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

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.

Frequently Asked Questions (FAQ)

What is COVID-19?

Coronavirus disease 2019 (COVID-19) is a respiratory illness that can spread from person to person. There are many types of human coronaviruses, including some that commonly cause mild upper-respiratory tract illnesses. COVID-19 is a new disease caused by the virus SARS-CoV-2, a novel coronavirus that has not previously been seen in humans. Current symptoms reported for patients with COVID-19 have included mild to severe respiratory illness with fever, cough, and difficulty breathing.1

SARS-CoV=severe acute respiratory syndrome coronavirus.

Reference: 1. US Food and Drug Administration. Coronavirus disease 2019 (COVID-19) frequently asked questions. https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/coronavirus-disease-2019-covid-19-frequently-asked-questions. Updated March 30, 2020. Accessed April 1, 2020.

How does remdesivir work?

Remdesivir is an adenosine nucleotide prodrug that distributes into cells where it is metabolized to form the pharmacologically active nucleoside triphosphate metabolite. Metabolism of remdesivir to remdesivir triphosphate has been demonstrated in multiple cell types.

Remdesivir triphosphate acts as an analog of adenosine triphosphate (ATP) and competes with the natural ATP substrate for incorporation into nascent RNA chains by the SARS-CoV-2 RNA-dependent RNA polymerase, which results in delayed chain termination during replication of the viral RNA.1

The clinical efficacy and safety of remdesivir for the treatment of COVID-19 is not yet known.

RNA=ribonucleic acid; SARS-CoV=severe acute respiratory syndrome coronavirus.

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

Who is eligible for remdesivir under the Emergency Use Authorization (EUA)?

Remdesivir is authorized for use under an EUA for treatment of patients hospitalized with suspected or laboratory-confirmed SARS-CoV-2 infection and severe disease. Severe disease is defined as patients with an oxygen saturation (SpO2) ≤94% on room air or requiring supplemental oxygen, requiring mechanical ventilation, and/or requiring extracorporeal membrane oxygenation (ECMO). Specifically, remdesivir is only authorized for hospitalized adult and pediatric patients for whom use of an intravenous agent is clinically appropriate.1

SARS-CoV=severe acute respiratory syndrome coronavirus.

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

How is the US government deciding on allocation of donated remdesivir?

The US government is coordinating the donation and distribution of remdesivir by determining how much drug each state will receive. State public health departments will identify which local hospitals will receive remdesivir and how much drug each hospital will receive. Gilead and AmerisourceBergen are working under the guidance of the federal and state governments, and state public health departments for the distribution of remdesivir. AmerisourceBergen will ship to locations as directed by the US government.

For further information, please see the HHS May 9, 2020 announcement available here.

What are the available safety data for remdesivir?

Remdesivir is an unapproved investigational product, and there are limited clinical data available. Available clinical safety information can be found here.

What is the guidance on preparation, dosage, and administration of remdesivir?

Remdesivir is supplied as an injection solution or as a lyophilized powder for injection. Remdesivir must be administered intravenously.1

Instructions for preparation, dosing, and administration of remdesivir IV solution can be found in Section 2 of the EUA Fact Sheet for Healthcare Providers.

Download the Pharmacy Guide with information about preparation, dosing, and administration of remdesivir IV solution.

IV=intravenous.

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

What is an Emergency Use Authorization (EUA)?

The Secretary of HHS has declared a public health emergency that justifies the emergency use of remdesivir to treat COVID-19 caused by SARs-CoV-2. In response, the FDA has issued an EUA for the unapproved product, remdesivir, for the treatment of COVID-19. As a healthcare provider, you must comply with the mandatory requirements of the EUA.

The FDA issued this EUA, requested by Gilead Sciences, Inc. and based on their submitted data.

Although limited scientific information is available, based on the totality of the scientific evidence available to date, it is reasonable to believe that remdesivir may be effective for the treatment of COVID-19 in patients as specified in the Fact Sheet.

This EUA for remdesivir will end when the Secretary determines that the circumstances justifying the EUA no longer exist or when there is a change in the approval status of the product such that an EUA is no longer needed.1

Healthcare providers should visit ClinicalTrials.gov to determine whether a patient may be eligible for enrollment in a clinical trial.

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

How can I register my patients for a clinical trial?

Gilead Sciences Inc., itself and in collaboration with global health authorities, is sponsoring numerous clinical trials to evaluate the safety and efficacy of remdesivir.1

For an overview of trials and trial sites, please visit ClinicalTrials.gov.

Reference: 1. Data on file. Gilead Sciences, Inc.

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.

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.