Veklury® (remdesivir) Emergency Use for Pediatric Patients
For U.S. Healthcare Professionals only.
Fact Sheet for Healthcare Providers
Fact Sheet for Parents and Caregivers
Fact Sheet for Parents and Caregivers in Spanish
FDA Emergency Use Authorization Letter
Dear Healthcare Provider Letter
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 pediatric patients less than 12 years of age or weighing 3.5 kg to less than 40 kg with 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 approved product, Veklury, for this unapproved use for the treatment of COVID-19.
- Veklury is authorized for use under an EUA for treatment of hospitalized pediatric patients less than 12 years of age weighing at least 3.5 kg or hospitalized pediatric patients weighing 3.5 kg to less than 40 kg with suspected or laboratory confirmed COVID-19 for whom use of an intravenous (IV) agent is clinically appropriate.
- Individuals determined as being appropriate for acute inpatient hospitalization and who are admitted or transferred to an alternate care site that is capable of providing acute care that is comparable to general inpatient hospital care are within the terms and conditions of the FDA Letter of Authorization.
- The emergency use of Veklury in pediatric patients less than 12 years of age or weighing 3.5 kg to less than 40 kg is an investigational use that has not been approved by the FDA. It is not yet known if Veklury is safe and effective for this use.
- This emergency 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.
Additional Information for Healthcare Providers:
- Healthcare providers should review the Fact Sheet for Healthcare Providers for information on the authorized use of Veklury in pediatric patients and mandatory requirements of the EUA.
- Veklury must be administered by intravenous infusion. Dosage and administration instructions for pediatric patients less than 12 years of age or weighing 3.5 kg to less than 40 kg 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 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.