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Lagevrio (molnupiravir)

Important Information About Lagevrio

Lagevrio (molnupiravir) is an oral antiviral drug that should be initiated as soon as possible after diagnosis of COVID-19 and within 5 days of symptom onset. Lagevrio has been authorized for adults aged 18 years and older with a current diagnosis of mild to moderate COVID-19 who are at high risk for progressing to severe COVID-19 including hospitalization or death, and for whom alternative COVID-19 treatment options authorized by FDA are not accessible or clinically appropriate.

Lagevrio is available for patients by prescription only. Prescriptions can be obtained from your health care provider or through the Test to Treat program.

Emergency Use Authorization of Lagevrio

On December 23, 2021, the U.S. Food and Drug Administration granted Emergency Use Authorization (EUA) for the COVID-19 oral antiviral therapeutic Lagevrio. Lagevrio is authorized for the treatment of mild to moderate COVID-19 in adults ages 18 years and older, who are at high risk for progressing to severe COVID-19 and for whom alternative COVID-19 treatment options are not accessible or clinically appropriate.

Lagevrio is not authorized for the pre-exposure or post-exposure prevention of COVID-19 or for initiation of treatment in those requiring hospitalization due to severe or critical COVID-19. Lagevrio is not a substitute for vaccination in individuals for whom COVID-19 vaccination and a booster dose are recommended.

Distribution of Lagevrio

The Administration for Strategic Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS) oversees the fair and equitable allocation of Lagevrio to state and territorial health departments, Test to Treat sites, and select Health Resources and Services Administration (HRSA)-funded health centers. This medication is provided for free by the USG.

State and territorial health departments, pharmacy partners, and other central partners distribute product to dispensing sites across the nation, and the distributor will ship product directly to sites, which include pharmacies, doctors’ offices, clinics, hospitals, urgent care centers, and local health departments.

Lagevrio FDA EUA Resources

Lagevrio

 

Lagevrio (molnupiravir)

Hello, I’m Dr. Colin Shepard. I serve as the CDC Liaison to the HHS Assistant Secretary for Preparedness and Response, also called ASPR. I want to talk about one of the therapeutics that can help people with COVID-19—Lagevrio, also known as molnupiravir.

What is Lagevrio?

Lagevrio is an oral antiviral used to help fight the coronavirus infection by stopping the coronavirus 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 Lagevrio?

Lagevrio is for adults 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 high risk, please see the resources provided in the description. Lagevrio is for people who have a positive COVID-19 rapid or PCR test with mild to moderate symptoms and who are not in the hospital. It should be administered as early as possible but needs to be given within 5 days of symptom onset.

How is Lagevrio administered?

Lagevrio requires a prescription. It is available through a pharmacy or health care clinic, including Test to Treat locations where these antivirals are being distributed for use at home. Patients will take pills twice a day for 5 days.

What are the limitations of use for Lagevrio?

Lagevrio is not for everyone. The medication is not for anyone under the age of 18 or pregnant women. It is not appropriate to start Lagevrio if you are already hospitalized for COVID-19. There are no known drug interactions with Lagevrio.

Lagevrio is one of several COVID-19 therapeutic options. Watch the other Outpatient COVID-19 Therapeutics Videos in this series for more information. Visit us online at https://aspr.hhs.gov/COVID-19 and please see the resources linked in the description to learn more. You can connect with ASPR on social media platforms to stay up to date on our latest posts and information that we share. Please email any questions to COVID19therapeutics@hhs.gov.

Thank you for your time.

Watch this video, featuring Colin Shepard, MD, CDC liaison to ASPR, as he discusses Lagevrio (molnupiravir), an oral antiviral authorized for the treatment of mild to moderate COVID‑19 for certain adults whom alternative COVID‑19 treatment options are not clinically appropriate.

Lagevrio Frequently Asked Questions

Download Lagevrio Information Sheet 138KB PDF

Authorization

Eligibility

Testing and Prescriptions

Patient Information