus in all individuals at risk for renal dysfunction or with mild renal dysfunction (routinely)
-Musculoskeletal: Bone mineral density in patients with history of pathologic bone fracture or other risk factors for osteoporosis or bone loss
-Renal: CrCl in all individuals (before starting and as clinically appropriate during therapy); calculated CrCl in all individuals at risk for renal dysfunction or with mild renal dysfunction (routinely)

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