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Emtricitabine / Tenofovir Dosage

Medically reviewed on August 1, 2018.

Applies to the following strengths: 200 mg-300 mg; 100 mg-150 mg; 133 mg-200 mg; 167 mg-250 mg; 200 mg-25 mg

Usual Adult Dose for HIV Infection

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

Comments:
-Emtricitabine-tenofovir alafenamide is recommended for patients at least 35 kg.

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:
-Individuals must have a negative HIV-1 test immediately before starting this product for HIV-1 preexposure prophylaxis (PrEP).
-If clinical symptoms of acute viral infection are present and recent (less than 1 month) exposures are suspected, the start of HIV-1 PrEP should be delayed for at least 1 month and HIV-1 status should be reconfirmed or a test approved/cleared by the US FDA as an aid in the diagnosis of HIV-1 infection (including acute or primary HIV-1 infection) should be used.
-This product should be used only as part of a comprehensive prevention plan that includes other prevention measures (e.g., safer sex practices); this product 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 PrEP to reduce the risk of sexually acquired HIV-1 in at-risk individuals

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 product plus raltegravir is recommended as the preferred regimen for HIV postexposure prophylaxis; this product 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 product plus (raltegravir or dolutegravir) is recommended as the preferred regimen for nonoccupational postexposure prophylaxis of HIV infection in adults (including pregnant women [should be at least 8 weeks from last menstrual period if using dolutegravir]) with CrCl at least 60 mL/min; this product plus darunavir/ritonavir is recommended as an alternative regimen for such patients. If other alternatives are considered, this product 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:
-Weight at least 25 kg: Emtricitabine 200 mg-tenofovir alafenamide 25 mg (1 tablet) orally once a day

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

Comments:
-Safety and efficacy of emtricitabine-tenofovir alafenamide coadministered with an HIV-1 protease inhibitor that is used with ritonavir or cobicistat have not been established in patients weighing less than 35 kg.
-Emtricitabine-tenofovir DF is recommended for pediatric patients who can swallow a tablet.
-Weight should be monitored periodically; the emtricitabine-tenofovir DF dose should be adjusted accordingly.

Uses:
-Emtricitabine-tenofovir alafenamide: In combination with other antiretroviral agents, for the treatment of HIV-1 infection in patients at least 35 kg; in combination with other antiretroviral agents (excluding protease inhibitors that require a CYP450 3A inhibitor), for the treatment of HIV-1 infection in patients at least 25 kg and less than 35 kg
-Emtricitabine-tenofovir DF: In combination with other antiretroviral agents, for the treatment of HIV-1 infection in patients at least 17 kg

Usual Pediatric Dose for Pre-Exposure Prophylaxis

Adolescents at least 35 kg: Emtricitabine 200 mg-tenofovir DF 300 mg (1 tablet) orally once a day

Comments:
-Individuals must have a negative HIV-1 test immediately before starting this product for HIV-1 PrEP.
-If clinical symptoms of acute viral infection are present and recent (less than 1 month) exposures are suspected, the start of HIV-1 PrEP should be delayed for at least 1 month and HIV-1 status should be reconfirmed or a test approved/cleared by the US FDA as an aid in the diagnosis of HIV-1 infection (including acute or primary HIV-1 infection) should be used.
-This product should be used only as part of a comprehensive prevention plan that includes other prevention measures (e.g., safer sex practices); this product 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 product 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 PrEP to reduce the risk of sexually acquired HIV-1 in at-risk individuals

Usual Pediatric Dose for Nonoccupational Exposure

US CDC Recommendations:
-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 product plus (raltegravir or dolutegravir) is recommended as the preferred regimen for nonoccupational postexposure prophylaxis of HIV infection in adolescents (including pregnant women [should be at least 8 weeks from last menstrual period if using dolutegravir]) with CrCl at least 60 mL/min; this product plus darunavir/ritonavir is recommended as an alternative regimen for such patients. If other alternatives are considered, this product 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 (estimated CrCl 30 to 49 mL/min): Emtricitabine 200 mg-tenofovir DF 300 mg (1 tablet) orally every 48 hours
-Severe renal dysfunction (estimated CrCl less than 30 mL/min): Not recommended.

Pediatric patients: Data not available

HIV-1 PrEP:
-Estimated CrCl less than 60 mL/min: Not recommended.

