Emtricitabine

Emtricitabine
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: Gloria Picoy [2]

Disclaimer

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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, including fatal cases, have been reported with the use of nucleoside analogs alone or in combination with other antiretrovirals. Emtricitabine is not approved for the treatment of chronic hepatitis B virus (HBV) infection and the safety and efficacy of EMTRIVA have not been established in patients coinfected with HBV and HIV-1. Severe acute exacerbations of hepatitis B have been reported in patients who have discontinued EMTRIVA. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who are coinfected with HIV-1 and HBV and discontinue EMTRIVA. If appropriate, initiation of anti-hepatitis B therapy may be warranted.

Overview

Emtricitabine is a nucleoside reverse transcriptase inhibitor that is FDA approved for the treatment of HIV-1 infection in combination with other antiretroviral agents. There is a Black Box Warning for this drug as shown here. Common adverse reactions include headache, diarrhea, nausea, fatigue, dizziness, depression, insomnia, abnormal dreams, rash, abdominal pain, asthenia, increased cough, rhinitis and skin hyperpigmentation (pediatric patients).

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Emtricitabine is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection.

• Dosage:

• Capsules: one 200 mg capsule administered once daily orally.
• Oral solution: 240 mg (24 mL) administered once daily orally.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Emtricitabine in adult patients.

Non–Guideline-Supported Use

• Chronic type B viral hepatitis

• Dosage: 200 mg/day for 48 weeks Lim SG, Ng TM, Kung N, Krastev Z, Volfova M, Husa P, et al. (2006). "A double-blind placebo-controlled study of emtricitabine in chronic hepatitis B". Arch. Intern. Med. 166 (1): 49–56. doi:10.1001/archinte.166.1.49. PMID 16401810.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Emtricitabine is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection.

• Dosage in pediatric patients between 0–3 months of age

• Oral solution: 3 mg per kg administered once daily orally.

• Dosage in pediatric patients between 3 months through 17 years

• Oral solution: 6 mg per kg up to a maximum of 240 mg (24 mL) administered once daily orally.
• Capsules: for children weighing more than 33 kg who can swallow an intact capsule, one 200 mg capsule administered once daily orally.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Emtricitabine in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Emtricitabine in pediatric patients.

Contraindications

There is limited information regarding Emtricitabine 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, including fatal cases, have been reported with the use of nucleoside analogs alone or in combination with other antiretrovirals. Emtricitabine is not approved for the treatment of chronic hepatitis B virus (HBV) infection and the safety and efficacy of EMTRIVA have not been established in patients coinfected with HBV and HIV-1. Severe acute exacerbations of hepatitis B have been reported in patients who have discontinued EMTRIVA. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who are coinfected with HIV-1 and HBV and discontinue EMTRIVA. If appropriate, initiation of anti-hepatitis B therapy may be warranted.

There is limited information regarding Emtricitabine Warnings' in the drug label.

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Emtricitabine Clinical Trials Experience in the drug label.

Postmarketing Experience

There is limited information regarding Emtricitabine Postmarketing Experience in the drug label.

Drug Interactions

There is limited information regarding Emtricitabine Drug Interactions in the drug label.

Use in Specific Populations

Pregnancy

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

Labor and Delivery

There is no FDA guidance on use of Emtricitabine during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Emtricitabine in women who are nursing.

Pediatric Use

There is no FDA guidance on the use of Emtricitabine in pediatric settings.

Geriatic Use

There is no FDA guidance on the use of Emtricitabine in geriatric settings.

Gender

There is no FDA guidance on the use of Emtricitabine with respect to specific gender populations.

Race

There is no FDA guidance on the use of Emtricitabine with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Emtricitabine in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Emtricitabine in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Emtricitabine in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Emtricitabine in patients who are immunocompromised.

Administration and Monitoring

Administration

There is limited information regarding Emtricitabine Administration in the drug label.

Monitoring

There is limited information regarding Emtricitabine Monitoring in the drug label.

IV Compatibility

There is limited information regarding the compatibility of Emtricitabine and IV administrations.

Overdosage

There is limited information regarding Emtricitabine 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 Emtricitabine Pharmacology in the drug label.

Mechanism of Action

There is limited information regarding Emtricitabine Mechanism of Action in the drug label.

Structure

There is limited information regarding Emtricitabine Structure in the drug label.

Pharmacodynamics

There is limited information regarding Emtricitabine Pharmacodynamics in the drug label.

Pharmacokinetics

There is limited information regarding Emtricitabine Pharmacokinetics in the drug label.

Nonclinical Toxicology

There is limited information regarding Emtricitabine Nonclinical Toxicology in the drug label.

Clinical Studies

There is limited information regarding Emtricitabine Clinical Studies in the drug label.

How Supplied

There is limited information regarding Emtricitabine How Supplied in the drug label.

Storage

There is limited information regarding Emtricitabine 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 Emtricitabine Patient Counseling Information in the drug label.

Precautions with Alcohol

Alcohol-Emtricitabine 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 Emtricitabine Brand Names in the drug label.

Look-Alike Drug Names

There is limited information regarding Emtricitabine 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.

Emtricitabine
EMTRIVA® FDA Package Insert
Description
Clinical Pharmacology
Microbiology
Indications and Usage
Contraindications
Warnings and Precautions
Adverse Reactions
Overdosage
Clinical Studies
Dosage and Administration
How Supplied
Labels and Packages

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [3]; Associate Editor(s)-in-Chief: Ahmed Zaghw, M.D. [4]

Overview

Emtricitabine (FTC), with trade name Emtriva (formerly Coviracil), is a nucleoside reverse transcriptase inhibitor (NRTI) for the treatment of HIV infection in adults and children.

Emtricitabine is also marketed in a fixed-dose combination with tenofovir (Viread) under the brand name Truvada. A fixed-dose triple combination of emtricitabine, tenofovir and efavirenz (Sustiva, marketed by Bristol-Myers Squibb) was approved by the U.S. Food and Drug Administration (FDA) on July 12, 2006 under the brand name Atripla.

Emtricitabine makes up one fourth of the Quad pill (brand name: Stribild).

Category

Antiretroviral

US Brand Names

EMTRIVA^®

FDA Package Insert

Description | Clinical Pharmacology | Microbiology | Indications and Usage | Contraindications | Warnings and Precautions | Adverse Reactions | Overdosage | Clinical Studies | Dosage and Administration | How Supplied | Labels and Packages

Historical Perspective

Emtricitabine was discovered by Dr. Dennis C. Liotta, Dr. Raymond F. Schinazi, and Dr. Woo-Baeg Choi of Emory University and licensed toTriangle Pharmaceuticals by Emory in 1996. Triangle Pharmaceuticals was acquired in 2003 by Gilead Sciences, who completed development and now market the product with the brand name Emtriva.

It was approved by the FDA July 2, 2003. It is very similar to lamivudine (3TC) and cross-resistance between the two is near-universal.

Mechanism of Action

Emtricitabine is an analogue of cytidine which serves as a nucleoside reverse transcriptase inhibitor (NRTI). The drug becomes phosphorylated intracellularly to emtricitabine 5'-triphosphate and interferes with HIV RNA-dependent DNA polymerase resulting in inhibition of viral replication.