Efavirenz, Emtricitabine, and Tenofovir disoproxil fumarate

Efavirenz, Emtricitabine, and Tenofovir disoproxil fumarate
Black Box Warning
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Deepika Beereddy, MBBS [2]

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Black Box Warning

WARNING: LACTIC ACIDOSIS/SEVERE HEPATOMEGALY WITH STEATOSIS and POST TREATMENT EXACERBATION OF HEPATITIS B See full prescribing information for complete Boxed Warning. Lactic acidosis and severe hepatomegaly with steatosis and Post treatment exacerbation of hepatitis B: Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogs, including tenofovir disoproxil fumarate, a component of ATRIPLA. ATRIPLA is not approved for the treatment of chronic hepatitis B virus (HBV) infection. Severe acute exacerbations of hepatitis B have been reported in patients coinfected with HBV and HIV-1 who have discontinued EMTRIVA or VIREAD, two of the components of ATRIPLA. Hepatic function should be monitored closely in these patients. If appropriate, initiation of anti-hepatitis B therapy may be warranted.

Overview

Efavirenz, Emtricitabine, and Tenofovir disoproxil fumarate is an Anti-HIV Agent that is FDA approved for the treatment of HIV-1 infection. There is a Black Box Warning for this drug as shown here. Common adverse reactions include diarrhea, nausea, fatigue, headache, dizziness, depression, insomnia, abnormal dreams, and rash.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

There is limited information regarding Efavirenz, Emtricitabine, and Tenofovir disoproxil fumarate FDA-Labeled Indications and Dosage (Adult) in the drug label.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Efavirenz, Emtricitabine, and Tenofovir disoproxil fumarate in adult patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Efavirenz, Emtricitabine, and Tenofovir disoproxil fumarate in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding Efavirenz, Emtricitabine, and Tenofovir disoproxil fumarate FDA-Labeled Indications and Dosage (Pediatric) in the drug label.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Efavirenz, Emtricitabine, and Tenofovir disoproxil fumarate in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Efavirenz, Emtricitabine, and Tenofovir disoproxil fumarate in pediatric patients.

Contraindications

There is limited information regarding Efavirenz, Emtricitabine, and Tenofovir disoproxil fumarate Contraindications in the drug label.

Warnings

WARNING: LACTIC ACIDOSIS/SEVERE HEPATOMEGALY WITH STEATOSIS and POST TREATMENT EXACERBATION OF HEPATITIS B See full prescribing information for complete Boxed Warning. Lactic acidosis and severe hepatomegaly with steatosis and Post treatment exacerbation of hepatitis B: Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogs, including tenofovir disoproxil fumarate, a component of ATRIPLA. ATRIPLA is not approved for the treatment of chronic hepatitis B virus (HBV) infection. Severe acute exacerbations of hepatitis B have been reported in patients coinfected with HBV and HIV-1 who have discontinued EMTRIVA or VIREAD, two of the components of ATRIPLA. Hepatic function should be monitored closely in these patients. If appropriate, initiation of anti-hepatitis B therapy may be warranted.

There is limited information regarding Efavirenz, Emtricitabine, and Tenofovir disoproxil fumarate Warnings' in the drug label.

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Efavirenz, Emtricitabine, and Tenofovir disoproxil fumarate Clinical Trials Experience in the drug label.

Postmarketing Experience

There is limited information regarding Efavirenz, Emtricitabine, and Tenofovir disoproxil fumarate Postmarketing Experience in the drug label.

Drug Interactions

There is limited information regarding Efavirenz, Emtricitabine, and Tenofovir disoproxil fumarate Drug Interactions in the drug label.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): There is no FDA guidance on usage of Efavirenz, Emtricitabine, and Tenofovir disoproxil fumarate in women who are pregnant.
Pregnancy Category (AUS): There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Efavirenz, Emtricitabine, and Tenofovir disoproxil fumarate in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Efavirenz, Emtricitabine, and Tenofovir disoproxil fumarate during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Efavirenz, Emtricitabine, and Tenofovir disoproxil fumarate in women who are nursing.

Pediatric Use

There is no FDA guidance on the use of Efavirenz, Emtricitabine, and Tenofovir disoproxil fumarate in pediatric settings.

Geriatic Use

There is no FDA guidance on the use of Efavirenz, Emtricitabine, and Tenofovir disoproxil fumarate in geriatric settings.

Gender

There is no FDA guidance on the use of Efavirenz, Emtricitabine, and Tenofovir disoproxil fumarate with respect to specific gender populations.

Race

There is no FDA guidance on the use of Efavirenz, Emtricitabine, and Tenofovir disoproxil fumarate with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Efavirenz, Emtricitabine, and Tenofovir disoproxil fumarate in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Efavirenz, Emtricitabine, and Tenofovir disoproxil fumarate in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Efavirenz, Emtricitabine, and Tenofovir disoproxil fumarate in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Efavirenz, Emtricitabine, and Tenofovir disoproxil fumarate in patients who are immunocompromised.

Administration and Monitoring

Administration

There is limited information regarding Efavirenz, Emtricitabine, and Tenofovir disoproxil fumarate Administration in the drug label.

Monitoring

There is limited information regarding Efavirenz, Emtricitabine, and Tenofovir disoproxil fumarate Monitoring in the drug label.

IV Compatibility

There is limited information regarding the compatibility of Efavirenz, Emtricitabine, and Tenofovir disoproxil fumarate and IV administrations.

Overdosage

There is limited information regarding Efavirenz, Emtricitabine, and Tenofovir disoproxil fumarate overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.

Pharmacology

There is limited information regarding Efavirenz, Emtricitabine, and Tenofovir disoproxil fumarate Pharmacology in the drug label.

Mechanism of Action

There is limited information regarding Efavirenz, Emtricitabine, and Tenofovir disoproxil fumarate Mechanism of Action in the drug label.

Structure

There is limited information regarding Efavirenz, Emtricitabine, and Tenofovir disoproxil fumarate Structure in the drug label.

Pharmacodynamics

There is limited information regarding Efavirenz, Emtricitabine, and Tenofovir disoproxil fumarate Pharmacodynamics in the drug label.

Pharmacokinetics

There is limited information regarding Efavirenz, Emtricitabine, and Tenofovir disoproxil fumarate Pharmacokinetics in the drug label.

Nonclinical Toxicology

There is limited information regarding Efavirenz, Emtricitabine, and Tenofovir disoproxil fumarate Nonclinical Toxicology in the drug label.

Clinical Studies

There is limited information regarding Efavirenz, Emtricitabine, and Tenofovir disoproxil fumarate Clinical Studies in the drug label.

How Supplied

There is limited information regarding Efavirenz, Emtricitabine, and Tenofovir disoproxil fumarate How Supplied in the drug label.

Storage

There is limited information regarding Efavirenz, Emtricitabine, and Tenofovir disoproxil fumarate Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Efavirenz, Emtricitabine, and Tenofovir disoproxil fumarate Patient Counseling Information in the drug label.

Precautions with Alcohol

Alcohol-Efavirenz, Emtricitabine, and Tenofovir disoproxil fumarate interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

There is limited information regarding Efavirenz, Emtricitabine, and Tenofovir disoproxil fumarate Brand Names in the drug label.

Look-Alike Drug Names

There is limited information regarding Efavirenz, Emtricitabine, and Tenofovir disoproxil fumarate Look-Alike Drug Names in the drug label.

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.