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 VEKLURY (remdesivir) to treat coronavirus disease 2019 (COVID-19) caused by SARS-CoV-2 infection. In response, the US Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for the unapproved product, VEKLURY, for the treatment of COVID-19.

Authorized Use

VEKLURY® (remdesivir) is authorized for use under an EUA only for the treatment of adult and pediatric patients hospitalized with suspected or laboratory-confirmed COVID-19, and for whom use of an intravenous (IV) agent is clinically appropriate. VEKLURY must be administered via IV infusion.

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 VEKLURY work?

VEKLURY (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 VEKLURY for the treatment of COVID-19 is not yet known.

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

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

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

VEKLURY (remdesivir) is authorized for use under an EUA only for the treatment of adult and pediatric patients hospitalized with suspected or laboratory-confirmed COVID-19, and for whom use of an intravenous (IV) agent is clinically appropriate. VEKLURY must be administered via IV infusion.1

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

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

Gilead has entered into an agreement with the US Department of Health and Human Services (HHS) whereby HHS and states will continue to manage allocation to hospitals until the end of September. After this period, once supplies are less constrained, HHS will no longer manage allocation. The Assistant Secretary for Preparedness and Response (ASPR) within HHS will work with state and US territory health authorities to identify the hospitals that are eligible to receive drug supply under a twice-monthly allocation process. Using a list of hospitals identified by state and US territory health authorities, AmerisourceBergen will proactively confirm the amounts the hospitals want to purchase.

What are the available safety data for VEKLURY?

VEKLURY 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 VEKLURY?

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

Instructions for preparation, dosing, and administration of VEKLURY (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 VEKLURY (remdesivir) IV solution.

IV=intravenous.

Reference: 1. VEKLURY. 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 VEKLURY to treat COVID-19 caused by SARs-CoV-2. In response, the FDA has issued an EUA for the unapproved product, VEKLURY, 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 VEKLURY may be effective for the treatment of COVID-19 in patients as specified in the Fact Sheet.

This EUA for VEKLURY 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. VEKLURY. 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 VEKLURY.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 VEKLURY (remdesivir) to treat coronavirus disease 2019 (COVID-19) caused by SARS-CoV-2 infection. In response, the US Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for the unapproved product, VEKLURY, for the treatment of COVID-19.

  • VEKLURY is an investigational drug that has not been approved by the FDA for any use. It is not yet known if VEKLURY is safe and effective for the treatment of COVID-19.
  • The distribution of VEKLURY has been authorized only for the treatment of hospitalized patients with COVID-19. 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 VEKLURY and mandatory requirements of the EUA.
  • VEKLURY 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 designees are responsible for mandatory FDA MedWatch reporting of all medication errors and serious adverse events or deaths occurring during VEKLURY treatment and considered to be potentially attributable to VEKLURY. 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.

Authorized Use

VEKLURY® (remdesivir) is authorized for use under an EUA only for the treatment of adult and pediatric patients hospitalized with suspected or laboratory-confirmed COVID-19, and for whom use of an intravenous (IV) agent is clinically appropriate. VEKLURY must be administered via IV infusion.

Safety Information

VEKLURY 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 VEKLURY use.

Warnings and precautions:

  • Hypersensitivity reactions, including infusion-related and anaphylactic reactions, have been observed during and following administration of VEKLURY. Slower infusion rates, with a maximum infusion time of up to 120 minutes, can be considered to potentially prevent symptoms of hypersensitivity. If signs and symptoms of a clinically significant hypersensitivity reaction occur, immediately discontinue administration of VEKLURY and initiate appropriate treatment. The use of VEKLURY is contraindicated in patients with known hypersensitivity to VEKLURY.
  • Transaminase elevations have been observed in healthy volunteers and patients with COVID-19 in clinical trials who received VEKLURY. Do not initiate VEKLURY 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.
  • Risk of reduced antiviral activity when coadministered with chloroquine or hydroxychloroquine. Coadministration of VEKLURY and chloroquine phosphate or hydroxychloroquine sulfate is not recommended based on in vitro data demonstrating an antagonistic effect of chloroquine on the intracellular metabolic activation and antiviral activity of VEKLURY.

Patient monitoring:

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 VEKLURY. The decision to continue or discontinue VEKLURY 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.