Monograph: Remdesivir

Remdesivir

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Full Title

Remdesivir

Generic Name

Remdesivir

Chemical Name

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INV Number

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Classification

CAS Number

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Introduction

Introduction

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Description

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Spectrum

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Resistance

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Uses

Uses

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Coronavirus Disease 2019 (COVID-19)

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Emergency Use Authorization (EUA)

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Clinical Experience

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Placebo-controlled Trial in Hospitalized Adults with Severe COVID-19

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Adaptive, Placebo-controlled Trial in Hospitalized Adults with Mild/Moderate or Severe COVID-19

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Open-label Trial in Hospitalized Patients with Severe COVID-19

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Open-label Trial in Hospitalized Patients with Moderate COVID-19

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Compassionate Use Data

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Dosage and Administration

Dosage and Administration

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General

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Administration

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IV Infusion

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Preparation of Lyophilized Powder for Adults and Pediatric Patients Weighing 40 kg or More

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Table 1. Reconstituted Lyophilized Powder: Dilution Instructions for Preparing Loading Dose (200 mg) and Maintenance Doses (100 mg) of Remdesivir for Adults and Pediatric Patients Weighing 40 kg or More.26

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Preparation of Lyophilized Powder for Pediatric Patients Weighing 3.5 to less than 40 kg

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Preparation of Solution Concentrate for Adults and Pediatric Patients Weighing 40 kg or More

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Table 2. Solution Concentrate: Dilution Instructions for Preparing Loading Dose (200 mg) and Maintenance Doses (100 mg) of Remdesivir for Adults and Pediatric Patients Weighing 40 kg or More.26

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Rate of Administration

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Table 3. Recommended Rate of IV Infusion in Adults and Pediatric Patients Weighing 40 kg or More.26

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Table 4. Recommended Rate of IV Infusion in Pediatric Patients Weighing 3.5 to less than 40 kg.26

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Dosage

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Adult Dosage

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Coronavirus Disease 2019 (COVID-19)

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Pediatric Dosage

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Coronavirus Disease 2019 (COVID-19)

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Special Populations

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Hepatic Impairment

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Renal Impairment

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Geriatric Patients

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Cautions

Cautions

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Contraindications

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Warnings/Precautions

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Patient Monitoring and Mandatory FDA MedWatch Reporting

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Hypersensitivity and Infusion-related Reactions

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Increased Risk of Aminotransferase Elevations

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Risk of Reduced Antiviral Activity if Used Concomitantly with Chloroquine or Hydroxychloroquine

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Specific Populations

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Pregnancy

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Lactation

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Pediatric Use

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Geriatric Use

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Hepatic Impairment

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Renal Impairment

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Common Adverse Effects

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Drug Interactions

Drug Interactions

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Drugs Affecting Hepatic Microsomal Enzymes or Transport Systems

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Chloroquine and Hydroxychloroquine

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Dexamethasone

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Pharmacokinetics

Pharmacokinetics

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Absorption

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Distribution

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Elimination

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Stability Section

Stability

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Powder for Injection, for IV Infusion

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Solution Concentrate for Injection, for IV Infusion

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Advice to Patients

Advice to Patients

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Preparations

Preparations

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Remdesivir

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Common general statement Elements

Additional Information

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References

References

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Copyright

AHFS® Drug Information. © Copyright, 1959-2020, Selected Revisions October 5, 2020. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, Maryland 20814.

† Use is not currently included in the labeling approved by the US Food and Drug Administration.

Quelle

AHFS Drug Information