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

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.

Granted Emergency Use Authorization (EUA) by the FDA for the treatment of COVID-191

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.

EUA Fact Sheets

Remdesivir is an investigational drug, and there is no Prescribing Information. However, the FDA has authorized distribution of this investigational drug with Fact Sheets for healthcare providers and patients.

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SARS-CoV=severe acute respiratory syndrome coronavirus.

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.

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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.