Skip to Content

Efavirenz / Emtricitabine / Tenofovir Dosage

Applies to the following strength(s): 600 mg-200 mg-300 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

1 tablet orally once a day

Use: As a complete regimen or in combination with other antiretroviral agents for the treatment of HIV-1 infection

Usual Adult Dose for Nonoccupational Exposure

US CDC recommendations: 1 tablet orally once a day
Duration of therapy: 28 days

Comments:
-The components of this drug are recommended as a preferred NNRTI-based regimen for nonoccupational postexposure prophylaxis of HIV infection.
-Prophylaxis should be started as soon as possible, within 72 hours of exposure.
-Current guidelines should be consulted for additional information.

Usual Adult Dose for Occupational Exposure

US Public Health Service working group recommendations: 1 tablet orally once a day
Duration of therapy: 28 days, if tolerated

Comments:
-Only with expert consultation, an alternative regimen for use as HIV postexposure prophylaxis
-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 Pediatric Dose for HIV Infection

12 years or older weighing at least 40 kg: 1 tablet orally once a day

Use: As a complete regimen or in combination with other antiretroviral agents for the treatment of HIV-1 infection

Renal Dose Adjustments

Estimated CrCl less than 50 mL/min: Not recommended.

Liver Dose Adjustments

Mild liver dysfunction: No adjustment recommended; caution recommended.
Moderate or severe liver dysfunction: Not recommended.

Dose Adjustments

Concomitant rifampin:
Patients weighing 50 kg or more: An additional 200 mg/day of efavirenz is recommended.

Precautions

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 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 coinfected with HBV and HIV-1 after stopping emtricitabine or tenofovir. Hepatic function of coinfected 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.

This drug should only be used in patients 12 years or older who weigh at least 40 kg. The dose adjustments recommended for patients younger than 12 years for each component cannot be made with the fixed-dose combination tablet; this drug is not recommended for use in these patients.

Consult WARNINGS section for additional precautions.

Dialysis

Estimated CrCl less than 50 mL/min: Not recommended.

Comments:
-Hemodialysis removes about 30% of the emtricitabine dose over a 3-hour dialysis period starting within 1.5 hours of dosing.
-Tenofovir is removed by hemodialysis with an extraction coefficient of about 54%; about 10% of the tenofovir dose is removed over a 4-hour hemodialysis session.
-Hemodialysis is unlikely to significantly remove efavirenz from the blood.

Other Comments

Administration advice:
-Administer on an empty stomach.
-Dosing at bedtime may improve tolerability of nervous system symptoms.

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

Monitoring:
-General: Pregnancy testing (before starting therapy)
-Hepatic: Liver enzymes (before and during therapy); for chronic HBV in all patients (before therapy); hepatic function of HIV-1/HBV-coinfected patients with clinical and laboratory follow-up (for at least several months after stopping therapy)
-Metabolic: Serum phosphorus in patients at risk of renal dysfunction (before starting and periodically during therapy)
-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 patients (before starting and as clinically appropriate during therapy); estimated CrCl, urine glucose, and urine protein in patients at risk of renal dysfunction (before starting and periodically during therapy)

Patient advice:
-This drug may impair mental abilities needed to perform potentially hazardous tasks (e.g., driving, operating machinery); CNS effects may be additive if used with alcohol or psychoactive drugs. Avoid hazardous tasks if CNS symptoms (e.g., dizziness, impaired concentration, drowsiness) occur.

Hide