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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.

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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.

Frequently Asked Questions

Why is allocation by the US government necessary and what is the significance of the time frame?

Although the supply of remdesivir will begin to increase in July, we still do not have enough supply to meet demand. While supply remains constrained, we have agreed with the US government to continue with the existing allocation mechanism established for donated product to ensure there is no disruption in supply to hospitals and patients in need. Although it is difficult to predict spikes in the pandemic, we believe that by the end of September, remdesivir supply will have increased enough to transition to a more traditional supply chain.

How will the distribution and allocation work?

Gilead will sell remdesivir to a single US distributor for remdesivir, AmerisourceBergen, which will then sell product to hospitals identified by the US government. The ASPR of HHS will work with state and US territory health authorities to identify the hospitals that are eligible to receive drug supply and their twice-monthly allocation, and hospitals will work directly with AmerisourceBergen to purchase remdesivir.

How can hospitals order remdesivir?

ASPR will provide the allocation amount to state and US territory health authorities, who will in turn identify the hospitals that are eligible to receive drug supply. AmerisourceBergen will receive this information from ASPR and the state and US territory health authorities. AmerisourceBergen will proactively phone hospitals to confirm that they have been allocated a certain amount and can accept orders within that allocated amount. AmerisourceBergen will ship remdesivir directly to hospitals. This is a change from the process that was in place for donated product. During the donation time period, remdesivir was shipped by state and US territory authorities to allocated hospitals.

How does my hospital receive remdesivir if it's not in the AmerisourceBergen network?

The US government has directed hospitals to seek information from state public health departments regarding allocation to specific hospitals. The fact that your hospital is not an AmerisourceBergen customer will not impact the allocation decisions of your state public health department.

Facts about genuine remdesivir:

Remdesivir Blue Cap Remdesivir Red Cap Vials of remdesivir.

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.

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.

Safety Information

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 and precautions:

  • Hypersensitivity reactions, including infusion-related and anaphylactic reactions, have been observed during and following administration of remdesivir. 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 remdesivir and initiate appropriate treatment. The use of remdesivir is contraindicated in patients with known hypersensitivity to remdesivir.
  • Transaminase elevations have been observed in healthy volunteers and patients with COVID-19 in clinical trials who received remdesivir. 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.
  • Risk of reduced antiviral activity when coadministered with chloroquine or hydroxychloroquine. Coadministration of remdesivir 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 remdesivir.

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 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.