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Emtricitabine / Tenofovir Dosage

Applies to the following strength(s): 200 mg-300 mg ; 100 mg-150 mg ; 133 mg-200 mg ; 167 mg-250 mg ; 200 mg-25 mg

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

Emtricitabine 200 mg-tenofovir alafenamide 25 mg (1 tablet) orally once a day
Emtricitabine 200 mg-tenofovir DF 300 mg (1 tablet) orally once a day

Comments:
-Patients should be tested for HBV infection before starting this drug.
-In all patients, estimated CrCl, urine glucose, and urine protein should be assessed before starting emtricitabine-tenofovir alafenamide and should be monitored during therapy.
-Emtricitabine-tenofovir alafenamide is recommended for patients at least 35 kg.
-Emtricitabine-tenofovir DF is not recommended as a component of a triple nucleoside regimen; it should not be used with other emtricitabine-containing, tenofovir-containing, or lamivudine-containing products.
-Use of emtricitabine-tenofovir DF in therapy-experienced patients should be guided by laboratory testing and treatment history.

Use: In combination with other antiretroviral agents, for treatment of HIV-1 infection

Usual Adult Dose for Pre-Exposure Prophylaxis

Emtricitabine 200 mg-tenofovir DF 300 mg (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 (and current guidelines) 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: Emtricitabine 200 mg-tenofovir DF 300 mg (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.
-Current guidelines should be consulted for additional information.

Usual Adult Dose for Nonoccupational Exposure

US CDC recommendations: Emtricitabine 200 mg-tenofovir DF 300 mg (1 tablet) orally once a day
Duration of therapy: 28 days

Comments:
-This drug plus (raltegravir or dolutegravir) is recommended as the preferred regimen for nonoccupational postexposure prophylaxis of HIV infection in adults (including pregnant women) with CrCl at least 60 mL/min; this drug plus darunavir/ritonavir is recommended as an alternative regimen for such patients. If other alternatives are considered, this drug is recommended as a component in various regimens.
-Prophylaxis should be started as soon as possible, within 72 hours of exposure.
-Current guidelines should be consulted for additional information.

Usual Pediatric Dose for HIV Infection

Emtricitabine-tenofovir alafenamide:
12 years or older and at least 35 kg: Emtricitabine 200 mg-tenofovir alafenamide 25 mg (1 tablet) orally once a day

Emtricitabine-tenofovir DF:
17 to less than 22 kg: Emtricitabine 100 mg-tenofovir DF 150 mg (1 tablet) orally once a day
22 to less than 28 kg: Emtricitabine 133 mg-tenofovir DF 200 mg (1 tablet) orally once a day
28 to less than 35 kg: Emtricitabine 167 mg-tenofovir DF 250 mg (1 tablet) orally once a day
At least 35 kg: Emtricitabine 200 mg-tenofovir DF 300 mg (1 tablet) orally once a day

Comments:
-Patients should be tested for HBV infection before starting this drug.
-In all patients, estimated CrCl, urine glucose, and urine protein should be assessed before starting emtricitabine-tenofovir alafenamide and should be monitored during therapy.
-Emtricitabine-tenofovir DF is recommended for pediatric patients who can swallow a whole tablet.
-Emtricitabine-tenofovir DF is not recommended as a component of a triple nucleoside regimen; it should not be used with other emtricitabine-containing, tenofovir-containing, or lamivudine-containing products.
-Use of emtricitabine-tenofovir DF in therapy-experienced patients should be guided by laboratory testing and treatment history.

Use: In combination with other antiretroviral agents, for treatment of HIV-1 infection

Usual Pediatric Dose for Nonoccupational Exposure

US CDC recommendations for adolescents 13 years or older: Emtricitabine 200 mg-tenofovir DF 300 mg (1 tablet) orally once a day
Duration of therapy: 28 days

Comments:
-This drug plus (raltegravir or dolutegravir) is recommended as the preferred regimen for nonoccupational postexposure prophylaxis of HIV infection in adolescents with CrCl at least 60 mL/min; this drug plus darunavir/ritonavir is recommended as an alternative regimen for such patients. If other alternatives are considered, this drug is recommended as a component in various regimens.
-Prophylaxis should be started as soon as possible, within 72 hours of exposure.
-Current guidelines should be consulted for additional information.

