Emtricitabine / Tenofovir Dosage

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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 therapy-experienced patients should be guided by laboratory testing and treatment history.

Use: In combination with other antiretroviral agents (such as NNRTIs or protease inhibitors), for treatment of HIV-1 infection

Usual Adult Dose for Pre-Exposure Prophylaxis

1 tablet orally once a day

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

Use: 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 Occupational Exposure

US Public Health Service working group recommendations: 1 tablet orally once a day
Duration of therapy: 28 days, if tolerated

Comments:
-This drug plus raltegravir is recommended as the preferred regimen for HIV postexposure prophylaxis; this drug is also recommended as a component in various alternative regimens.
-Prophylaxis should be started as soon as possible, preferably within hours after exposure.
-The optimal duration of prophylaxis is unknown and may differ based on institution protocol.
-The most current therapeutic guidelines should be consulted for more information.
-Not approved by US FDA.

Usual Adult Dose for Nonoccupational Exposure

US CDC recommendations: 1 tablet orally once a day
Duration of therapy: 28 days

Comments:
-This drug plus efavirenz is recommended as a preferred NNRTI-based regimen for nonoccupational postexposure prophylaxis of HIV infection; this drug is also recommended as a component in various alternative protease inhibitor-based regimens.
-Prophylaxis should be started as soon as possible, within 72 hours of exposure.
-The most current therapeutic guidelines should be consulted for more information.
-Not approved by US FDA.

Usual Pediatric Dose for HIV Infection

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

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

Use: In combination with other antiretroviral agents (such as NNRTIs 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:
Estimated CrCl less than 60 mL/min: Not recommended.

Comments:
-If estimated 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

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. For additional information: www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm111350.htm

US BOXED WARNINGS:
-LACTIC ACIDOSIS/SEVERE HEPATOMEGALY WITH STEATOSIS: Lactic acidosis and severe hepatomegaly with steatosis (including fatalities) reported with nucleoside analogs in combination with other antiretrovirals.
-POSTTREATMENT ACUTE EXACERBATION OF HEPATITIS B: This drug is not approved for treatment of chronic HBV infection; safety and efficacy not established in patients infected with HBV. Severe acute exacerbations of hepatitis B reported in patients coinfected with HBV and HIV-1 after stopping this drug. Hepatic function of HBV-infected patients should be closely monitored with clinical and laboratory follow-up for at least several months after stopping this drug. If appropriate, initiation/resumption of antihepatitis B therapy may be necessary.
-DRUG RESISTANCE RISK WITH PREEXPOSURE PROPHYLAXIS USE IN UNDIAGNOSED HIV-1 INFECTION: Emtricitabine-tenofovir for preexposure prophylaxis (PrEP) must only be prescribed to individuals confirmed to be HIV-negative immediately before starting and periodically (at least every 3 months) during use. Drug-resistant HIV-1 variants identified with use of this drug for PrEP after undetected acute HIV-1 infection. This drug should not be started for a PrEP indication if signs/symptoms of acute HIV-1 infection are present unless negative infection status confirmed.

Safety and efficacy have not been established in HIV-1-infected patients younger than 12 years or weighing less than 35 kg; since it is a fixed-dose combination tablet, this drug cannot be adjusted for these patients. Safety and efficacy of emtricitabine-tenofovir for PrEP have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

Not recommended.

Other Comments

Administration advice:
-May take with or without food; AUC of tenofovir 35% higher when taken with high-fat or light meal (compared to fasted state).
-Consult the manufacturer product information regarding missed doses.

Storage requirements:
-Store in original bottle; keep bottle tightly closed.

Monitoring:
-General: HIV-1 screening tests (before starting and at least every 3 months during PrEP)
-Hepatic: Hepatic function of HBV-infected patients with clinical and laboratory follow-up (for at least several months after stopping this drug)
-Infections/Infestations: For chronic HBV in all individuals (before therapy)
-Metabolic: Serum phosphorus in all individuals at risk of renal dysfunction (before starting and periodically during therapy) 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: Estimated CrCl in all individuals (before starting and as clinically appropriate during therapy); estimated CrCl, urine glucose, and urine protein in all individuals at risk of renal dysfunction (before starting and periodically during therapy) or with mild renal dysfunction (routinely)

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