Remdesivir: Difference between revisions
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{{DrugProjectFormSinglePage | {{DrugProjectFormSinglePage | ||
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|genericName= Remdesivir | |||
|aOrAn=an | |genericName= | ||
|drugClass=[[adenosine]] [[nucleotide]] prodrug | Remdesivir | ||
|indicationType=treatment | |||
|indication=suspected or laboratory confirmed [[COVID-19| | |aOrAn= | ||
an | |||
|drugClass | |||
=[[adenosine]] [[nucleotide]] prodrug | |||
|indicationType= | |||
treatment | |||
|indication= | |||
patients hospitalized with suspected or laboratory confirmed [[COVID-19|SARS-CoV-2 infection]] and severe disease under an Emergency Use Authorization (EUA). Severe disease is defined as patients with an [[oxygen saturation|oxygen saturation (SpO2)]] ≤94% on room air or requiring supplemental [[oxygen]] or requiring [[mechanical ventilation]] or requiring [[ECMO|extracorporeal membrane oxygenation (ECMO)]]. Specifically, remdesivir is only authorized for hospitalized adult and pediatric patients for whom use of an [[intravenous|intravenous (IV)]] agent is clinically appropriate. | |||
|adverseReactions= | |adverseReactions= | ||
<!--Black Box Warning--> | <!--Black Box Warning--> | ||
|blackBoxWarningTitle= | |blackBoxWarningTitle= | ||
Revision as of 16:49, 2 July 2020
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1];
Disclaimer
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Overview
Remdesivir is an adenosine nucleotide prodrug that is FDA approved for the treatment of patients hospitalized with suspected or laboratory confirmed SARS-CoV-2 infection and severe disease under an Emergency Use Authorization (EUA). Severe disease is defined as patients with an oxygen saturation (SpO2) ≤94% on room air or requiring supplemental oxygen or requiring mechanical ventilation or requiring extracorporeal membrane oxygenation (ECMO). Specifically, remdesivir is only authorized for hospitalized adult and pediatric patients for whom use of an intravenous (IV) agent is clinically appropriate.. Common adverse reactions include .
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
Dosing Information
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Remdesivir in adult patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Remdesivir in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding FDA-Labeled Use of Remdesivir in pediatric patients.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Remdesivir in pediatric patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Remdesivir in pediatric patients.
Contraindications
There is limited information regarding Remdesivir Contraindications in the drug label.
Warnings
Precautions
Adverse Reactions
Clinical Trials Experience
Potential Adverse Reactions
Postmarketing Experience
There is limited information regarding Remdesivir Postmarketing Experience in the drug label.
Drug Interactions
There is limited information regarding Remdesivir Drug Interactions in the drug label.
Use in Specific Populations
Pregnancy
Pregnancy Category (FDA):
There is no FDA guidance on usage of Remdesivir in women who are pregnant.
Pregnancy Category (AUS):
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Remdesivir in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Remdesivir during labor and delivery.
Nursing Mothers
There is no FDA guidance on the use of Remdesivir in women who are nursing.
Pediatric Use
There is no FDA guidance on the use of Remdesivir in pediatric settings.
Geriatic Use
There is no FDA guidance on the use of Remdesivir in geriatric settings.
Gender
There is no FDA guidance on the use of Remdesivir with respect to specific gender populations.
Race
There is no FDA guidance on the use of Remdesivir with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Remdesivir in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Remdesivir in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Remdesivir in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Remdesivir in patients who are immunocompromised.
Administration and Monitoring
Administration
There is limited information regarding Remdesivir Administration in the drug label.
Monitoring
There is limited information regarding Monitoring of Remdesivir in the drug label.
IV Compatibility
There is limited information regarding IV Compatibility of Remdesivir in the drug label.
Overdosage
There is limited information regarding Remdesivir 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 Remdesivir Pharmacology in the drug label.
Mechanism of Action
There is limited information regarding Remdesivir Mechanism of Action in the drug label.
Structure
There is limited information regarding Remdesivir Structure in the drug label.
Pharmacodynamics
There is limited information regarding Remdesivir Pharmacodynamics in the drug label.
Pharmacokinetics
There is limited information regarding Remdesivir Pharmacokinetics in the drug label.
Nonclinical Toxicology
There is limited information regarding Remdesivir Nonclinical Toxicology in the drug label.
Clinical Studies
There is limited information regarding Remdesivir Clinical Studies in the drug label.
How Supplied
There is limited information regarding Remdesivir How Supplied in the drug label.
Storage
There is limited information regarding Remdesivir Storage in the drug label.
Images
Drug Images
{{#ask: Page Name::Remdesivir |?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::Remdesivir |?Label Name |format=template |template=DrugLabelImages |mainlabel=- |sort=Label Page }}
Patient Counseling Information
There is limited information regarding Remdesivir Patient Counseling Information in the drug label.
Precautions with Alcohol
Alcohol-Remdesivir interaction has not been established. Talk to your doctor regarding the effects of taking alcohol with this medication.
Brand Names
There is limited information regarding Remdesivir Brand Names in the drug label.
Look-Alike Drug Names
There is limited information regarding Remdesivir 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.