Etravirine: Difference between revisions
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{{DrugProjectFormSinglePage | {{DrugProjectFormSinglePage | ||
|authorTag={{KS}} | |authorTag={{KS}} | ||
|aOrAn=a | |aOrAn=a | ||
|adverseReactions=<!--Black Box Warning--> | |adverseReactions=<!--Black Box Warning--> | ||
|blackBoxWarningTitle=<span style="color:#FF0000;">ConditionName: </span> | |blackBoxWarningTitle=<span style="color:#FF0000;">ConditionName: </span> | ||
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<!--FDA-Labeled Indications and Dosage (Adult)--> | <!--FDA-Labeled Indications and Dosage (Adult)--> | ||
|fdaLIADAdult=== | |fdaLIADAdult===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. | ||
|offLabelAdultGuideSupport=There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in adult patients. | |||
= | |offLabelAdultNoGuideSupport=There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in adult patients. | ||
<!--FDA-Labeled Indications and Dosage (Pediatric)--> | <!--FDA-Labeled Indications and Dosage (Pediatric)--> | ||
|fdaLIADPed= | |fdaLIADPed=There is limited information regarding <i>FDA-Labeled Use</i> of {{PAGENAME}} in pediatric patients. | ||
<!--Guideline-Supported Use (Pediatric)--> | <!--Guideline-Supported Use (Pediatric)--> | ||
|offLabelPedGuideSupport= | |offLabelPedGuideSupport=There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients. | ||
There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients. | |||
|offLabelPedNoGuideSupport=There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients. | |||
|contraindications=* | |||
|clinicalTrials=There is limited information regarding <i>Clinical Trial Experience</i> of | |||
|postmarketing=There is limited information regarding <i>Postmarketing Experience</i> of {{PAGENAME}} in the drug label. | |postmarketing=There is limited information regarding <i>Postmarketing Experience</i> of {{PAGENAME}} in the drug label. | ||
|useInPregnancyFDA=* '''Pregnancy Category''' | |useInPregnancyFDA=* '''Pregnancy Category''' | ||
|useInPregnancyAUS=* | |useInPregnancyAUS=* | ||
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of {{PAGENAME}} in women who are pregnant. | There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of {{PAGENAME}} in women who are pregnant. | ||
|useInLaborDelivery=There is no FDA guidance on use of {{PAGENAME}} during labor and delivery. | |useInLaborDelivery=There is no FDA guidance on use of {{PAGENAME}} during labor and delivery. |
Revision as of 14:59, 16 February 2015
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Kiran Singh, M.D. [2]
Disclaimer
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Overview
Etravirine is a {{{drugClass}}} that is FDA approved for the {{{indicationType}}} 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.
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)
There is limited information regarding FDA-Labeled Use of Etravirine in pediatric patients.
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
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
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
{{#ask: Page Name::Etravirine |?Pill Name |?Drug Name |?Pill Ingred |?Pill Imprint |?Pill Dosage |?Pill Color |?Pill Shape |?Pill Size (mm) |?Pill Scoring |?NDC |?Drug Author |format=template |template=DrugPageImages |mainlabel=- |sort=Pill Name }}
Package and Label Display Panel
{{#ask: Label Page::Etravirine |?Label Name |format=template |template=DrugLabelImages |mainlabel=- |sort=Label Page }}
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
- ®[1]
Look-Alike Drug Names
- A® — B®[2]
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.
- ↑ Empty citation (help)
- ↑ "http://www.ismp.org". External link in
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