Veklury® (remdesivir) Emergency Use for Pediatric Patients
For U.S. Healthcare Professionals only.
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 weighing 3.5 kg to less than 40 kg or pediatric patients less than 12 years of age weighing at least 3.5 kg with positive results of direct SARS-CoV-2 viral testing. 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 COVID-19 in pediatric patients weighing 3.5 kg to less than 40 kg or pediatric patients less than 12 years of age weighing at least 3.5 kg with positive results of direct SARS-CoV-2, who are:
- Hospitalized, or
- Not hospitalized and have mild-to-moderate COVID-19, and are at high risk for progression to severe COVID-19, including hospitalization or death.
- The emergency use of Veklury in pediatric patients weighing 3.5 kg to less than 40 kg or less than 12 years of age weighing at least 3.5kg 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 only authorized 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 weighing 3.5 kg to less than 40 kg or less than 12 years of age weighing at least 3.5 kg are described in the Fact Sheet for Healthcare Providers, available here.
- Healthcare providers and/or their designee are responsible for mandatory reporting of all serious adverse events and medication errors potentially related to VEKLURY within 7 calendar days from the healthcare provider’s awareness 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 the approved use of Veklury for COVID-19 in adults and pediatric patients ≥12 old and weighing ≥40 kg, please see the full Prescribing Information, available here.