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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 the U.S. Food and Drug Administration (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.

Lagevrio is not a substitute for vaccination in individuals for whom COVID-19 vaccination and a booster dose are recommended.

Emergency Use Authorization of Lagevrio

On December 23, 2021, FDA granted Lagevrio Emergency Use Authorization (EUA)

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 jurisdiction health departments, Test to Treat sites, long-term care providers, and some health centers funded by the Health Resources and Services Administration. This medication is provided for free by the U.S. government.

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

Lagevrio FDA EUA Resources



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 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

Thank you for your time.

Watch this video, featuring Colin Shepard, M.D., Centers for Disease Control and Prevention (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



Per the current CDC’s Interim Clinical Considerations for COVID-19 Treatment in Outpatients guidelines, risk factors include:

For additional information, please see the National Institutes of Health’s COVID-19 Treatment Guidelines: Clinical Spectrum of SARS-CoV-2 Infection.

Health care providers should proactively counsel high-risk patients about the availability of effective therapeutics and discuss a COVID-19 Action Plan with their patients.

Antiviral treatment of outpatients at risk for severe COVID-19 may reduce the risk of hospitalization and death.

In clinical trials done prior to authorization, Lagevrio was associated with an adjusted relative risk reduction of 30% in all-cause hospitalization or death through Day 29.1

Observational data, including from Israel2 and Hong Kong3 is consistent with benefit in high-risk patients:

  • 46% risk reduction in hospitalizations and death compared to the untreated for patients 75 and older2
  • 49% risk reduction in death compared to non-users3


  1. Angélica Jayk Bernal, et al. N Engl J Med 2022; 386:509-520
  2. Ronza Najjar-Debbiny, et al. Clinical Infectious Diseases, 2022; ciac781,
  3. Carlos K.H. Wong, et al. Lancet Infectious Disease,2022; doi:

Yes, health care providers and patients must be aware of the following warnings and precautions:

  • Lagevrio is not recommended for use during pregnancy because of risk it may cause fetal harm. Prior to initiating treatment with Lagevrio, health care providers should assess whether an individual of childbearing potential is pregnant, if clinically indicated.
  • Individuals with reproductive potential are advised to use a reliable method of contraception correctly and consistently, as applicable, for the duration of treatment and for appropriate time after the last dose per section 8.3 in the Fact Sheet for Healthcare Providers.
  • Breastfeeding is not recommended during treatment with Lagevrio and for 4 days after final dose.
  • Hypersensitivity reactions, including anaphylaxis, have been reported with Lagevrio. Please refer to the Lagevrio fact sheet for health care providers for additional information on warnings and precautions.
  • Paxlovid (oral antiviral) is a preferred oral antiviral authorized for the treatment of mild to moderate COVID-19 illness.
  • Veklury (remdesivir) is a preferred treatment with approval for mild to moderate COVID-19. Veklury is given intravenously, once a day for 3 consecutive days.

Testing and Prescriptions

An individual’s health care provider is the best first option for assessment and for prescribing patients who have symptoms consistent with mild to moderate COVID-19.

For individuals who do not have timely access to their own health care provider, there are more than 2,700 Test to Treat sites where patients can get tested, assessed for COVID-19 therapeutic eligibility, and have their prescription filled. Telehealth options are also widely available. A Test to Treat call center is also available at 1-800-232-0233 (TTY 1-888-720-7489) to get help in English, Spanish, and more than 150 other languages. The Disability Information and Access Line (DIAL) is also available to specifically help people with disabilities access services. To get help, call 1-888-677-1199, Monday through Friday from 9 AM to 8 PM ET or email

To fill a prescription, there are more than 40,000 locations nationwide available to provide oral antivirals, including Lagevrio.

Patient Information