This page is intended for US Healthcare Professionals EUA FACT SHEETS HCP | PATIENT
Dosing and Administration

The Secretary of the Department of Health and Human Services has declared a public health emergency that justifies the emergency use of remdesivir to treat coronavirus disease 2019 (COVID-19) caused by SARS-CoV-2 infection. In response, the U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for the unapproved product, remdesivir, for the treatment of COVID-19.

Authorized Use

Remdesivir (GS-5734™) is authorized for use under an EUA only for the treatment of patients with suspected or laboratory-confirmed SARS-CoV-2 infection and severe COVID-19. Severe disease is defined as patients with an oxygen saturation (SpO2) ≤94% on room air or requiring supplemental oxygen, mechanical ventilation, and/or extracorporeal membrane oxygenation (ECMO). Remdesivir is authorized for adult or pediatric patients who are admitted to a hospital and for whom use of an IV agent is clinically appropriate. Remdesivir must be administered intravenously.

Ensuring the Authenticity of Remdesivir

Gilead is committed to patient safety and ensuring that people have accurate information about investigational remdesivir, including how it is accessed and administered. We are actively monitoring for fraudulent offers of illegitimate remdesivir to protect patients from products that might be dangerous and lead to serious and life-threatening harm.

Facts about genuine remdesivir:

Remdesivir Vials of remdesivir.

If you believe you have purchased or have been offered counterfeit remdesivir, please report it to the FDA and to anticounterfeiting@gilead.com.

Dosing and Administration1

For adult and pediatric patients ≥40 kg requiring mechanical ventilation and/or ECMO

Recommended Treatment Course Is 10 Days

  • DAY 1

    200 mg IV

    Loading dose of 200 mg

  • DAYS 2-10

    100 mg IV

    Once-daily dose of 100 mg

For adult and pediatric patients ≥40 kg NOT requiring mechanical ventilation and/or ECMO

Recommended Treatment Course Is 5 Days

  • DAY 1

    200 mg IV

    Loading dose of 200 mg

  • DAYS 2-5

    100 mg IV

    Once-daily dose of 100 mg

Treatment may be extended to a total of 10 days if a patient has not demonstrated clinical improvement by day 5.

Remdesivir is to be administered via intravenous infusion in a total volume of up to 250 mL 0.9% saline over 30 to 120 minutes for adult patients.

The optimal dosing and duration of remdesivir for the treatment of COVID-19 is unknown. The suggested dose under this EUA is described in the Fact Sheet for Healthcare Providers. The suggested dose and duration may be updated as data from clinical trials becomes available.

Pediatric patients 3.5 kg to <40 kg:

Pregnancy:

Renal impairment:

Hepatic impairment:

Drug interactions:

Please See the EUA Fact Sheet for Healthcare Providers for More Information About Dosing, Preparation, and Administration of Remdesivir IV Solution, Including Instructions for Pediatric Patients Weighing Less Than 40 kg.

How Remdesivir Is Supplied

Remdesivir Is Manufactured in Two Ways:

IMPORTANT:
This product contains no preservative. Care should be taken to prevent inadvertent microbial contamination. Any unused portion of a single-dose remdesivir vial should be discarded after a diluted solution is prepared. Do not discard unused and unopened intact vials.

A Pharmacy Guide About the Preparation, Dosing, and Administration of Remdesivir for Adult Patients Is Available:

ALT=alanine aminotransferase; eGFR=estimated glomerular filtration rate; INR=international normalized ratio; IV=intravenous; SARS-CoV=severe acute respiratory syndrome coronavirus; ULN=upper limit of normal.

Important Information

The Secretary of the Department of Health and Human Services has declared a public health emergency that justifies the emergency use of remdesivir to treat coronavirus disease 2019 (COVID-19) caused by SARS-CoV-2 infection. In response, the U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for the unapproved product, remdesivir, for the treatment of COVID-19.

  • Remdesivir is an investigational drug that has not been approved by the FDA for any use. It is not yet known if remdesivir is safe and effective for the treatment of COVID-19.
  • The distribution of remdesivir has been authorized only for the treatment of hospitalized patients with severe COVID-19. It is not authorized for the treatment of any other viruses or pathogens.
  • This use is authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use, unless the authorization is terminated or revoked sooner.
  • The FDA issued this EUA, requested by Gilead Sciences and based on their submitted data. The FDA Letter of Authorization for the EUA is available here.

Additonal Information for Healthcare Providers:

  • Healthcare providers should review the Fact Sheet for Healthcare Providers for information on the authorized use of remdesivir and mandatory requirements of the EUA.
  • Remdesivir must be administered intravenously. The optimal duration of treatment for COVID-19 is unknown. The suggested dose durations under this EUA are described in the Fact Sheet for Healthcare Providers, available here.

Healthcare providers and/or their designee are responsible for mandatory FDA MedWatch reporting of all medication errors and serious adverse events or deaths occurring during remdesivir treatment and considered to be potentially attributable to remdesivir. These events must be reported within 7 calendar days from the onset of the event.

MedWatch adverse event reports can be submitted to the FDA online here, or by calling 1-800-FDA-1088.

  • For information about clinical trials that are testing the use of remdesivir for the treatment of COVID-19, please see www.clinicaltrials.gov.

Authorized Use

Remdesivir (GS-5734™) is authorized for use under an EUA only for the treatment of patients with suspected or laboratory-confirmed SARS-CoV-2 infection and severe COVID-19. Severe disease is defined as patients with an oxygen saturation (SpO2) ≤94% on room air or requiring supplemental oxygen, mechanical ventilation, and/or extracorporeal membrane oxygenation (ECMO). Remdesivir is authorized for adult or pediatric patients who are admitted to a hospital and for whom use of an IV agent is clinically appropriate. Remdesivir must be administered intravenously.

Overall Safety Summary

Remdesivir is an unapproved investigational product, and there are limited clinical data available. Serious and unexpected adverse events may occur that have not been previously reported with remdesivir use.

Warnings: In clinical studies with remdesivir, infusion-related reactions and liver transaminase elevations have been observed. Remdesivir should not be used in patients who are hypersensitive to any ingredient of remdesivir. If signs and symptoms of a clinically significant infusion reaction occur, immediately discontinue administration of remdesivir and initiate appropriate treatment. Do not initiate remdesivir in patients with ALT ≥5x ULN; discontinue therapy in patients who develop ALT ≥5x ULN or ALT elevation accompanied by signs or symptoms of liver inflammation or increasing conjugated bilirubin, alkaline phosphatase, or INR.

Patients should have appropriate clinical and laboratory monitoring to aid in early detection of any potential adverse events. Monitor renal and hepatic function prior to initiating and daily during therapy with remdesivir; additionally monitor serum chemistries and hematology daily during therapy. The decision to continue or discontinue remdesivir therapy after development of an adverse event should be made based on the clinical risk/benefit assessment for the individual patient. For additional information and mandatory adverse event reporting, please see the Fact Sheet for Healthcare Providers.

Reference: 1. Remdesivir [EUA Fact Sheet]. Foster City, CA: Gilead Sciences, Inc.; 2020.

Information about the EUA:

Information about COVID-19:

Gilead is working closely with global health authorities and is focused on contributing our antiviral expertise and resources to help patients and communities impacted by COVID-19.