Usual Adult Dose for HIV Infection

Capsules: 200 mg orally once a day
Oral solution: 240 mg orally once a day

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

Usual Adult Dose for Occupational Exposure

US Public Health Service Working Group Recommendations:

• Capsules: 200 mg orally once a day

Duration of therapy: 28 days, if tolerated

Comments:

• This drug and tenofovir disoproxil fumarate (DF) (as emtricitabine-tenofovir DF) 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:

• Capsules: 200 mg orally once a day

Duration of therapy: 28 days

Comments:

• This drug and tenofovir DF (as emtricitabine-tenofovir DF) 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 and tenofovir DF (as emtricitabine-tenofovir DF) 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

Oral solution:

• Aged 0 to 3 months: 3 mg/kg orally once a day
• Aged 3 months through 17 years: 6 mg/kg orally once a day

Maximum dose: 240 mg/dose

Capsules:

• Aged 3 months through 17 years, weighing more than 33 kg, and able to swallow intact capsule: 200 mg orally once a day

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

Usual Pediatric Dose for Nonoccupational Exposure

US CDC Recommendations:
Oral solution:

• Aged 0 to 3 months: 3 mg/kg orally once a day
• Aged 3 months through 17 years: 6 mg/kg orally once a day

Maximum dose: 240 mg/dose

Capsules:

• Aged 3 months through 17 years, weighing more than 33 kg, and able to swallow intact capsule: 200 mg orally once a day

Duration of therapy: 28 days

Comments:

• This drug is recommended as a component of a preferred (or alternative) 3-drug regimen for nonoccupational postexposure prophylaxis of HIV infection in children (aged 4 weeks to 12 years); a pediatric HIV-specialist should be consulted for neonates (aged 0 to 27 days).
• This drug and tenofovir DF (as emtricitabine-tenofovir DF) plus (raltegravir or dolutegravir) is recommended as the preferred regimen for nonoccupational postexposure prophylaxis of HIV infection in adolescents (13 years or older) with CrCl at least 60 mL/min; this drug and tenofovir DF (as emtricitabine-tenofovir DF) 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

Adults:
Capsules:

• CrCl 30 to 49 mL/min: 200 mg orally every 48 hours
• CrCl 15 to 29 mL/min: 200 mg orally every 72 hours
• CrCl less than 15 mL/min: 200 mg orally every 96 hours

Oral solution:

• CrCl 30 to 49 mL/min: 120 mg orally every 24 hours
• CrCl 15 to 29 mL/min: 80 mg orally every 24 hours
• CrCl less than 15 mL/min: 60 mg orally every 24 hours

Pediatric patients: Insufficient data to recommend dose adjustments; however, dose reductions or increased dosing intervals (similar to adjustments for adults) should be considered.

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.

Liver Dose Adjustments

Data not available

Precautions

US BOXED WARNING:

• POSTTREATMENT EXACERBATION OF HEPATITIS B: This drug 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 who have stopped this drug. Hepatic function of HIV-1/HBV-coinfected patients should be closely monitored with clinical and laboratory follow-up for at least several months after stopping this drug. If appropriate, initiation of antihepatitis B therapy may be necessary.

Consult WARNINGS section for additional precautions.

Dialysis

Adults:
Hemodialysis:

• Capsules: 200 mg orally every 96 hours
• Oral Solution: 60 mg orally every 24 hours

Pediatric patients: Insufficient data to recommend dose adjustments; however, dose reductions or increased dosing intervals (similar to adjustments for adults) should be considered.

Comments:

• Dose should be administered after dialysis when used on dialysis days.
• 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.

Other Comments

Administration advice:

• May administer without regard to food

Storage requirements:

• Capsules: Store at 25C (77F); excursions permitted to 15C to 30C (59F to 86F).
• Oral solution: Store refrigerated 2C to 8C (36F to 46F), do not freeze; alternatively, may store at 25C (77F), with excursions permitted to 15C to 30C (59F to 86F), for up to 3 months

General:

• Use of this drug in therapy-experienced patients should be guided by laboratory testing and treatment history.
• This drug should not be used with other emtricitabine- or lamivudine-containing products.

Monitoring:

• General: Clinical response to therapy in patients with CrCl less than 50 mL/min
• Hepatic: For chronic HBV in all patients (before therapy); hepatic function with clinical and laboratory follow-up in HIV-1/HBV-coinfected patients (for at least several months after stopping therapy)
• Renal: Renal function in patients with CrCl less than 50 mL/min

Patient advice:

• Read the US FDA-approved patient labeling (Patient Information).

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