Emtricitabine, Rilpivirine Hydrochloride, And Tenofovir Disoproxil Fumarate: Difference between revisions
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|fdaLIADAdult=COMPLERA, a combination of two nucleoside analog HIV 1 reverse transcriptase inhibitors (emtricitabine and tenofovir disoproxil fumarate) and one non-nucleoside reverse transcriptase inhibitor (rilpivirine), is indicated for use as a complete regimen for the treatment of HIV-1 infection in adult patients with no antiretroviral treatment history and with HIV-1 RNA less than or equal to 100,000 copies/mL at the start of therapy, and in certain virologically-suppressed (HIV-1 RNA <50 copies/mL) adult patients on a stable antiretroviral regimen at start of therapy in order to replace their current antiretroviral treatment regimen (see below). | |||
The following points should be considered when initiating therapy with COMPLERA in adult patients with no antiretroviral treatment history: | |||
More rilpivirine-treated subjects with HIV-1 RNA greater than 100,000 copies/mL at the start of therapy experienced virologic failure (HIV-1 RNA ≥50 copies/mL) compared to rilpivirine-treated subjects with HIV-1 RNA less than or equal to 100,000 copies/mL. | |||
Regardless of HIV-1 RNA level at the start of therapy, more rilpivirine-treated subjects with CD4+ cell count less than 200 cells/mm3 experienced virologic failure compared to rilpivirine-treated subjects with CD4+ cell count greater than or equal to 200 cells/mm3. | |||
The observed virologic failure rate in rilpivirine-treated subjects conferred a higher rate of overall treatment resistance and cross-resistance to the NNRTI class compared to efavirenz. | |||
More subjects treated with rilpivirine developed tenofovir and lamivudine/emtricitabine associated resistance compared to efavirenz. | |||
The efficacy of COMPLERA was established in patients who were virologically-suppressed (HIV-1 RNA <50 copies/mL) on stable ritonavir-boosted protease inhibitor-containing regimen. The following points should be met when considering replacing the current regimen with COMPLERA in virologically-suppressed adults: | |||
Patients should have no history of virologic failure. | |||
Patients should have been stably suppressed (HIV-1 RNA <50 copies/mL) for at least 6 months prior to switching therapy. | |||
Patients should currently be on their first or second antiretroviral regimen prior to switching therapy. | |||
Patients should have no current or past history of resistance to any of the three components of COMPLERA. | |||
Additional monitoring of HIV-1 RNA and regimen tolerability is recommended after replacing therapy to assess for potential virologic failure or rebound. | |||
COMPLERA is not recommended for patients less than 18 years of age. | |||
'''DOSAGE AND ADMINISTRATION''' | |||
Adults: The recommended dose of COMPLERA is one tablet taken orally once daily with food. | |||
Renal Impairment: Because COMPLERA is a fixed-dose combination, it should not be prescribed for patients requiring dose reduction such as those with moderate or severe renal impairment (estimated creatinine clearance below 50 mL per minute). | |||
Rifabutin Coadministration: If COMPLERA is coadministered with rifabutin, an additional 25 mg tablet of rilpivirine (Edurant®) once per day is recommended to be taken concomitantly with COMPLERA and with a meal for the duration of the rifabutin coadministration. | |||
|offLabelAdultGuideSupport=There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of Emtricitabine, Rilpivirine Hydrochloride, And Tenofovir Disoproxil Fumarate in adult patients. | |offLabelAdultGuideSupport=There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of Emtricitabine, Rilpivirine Hydrochloride, And Tenofovir Disoproxil Fumarate in adult patients. | ||
|offLabelAdultNoGuideSupport=There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of Emtricitabine, Rilpivirine Hydrochloride, And Tenofovir Disoproxil Fumarate in adult patients. | |offLabelAdultNoGuideSupport=There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of Emtricitabine, Rilpivirine Hydrochloride, And Tenofovir Disoproxil Fumarate in adult patients. | ||
Revision as of 20:01, 25 August 2014
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1];
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Overview
Emtricitabine, Rilpivirine Hydrochloride, And Tenofovir Disoproxil Fumarate is an anti- HIV agent that is FDA approved for the treatment of HIV infection. Common adverse reactions include depressive disorders, insomnia, and headache, diarrhea, nausea, fatigue, dizziness, abnormal dreams, and rash..
