Remdesivir
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1];
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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)
Dosage and Administration
Important Testing Prior to and During Treatment and Route of Administration
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
Remdesivir is contraindicated in patients with known hypersensitivity to any ingredient of remdesivir.
Warnings
There are limited clinical data available for remdesivir. Serious and unexpected adverse events may occur that have not been previously reported with remdesivir use.
Hypersensitivity Including Infusion-Related and Anaphylactic Reactions
Hypersensitivity reactions including infusion-related and anaphylactic reactions have been observed during and following administration of remdesivir. Signs and symptoms may include hypotension, tachycardia, bradycardia, dyspnea, wheezing, angioedema, rash, nausea, vomiting, diaphoresis, and shivering. Slower infusion rates, with a maximum infusion time of up to 120 minutes, can be considered to potentially prevent these signs and symptoms. If signs and symptoms of a clinically significant hypersensitivity reaction occur, immediately discontinue administration of remdesivir and initiate appropriate treatment. The use of remdesivir is contraindicated in patients with known hypersensitivity to remdesivir.
Increased Risk of Transaminase Elevations
Transaminase elevations have been observed in healthy volunteers who received 200 mg of remdesivir followed by 100 mg doses for 5-10 days. Transaminase elevations have also been reported in patients with COVID-19 who received remdesivir in clinical trials. As transaminase elevations have been reported as a component of COVID-19, including in patients receiving placebo in clinical trials of remdesivir, discerning the contribution of remdesivir to transaminase elevations in this patient population is challenging.
Hepatic laboratory testing should be performed in all patients prior to starting remdesivir and daily while receiving remdesivir.
- Remdesivir should not be initiated in patients with ALT greater than or equal to 5 times the upper limit of normal at baseline.
- Remdesivir should be discontinued in patients who develop:
- ALT greater than or equal to 5 times the upper limit of normal during treatment with remdesivir. Remdesivir may be restarted when ALT is less than 5 times the upper limit of normal.
OR
- ALT elevation accompanied by signs or symptoms of liver inflammation or increasing conjugated bilirubin, alkaline phosphatase, or INR.
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
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Package and Label Display Panel
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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.