Comments (emtricitabine-tenofovir DF):
-Treatment of HIV-1 infection: Safety and efficacy of the dosing interval adjustment recommendations in patients with moderate renal dysfunction have not been clinically evaluated; clinical response to therapy and renal function should be closely monitored in these patients.
-HIV-1 PrEP: If estimated CrCl decreases in uninfected individuals during use of this product, 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.accessdata.fda.gov/scripts/cder/rems/index.cfm

US BOXED WARNINGS:
-POSTTREATMENT ACUTE EXACERBATION OF HEPATITIS B (EMTRICITABINE-TENOFOVIR ALAFENAMIDE): This product is not approved for treatment of chronic HBV infection; safety and efficacy not established in patients 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 this product is stopped. Hepatic function of HBV/HIV-1-coinfected patients should be closely monitored with clinical and laboratory follow-up for at least several months after stopping this product. If appropriate, initiation/resumption of antihepatitis B therapy may be necessary.
-POSTTREATMENT ACUTE EXACERBATION OF HEPATITIS B (EMTRICITABINE-TENOFOVIR DF): Severe acute exacerbations of HBV reported in HBV-infected patients after stopping this product. Hepatic function of HBV-infected patients should be closely monitored with clinical and laboratory follow-up for at least several months after stopping this product. If appropriate, initiation/resumption of antihepatitis B therapy may be necessary.
-DRUG RESISTANCE RISK WITH HIV-1 PREEXPOSURE PROPHYLAXIS USE IN UNDIAGNOSED EARLY HIV-1 INFECTION (EMTRICITABINE-TENOFOVIR DF): This product used for HIV-1 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 product for HIV-1 PrEP after undetected acute HIV-1 infection. This product should not be started for HIV-1 PrEP if signs/symptoms of acute HIV-1 infection are present unless negative infection status confirmed.

CONTRAINDICATIONS:
-Emtricitabine-tenofovir alafenamide: None
-Emtricitabine-tenofovir DF: For HIV-1 PrEP in individuals with unknown or positive HIV-1 status

Emtricitabine-tenofovir alafenamide: Safety and efficacy have not been established in patients weighing less than 25 kg.

Emtricitabine-tenofovir DF:
-Treatment of 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 product cannot be adjusted for these patients.
-HIV-1 PrEP: Safety and efficacy have not been established in patients younger than adolescents or in adolescents weighing less than 35 kg.

Consult WARNINGS section for additional precautions.

Dialysis

Emtricitabine-tenofovir alafenamide: Data not available

Emtricitabine-tenofovir DF:
-Hemodialysis: Not recommended.

Other Comments

Administration advice:
-Test patients for HBV infection before/when starting this drug.
-Emtricitabine-tenofovir alafenamide: In all patients, assess estimated CrCl, urine glucose, and urine protein before starting this product and monitor during therapy.
-Emtricitabine-tenofovir DF: In all patients, assess serum creatinine, estimated CrCl, urine glucose, and urine protein before starting this product and during therapy as clinically appropriate; in patients with chronic kidney disease, also assess serum phosphorus.
-Emtricitabine-tenofovir DF: Screen all patients for HIV-1 infection before starting this product for HIV-1 PrEP and at least once every 3 months during use of this product.
-May administer with or without food
-Ensure pediatric patients can swallow the tablet.
-Do not use emtricitabine-tenofovir alafenamide as PrEP to reduce risk of sexually-acquired HIV-1 in high-risk individuals.
-Consult the manufacturer product information regarding missed doses.

Storage requirements:
-Store in original bottle; keep bottle tightly closed.
-Emtricitabine-tenofovir alafenamide: Store below 30C (86F).
-Emtricitabine-tenofovir DF: Store at 25C (77F); excursions permitted to 15C to 30C (59F to 86F).

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 patients (before/when starting therapy); for HIV-1 (before starting and at least every 3 months during HIV-1 PrEP)
-Metabolic: Serum phosphorus in patients with chronic kidney disease (before starting and periodically during therapy)
-Musculoskeletal: Bone mineral density in patients using emtricitabine-tenofovir DF with history of pathologic bone fracture or other risk factors for osteoporosis or bone loss
-Renal: Estimated CrCl, urine glucose, and urine protein in all patients using emtricitabine-tenofovir alafenamide (before starting and during therapy); serum creatinine, estimated CrCl, urine glucose, and urine protein in all patients using emtricitabine-tenofovir DF (before starting and as clinically appropriate during therapy)

Patient advice:
-Read the US FDA-approved patient labeling (Patient Information [emtricitabine-tenofovir alafenamide]; Medication Guide [emtricitabine-tenofovir DF]).
-Avoid taking this drug with concurrent/recent use of nephrotoxic agents.
-Stop this drug if symptoms suggesting lactic acidosis or pronounced hepatotoxicity develop.
-If you also have HBV, do not stop this drug without consulting healthcare provider.
-Notify healthcare provider at once of any symptoms of infection.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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