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
COMPLERA, a combination of two nucleoside analog HIV 1 reverse transcriptase inhibitors (emtricitabine and tenofovir disoproxil fumarate) and one non-nucleoside reverse transcriptase inhibitor (rilpivirine), is indicated for use as a complete regimen for the treatment of HIV-1 infection in adult patients with no antiretroviral treatment history and with HIV-1 RNA less than or equal to 100,000 copies/mL at the start of therapy, and in certain virologically-suppressed (HIV-1 RNA <50 copies/mL) adult patients on a stable antiretroviral regimen at start of therapy in order to replace their current antiretroviral treatment regimen (see below).
The following points should be considered when initiating therapy with COMPLERA in adult patients with no antiretroviral treatment history:
More rilpivirine-treated subjects with HIV-1 RNA greater than 100,000 copies/mL at the start of therapy experienced virologic failure (HIV-1 RNA ≥50 copies/mL) compared to rilpivirine-treated subjects with HIV-1 RNA less than or equal to 100,000 copies/mL.
Regardless of HIV-1 RNA level at the start of therapy, more rilpivirine-treated subjects with CD4+ cell count less than 200 cells/mm3 experienced virologic failure compared to rilpivirine-treated subjects with CD4+ cell count greater than or equal to 200 cells/mm3.
The observed virologic failure rate in rilpivirine-treated subjects conferred a higher rate of overall treatment resistance and cross-resistance to the NNRTI class compared to efavirenz.
More subjects treated with rilpivirine developed tenofovir and lamivudine/emtricitabine associated resistance compared to efavirenz.
The efficacy of COMPLERA was established in patients who were virologically-suppressed (HIV-1 RNA <50 copies/mL) on stable ritonavir-boosted protease inhibitor-containing regimen. The following points should be met when considering replacing the current regimen with COMPLERA in virologically-suppressed adults:
Patients should have no history of virologic failure.
Patients should have been stably suppressed (HIV-1 RNA <50 copies/mL) for at least 6 months prior to switching therapy.
Patients should currently be on their first or second antiretroviral regimen prior to switching therapy.
Patients should have no current or past history of resistance to any of the three components of COMPLERA.
Additional monitoring of HIV-1 RNA and regimen tolerability is recommended after replacing therapy to assess for potential virologic failure or rebound.
COMPLERA is not recommended for patients less than 18 years of age.
DOSAGE AND ADMINISTRATION
Adults: The recommended dose of COMPLERA is one tablet taken orally once daily with food.
Renal Impairment: Because COMPLERA is a fixed-dose combination, it should not be prescribed for patients requiring dose reduction such as those with moderate or severe renal impairment (estimated creatinine clearance below 50 mL per minute).
Rifabutin Coadministration: If COMPLERA is coadministered with rifabutin, an additional 25 mg tablet of rilpivirine (Edurant®) once per day is recommended to be taken concomitantly with COMPLERA and with a meal for the duration of the rifabutin coadministration.
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Emtricitabine, Rilpivirine Hydrochloride, And Tenofovir Disoproxil Fumarate in adult patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Emtricitabine, Rilpivirine Hydrochloride, And Tenofovir Disoproxil Fumarate in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding Emtricitabine, Rilpivirine Hydrochloride, 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 Emtricitabine, Rilpivirine Hydrochloride, And Tenofovir Disoproxil Fumarate in pediatric patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Emtricitabine, Rilpivirine Hydrochloride, And Tenofovir Disoproxil Fumarate in pediatric patients.
Contraindications
Coadministration of COMPLERA is contraindicated with drugs where significant decreases in rilpivirine plasma concentrations may occur, which may result in loss of virologic response and possible resistance and cross-resistance.
Warnings
There is limited information regarding Emtricitabine, Rilpivirine Hydrochloride, And Tenofovir Disoproxil Fumarate Warnings' in the drug label.
Adverse Reactions
Clinical Trials Experience
There is limited information regarding Emtricitabine, Rilpivirine Hydrochloride, And Tenofovir Disoproxil Fumarate Clinical Trials Experience in the drug label.
Postmarketing Experience
There is limited information regarding Emtricitabine, Rilpivirine Hydrochloride, And Tenofovir Disoproxil Fumarate Postmarketing Experience in the drug label.
Drug Interactions
There is limited information regarding Emtricitabine, Rilpivirine Hydrochloride, 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 Emtricitabine, Rilpivirine Hydrochloride, And Tenofovir Disoproxil Fumarate in women who are pregnant.
Pregnancy Category (AUS):
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Emtricitabine, Rilpivirine Hydrochloride, And Tenofovir Disoproxil Fumarate in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Emtricitabine, Rilpivirine Hydrochloride, And Tenofovir Disoproxil Fumarate during labor and delivery.
