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Veklury (remdesivir)

Important information about Veklury

Veklury (remdesivir) is an antiviral drug that has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of adults and pediatric patients (28 days of age and older and weighing at least 3 kg) with positive results of SARS-CoV-2 viral testing. Veklury is for people who are hospitalized or not hospitalized with mild to moderate COVID-19 symptoms and are at high risk for progression to severe COVID-19, including hospitalization or death.

Veklury is administered as an IV infusion over the course of multiple days. It should be initiated within 7 days of symptom onset. Please see FDA-Approved Drugs: Veklury for a full list of drug specifications.

FDA Approval of Veklury

On April 25, 2022, the FDA approved a supplemental new drug application for Veklury for the treatment of pediatric patients. Veklury was the first approved COVID-19 treatment in the United States. The drug was initially approved for the treatment of hospitalized adults, but is currently approved for the treatment of both hospitalized and non-hospitalized adult and pediatric patients. Veklury was first issued Emergency Use Authorization (EUA) on May 1, 2020.

Availability of Veklury

Veklury is now available in hospitals nationwide through standard commercial channels. The U.S. government stopped managing distribution of this product in October 2020 when it was determined supply was sufficient to meet demand.

From May to September 2020, the U.S. Department of Health and Human Services Administration for Strategic Preparedness and Response (HHS/ASPR) managed the fair and equitable allocation of Veklury (remdesivir), while it was a scarce resource. From May 4 – June 29, 2020, 23, 496 cases of donated Veklury were distributed to jurisdictions across the country, including states, U.S. territories, the freely associated states, the Department of Defense, the Department of State, the Veterans Health Administration, the National Institutes of Health, and the Indian Health Service. From July 6 – October 4, 2020, 109,544 cases of the drug were made available to jurisdictions across the country for purchase by administration sites. Each case contained 40 vials of the product.

Historical Veklury Allocation Tables

Veklury Resources

Veklury

 

Veklury (remdesivir)

Hello, I am Dr. Michael Anderson. I’m an intensive care physician and a senior advisor at the Department of Health and Human Services Office of the Assistant Secretary for Preparedness & Response, also known as ASPR. At ASPR I help guide the novel COVID-19 therapeutics as well as focus on a pediatric response agenda.

I want to talk about one of the therapeutics that can help people with COVID-19 remdesivir, also known as Veklury®.

What is Veklury?

Veklury is an antiviral administered with an IV, used to help fight the coronavirus infection by stopping the virus from replicating in the body. This lowers the viral load, reducing the chances of the illness progressing to more serious symptoms and hospitalization.

Who is eligible for Veklury?

Veklury is for adults and children who are at high risk for developing serious symptoms of COVID-19 that may lead to hospitalization or death. For more information about who is at risk, please see the resources provided in the description.

Veklury is for people who have tested positive for COVID-19 either through PCR or rapid antigen testing. Veklury may be used for outpatients and patients in the hospital. For people who are not in the hospital, their symptoms should be mild to moderate. Veklury should be administered as soon as possible after testing positive for COVID-19. Studies have shown it needs to be given within seven days of symptom onset to be effective at lowering your risk of progression.

How is Veklury administered?

Veklury is given as an intravenous infusion once a day for three days. The dose should be adjusted for children.

What are the limitations of use for Veklury?

Veklury is not for children weighing less than 3.5 kg or 7.7 lb. Veklury should be stopped if a liver enzyme called ALT rises to 10 times above the normal limit or if your ALT level elevation is accompanied by signs of liver inflammation. Veklury is not recommended in patients with severe kidney disease or an eGFR of less than 30 mL/min. This also applies to full-term neonates with a serum creatinine of 1 mg/dL or greater. Unlike some COVID-19 therapies, the chances of drug interactions with Veklury are really very low.

Veklury is one of several COVID-19 therapeutic options. I urge you to watch the other videos in this outpatient series. Also visit us online at https://aspr.hhs.gov/COVID-19 and please see the resources linked in the description to learn more. You can also connect with ASPR on social media platforms to stay up to date on our latest posts and information. And if you have any questions, I urge you to email us at COVID19therapeutics@hhs.gov.

Thank you for your time.

In this video Michael Anderson, MD, MBA, senior advisor at ASPR, describes the use and administration of Veklury® (remdesivir), an antiviral IV drug for the treatment of certain adults and pediatric patients who have a positive SARS‑CoV‑2 test.

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