Emtricitabine / Tenofovir Dosage

Medically reviewed by Drugs.com. Last updated on Oct 6, 2023.

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: For specific dosing recommendations for coadministered antiretroviral drugs, the respective manufacturer product information should be consulted.

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

Usual Adult Dose for Pre-Exposure Prophylaxis

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 must have a negative HIV-1 test immediately before starting this drug for HIV-1 preexposure prophylaxis (PrEP).
• This drug should be used as part of a comprehensive prevention plan that includes other prevention measures (including adherence to daily dosing and safer sex practices) to reduce the risk of sexually transmitted infections (STIs).
• Uninfected patients 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.

Uses:

• Emtricitabine-tenofovir alafenamide: In at-risk patients, for PrEP to reduce the risk of sexually acquired HIV-1 infection, excluding patients at risk from receptive vaginal sex
• Emtricitabine-tenofovir DF: In at-risk patients, for PrEP to reduce the risk of sexually acquired HIV-1 infection

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:

• Weight 14 to less than 25 kg: Emtricitabine 120 mg-tenofovir alafenamide 15 mg (1 tablet) orally once a day
• 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 pediatric patients weighing less than 35 kg.
• Emtricitabine-tenofovir alafenamide: For specific dosing recommendations for coadministered antiretroviral drugs, the respective manufacturer product information should be consulted.
• 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 14 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 alafenamide 25 mg (1 tablet) orally once a day
• Emtricitabine 200 mg-tenofovir DF 300 mg (1 tablet) orally once a day

Comments:

• Patients must have a negative HIV-1 test immediately before starting this drug for HIV-1 PrEP.
• This drug should be used as part of a comprehensive prevention plan that includes other prevention measures (including adherence to daily dosing and safer sex practices) to reduce the risk of STIs.
• Uninfected patients 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.

Uses:

• Emtricitabine-tenofovir alafenamide: In at-risk patients, for PrEP to reduce the risk of sexually acquired HIV-1 infection, excluding patients at risk from receptive vaginal sex
• Emtricitabine-tenofovir DF: In at-risk patients, for PrEP to reduce the risk of sexually acquired HIV-1

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 drug plus (raltegravir or dolutegravir) is recommended as the preferred regimen for nonoccupational postexposure prophylaxis of HIV infection in adolescents (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.

Renal Dose Adjustments

Emtricitabine-tenofovir alafenamide:

• Severe renal dysfunction (estimated CrCl 15 to less than 30 mL/min) or ESRD (estimated CrCl less than 15 mL/min) not receiving chronic hemodialysis: 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:

• Renal dysfunction: Data not available

HIV-1 PrEP:

• Estimated CrCl less than 60 mL/min: Not recommended

Comments:

• For the treatment of HIV-1 infection, 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 adults with CrCl less than 15 mL/min (with or without hemodialysis).
• For the treatment of HIV-1 infection with emtricitabine-tenofovir DF, 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.
• For HIV-1 PrEP, if a decrease in estimated CrCl is seen in uninfected patients during use of emtricitabine-tenofovir DF, 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

US BOXED WARNINGS:

• POSTTREATMENT ACUTE EXACERBATION OF HEPATITIS B: Severe acute exacerbations of HBV reported in HBV-infected patients after stopping products containing emtricitabine and/or tenofovir DF (including emtricitabine-tenofovir DF) and may occur when emtricitabine-tenofovir alafenamide is 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, antihepatitis B therapy may be necessary.
• DRUG RESISTANCE RISK WITH HIV-1 PREEXPOSURE PROPHYLAXIS USE IN UNDIAGNOSED EARLY HIV-1 INFECTION: This drug used for HIV-1 preexposure prophylaxis (PrEP) must only be prescribed to patients confirmed to be HIV-negative immediately before starting and at least every 3 months during use. Drug-resistant HIV-1 variants have been identified with use of emtricitabine-tenofovir DF for HIV-1 PrEP after undetected acute HIV-1 infection. This drug should not be started for HIV-1 PrEP if signs/symptoms of acute HIV-1 infection are present unless negative infection status confirmed.

CONTRAINDICATIONS:

• For HIV-1 PrEP in patients with unknown or positive HIV-1 status

Emtricitabine-tenofovir alafenamide:

• Treatment of HIV-1 infection: Safety and efficacy have not been established in pediatric patients weighing less than 14 kg.
• When coadministered with an HIV-1 protease inhibitor that is used with ritonavir or cobicistat: Safety and efficacy have not been established in pediatric patients weighing less than 35 kg.
• HIV-1 PrEP: Safety and efficacy have not been established in pediatric patients weighing less than 35 kg.

Emtricitabine-tenofovir DF:

• Treatment of HIV-1 infection: This drug is not approved for use in pediatric patients weighing less than 17 kg.
• HIV-1 PrEP: Safety and efficacy have not been established in pediatric patients weighing less than 35 kg.

Consult WARNINGS section for additional precautions.

Dialysis

Emtricitabine-tenofovir alafenamide:
Adults:

• ESRD (estimated CrCl less than 15 mL/min) receiving chronic hemodialysis: No adjustment recommended

Emtricitabine-tenofovir DF:

• Hemodialysis: Not recommended

Comments (emtricitabine-tenofovir alafenamide):

• On days of hemodialysis, the daily dose should be administered after completion of hemodialysis treatment.
• Safety and efficacy of this drug coadministered with an HIV-1 protease inhibitor that is used with ritonavir or cobicistat have not been established in patients with ESRD.

Other Comments

Administration advice:

• Test patients for HBV infection before/when starting this drug.
• In all patients, assess serum creatinine, estimated CrCl, urine glucose, and urine protein before/when starting this drug and during therapy as clinically appropriate; in patients with chronic kidney disease, also assess serum phosphorus.
• Screen all patients for HIV-1 infection just before starting this drug for HIV-1 PrEP, at least once every 3 months during use of this drug, and upon diagnosis of any other STIs.
• If clinical symptoms consistent with acute HIV-1 infection are present or recent (less than 1 month) exposures to HIV-1 are suspected, use a test approved/cleared by the US FDA as an aid in the diagnosis of acute or primary HIV-1 infection.
• Administer with or without food.
• Ensure pediatric patients can swallow the tablet.
• Do not use emtricitabine-tenofovir alafenamide as PrEP in patients at risk of HIV-1 from receptive vaginal sex (efficacy not evaluated).
• Consult the manufacturer product information regarding missed doses.

Storage requirements:

• Store in original container.
• Keep bottle tightly closed.
• 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: Serum creatinine, estimated CrCl, urine glucose, and urine protein in all patients (before starting and as clinically appropriate during therapy)

Patient advice:

• Read the US FDA-approved patient labeling (Medication Guide).
• 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 health care provider.
• Notify health care 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.

Medical Disclaimer