Renal Dose Adjustments

Emtricitabine-tenofovir alafenamide:
-Severe renal dysfunction (estimated CrCl less than 30 mL/min): Not recommended.

Emtricitabine-tenofovir DF:
Treatment of HIV-1 Infection:
Adults:
-Mild renal dysfunction (CrCl 50 to 80 mL/min): No adjustment recommended.
-Moderate renal dysfunction (CrCl 30 to 49 mL/min): Emtricitabine 200 mg-tenofovir DF 300 mg (1 tablet) orally every 48 hours
-Severe renal dysfunction (CrCl less than 30 mL/min): Not recommended.

Pediatric patients: Data not available

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

Comments (emtricitabine-tenofovir DF):
-Routine monitoring of estimated CrCl, serum phosphorus, urine glucose, and urine protein recommended for all patients (with or without HIV-1 infection) with mild renal dysfunction.
-Safety and efficacy of the dosing interval adjustment have not been clinically evaluated in patients with moderate renal dysfunction; clinical response to therapy and renal function should be closely monitored in these patients.
-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

Emtricitabine-tenofovir alafenamide:
-Mild or moderate liver dysfunction (Child-Pugh A or B): No adjustment recommended.
-Severe liver dysfunction (Child-Pugh C): Data not available

Emtricitabine-tenofovir DF: Data not available

Precautions

The US FDA requires a Risk Evaluation and Mitigation Strategy (REMS) for emtricitabine-tenofovir DF for a preexposure prophylaxis indication. It includes elements to assure safe use. For additional information: www.fda.gov/REMS

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 (including those coinfected with HBV and HIV-1). Severe acute exacerbations of hepatitis B reported in patients coinfected with HBV and HIV-1 after stopping products containing emtricitabine and/or tenofovir DF, and may occur when tenofovir alafenamide-containing products are stopped. 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 DF 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.

Emtricitabine-tenofovir alafenamide: Safety and efficacy have not been established in patients younger than 12 years or weighing less than 35 kg.

Emtricitabine-tenofovir DF:
-HIV-1 infection: Safety and efficacy have not been established in patients weighing less than 17 kg; since it is a fixed-dose combination tablet, this drug cannot be adjusted for these patients.
-PrEP: Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

Emtricitabine-tenofovir alafenamide: Data not available
Emtricitabine-tenofovir DF: Not recommended.

Other Comments

Administration advice:
-May take with or without food
-Ensure children are able to swallow the tablet whole.
-Do not use emtricitabine-tenofovir alafenamide as PrEP to reduce risk of sexually-acquired HIV-1 in high-risk adults.
-Consult the manufacturer product information regarding missed doses.

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

General:
-As part of patient counseling, healthcare providers must review the emtricitabine-tenofovir DF Medication Guide with each uninfected individual using this drug for PrEP.

Monitoring:
-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); for HIV-1 (before starting and at least every 3 months during PrEP)
-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 using emtricitabine-tenofovir DF (before starting and as clinically appropriate during therapy); estimated CrCl, urine glucose, and urine protein in all patients using emtricitabine-tenofovir alafenamide or in all individuals using emtricitabine-tenofovir DF who are at risk of renal dysfunction (before starting and periodically during therapy) or who have mild renal dysfunction (routinely)

Patient advice:
-Read the US FDA-approved patient labeling (Patient Information [emtricitabine-tenofovir alafenamide] or Medication Guide [emtricitabine-tenofovir DF]).
-Stop this drug if symptoms suggesting lactic acidosis or pronounced hepatotoxicity develop.
-If you also have HBV, do not stop emtricitabine-tenofovir alafenamide without consulting healthcare provider.
-Do not stop emtricitabine-tenofovir DF without consulting healthcare provider.

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