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 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.

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

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.

EUA Fact Sheets

VEKLURY 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 and caregivers.

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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 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.

Reference: 1. VEKLURY. 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.