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.

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.

• 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

• 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

• 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.

• 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

• 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.

• 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

• 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

• 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

• Renal dysfunction: Data not available

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

• 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

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.

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

• 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.

• 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.

Dialysis

Emtricitabine-tenofovir alafenamide:
Adults:

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

• Hemodialysis: Not recommended

• 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.

• Store in original container.
• Keep bottle tightly closed.
• Store at 25C (77F); excursions permitted to 15C to 30C (59F to 86F).

• 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)

• 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.