Etravirine

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Etravirine
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: Kiran Singh, M.D. [2]

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Overview

Etravirine is a {{{drugClass}}} that is FDA approved for the treatment of {{{indication}}}. Common adverse reactions include .

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Indications

  • INTELENCE®1, in combination with other antiretroviral agents, is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in antiretroviral treatment-experienced patients ages 6 years and older, who have evidence of viral replication and HIV-1 strains resistant to a non-nucleoside reverse transcriptase inhibitor (NNRTI) and other antiretroviral agents.
  • The indication for adult use is based on Week 48 analyses from 2 randomized, double-blind, placebo-controlled trials of INTELENCE®. Both studies were conducted in clinically advanced, 3-class antiretroviral (NNRTI, N[t]RTI, PI) treatment-experienced adults. The indication for pediatric use is based on 24-week analyses of a single-arm, Phase 2 trial in antiretroviral treatment-experienced pediatric subjects 6 years to less than 18 years of age.
  • In treatment-experienced adult and pediatric patients, the following points should be considered when initiating therapy with INTELENCE®:
  • Treatment history and resistance testing should guide the use of INTELENCE® due to concerns for potential cross-resistance .
  • In patients who have experienced virologic failure on an NNRTI-containing regimen, do not use INTELENCE® in combination with only N[t]RTIs .
  • The use of other active antiretroviral agents with INTELENCE® is associated with an increased likelihood of treatment response.
  • The safety and efficacy of INTELENCE® have not been established in treatment-naïve adult patients.

Dosage

The recommended oral dose of INTELENCE® tablets is 200 mg (one 200 mg tablet or two 100 mg tablets) taken twice daily following a meal. The type of food does not affect the exposure to etravirine.

DOSAGE FORMS AND STRENGTHS

INTELENCE® 25 mg Tablets

  • INTELENCE® 25 mg tablets are supplied as white to off-white, oval, scored tablets debossed with "TMC" on one side.

INTELENCE® 100 mg Tablets

  • INTELENCE® 100 mg tablets are supplied as white to off-white oval tablets debossed with "TMC125" on one side and "100" on the other side.

INTELENCE® 200 mg Tablets

  • INTELENCE® 200 mg tablets are supplied as white to off-white, biconvex, oblong tablets debossed with "T200" on one side.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

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

Non–Guideline-Supported Use

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

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Indications

  • INTELENCE®1, in combination with other antiretroviral agents, is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in antiretroviral treatment-experienced patients ages 6 years and older, who have evidence of viral replication and HIV-1 strains resistant to a non-nucleoside reverse transcriptase inhibitor (NNRTI) and other antiretroviral agents.
  • The indication for adult use is based on Week 48 analyses from 2 randomized, double-blind, placebo-controlled trials of INTELENCE®. Both studies were conducted in clinically advanced, 3-class antiretroviral (NNRTI, N[t]RTI, PI) treatment-experienced adults. The indication for pediatric use is based on 24-week analyses of a single-arm, Phase 2 trial in antiretroviral treatment-experienced pediatric subjects 6 years to less than 18 years of age.
  • In treatment-experienced pediatric patients, the following points should be considered when initiating therapy with INTELENCE®:
  • Treatment history and resistance testing should guide the use of INTELENCE® due to concerns for potential cross-resistance .
  • In patients who have experienced virologic failure on an NNRTI-containing regimen, do not use INTELENCE® in combination with only N[t]RTIs .
  • The use of other active antiretroviral agents with INTELENCE® is associated with an increased likelihood of treatment response.
  • The safety and efficacy of INTELENCE® have not been established in treatment-naïve adult patients.

Dosage

Pediatric Patients (6 years to less than 18 years of age)

The recommended dose of INTELENCE® for pediatric patients 6 years to less than 18 years of age and weighing at least 16 kg is based on body weight (see TABLE BELOW) not exceeding the recommended adult dose. INTELENCE® tablet(s) should be taken orally, following a meal. The type of food does not affect the exposure to etravirine.

This image is provided by the National Library of Medicine.
  • The safety and efficacy of INTELENCE® have not been established in children less than 6 years of age

DOSAGE FORMS AND STRENGTHS

INTELENCE® 25 mg Tablets

  • INTELENCE® 25 mg tablets are supplied as white to off-white, oval, scored tablets debossed with "TMC" on one side.

INTELENCE® 100 mg Tablets

  • INTELENCE® 100 mg tablets are supplied as white to off-white oval tablets debossed with "TMC125" on one side and "100" on the other side.

INTELENCE® 200 mg Tablets

  • INTELENCE® 200 mg tablets are supplied as white to off-white, biconvex, oblong tablets debossed with "T200" on one side.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

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

Non–Guideline-Supported Use

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

Contraindications

Warnings

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

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Clinical Trial Experience of

Postmarketing Experience

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

Drug Interactions

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

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA):

  • Pregnancy Category


Pregnancy Category (AUS):

There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Etravirine in women who are pregnant.

Labor and Delivery

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

Nursing Mothers

There is no FDA guidance on the use of Etravirine with respect to nursing mothers.

Pediatric Use

There is no FDA guidance on the use of Etravirine with respect to pediatric patients.

Geriatic Use

There is no FDA guidance on the use of Etravirine with respect to geriatric patients.

Gender

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

Race

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

Renal Impairment

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

Hepatic Impairment

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

Females of Reproductive Potential and Males

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

Immunocompromised Patients

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

Administration and Monitoring

Administration

  • Oral
  • Intravenous

Monitoring

There is limited information regarding Monitoring of Etravirine in the drug label.

  • Description

IV Compatibility

There is limited information regarding IV Compatibility of Etravirine in the drug label.

Overdosage

Acute Overdose

Signs and Symptoms

  • Description

Management

  • Description

Chronic Overdose

There is limited information regarding Chronic Overdose of Etravirine in the drug label.

Pharmacology

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

Mechanism of Action

Structure

File:Etravirine01.png
This image is provided by the National Library of Medicine.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Etravirine in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Etravirine in the drug label.

Nonclinical Toxicology

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

Clinical Studies

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

How Supplied

Storage

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

Precautions with Alcohol

  • Alcohol-Etravirine interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

Look-Alike Drug Names

Drug Shortage Status

Price

References

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

  1. ↑ Empty citation (help)
  2. ↑ "http://www.ismp.org". External link in |title= (help)

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