Nursing Mothers
There is no FDA guidance on the use of Emtricitabine, Rilpivirine Hydrochloride, And Tenofovir Disoproxil Fumarate in women who are nursing.
Pediatric Use
There is no FDA guidance on the use of Emtricitabine, Rilpivirine Hydrochloride, And Tenofovir Disoproxil Fumarate in pediatric settings.
Geriatic Use
There is no FDA guidance on the use of Emtricitabine, Rilpivirine Hydrochloride, And Tenofovir Disoproxil Fumarate in geriatric settings.
Gender
There is no FDA guidance on the use of Emtricitabine, Rilpivirine Hydrochloride, And Tenofovir Disoproxil Fumarate with respect to specific gender populations.
Race
There is no FDA guidance on the use of Emtricitabine, Rilpivirine Hydrochloride, And Tenofovir Disoproxil Fumarate with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Emtricitabine, Rilpivirine Hydrochloride, And Tenofovir Disoproxil Fumarate in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Emtricitabine, Rilpivirine Hydrochloride, And Tenofovir Disoproxil Fumarate in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Emtricitabine, Rilpivirine Hydrochloride, And Tenofovir Disoproxil Fumarate in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Emtricitabine, Rilpivirine Hydrochloride, And Tenofovir Disoproxil Fumarate in patients who are immunocompromised.
Administration and Monitoring
Administration
There is limited information regarding Emtricitabine, Rilpivirine Hydrochloride, And Tenofovir Disoproxil Fumarate Administration in the drug label.
Monitoring
There is limited information regarding Emtricitabine, Rilpivirine Hydrochloride, And Tenofovir Disoproxil Fumarate Monitoring in the drug label.
IV Compatibility
There is limited information regarding the compatibility of Emtricitabine, Rilpivirine Hydrochloride, And Tenofovir Disoproxil Fumarate and IV administrations.
Overdosage
There is limited information regarding Emtricitabine, Rilpivirine Hydrochloride, 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 Emtricitabine, Rilpivirine Hydrochloride, And Tenofovir Disoproxil Fumarate Pharmacology in the drug label.
Mechanism of Action
There is limited information regarding Emtricitabine, Rilpivirine Hydrochloride, And Tenofovir Disoproxil Fumarate Mechanism of Action in the drug label.
Structure
There is limited information regarding Emtricitabine, Rilpivirine Hydrochloride, And Tenofovir Disoproxil Fumarate Structure in the drug label.
Pharmacodynamics
There is limited information regarding Emtricitabine, Rilpivirine Hydrochloride, And Tenofovir Disoproxil Fumarate Pharmacodynamics in the drug label.
Pharmacokinetics
There is limited information regarding Emtricitabine, Rilpivirine Hydrochloride, And Tenofovir Disoproxil Fumarate Pharmacokinetics in the drug label.
Nonclinical Toxicology
There is limited information regarding Emtricitabine, Rilpivirine Hydrochloride, And Tenofovir Disoproxil Fumarate Nonclinical Toxicology in the drug label.
Clinical Studies
There is limited information regarding Emtricitabine, Rilpivirine Hydrochloride, And Tenofovir Disoproxil Fumarate Clinical Studies in the drug label.
How Supplied
There is limited information regarding Emtricitabine, Rilpivirine Hydrochloride, And Tenofovir Disoproxil Fumarate How Supplied in the drug label.
Storage
There is limited information regarding Emtricitabine, Rilpivirine Hydrochloride, And Tenofovir Disoproxil Fumarate Storage in the drug label.
Images
Drug Images
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Package and Label Display Panel
{{#ask: Label Page::Emtricitabine, Rilpivirine Hydrochloride, And Tenofovir Disoproxil Fumarate |?Label Name |format=template |template=DrugLabelImages |mainlabel=- |sort=Label Page }}
Patient Counseling Information
There is limited information regarding Emtricitabine, Rilpivirine Hydrochloride, And Tenofovir Disoproxil Fumarate Patient Counseling Information in the drug label.
Precautions with Alcohol
Alcohol-Emtricitabine, Rilpivirine Hydrochloride, 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 Emtricitabine, Rilpivirine Hydrochloride, And Tenofovir Disoproxil Fumarate Brand Names in the drug label.
Look-Alike Drug Names
There is limited information regarding Emtricitabine, Rilpivirine Hydrochloride, 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.